https://recallregister.com/New FDA enforcement events for food, drugs and devices.enWed, 23 Sep 2026 12:00:00 GMThttps://recallregister.com/fda/ii/99058/recallregister:fda:device/99058Wed, 23 Sep 2026 12:00:00 GMTFDA event 99058, device. Class II. FDA report date: 23 Sep 2026. Recalling firm: ICU Medical, Inc. Reason for recall, in the words of FDA: "Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber wall. The presence of discoloration and particulate matter in the fluid path has not been ruled out."https://recallregister.com/month/2026-09/#fda-99298recallregister:fda:device/99298Wed, 23 Sep 2026 12:00:00 GMTFDA event 99298, device. Class I. FDA report date: 23 Sep 2026. Reason for recall, in the words of FDA: "Due to discrepancies in specific attributes in the performance data for infusion sets, which may lead to inappropriate pump performance."https://recallregister.com/fda/ii/99356/recallregister:fda:device/99356Wed, 23 Sep 2026 12:00:00 GMTFDA event 99356, device. Class II. FDA report date: 23 Sep 2026. Recalling firm: Nuclein LLC. Reason for recall, in the words of FDA: "Due to a software issue"https://recallregister.com/fda/ii/99452/recallregister:fda:device/99452Wed, 23 Sep 2026 12:00:00 GMTFDA event 99452, device. Class II. FDA report date: 23 Sep 2026. Recalling firm: Wilson-Cook Medical Inc. Reason for recall, in the words of FDA: "Due to issue with endoscope adherence and inability to spray powder. Firm will provide an updated Instruction for Use (IFU)."https://recallregister.com/fda/ii/99512/recallregister:fda:device/99512Wed, 23 Sep 2026 12:00:00 GMTFDA event 99512, device. Class II. FDA report date: 23 Sep 2026. Recalling firm: restor3d Inc. Reason for recall, in the words of FDA: "Ankle implantation systems were packaged with incorrect patient-specific cutting guides, which may result in: delayed surgery, the need to use standard instrumentation, reduced fixation or poor alignment of implants, implant loosening/migration, or need for revision surgery."https://recallregister.com/month/2026-09/#fda-99515recallregister:fda:device/99515Wed, 23 Sep 2026 12:00:00 GMTFDA event 99515, device. Class II. FDA report date: 23 Sep 2026. Recalling firm: F & A Foundation. Reason for recall, in the words of FDA: "Bone fixation staple requires a new 510(k); the performance characteristics of this device have not been adequately established."https://recallregister.com/fda/i/99534/recallregister:fda:device/99534Wed, 23 Sep 2026 12:00:00 GMTFDA event 99534, device. Class I. FDA report date: 23 Sep 2026. Recalling firm: Bard Access Systems, Inc. Reason for recall, in the words of FDA: "this is a downstream recall of class I recall RES 98777"https://recallregister.com/fda/i/99546/recallregister:fda:device/99546Wed, 23 Sep 2026 12:00:00 GMTFDA event 99546, device. Class I. FDA report date: 23 Sep 2026. Recalling firm: Nova Biomedical Corporation. Reason for recall, in the words of FDA: "A software synchronization/timing issue in the barcode scanning and patient data processing component that causes the device to intermittently retain a previously scanned barcode including patient identification (ID) barcodes and quality control (QC) solution ID barcodes when a new barcode is scanned, resulting in the prior barcode information remaining displayed on the screen for the current…"https://recallregister.com/fda/ii/99558/recallregister:fda:device/99558Wed, 23 Sep 2026 12:00:00 GMTFDA event 99558, device. Class II. FDA report date: 23 Sep 2026. Recalling firm: Howmedica Osteonics Corp. Reason for recall, in the words of FDA: "Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to hazards such as excessive wear debris, material fragments, fractured device, or disassociated device. Potential harms include revision surgery, pain, and…"https://recallregister.com/fda/ii/99566/recallregister:fda:device/99566Wed, 23 Sep 2026 12:00:00 GMTFDA event 99566, device. Class II. FDA report date: 23 Sep 2026. Recalling firm: Philips North America. Reason for recall, in the words of FDA: "Due to software malfunction, patient information system may freeze and become unresponsive."https://recallregister.com/fda/ii/99583/recallregister:fda:device/99583Wed, 23 Sep 2026 12:00:00 GMTFDA event 99583, device. Class II. FDA report date: 23 Sep 2026. Recalling firm: Medline Industries, LP. Reason for recall, in the words of FDA: "The kits contain a Retrograde Coronary Sinus Perfusion (RCSP) cannulae that has the potential for a sterile barrier breach. Sterility of the product cannot be assured. If a compromised pouch seal is not identified prior to use and the cannula is used, there is a potential risk of infection or other complications associated with the use of a non-sterile device, including hemolysis, foreign body…"https://recallregister.com/fda/ii/99593/recallregister:fda:device/99593Wed, 23 Sep 2026 12:00:00 GMTFDA event 99593, device. Class II. FDA report date: 23 Sep 2026. Reason for recall, in the words of FDA: "Retrospectively reported: Pen needles labeled 'For Investigational Use Only' were inadvertently distributed as commercially marketed devices."https://recallregister.com/fda/ii/99608/recallregister:fda:device/99608Wed, 23 Sep 2026 12:00:00 GMTFDA event 99608, device. Class II. FDA report date: 23 Sep 2026. Recalling firm: Happiest Baby, Inc. Reason for recall, in the words of FDA: "Extra small (ES) and Extra-large (XL) infant sleep sacks have not been reviewed for safety and effectiveness by the FDA."https://recallregister.com/fda/ii/99621/recallregister:fda:device/99621Wed, 23 Sep 2026 12:00:00 GMTFDA event 99621, device. Class II. FDA report date: 23 Sep 2026. Recalling firm: NOXBOX LTD. Reason for recall, in the words of FDA: "Potential for oxygen tubing leaks due to failure of the tubing or tubing connection, which may lead to oxygen desaturation."https://recallregister.com/fda/ii/99628/recallregister:fda:device/99628Wed, 23 Sep 2026 12:00:00 GMTFDA event 99628, device. Class II. FDA report date: 23 Sep 2026. Recalling firm: Medical Action Industries, Inc. 306. Reason for recall, in the words of FDA: "Blood culture convenience kits contain a component subject to a drug recall that due to an an open or incomplete seal on the packaging of the applicator may compromise the component's sterile barrier and if used may lead to localized skin or soft tissue infection."https://recallregister.com/fda/ii/99630/recallregister:fda:device/99630Wed, 23 Sep 2026 12:00:00 GMTFDA event 99630, device. Class II. FDA report date: 23 Sep 2026. Recalling firm: Boston Scientific Corporation. Reason for recall, in the words of FDA: "A subset of power adapters used with the connect console may exhibit higher-than-expected resistance in the electrical grounding path. As a result, the power adaptor may fail electrical safety testing during installation."https://recallregister.com/fda/ii/99634/recallregister:fda:device/99634Wed, 23 Sep 2026 12:00:00 GMTFDA event 99634, device. Class II. FDA report date: 23 Sep 2026. Recalling firm: Stryker Sustainability Solutions. Reason for recall, in the words of FDA: "Reusable access port system may crack or seperate during use."https://recallregister.com/fda/ii/99637/recallregister:fda:device/99637Wed, 23 Sep 2026 12:00:00 GMTFDA event 99637, device. Class II. FDA report date: 23 Sep 2026. Recalling firm: GE Medical Systems Information Technologies Inc. Reason for recall, in the words of FDA: "Device may not resume patient monitoring for at least 3 minutes following system restart. Issue can lead to potential delay in recognition of clinically significant events."https://recallregister.com/fda/ii/99648/recallregister:fda:device/99648Wed, 23 Sep 2026 12:00:00 GMTFDA event 99648, device. Class II. FDA report date: 23 Sep 2026. Recalling firm: ICU Medical, Inc. Reason for recall, in the words of FDA: "Reservoirs may exhibit medication leakage at the joint between luer connector and tubing. Issue could result in delay or interruption of therapy, under delivery of medication, exposure to infectious or toxic agents, or air embolus."https://recallregister.com/fda/ii/99649/recallregister:fda:device/99649Wed, 23 Sep 2026 12:00:00 GMTFDA event 99649, device. Class II. FDA report date: 23 Sep 2026. Recalling firm: Datex-Ohmeda, Inc. Reason for recall, in the words of FDA: "Anesthesia Delivery Systems containing certain electronic gas mixer assemblies can automatically transition to Alternate O2 control. In Alternate O2 control, the system delivers 100% O2 to the breathing system enabling continued controlled or manual ventilation and initiates audible and visual alarms. When this issue occurs, anesthetic agent delivery will be interrupted and requires clinician…"https://recallregister.com/fda/ii/99661/recallregister:fda:device/99661Wed, 23 Sep 2026 12:00:00 GMTFDA event 99661, device. Class II. FDA report date: 23 Sep 2026. Recalling firm: GE Healthcare. Reason for recall, in the words of FDA: "Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be displayed under the wrong patient record, which could lead to misdiagnosis or a delay in patient care."https://recallregister.com/month/2026-09/#fda-99664recallregister:fda:device/99664Wed, 23 Sep 2026 12:00:00 GMTFDA event 99664, device. Class II. FDA report date: 23 Sep 2026. Recalling firm: PI CARDIA LTD. Reason for recall, in the words of FDA: "Transfemoral catheter, positing arm may detached due to weld issue."https://recallregister.com/fda/ii/99667/recallregister:fda:device/99667Wed, 23 Sep 2026 12:00:00 GMTFDA event 99667, device. Class II. FDA report date: 23 Sep 2026. Recalling firm: Medline Industries, LP. Reason for recall, in the words of FDA: "Kits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterility. If not detected prior to use, issue may lead to contamination of sterile field or patient infection if product is used."https://recallregister.com/fda/ii/99668/recallregister:fda:device/99668Wed, 23 Sep 2026 12:00:00 GMTFDA event 99668, device. Class II. FDA report date: 23 Sep 2026. Recalling firm: Maquet Cardiopulmonary Gmbh. Reason for recall, in the words of FDA: "The packaging may not consistently maintain sterile barrier integrity."https://recallregister.com/fda/i/99669/recallregister:fda:device/99669Wed, 23 Sep 2026 12:00:00 GMTFDA event 99669, device. Class I. FDA report date: 23 Sep 2026. Recalling firm: Medline Industries, LP. Reason for recall, in the words of FDA: "The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergillus penicillioides. Contamination of skin preparation products with Aspergillus penicillioides may lead to serious adverse health consequences, including systemic infection, sepsis, illness, and death."https://recallregister.com/fda/i/99671/recallregister:fda:device/99671Wed, 23 Sep 2026 12:00:00 GMTFDA event 99671, device. Class I. FDA report date: 23 Sep 2026. Recalling firm: Abiomed, Inc. Reason for recall, in the words of FDA: "The potential for purge cassette recognition issues due to the failure of the purge flag component of the purge pressure sensor assembly."https://recallregister.com/fda/i/99672/recallregister:fda:device/99672Wed, 23 Sep 2026 12:00:00 GMTFDA event 99672, device. Class I. FDA report date: 23 Sep 2026. Recalling firm: AVID Medical, Inc. Reason for recall, in the words of FDA: "Convenience kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which are contaminated with Aspergillus penicillioides"https://recallregister.com/fda/ii/99677/recallregister:fda:device/99677Wed, 23 Sep 2026 12:00:00 GMTFDA event 99677, device. Class II. FDA report date: 23 Sep 2026. Recalling firm: Mirion Technologies (Capintec), Inc. Reason for recall, in the words of FDA: "Potential for failure of the tension bolt which would allow the spring arm to unexpectedly fall to its lowest position, which is approximately 25 inches (63.5 cm) from the ground."https://recallregister.com/month/2026-09/#fda-99685recallregister:fda:device/99685Wed, 23 Sep 2026 12:00:00 GMTFDA event 99685, device. Class II. FDA report date: 23 Sep 2026. Recalling firm: WELL LEAD MEDICAL CO. LTD. Reason for recall, in the words of FDA: "The 6Fr suction catheter could not pass through the samples smoothly."https://recallregister.com/fda/ii/99698/recallregister:fda:device/99698Wed, 23 Sep 2026 12:00:00 GMTFDA event 99698, device. Class II. FDA report date: 23 Sep 2026. Recalling firm: Bayer Medical Care, Inc. Reason for recall, in the words of FDA: "Some devices may not have been properly sterilized due to a manufacturing sterilization issue."https://recallregister.com/fda/ii/99707/recallregister:fda:device/99707Wed, 23 Sep 2026 12:00:00 GMTFDA event 99707, device. Class II. FDA report date: 23 Sep 2026. Recalling firm: Straumann USA LLC. Reason for recall, in the words of FDA: "There is a discrepancy between the product identification on the packaging and the dimensions of the implant contained inside."https://recallregister.com/month/2026-09/#fda-99720recallregister:fda:device/99720Wed, 23 Sep 2026 12:00:00 GMTFDA event 99720, device. Class II. FDA report date: 23 Sep 2026. Reason for recall, in the words of FDA: "When a bolus is included in a treatment plan and sent for secondary dose calculation, the software accounts for it but does not display this clearly, which may lead users to incorrectly omit the bolus during treatment and deliver the prescribed dose to the wrong tissue depth."https://recallregister.com/fda/i/99758/recallregister:fda:device/99758Wed, 23 Sep 2026 12:00:00 GMTFDA event 99758, device. Class I. FDA report date: 23 Sep 2026. Recalling firm: AVID Medical, Inc. Reason for recall, in the words of FDA: "Potential for product quality and sterility issues regarding kits containing Sodium Chloride ampules subject to recall by Spectra Medical."https://recallregister.com/fda/ii/99654/recallregister:fda:drug/99654Wed, 23 Sep 2026 12:00:00 GMTFDA event 99654, drug. Class II. FDA report date: 23 Sep 2026. Recalling firm: Safecor Health, LLC. Reason for recall, in the words of FDA: "Failed Stability Specifications"https://recallregister.com/month/2026-09/#fda-99709recallregister:fda:drug/99709Wed, 23 Sep 2026 12:00:00 GMTFDA event 99709, drug. Class I. FDA report date: 23 Sep 2026. Recalling firm: VITRUVIAS THERAPEUTICS INC. Reason for recall, in the words of FDA: "Superpotent Drug"https://recallregister.com/month/2026-09/#fda-99794recallregister:fda:drug/99794Wed, 23 Sep 2026 12:00:00 GMTFDA event 99794, drug. Class II. FDA report date: 23 Sep 2026. Recalling firm: SUN PHARMA /TARO. Reason for recall, in the words of FDA: "Failed Content Uniformity Specifications. Out of Specification for Assay during analysis at the 24- month long term stability station, at (25°C,60%RH)."https://recallregister.com/month/2026-09/#fda-99806recallregister:fda:drug/99806Wed, 23 Sep 2026 12:00:00 GMTFDA event 99806, drug. Class II. FDA report date: 23 Sep 2026. Recalling firm: Inventia Healthcare Limited. Reason for recall, in the words of FDA: "Failed Dissolution Specifications"https://recallregister.com/fda/ii/99824/recallregister:fda:drug/99824Wed, 23 Sep 2026 12:00:00 GMTFDA event 99824, drug. Class II. FDA report date: 23 Sep 2026. Recalling firm: Pfizer. Reason for recall, in the words of FDA: "Lack of Assurance of Sterility"https://recallregister.com/fda/unclassified/99876/recallregister:fda:drug/99876Wed, 23 Sep 2026 12:00:00 GMTFDA event 99876, drug. Not yet classified. FDA report date: 23 Sep 2026. Recalling firm: SUN PHARMACEUTICAL INDUSTRIES INC. Reason for recall, in the words of FDA: "Failed Stability Specifications"https://recallregister.com/fda/ii/99572/recallregister:fda:food/99572Wed, 23 Sep 2026 12:00:00 GMTFDA event 99572, food. Class II. FDA report date: 23 Sep 2026. Recalling firm: Elegant Foods, LLC. Reason for recall, in the words of FDA: "Undeclared sulfites"https://recallregister.com/fda/i/99594/recallregister:fda:food/99594Wed, 23 Sep 2026 12:00:00 GMTFDA event 99594, food. Class I. FDA report date: 23 Sep 2026. Recalling firm: NatureBest Pre-Cut & Produce LLc. Reason for recall, in the words of FDA: "Jalapenos have the potential to be contaminated with Salmonella"https://recallregister.com/fda/i/99611/recallregister:fda:food/99611Wed, 23 Sep 2026 12:00:00 GMTFDA event 99611, food. Class I. FDA report date: 23 Sep 2026. Recalling firm: Taylor Fresh Foods Inc. Reason for recall, in the words of FDA: "Potential contamination with Salmonella."https://recallregister.com/fda/i/99737/recallregister:fda:food/99737Wed, 23 Sep 2026 12:00:00 GMTFDA event 99737, food. Class I. FDA report date: 23 Sep 2026. Recalling firm: Everything Sprouts, LLC. Reason for recall, in the words of FDA: "Sprouts may be contaminated with STEC E. coli and/or Salmonella."https://recallregister.com/month/2026-09/#fda-99744recallregister:fda:food/99744Wed, 23 Sep 2026 12:00:00 GMTFDA event 99744, food. Class II. FDA report date: 23 Sep 2026. Recalling firm: Buckhead Meat Company D.B.A. Trinity Seafood. Reason for recall, in the words of FDA: "The Firm was notified by NJ Department of Health of two samples collected from tuna with reported high levels of scombrotoxin."https://recallregister.com/month/2026-09/#fda-99755recallregister:fda:food/99755Wed, 23 Sep 2026 12:00:00 GMTFDA event 99755, food. Class II. FDA report date: 23 Sep 2026. Recalling firm: Quality Dairy Farms Inc. Reason for recall, in the words of FDA: "Undeclared peanuts"https://recallregister.com/month/2026-09/#fda-99780recallregister:fda:food/99780Wed, 23 Sep 2026 12:00:00 GMTFDA event 99780, food. Class II. FDA report date: 23 Sep 2026. Recalling firm: Panorama Produce Sales Inc. Reason for recall, in the words of FDA: "Product may be contaminated with Salmonella"https://recallregister.com/month/2026-09/#fda-99803recallregister:fda:food/99803Wed, 23 Sep 2026 12:00:00 GMTFDA event 99803, food. Class II. FDA report date: 23 Sep 2026. Recalling firm: Best Friends Bakery, LLC. Reason for recall, in the words of FDA: "Peanuts & Eggs. The firm list peanuts in the ingredient statement but omitted them from the contain statement. They also have eggs listed in the contain statement but there are no eggs in the product."https://recallregister.com/fda/iii/99815/recallregister:fda:food/99815Wed, 23 Sep 2026 12:00:00 GMTFDA event 99815, food. Class III. FDA report date: 23 Sep 2026. Recalling firm: Tiffany Food Corp. Reason for recall, in the words of FDA: "Unapproved dye Ponceau 4R"https://recallregister.com/month/2026-09/#fda-99830recallregister:fda:food/99830Wed, 23 Sep 2026 12:00:00 GMTFDA event 99830, food. Class I. FDA report date: 23 Sep 2026. Recalling firm: FOODS ALIVE INC. Reason for recall, in the words of FDA: "Potential Salmonella contamination"https://recallregister.com/month/2026-09/#fda-99831recallregister:fda:food/99831Wed, 23 Sep 2026 12:00:00 GMTFDA event 99831, food. Class I. FDA report date: 23 Sep 2026. Recalling firm: Frutas y Hortalizas del Sur S.A. Reason for recall, in the words of FDA: "Potential E. coli O145:H28 Contamination"https://recallregister.com/month/2026-09/#fda-99841recallregister:fda:food/99841Wed, 23 Sep 2026 12:00:00 GMTFDA event 99841, food. Class I. FDA report date: 23 Sep 2026. Recalling firm: Optimus Inc. d/b/a/ Markys Caviar. Reason for recall, in the words of FDA: "The firm was notified by their Brie Cheese supplier that sample results revealed the presence of Listeria monocytogenes."https://recallregister.com/fda/unclassified/99869/recallregister:fda:food/99869Wed, 23 Sep 2026 12:00:00 GMTFDA event 99869, food. Not yet classified. FDA report date: 23 Sep 2026. Recalling firm: KRAFT HEINZ FOODS COMPANY. Reason for recall, in the words of FDA: "undeclared ingredients including but not limited to mustard"https://recallregister.com/fda/ii/98840/recallregister:fda:device/98840Wed, 16 Sep 2026 12:00:00 GMTFDA event 98840, device. Class II. FDA report date: 16 Sep 2026. Recalling firm: C.R. Bard Inc. Reason for recall, in the words of FDA: "Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays."https://recallregister.com/fda/ii/99525/recallregister:fda:device/99525Wed, 16 Sep 2026 12:00:00 GMTFDA event 99525, device. Class II. FDA report date: 16 Sep 2026. Recalling firm: AVID Medical, Inc. Reason for recall, in the words of FDA: "Convenience kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which lacks sterility assurance due to to wrinkles in the paper lidding which may breach the seal area."https://recallregister.com/fda/ii/99568/recallregister:fda:device/99568Wed, 16 Sep 2026 12:00:00 GMTFDA event 99568, device. Class II. FDA report date: 16 Sep 2026. Recalling firm: HeartSine Technologies Ltd. Reason for recall, in the words of FDA: "Due to a damaged (over stretched) membrane tail that causes an intermittent fault."https://recallregister.com/fda/ii/99573/recallregister:fda:device/99573Wed, 16 Sep 2026 12:00:00 GMTFDA event 99573, device. Class II. FDA report date: 16 Sep 2026. Recalling firm: Nipro Renal Soultions USA, Corporation. Reason for recall, in the words of FDA: "Hemodialysis concentrates contain high endotoxin levels"https://recallregister.com/fda/ii/99601/recallregister:fda:device/99601Wed, 16 Sep 2026 12:00:00 GMTFDA event 99601, device. Class II. FDA report date: 16 Sep 2026. Recalling firm: Lutronic Corporation. Reason for recall, in the words of FDA: "Utilizing higher fluences at 1064nm wavelength with current cryogen parameters may result in a spark/loud noise during treatment, potentially resulting in patient burn."https://recallregister.com/fda/i/99613/recallregister:fda:device/99613Wed, 16 Sep 2026 12:00:00 GMTFDA event 99613, device. Class I. FDA report date: 16 Sep 2026. Recalling firm: Medical Action Industries, Inc. 306. Reason for recall, in the words of FDA: "Kits containing Sodium Chloride ampules subject to another recall are recalled due to potentially compromised sterility."https://recallregister.com/fda/i/99626/recallregister:fda:device/99626Wed, 16 Sep 2026 12:00:00 GMTFDA event 99626, device. Class I. FDA report date: 16 Sep 2026. Recalling firm: Given Imaging Ltd. Reason for recall, in the words of FDA: "Capsule may fail to attach to the esophagus or detach from the delivery device. Risks include patient aspiration/inhalation, perforation of esophagus, obstruction of the airway, hemorrhage/blood loss/bleeding, laceration of the esophagus, a delay in diagnosis, and foreign bodies remaining in the patient."https://recallregister.com/fda/ii/99658/recallregister:fda:device/99658Wed, 16 Sep 2026 12:00:00 GMTFDA event 99658, device. Class II. FDA report date: 16 Sep 2026. Recalling firm: Windstone Medical Packaging, Inc. Reason for recall, in the words of FDA: "The convenience kits contain .0.9% Sodium Chloride Injection, USP products in Single Dose freeflex bags, which may contain blue Break-off-Parts (BOPs) that have detached from the infusion port during manipulation."https://recallregister.com/fda/ii/99680/recallregister:fda:device/99680Wed, 16 Sep 2026 12:00:00 GMTFDA event 99680, device. Class II. FDA report date: 16 Sep 2026. Recalling firm: Atrium Medical Corporation. Reason for recall, in the words of FDA: "An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters."https://recallregister.com/fda/i/99670/recallregister:fda:drug/99670Wed, 16 Sep 2026 12:00:00 GMTFDA event 99670, drug. Class I. FDA report date: 16 Sep 2026. Recalling firm: American Regent, Inc. Reason for recall, in the words of FDA: "Presence of Particulate Matter and Lack of Assurance of Sterility. Particulate matter identified as nylon, cellulosic, acrylic, polyethylene and glass and broken and leaking vials."https://recallregister.com/fda/i/99679/recallregister:fda:drug/99679Wed, 16 Sep 2026 12:00:00 GMTFDA event 99679, drug. Class I. FDA report date: 16 Sep 2026. Recalling firm: Baxter Healthcare Corporation. Reason for recall, in the words of FDA: "Presence of Particulate Matter: particulate matter identified as stainless steel particles in the solution."https://recallregister.com/fda/i/99703/recallregister:fda:drug/99703Wed, 16 Sep 2026 12:00:00 GMTFDA event 99703, drug. Class I. FDA report date: 16 Sep 2026. Recalling firm: B BRAUN MEDICAL INC. Reason for recall, in the words of FDA: "Presence of Particulate Matter: particulate matter identified as iron oxide, inorganic material, cellulose cotton fiber or polystyrene"https://recallregister.com/fda/iii/99733/recallregister:fda:drug/99733Wed, 16 Sep 2026 12:00:00 GMTFDA event 99733, drug. Class III. FDA report date: 16 Sep 2026. Recalling firm: Ajanta Pharma USA Inc. Reason for recall, in the words of FDA: "Failed impurities/degradation specifications: (OOS) for Organic Impurities by HPLC (Impurity-A) during testing at the 18 months long term stability. Result: 1.1 percent. Spec: 1.0 percent."https://recallregister.com/month/2026-09/#fda-99756recallregister:fda:drug/99756Wed, 16 Sep 2026 12:00:00 GMTFDA event 99756, drug. Class III. FDA report date: 16 Sep 2026. Recalling firm: ImprimisRx NJ LLC. Reason for recall, in the words of FDA: "Subpotent Drug"https://recallregister.com/fda/ii/99837/recallregister:fda:drug/99837Wed, 16 Sep 2026 12:00:00 GMTFDA event 99837, drug. Class II. FDA report date: 16 Sep 2026. Recalling firm: OurPharma LLC. Reason for recall, in the words of FDA: "Labeling: Not Elsewhere Classified: Complaint received on 08/31/2026 regarding the discrepancy of the IV bag expiry (07/31/2026 and 11/30/2026) and the product expiry (12/09/2026)."https://recallregister.com/month/2026-09/#fda-99636recallregister:fda:food/99636Wed, 16 Sep 2026 12:00:00 GMTFDA event 99636, food. Class I. FDA report date: 16 Sep 2026. Recalling firm: EXOTIQUE FOODS CANADA. Reason for recall, in the words of FDA: "Undeclared Wheat."https://recallregister.com/month/2026-09/#fda-99675recallregister:fda:food/99675Wed, 16 Sep 2026 12:00:00 GMTFDA event 99675, food. Class II. FDA report date: 16 Sep 2026. Recalling firm: L-Nutra Inc. Reason for recall, in the words of FDA: "Undeclared allergen (tree nuts): hazelnut, cashew, and pistachio."https://recallregister.com/month/2026-09/#fda-99682recallregister:fda:food/99682Wed, 16 Sep 2026 12:00:00 GMTFDA event 99682, food. Class II. FDA report date: 16 Sep 2026. Recalling firm: Ferrero USA. Reason for recall, in the words of FDA: "Undeclared milk and pecans"https://recallregister.com/month/2026-09/#fda-99684recallregister:fda:food/99684Wed, 16 Sep 2026 12:00:00 GMTFDA event 99684, food. Class I. FDA report date: 16 Sep 2026. Recalling firm: EURO FOODS GROUP USA NJ INC. Reason for recall, in the words of FDA: "The firm imported and distributed dried ribbon fish that was not properly eviscerated prior to drying."https://recallregister.com/month/2026-09/#fda-99822recallregister:fda:food/99822Wed, 16 Sep 2026 12:00:00 GMTFDA event 99822, food. Class I. FDA report date: 16 Sep 2026. Recalling firm: International Sprout Holdings, Inc. Reason for recall, in the words of FDA: "Potential E. coli and Salmonella contamination"https://recallregister.com/fda/ii/99334/recallregister:fda:device/99334Wed, 09 Sep 2026 12:00:00 GMTFDA event 99334, device. Class II. FDA report date: 9 Sep 2026. Recalling firm: Medline Industries, LP. Reason for recall, in the words of FDA: "The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding which may extend to the seal area. If the sterile barrier is compromised, patients and users may be exposed to microbial contamination. Potential health consequences may include no injury, localized infection, or, less…"https://recallregister.com/fda/ii/99469/recallregister:fda:device/99469Wed, 09 Sep 2026 12:00:00 GMTFDA event 99469, device. Class II. FDA report date: 9 Sep 2026. Recalling firm: AVID Medical, Inc. Reason for recall, in the words of FDA: "The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed Neurological Sponges Non-Sterile Models 55992C to 55998C due to potential for unexpected variability of endotoxin levels on the products."https://recallregister.com/fda/ii/99496/recallregister:fda:device/99496Wed, 09 Sep 2026 12:00:00 GMTFDA event 99496, device. Class II. FDA report date: 9 Sep 2026. Recalling firm: Johnson & Johnson Surgical Vision, Inc. Reason for recall, in the words of FDA: "Surgical instructions sent for viscoelastic products used during ophthalmic viscosurgical cataract procedures including in part: If resistance is encountered during insertion, withdraw cannula and reassess the insertion conditions (i.e. insertion angle, incision size, etc.) before proceeding because forcing the cannula may cause corneal abrasion, iris trauma or descemet's membrane detachment."https://recallregister.com/fda/ii/99524/recallregister:fda:device/99524Wed, 09 Sep 2026 12:00:00 GMTFDA event 99524, device. Class II. FDA report date: 9 Sep 2026. Recalling firm: Boston Scientific Corporation. Reason for recall, in the words of FDA: "There is potential for a delay in AF Burden Alert notification affecting the server software which supports the Insertable Cardiac Monitors (ICMs). Delayed notification of an AF Burden Alert may delay clinical evaluation or therapeutic intervention of an atrial arrhythmia."https://recallregister.com/fda/ii/99531/recallregister:fda:device/99531Wed, 09 Sep 2026 12:00:00 GMTFDA event 99531, device. Class II. FDA report date: 9 Sep 2026. Recalling firm: Diagnostica Stago, Inc. Reason for recall, in the words of FDA: "A positive drift in QC values within the reagent's stated 4-hour onboard stability period was identified"https://recallregister.com/fda/ii/99543/recallregister:fda:device/99543Wed, 09 Sep 2026 12:00:00 GMTFDA event 99543, device. Class II. FDA report date: 9 Sep 2026. Recalling firm: Fresenius Medical Care Renal Therapies Group, LLC. Reason for recall, in the words of FDA: "Complaints of blue-green discoloration in product"https://recallregister.com/fda/ii/99550/recallregister:fda:device/99550Wed, 09 Sep 2026 12:00:00 GMTFDA event 99550, device. Class II. FDA report date: 9 Sep 2026. Recalling firm: B Braun Medical Inc. Reason for recall, in the words of FDA: "Specific lots of Discofix Stopcock Sets recalled due to an incorrect expiration date printed on the carton shipper label."https://recallregister.com/fda/ii/99553/recallregister:fda:device/99553Wed, 09 Sep 2026 12:00:00 GMTFDA event 99553, device. Class II. FDA report date: 9 Sep 2026. Recalling firm: Cardinal Health 200, LLC. Reason for recall, in the words of FDA: "The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing process. If a contaminated wipe is used on a patient, localized skin effects may occur. These may include irritation, erythema, or mild inflammation."https://recallregister.com/fda/ii/99556/recallregister:fda:device/99556Wed, 09 Sep 2026 12:00:00 GMTFDA event 99556, device. Class II. FDA report date: 9 Sep 2026. Recalling firm: Fresenius Medical Care Renal Therapies Group, LLC. Reason for recall, in the words of FDA: "Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line or pump segment. Leak during treatment may lead to blood loss and hypovolemia."https://recallregister.com/fda/ii/99557/recallregister:fda:device/99557Wed, 09 Sep 2026 12:00:00 GMTFDA event 99557, device. Class II. FDA report date: 9 Sep 2026. Recalling firm: Baxter Healthcare Corporation. Reason for recall, in the words of FDA: "A software issue that may occur during a Volume/Time (VOT) multi-syringe infusion when a syringe reaches empty and is replaced while a Volume To Be Infused (VTBI) remains."https://recallregister.com/fda/ii/99561/recallregister:fda:device/99561Wed, 09 Sep 2026 12:00:00 GMTFDA event 99561, device. Class II. FDA report date: 9 Sep 2026. Recalling firm: Medline Industries, LP. Reason for recall, in the words of FDA: "Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may have an open or incomplete seal on the applicator packaging. Use of potentially contaminated applicator may lead to localized skin or soft tissue infection, or systemic infection or infectious complications."https://recallregister.com/fda/ii/99784/recallregister:fda:device/99784Wed, 09 Sep 2026 12:00:00 GMTFDA event 99784, device. Class II. FDA report date: 9 Sep 2026. Recalling firm: Philips North America Llc. Reason for recall, in the words of FDA: "Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems that could affect the performance of the equipment."https://recallregister.com/fda/iii/99551/recallregister:fda:drug/99551Wed, 09 Sep 2026 12:00:00 GMTFDA event 99551, drug. Class III. FDA report date: 9 Sep 2026. Recalling firm: Bionpharma Inc. Reason for recall, in the words of FDA: "Presence of Foreign Tablets/Capsules"https://recallregister.com/fda/ii/99653/recallregister:fda:drug/99653Wed, 09 Sep 2026 12:00:00 GMTFDA event 99653, drug. Class II. FDA report date: 9 Sep 2026. Recalling firm: Mylan Pharmaceuticals Inc. Reason for recall, in the words of FDA: "Failed Dissolution Specifications; product failed to meet 18-month stability testing acceptance criteria"https://recallregister.com/month/2026-09/#fda-99657recallregister:fda:drug/99657Wed, 09 Sep 2026 12:00:00 GMTFDA event 99657, drug. Class II. FDA report date: 9 Sep 2026. Recalling firm: Sage Products, LLC. Reason for recall, in the words of FDA: "Cross Contamination with Other Products"https://recallregister.com/month/2026-09/#fda-99662recallregister:fda:drug/99662Wed, 09 Sep 2026 12:00:00 GMTFDA event 99662, drug. Class I. FDA report date: 9 Sep 2026. Recalling firm: OPTIMAL BALANCE PHARMACY. Reason for recall, in the words of FDA: "Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin."https://recallregister.com/fda/iii/99674/recallregister:fda:drug/99674Wed, 09 Sep 2026 12:00:00 GMTFDA event 99674, drug. Class III. FDA report date: 9 Sep 2026. Recalling firm: American Health Packaging. Reason for recall, in the words of FDA: "Labeling: Label Mix-up"https://recallregister.com/fda/i/99678/recallregister:fda:drug/99678Wed, 09 Sep 2026 12:00:00 GMTFDA event 99678, drug. Class I. FDA report date: 9 Sep 2026. Recalling firm: Baxter Healthcare Corporation. Reason for recall, in the words of FDA: "Presence of particulate matter: Particulates identified as fiberglass"https://recallregister.com/fda/iii/99705/recallregister:fda:drug/99705Wed, 09 Sep 2026 12:00:00 GMTFDA event 99705, drug. Class III. FDA report date: 9 Sep 2026. Recalling firm: Chiesi USA, Inc. Reason for recall, in the words of FDA: "Failed Stability Specifications: Out of specification stability result for the protein concentration profile."https://recallregister.com/fda/ii/99732/recallregister:fda:drug/99732Wed, 09 Sep 2026 12:00:00 GMTFDA event 99732, drug. Class II. FDA report date: 9 Sep 2026. Recalling firm: Golden State Medical Supply Inc. Reason for recall, in the words of FDA: "Failed Dissolution Specifications. Notification from the manufacturer that lot is being recalled due to failed dissolution"https://recallregister.com/fda/ii/99750/recallregister:fda:drug/99750Wed, 09 Sep 2026 12:00:00 GMTFDA event 99750, drug. Class II. FDA report date: 9 Sep 2026. Recalling firm: Mylan Pharmaceuticals Inc. Reason for recall, in the words of FDA: "Failed Dissolution Specifications"https://recallregister.com/fda/ii/99751/recallregister:fda:drug/99751Wed, 09 Sep 2026 12:00:00 GMTFDA event 99751, drug. Class II. FDA report date: 9 Sep 2026. Recalling firm: Lexia LLC. Reason for recall, in the words of FDA: "CGMP Deviations: Potential contamination of raw material"https://recallregister.com/month/2026-09/#fda-99368recallregister:fda:food/99368Wed, 09 Sep 2026 12:00:00 GMTFDA event 99368, food. Class I. FDA report date: 9 Sep 2026. Recalling firm: Fayus Inc. Reason for recall, in the words of FDA: "Undeclared milk."https://recallregister.com/fda/ii/99548/recallregister:fda:food/99548Wed, 09 Sep 2026 12:00:00 GMTFDA event 99548, food. Class II. FDA report date: 9 Sep 2026. Recalling firm: Ukrop's Homestyle Foods LLC. Reason for recall, in the words of FDA: "Foreign object: metal fragments"https://recallregister.com/fda/i/99587/recallregister:fda:food/99587Wed, 09 Sep 2026 12:00:00 GMTFDA event 99587, food. Class I. FDA report date: 9 Sep 2026. Recalling firm: Ron's Home Style Foods, Inc. Reason for recall, in the words of FDA: "Products were manufactured with jalapenos that have the potential to be contaminated with Salmonella"https://recallregister.com/month/2026-09/#fda-99615recallregister:fda:food/99615Wed, 09 Sep 2026 12:00:00 GMTFDA event 99615, food. Class I. FDA report date: 9 Sep 2026. Recalling firm: Marina Del Rey Foods inc. Reason for recall, in the words of FDA: "Product tested positive for undeclared milk."https://recallregister.com/month/2026-09/#fda-99644recallregister:fda:food/99644Wed, 09 Sep 2026 12:00:00 GMTFDA event 99644, food. Class I. FDA report date: 9 Sep 2026. Recalling firm: Savor Seasonings LLC. Reason for recall, in the words of FDA: "Product tested positive for undeclared milk allergen."https://recallregister.com/fda/ii/99646/recallregister:fda:food/99646Wed, 09 Sep 2026 12:00:00 GMTFDA event 99646, food. Class II. FDA report date: 9 Sep 2026. Recalling firm: Prince Bakery Inc. Reason for recall, in the words of FDA: "Sesame is not declared in the ingredient statement but is declared in the statement of identity."