Covidien, LLC: FDA recalls

FDA enforcement reports name Covidien, LLC as the recalling firm in 77 events. The events have 341 product records. The recalls started from 2012 to 2026. All the events are device recalls.

See the 77 events

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Enforcement events

77 events, newest first.

FDA enforcement events of Covidien, LLC
Initiated	Product (first record)	Type	Class	Records	Status
13 May 2026	EndoFLIP System that includes: ENDOFLIP 1 SYSTEM EF-100 05391530810050 10884521809307 REFURBISHED SYSTEM RFG-EF100 ENDOFLIP 1 10884521808096 05391530810166 DL ENDOFLIP 1 10884521786684 Endoscopic measuring system, including catheter components.	Device	Class II	1	Ongoing
23 Apr 2026	Covidien Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM REF: 90042	Device	Class II	3	Ongoing
23 Apr 2026	Covidien Shiley Disposable Decannulation Plug REF DDCP UDI-DI code: 10884522004060 Product Codes that include the Covidien Shiley Disposable Decannulation Plug are: Product Number / UDI-DI code 4DCFN 10884522006576 4DCFS 10884522006583 4DFEN 10884522006606 6DCFN 10884522006613 6DCFS 10884522006620 6DFEN…	Device	Class II	1	Ongoing
15 Apr 2026	COVIDIEN Shiley Tracheostomy Tube Cuffed with Inner Cannula REF 6FEN UDI-DI code: 60884522007028 The devices are intended for use in providing tracheal access for airway management. Shiley Tracheostomy Tubes are double cannula tracheostomy tubes with reusable inner cannulae (LPC, FEN, CFS, CFN, LGT) and twist-lock…	Device	Class II	1	Ongoing
30 Jan 2026	HealthCast "Vital Sync" Remote Patient Monitoring System which consists of: Product Number: VSLBASE03P / VITALSYNCSW03 Model / UDI-DI codes: Vital Sync 3.3.1 / 10884521844933 Vital Sync 3.4.0 / 10884521844940 Vital Sync 3.4.1 / 10884521847569 (OUS Only) Vital Sync 3.4.2 / 10884521856127 Product Number: VSLBASE04P /…	Device	Class II	1	Ongoing
25 Apr 2024	EsoFLIP, 30mm BALLOON DILATION CATHETER, REF ES-330, Rx Only	Device	Class II	1	Ongoing
2 Jun 2023	Covidien Cytosponge Cell Collection Device, REF: CYTO-201; and Covidien Cytosponge Cell Collection Kit, REF: CYTO-KIT-USM	Device	Class II	1	Ongoing
22 May 2023	Medtronic ILLUMISITE Platform Console, Model Number ILS-1000-CS	Device	Class II	1	Ongoing
23 Nov 2022	COVIDIEN Emprint Ablation Catheter with Thermosphere Technology, Bronchoscopic Ablation, REF CA108L1	Device	Class II	1	Ongoing
19 Aug 2022	Puritan Bennett 560 Ventilator, PB560, CFN 4096600	Device	Class II	1	Ongoing
8 Jun 2022	Palindrome Precision Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apheresis, and infusion.	Device	Class I	9	Ongoing
7 Jun 2022	TruClear Hysteroscopic Tissue Removal System Control Unit- designed to meet the requirements of intrauterine tissue removal. Model Number: 7209808	Device	Class II	1	Ongoing
17 Dec 2021	Chameleon PTA Balloon Dilation Catheter 8 mm x 40 mm, Chameleon PTA Balloon Catheter with Injection Port 8 mm x 40 mm; Cardiovascular. Product Numbers CH08-40-75GB and CH08-40-75US	Device	Class II	1	Ongoing
6 Dec 2021	LigaSure Blunt Tip Laparoscopic Sealer/Divider, Nano-Coated, Product Number LF1837	Device	Class II	1	Terminated
12 Nov 2021	Covidien Sonicision Battery Charger-intended to charge the Sonicision Reusable Battery Pack and to provide information on the battery charging progress and battery pack status Item Code: CBCA	Device	Class II	1	Ongoing
4 Nov 2021	Puritan Bennett 980 Series Ventilator, 980A1ENNISB	Device	Class I	16	Terminated
29 Sep 2021	Covidien Emprint Ablation Catheter with Thermosphere Technology Bronchoscopic Ablation, CFN CA108L1	Device	Class II	1	Terminated
23 Jun 2021	Covidien Sonicision Reusable Generator-converts electrical power from the battery pack to ultrasonic energy to drive the active blade. Product Number: SCGAA	Device	Class II	1	Terminated
23 Mar 2021	Covidien Tri-Staple 2.0 Reinforced Intelligent Reload 60 mm Medium/Thick-For use with Signia stapling system. Staple line reinforcement has applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection of tissue and creation of anastomosis. It may be used for transection and…	Device	Class II	1	Terminated
26 Feb 2021	CF Delivery Dev Caps Bravo x5, FGS-0635/FGS 0636 - Product Usage: intended to be used for gastroesophageal pH measurement and monitoring of gastric reflux in adults and children from 4 years of age.	Device	Class II	2	Ongoing
13 Jan 2021	Covidien Parietex hydrophilic anatomical mesh 15 cm x 10 cm polyester left - Product Usage: designed for the repair of inguinal hernias via laparoscopic or posterior open procedures Item Code: TECT1510AL	Device	Class II	1	Terminated
23 Nov 2020	Covidien TA Auto Suture Vascular Stapler with DST Series Technology 30mm-V 3. Intended for abdominal, gynecological, pediatric and thoracic surgical procedures for resection or transection of tissue. Item Number: TA30V3S	Device	Class II	2	Completed
16 Nov 2020	Capnostream 35 Portable Respiratory Monitor, Product numbers PM35MN02, PM35MN01, PM35MN05, DLPM35MN02 - Product Usage: use during both no motion and motion conditions and for patients who are well or poorly perfused.	Device	Class II	1	Ongoing
16 Oct 2020	Puritan Bennett 980 (PB980) Ventilator Series - Product Usage: for use on patient population sizes from Neonatal (NICU) through Adult who require respiratory support or mechanical ventilation SKU: 980X1ENDIUU 980X1ENDIUU 980X3FRAIQC 980X3DEDRAC 980X3ENNISB 980X3NLDRAC 980X3PLDIPC 980X3ESDIEC 980X3ITDIEC 980X3JADIJJ…	Device	Class II	1	Ongoing
26 Jun 2020	Beacon EUS Access System Preloaded Access 90degree Needle sterile, single-use, endoscopic ultrasound device consisting of a sharp stylet and an 18.5-gauge, echo-enhanced, tip-shaped, nitinol cannula intended to pierce tissue and then act as an access channel to facilitate guidewire placement to locations of the…	Device	Class II	2	Ongoing
12 May 2020	Multifire VersaTrack Auto Suture Hernia Stapler, 4.0mm, Part No. 174021 - Product Usage: has application in endoscopic general surgery procedures for fixation of mesh in the repair of hernial defects and in other surgical specialties for approximation of tissue(s).	Device	Class II	4	Ongoing
30 Apr 2020	Dover 100% Silicone Foley Catheter with Temperature Sensor 14FR 5CC2W, Product Code: 50514T - Product Usage: for Drainage of the Urinary bladder and simultaneous monitoring of temperature. Prescription use only.	Device	Class II	11	Terminated
10 Feb 2020	Covidien Force TriVerse Electrosurgical Devices, Product numbers FT3000 and FT3000DB, UDI 10884524000084 20884524000081; 10884524001937 20884524001934	Device	Class II	2	Terminated
17 Jan 2020	Covidien Endo GIA Ultra Universal Stapler 12 mm-intended for resection, transection in general surgery Item Code: EGIAUSTND	Device	Class II	1	Terminated
18 Dec 2019	Polysorb Braided Absorbable Suture 3/0 VIOLET 30" CV-24 (75CM), Item Code CL461 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.	Device	Class II	27	Terminated
17 May 2019	EGIA 30 ARTICULATING MED THICK SULU, Item Code EGIA30AMT	Device	Class II	12	Ongoing
29 Apr 2019	MAHURKAR and Argyle acute hemodialysis catheters, Material numbers 8813793009 8813793013 8813794005 8813794009 8813816005 8813816009 8813817005 8813817009 8815668007 8815668011 8815668021 8815668027 8817142005 8817143005 8817145005 8817146001 8817146007 8817149007 8817232018 8817232019 8817277007 8817277011…	Device	Class II	1	Terminated
13 Mar 2019	Covidien Endo Clinch II Auto Suture Grasper, 5mm REF: 174317 The Covidien Endo Clinch" II Auto Suture" grasper 5mm has a 5 mm diameter, rotating, insulated shaft approximately 31 cm in length and is designed for introduction and use through the appropriately sized Covidien" trocar sleeve or larger sized sleeve with…	Device	Class II	3	Terminated
15 Feb 2019	Kendall SCD Express Sterile Sleeves (Thigh Length), Model Number 9736	Device	Class II	1	Terminated
15 Nov 2018	Covidien Emprint Long Percutaneous Antenna with Thermosphere Technology, Material CA30L2 intended for use in percutaneous, laparoscopic, and intraoperative coagulation (ablation) of soft tissue, including partial or complete ablation of nonresectable liver tumors.	Device	Class II	3	Ongoing
5 Nov 2018	8Fr SAFE GRAD CAT W/Valve (Argyle Suction Catheter Kits with Chimney Valve), Model Number 36826	Device	Class II	1	Terminated
31 Oct 2018	Salem Sump Dual Lumen Stomach Tube 10 Fr/Ch (3.3 mm) x 36" (91 cm), Product Code 8888264911 Product Usage: The Salem Sump Tubes are intended for decompression and drainage of stomach contents following injury, illness, or surgery in patients with intestinal obstruction, and to prevent the distention of the stomach.	Device	Class II	1	Terminated
5 Oct 2018	Parietex Composite Parastomal Mesh (Product Number PCOPM15 / PCOPM20) Product Usage: The PCOPM15 and PCOPM20 reorder codes are circular in shape, made from a three-dimensional monofilament polyester fabric with a two-dimensional monofilament polyester central band. One side of the design is completely covered with…	Device	Class II	1	Terminated
18 Sep 2018	Puritan Bennett 980 (PB980) ventilator series: Puritan Bennett" 980 Pediatric Adult Ventilator Puritan Bennett" 980 Neonatal Ventilator Puritan Bennett" 980 Universal Ventilator Product Usage: The Puritan Bennett 980 Series Ventilator is designed for use on patient population sizes from Neonatal (NICU) through Adult…	Device	Class I	1	Terminated
17 Aug 2018	EEA Circular Stapler with Tri-Staple Technology, Part No. TRIEEA28MT TRIEEA28XT TRIEEA31MT TRIEEA31XT Product Usage: The EEA Circular Stapler with Tri-Staple Technology places a circular, triple staggered row of titanium staples and resects the excess tissue, creating a circular anastomosis.	Device	Class II	1	Terminated
1 Aug 2018	Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), REF 3332 Product Usage- as both primary and secondary dressing containing PHMB (polyhexamethylene biguanide) to resist bacterial colonization within the dressing and bacterial penetration through the dressing.	Device	Class II	6	Terminated
26 Jul 2018	Li-ion battery packs used in BIS Vista and BIS View Monitoring Systems. Product Number/CFN: 186-0208 UDI-Device Identifier (GTIN/UPN): 10884521130319	Device	Class II	1	Ongoing
11 Jul 2018	400mL, Premium, Urine Meter, 16 FR, Silicone Temperature Sensing Foley Traywith Cath-Secure Plus, Sterile, Item Code P4P16XTSD	Device	Class II	6	Terminated
15 Jun 2018	Polysorb Braided Absorbable Suture 1 36" 90 cm Undyed GS-21, Product Number CL-955	Device	Class II	1	Terminated
9 Apr 2018	EEA" Hemorrhoid and Prolapse Stapler Set with DST Series" Technology 3.5MM, Product Number HEM3335, GTIN Number 1 - 10884521047518, GTIN Number 2 - 20884521047515 Product Usage: The EEA Hemorrhoid and prolapse stapler set with DST Series Technology (instrument) is designed for use as a stapler instrument for control…	Device	Class II	2	Terminated
15 Mar 2018	LigaSure" Exact Dissector Nano Coated 20.6mm-21cm Product Usage: A bipolar electrosurgical instrument intended for use in open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired.	Device	Class II	1	Terminated
13 Dec 2017	Signia" Power Handle (SIGPHANDLE, SIGNVAL1 and SIGVAL20 - Kits) The Signia" Power Handle, when used with Endo GIA" single-use reloads and Endo GIA" single-use reloads with Tri-Staple" Technology, has applications in open and minimally invasive general abdominal, gynecological, pediatric, and thoracic surgery for…	Device	Class II	1	Terminated
21 Nov 2017	Rechargeable Li-ion battery used with Puritan Bennett TM 980 Series Ventilator System including Pediatric-Adult Ventilator, Neonatal Ventilator, Universal Ventilator; Battery Product Number: 10086042; UDI: 20884521700861 The rechargeable lithium-ion batteries are intended to provide a backup power source to the…	Device	Class II	1	Terminated
12 Oct 2017	Situate Gauze RF and X-Ray detectable. Product Number: G0804-16P02CN-1 Situate premium cotton are single use cotton disposable that must be used with the Situate delivery system. The disposable have an attached RF Tag, which is an electrically passive inductor like device that is sewn into the green pouch that you…	Device	Class II	1	Terminated
21 Sep 2017	GastriSail" Gastric Positioning Device Product Usage: The GastriSail gastric positioning system is indicated for use in gastric and bariatric surgical procedures for the application of suction, decompression and to radially expand the stomach, to drain gastric fluids, to test for leaks, to provide visible and tactile…	Device	Class II	1	Terminated
15 Sep 2017	Endo GIA" Radial Reload with Tri-Staple" Technology The Endo GIA radial reloads with Tri-Staple Technology have application in open or minimally invasive general abdominal, gynecologic and thoracic surgery for resection and transection of tissue and creation of anastomosis, as well as application deep in the pelvis,…	Device	Class II	1	Terminated
13 Sep 2017	Endo GIA Auto Suture Universal Articulating Loading Unit for use in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.	Device	Class II	1	Terminated
7 Aug 2017	Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 15cm, Material CA15L1	Device	Class II	6	Ongoing
9 May 2017	Covidien Endo Peanut 5mm Auto Suture Blunt Dissector Item Code: 173019 The instrument has indications in endoscopic surgery for swabbing small amounts of fluid or for blunt dissection of soft tissue(s) and structures, or as an aid in controlling minor intraoperative bleeding	Device	Class II	1	Terminated
3 Mar 2017	Covidien Curity Eye Pad Item Code: 03201 The sterile eye pad is a device that consists of a pad made of various materials, such as gauze and cotton, intended for use as a bandage over the eye for protection or absorption of secretions. It is supplied sterile to allow for use in the operating room, and for application…	Device	Class II	7	Terminated
23 Jan 2017	Premier Guard Sterile Drape For Use with Blair-Port Wand (02-0029) and Blair-Port Wand X (01-0046) Item Number: 01-0020 Used in conjunction RF Surgical Gauze detection systems to protect scanning device from contamination during various surgical procedures	Device	Class II	2	Terminated
16 Dec 2016	Covidien Nellcor SpO2 Forehead Sensor Item Code: RS10; The Covidien Nellcor Forehead SpO2Sensor, model RS10, is indicated for use when continuous non-invasive arterial oxygen saturation and pulse rate monitoring are required for patients weighing more than 40 kg.	Device	Class II	1	Terminated
14 Oct 2016	Covidien Precision Specimen Container- 4 oz (118 mL), Plastic Screw Top Cap, OR Packaged, Sterile Item Code: 17099	Device	Class II	1	Terminated
29 Sep 2016	Covidien Devon Light Glove packaged in sterile surgical kits Reference: 31140208 Product Usage: A disposable, sterile, single-use cover for compatible surgical light handles	Device	Class II	3	Terminated
6 Jun 2016	Covidien Cytosponge Cell Collection Kit. Contains Cytosponge Cell Collection Device, Specimen Jar with preservative. Item code CYTO-KIT-R Gastroenterology: Cytosponge Cell Collection Device is indicated for use in the collection and retrieval of surface cells in the esophagus. Currently the device is only available…	Device	Class II	2	Terminated
15 Apr 2016	Given Imaging Bravo pH capsule delivery device, 5-pack. In-Vitro Diagnostic for pH monitoring of gastric reflux Item Number: FGS-0312 The Bravo pH Monitoring System is intended to be used for gastroesophageal pH measurement and monitoring of gastric reflux in adults and children from 4 years of age. The Bravo pH…	Device	Class II	2	Terminated
3 Mar 2016	Curity Gauze Sponges, 16 ply 4" x 4" (10.2 cm x 10.2 cm), Sterile 10's in Soft Pouch; Item Number: 397310; Open mesh fabric intended to be used to inside the body or a surgical incision to control bleeding, absorb fluid, or protect organs.	Device	Class II	13	Terminated
22 Jan 2016	Covidien Dover CATCH KIT SOAP Item Code: 5205 Castile soap towelettes are used to clean the genital area for male and female patients	Device	Class II	34	Terminated
21 Jan 2016	Covidien Kangaroo Polyurethane Feeding Tube Radiopaque Line, Safe Enteral Connections 6.5 Fr/Ch (2.2 mm) x 36" (91 cm), Sterile; Catalog Number: 461438. Intended for pediatric feeding.	Device	Class II	2	Terminated
14 Oct 2015	Palindrome" Chronic Catheter Kit Symmetrical Tip, Tal VenaTrac" Stylet 14.5 Fr/Ch (4.8mm) X 33 cm Item Number: 8888145042 The Palindrome chronic catheter is intended for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted either percutaneously or by cutdown. Catheters grater than 40 cm implant…	Device	Class II	5	Terminated
19 Aug 2015	MediTrace Cadence Adult Multi-Function Defibrillation Electrodes Item Code:22550PC	Device	Class II	3	Terminated
6 Aug 2015	Monoject 0.9% Saline Flush Prefill Double Pouch Item Code: 8881570129 Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intravascular access devices.	Device	Class II	13	Terminated
31 Jul 2015	Covidien Argyle Infant Heel Warmers (no tab) Item Code: MH00002N Product Usage: Intended for application of the right amount of heat to an infants heel for blood sampling	Device	Class II	2	Terminated
28 Apr 2015	VenaSeal, Sapheon Closure System, Model # SP-101, VS-301 and VS-402. For vascular use.	Device	Class II	1	Terminated
23 Apr 2015	Palindrome SI Chronic Catheter Kit 14.5 Fr x 19cm Item Code: 8888245062 The Palindrome SI Chronic Catheter is indicated for acute and chronic hemodialysis, apheresis, and infusion.	Device	Class II	62	Terminated
16 Apr 2015	Covidien Devon Light Gloves, Sterile-Single Units A disposable, sterile, single-use cover for compatible surgical light handles. Catalog/Number/Description 31140208 3611 LIGHT GLOVE 31140216 3613 LIGHT GLOVE 31140257 3612 LIGHT GLOVE	Device	Class II	14	Terminated
18 Sep 2014	Covidien Medi-Trace Cadence and Kendall Adult Multi-Function Defibrillation Electrodes, Radiotransparent Part Number: 22660R	Device	Class I	6	Terminated
8 May 2014	Devon Supine, Lithotomy and Trendelenburg Positioning Kit; Product Code: 31151090 Product Usage: The device is intended to provide padding under the patient, and help maintain the position of an anesthetized patient during surgery.	Device	Class II	1	Terminated
16 Aug 2013	Monoject 0.9% Sodium Chloride Flush Syringe, 12 mL Syringe with 10 mL Fill Product ID: 8881570121 Product Usage: Both 0.9% Sodium Chloride Flush syringes and 10U/mL or 100U/mL Heparin Lock Flush syringes are sterile, single-use products which are intended for use in flushing and locking compatible intravenous…	Device	Class II	9	Terminated
12 Apr 2013	Curity I.V. Start Kit, Product ID: 80530 and Curity I.V. Start Kit Product ID: 8508. IV Start Kit.	Device	Class III	2	Terminated
8 Apr 2013	Medi-Trace Cadence Adult Radiotransparent Defibrillation Electrode Product ID: 22550R. Intended for use in cardioversion, pacing, ECG monitoring, and defibrillation procedures.	Device	Class II	2	Terminated
3 Aug 2012	HALO Flex Energy Generators Manufactured by B RRX Medical (now Covidien) 540 Oakmead Parkway Sunnyvale, CA 95085. The HALO Flex Energy Generator is indicated for use for the coagulation of soft tissue. The HALO Flex System is indicated for use in the coagulation of bleeding and non-bleeding sites in the…	Device	Class II	1	Terminated

An event with 1 product record and a class that is not Class I has no page. It has a row in this table.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Recalling firm: The firm that the FDA record names for a recall.

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Type and class

Covidien, LLC: events for each product type
Type		Events
Device		77

Covidien, LLC: events in each class
Class		Events
Class II		72
Class I		4
Class III		1

Share of the events of the firm in Class I: 5%
Share of all events on the register in Class I: 18%
Events with the status Ongoing: 23

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Events by year

FDA enforcement events of Covidien, LLC, by the year that the recall started. The largest year is 2018, with 12 events.

Official channels

FDA enforcement reportsThe FDA search of the weekly enforcement reports.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA: report a problemThe FDA page that shows where a report about a product goes.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Cite this page

Recall Register. Covidien, LLC: FDA recalls. https://recallregister.com/firm/covidien-llc/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
State of the firm address: MA, CT

The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.

A firm with more products can have more recalls. This site does not compare one firm with a different firm. How the register is made. Report an error.

Questions

Which classes do the FDA recalls of Covidien, LLC have?: Class II: 72 events. Class I: 4 events. Class III: 1 event. The class is for the product of a recall. It is not a class of the firm.
What is the newest FDA recall of Covidien, LLC?: FDA event 99176, which the firm started on 13 May 2026. The first product in the record is: EndoFLIP System that includes: ENDOFLIP 1 SYSTEM EF-100 05391530810050 10884521809307 REFURBISHED SYSTEM RFG-EF100 ENDOFLIP 1 10884521808096 05391530810166 DL ENDOFLIP 1 10884521786684 Endoscopic measuring system, including catheter components.
How many FDA recalls of Covidien, LLC have the status Ongoing?: 23 events have the status Ongoing in the openFDA file. openFDA says about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.