Recall Register

Recalls in September 2023

NHTSA received 55 vehicle recall campaigns in September 2023. NHTSA also received 6 child seat, tire or equipment campaigns. The NHTSA campaigns have 4,265,010 units in total. 25 CPSC recalls have a recall date in the month, with about 2,169,830 units. FDA enforcement reports of the month have 122 events.

All months

Counts

NHTSA vehicle campaigns
55August 2023: 69
NHTSA child seat, tire and equipment campaigns
6
Units in the NHTSA campaigns
4,265,010
CPSC product recalls
25August 2023: 27
FDA enforcement events
122August 2023: 143

Download all recalls of September 2023 (CSV)

NHTSA

Vehicles, child seats, tires and equipment.

NHTSA recall campaigns that NHTSA received in September 2023, newest first
ReceivedCampaignFirst vehicle or productComponentTypeManufacturerUnits
29 Sep 202323E072000Precision Power Control SystemElectrical SystemEquipmentPrecision Circuits Inc.176
29 Sep 202323V658000Forest River Salem 2024 and 1 moreStructureVehicleForest River, Inc.6
29 Sep 202323V659000Coachmen Prism 2023 and 5 moreEquipmentVehicleForest River, Inc.370
29 Sep 202323V660000Coachmen Brookstone 2024 and 2 moreElectrical SystemVehicleForest River, Inc.50
29 Sep 202323V661000Peterbilt 536 2021 and 23 moreService Brakes, AirVehiclePACCAR Incorporated254
29 Sep 202323V663000Winnebago Revel 2023 and 4 moreElectrical SystemVehicleWinnebago Industries, Inc.4,968
29 Sep 202323V664000Brinkley RV Model G 2024Electrical SystemVehicleBrinkley RV143
28 Sep 202323E071000Multiplex HC Relay CardEquipmentEquipmentFirefly Integrations, LLC113
28 Sep 202323V654000Ram 3500 2023 and 6 moreBack Over PreventionVehicleChrysler (FCA US, LLC)272,911
28 Sep 202323V655000Diamond C Trailers PX 2024 and 5 moreEquipmentVehicleDiamond C Trailer MFG.2,523
28 Sep 202323V656000Autocar Xpeditor 2022 and 2 moreSteeringVehicleAutocar, LLC1,131
28 Sep 202323V657000Nissan Ariya 2023Electrical SystemVehicleNissan North America, Inc.9,813
27 Sep 202323V653000Peterbilt 579 2021 and 7 moreFuel System, DieselVehiclePACCAR Incorporated1,315
25 Sep 202323E070000Goodride ST 200TiresEquipmentDexter Axle Company19,808
25 Sep 202323V652000Kia Sorento 2013 and 51 morePark-outside advisoryService Brakes, HydraulicVehicleKia America, Inc.1,730,192
22 Sep 202323V648000East TO West Blackthorn 2024 and 1 moreStructureVehicleForest River, Inc.46
22 Sep 202323V649000Kia Forte 2023Do-not-drive advisorySuspensionVehicleKia America, Inc.3,866
22 Sep 202323V650000Hyundai Kona 2024Seat BeltsVehicleHyundai Motor America2,354
22 Sep 202323V651000Hyundai Elantra Coupe 2014 and 43 morePark-outside advisoryService Brakes, HydraulicVehicleHyundai Motor America1,649,478
21 Sep 202323V645000Rolls-Royce Ghost 2021 and 2 moreElectrical SystemVehicleBMW of North America, LLC1,305
21 Sep 202323V647000Subaru Outback 2023 and 3 morePower TrainVehicleSubaru of America, Inc.4,311
20 Sep 202323V642000Cadillac Escalade ESV 2023 and 5 moreSuspensionVehicleGeneral Motors, LLC189
20 Sep 202323V643000Tiffin Allegro Bus 2017 and 16 moreEquipmentVehicleTiffin Motorhomes, Inc.1,188
20 Sep 202323V644000BMW 760I 2023 and 2 moreVisibility/WiperVehicleBMW of North America, LLC3,820
20 Sep 202323V646000Wabash National Van 2010 and 15 moreStructureVehicleWabash National Corporation3,711
20 Sep 202323V674000Chevrolet Cruze 2014 and 1 moreAir BagsVehicleGeneral Motors, LLC9,264
18 Sep 202323E068000Hyundam Industrial Fuel PumpFuel System, GasolineEquipmentHyundam Industrial183,323
18 Sep 202323E069000Mopar Gear Position Sensor and 1 morePower TrainEquipmentChrysler (FCA US, LLC)523
18 Sep 202323V640000Dodge Durango 2023Power TrainVehicleChrysler (FCA US, LLC)125
18 Sep 202323V641000Jeep Gladiator 2022 and 3 morePower TrainVehicleChrysler (FCA US, LLC)6,298
15 Sep 202323V637000Winnebago Porto 2021 and 16 moreEquipmentVehicleWinnebago Industries, Inc.5,369
15 Sep 202323V638000Forest River Palomino 2024 and 1 moreElectrical SystemVehicleForest River, Inc.39
15 Sep 202323V639000Kia Sorento 2019Back Over PreventionVehicleKia America, Inc.83,667
14 Sep 202323V635000Gillig LOW Floor 2022 and 1 morePower TrainVehicleGillig, LLC223
14 Sep 202323V636000Altec Digger Derrick 2019 and 19 moreEquipmentVehicleAltec Industries, Inc.53
13 Sep 202323V209000Thomas Built Buses SAF-T-Liner C2 2023 and 2 moreElectrical SystemVehicleDaimler Trucks North America, LLC380
13 Sep 202323V633000Toyota Tundra Hybrid 2023 and 1 moreEquipmentVehicleToyota Motor Engineering & Manufacturing21,781
13 Sep 202323V634000Kia Stinger 2020 and 3 moreFuel System, GasolineVehicleKia America, Inc.18,224
12 Sep 202323V631000Spartan Fire Gladiator 2021 and 13 moreParking BrakeVehicleSpartan Fire, LLC660
12 Sep 202323V632000Kentucky Trailer XL-12 2020 and 4 moreEquipmentVehicleKentucky Trailer Manufacturing3
11 Sep 202323V629000Mercedes-Benz GLC 300 2023Trailer HitchesVehicleMercedes-Benz USA, LLC12,118
11 Sep 202323V630000Genesis GV70 2022 and 4 moreFuel System, GasolineVehicleHyundai Motor America19,272
8 Sep 202323V625000Ford E-350 2025 and 5 morePower TrainVehicleFord Motor Company5,919
8 Sep 202323V626000Lincoln Aviator 2022 and 5 moreElectrical SystemVehicleFord Motor Company2,954
8 Sep 202323V627000Winnebago Travato 2023 and 7 moreEquipmentVehicleWinnebago Industries, Inc.8,583
8 Sep 202323V628000Nissan Sentra 2021 and 4 moreBack Over PreventionVehicleNissan North America, Inc.153,376
7 Sep 202323V622000BMW X6 2024 and 3 moreAir BagsVehicleBMW of North America, LLC2,352
7 Sep 202323V623000Alfa Romeo Tonale Phev 2024 and 3 morePark-outside advisoryElectrical SystemVehicleChrysler (FCA US, LLC)4,129
7 Sep 202323V624000Midwest Fire All-Poly Series 2022 and 1 morePower TrainVehicleMidwest Fire Equipment & Repair Company19
6 Sep 202323V619000Volkswagen Jetta 2019Electrical SystemVehicleVolkswagen Group of America, Inc.8
6 Sep 202323V620000Ducati Xdiavel S 2019 and 5 moreStructureVehicleDucati North America842
6 Sep 202323V621000Thomas Built Buses SAF-T-Liner C2 2024Electrical SystemVehicleDaimler Trucks North America, LLC679
5 Sep 202323E066000Covercraft Buick Envision Seat Cover and 2 moreSeatsEquipmentCovercraft Industries, LLC99
5 Sep 202323V616000Kenworth K270 2023 and 2 morePower TrainVehiclePACCAR Incorporated21
5 Sep 202323V617000Kenworth T280 2023 and 11 moreFuel System, DieselVehiclePACCAR Incorporated871
5 Sep 202323V618000Wilson DWH-750 2024TiresVehicleWilson Trailer Company1
1 Sep 202323V611000Forest River Sabre 2024EquipmentVehicleForest River, Inc.66
1 Sep 202323V612000East TO West Della Terra 2022 and 1 moreStructureVehicleForest River, Inc.2,994
1 Sep 202323V613000Audi RS E-Tron GT 2023 and 1 moreElectrical SystemVehicleVolkswagen Group of America, Inc.1,899
1 Sep 202323V614000Airstream Basecamp 2023 and 2 moreElectrical SystemVehicleAirstream, Inc.58
1 Sep 202323V615000Porsche Taycan Turbo S Cross Turi 2023 and 9 moreElectrical SystemVehiclePorsche Cars North America, Inc.4,777

A campaign that names 2 or more vehicles has a link to the first vehicle. The page of that vehicle shows the campaign in full.

Recall campaign: One recall in the NHTSA recall file, with one campaign number. A campaign can name many makes, models and model years.

Units: The number of vehicles or products that a recall can include. The manufacturer or the firm reports the number to the agency.

CPSC

Consumer products.

CPSC recalls with a recall date in September 2023
DateRecallFirmCategoryHazardUnitsCPSC number
29 Sep 2023Future Motion Recalls Onewheel Self-Balancing Electric Skateboards Due to Crash Hazard; Four Deaths ReportedFuture MotionCrash300,00023299
28 Sep 2023Polaris Recalls Ranger Recreational Off-Highway Vehicles and Pro XD Utility Vehicles, Gravely ATLAS Utility Vehicles, and Bobcat Utility Vehicles Due to Injury Hazard (Recall Alert)Polaris Industries28023796
28 Sep 2023Secura Recalls Air Fryers Due to Fire and Burn Hazards (Recall Alert)SecuraFire, Burn, Overheating6,40023794
28 Sep 2023Rust-Oleum Recalls Fluorescent Pink Spray Paint Due to Injury HazardRust-OleumImpact injury84,00023298
28 Sep 2023Nutraceutical Recalls Solaray Liposomal Multivitamins Due to Failure to Meet Child Resistant Packaging Requirement; Risk of PoisoningNutraceuticalPoisoning85,30023297
28 Sep 2023Procter & Gamble Recalls Zevo Fly, Gnat and Fruit Fly Insect Spray Due to Injury and Laceration HazardsThe Procter & GambleLaceration8,60023296
28 Sep 2023Trek Recalls Allant+ 7 Bicycles Due to Crash HazardTrek BicycleCrash7,00023295
21 Sep 2023FXI Recalls Novaform ComfortGrande and DreamAway Mattresses Due to Risk of Mold Exposure; Sold Exclusively at Costco (Recall Alert)FXIMould or bacteria48,00023793
21 Sep 2023Shimano Recalls Cranksets for Bicycles Due to Crash HazardShimano North America BicycleCrash680,00023294
21 Sep 2023H&M Recalls Men's Clasp Beaded Bracelets Due to Lead Poisoning Hazard; High Levels of Lead ContentH&M Hennes & MauritzLead or chemical, Poisoning, Violation of standard12,29023293
21 Sep 2023Make Believe Ideas Recalls Seven Rainbow Road Board Books Due to Choking HazardMake Believe IdeasChoking260,00023292
21 Sep 2023DR Power Equipment Recalls DR Power Chipper Shredders Due to Laceration HazardGenerac Power SystemsLaceration5,90023291
21 Sep 2023HONEY JOY Recalls Infant Swings Due to Suffocation Hazard and Violation of Federal Safety Standards; Sold Exclusively on Amazon.comHONEY JOYSuffocation, Violation of standard17023290
14 Sep 2023Best Buy Recalls Insignia and Yardbird Fire Tables with Lava Rocks Due to Burn and Impact Injury Hazards (Recall Alert)Best Buy Purchasing, LLC, a subsidiary of Best Buy Co., Inc. imported the Insignia fire tablesFire, Burn, Impact injury1,49023792
14 Sep 2023Generac Recalls Portable Generators Due to Serious Fire and Burn HazardsGenerac Power SystemsFire, Burn64,00023288
14 Sep 2023American Honda Motor Recalls Lawnmowers and Pressure Washer Engines Due to Injury HazardAmerican Honda Motor391,80023287
14 Sep 2023Buffalo Games Recalls Chuckle & Roar Ultimate Water Beads Activity Kits Due to Serious Ingestion, Choking and Obstruction Hazards; One Infant Death Reported; Sold Exclusively at TargetTargetChoking, Poisoning52,00023286
14 Sep 2023STIHL Recalls MSA 300 Chain Saws Due to Laceration HazardSTIHLLaceration2,80023282
14 Sep 2023TJX Recalls Foldable Bistro Set Chairs Due to Fall Hazard; Sold at Marshalls, T.J. Maxx, HomeGoods and Homesense StoresThe TJX CompaniesFall11,00023280
7 Sep 2023Whirlpool Recalls Stacked Commercial Clothes Dryers Sold Under the ADC Brand Due to Fire Hazard (Recall Alert)WhirlpoolFire, Overheating2,50023791
7 Sep 2023ARGO Recalls ARGO Xplorer All-Terrain Vehicles (ATVs) Due to Fire Hazard (Recall Alert)ARGOFire, Lead or chemical50023790
7 Sep 2023Lectric Ebikes Recalls Disc Brake Calipers Sold on Lectric E-Bicycles Due to Crash and Injury Hazards (Recall Alert)Lectric eBikesCrash45,00023789
7 Sep 2023Pirelli Tire Recalls P ZERO Race TLR Bicycle Tires Due to Fall HazardPirelli TireFall, Lead or chemical, Crash14,50023276
7 Sep 2023Engineered Controls International Recalls LP Gas Compact Regulators Due to Fire HazardEngineered Controls InternationalFire6,30023275
7 Sep 2023Emporia Recalls North America Smart Plugs Due to Electric Shock HazardEmporia EnergyElectric shock80,00023274

FDA

Food, drugs and devices.

72 device, 30 food, 20 drug. 92 Class II, 17 Class I, 13 Class III.

FDA enforcement events with a report date in September 2023
InitiatedProduct (first record)Recalling firmTypeClassRecords
8 Sep 2023SANDIMMUNE Oral Solution (cyclosporine oral solution, USP) 100 mg/mL, 50 mL bottle, Rx Only, Manufactured by: DELPHARM Huningue S.A.S., Huningue, France, Distributed by: Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936, NDC 0078-0110-22.Novartis Pharmaceuticals Corp.DrugClass I1
7 Sep 2023Cequa (cyclosporine ophthalmic solution) 0.09%, 60 Single-Use Vials (6 pouches x 10 single-use vials (0.25 mL each)), Rx only, Manufactured for Sun Pharma Global FZE by: Laboratoire Unither, Coutances, France NDC 47335-506-96SUN PHARMACEUTICAL INDUSTRIES INCDrugClass III1
5 Sep 2023Pantoprazole Sodium for Injection 40mg per vial, Single dose vials NDC 71839-122-01 Packaged as (a) 10 Single-dose vials, NDC 71839-122-10; (b) 25 Single-dose vials, NDC 71839-122-25; Rx Only, Mfd. in India for and Distributed by: BE Pharmaceuticals Inc. 203 New Edition Court Cary, NC 27511. Event 92968BE PHARMACEUTICALS AGDrugClass II1
5 Sep 2023Kroger Mint Burst ANTISEPTIC MOUTH RINSE ANTIGINGIVITIS/ANTIPLAQUE (Eucalyptol 0.092%, menthol 0.042%, Methyl salicylate 0.06%, thymol 0.064%), packaged in 16.9 FL OZ (500 mL) bottle, DISTRIBUTED BY THEKROGER CO. CINCINNATI, OHIO 45202, UPC 011110380807Vi-Jon, LLCDrugClass III1
5 Sep 2023LA ORIGINAL - THE ORIGINAL, NUT DIET MAX, Nuez de la IndiaOBC GROUP CORPFoodClass I2
1 Sep 2023TRP Natural Eyes, Aging Eye Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502 NDC: 17312-027-15.AMMAN PHARMACEUTICAL INDUSTRIESDrugClass II17
31 Aug 2023smith&nephew LEGION OXINUM POSTERIOR STABILIZED NONPOROUS FERMOAL COMPONENT, SIZE 5N, LEFT, NARROW, REF 71421265; knee jointSmith & Nephew IncDeviceClass II1
31 Aug 2023US Foods: Peanut Butter Toffee Bar, 3.4oz unit size, packaged in flow wrap, 24 packages per case Event 92998Killer Brownie LtdFoodClass II1
31 Aug 2023F-Bombs Original Truffles: 12 ounce plastic packaging, plastic packaging is packed into 4x4x2 cardboard boxes. UPC 850036018001Fox Confections LLCFoodClass II7
30 Aug 2023Sucralfate Oral Suspension 1g per 10mL, FOR ORAL ADMINISTRATION ONLY (414 mL bottle), Rx Only, Manufactured and Distributed by: VistaPharm, Inc. Largo, FL 33771, NDC 66689-305-16VistaPharm LLCDrugClass II1
30 Aug 2023Radish Turnip Cake (w/o shrimp): The product comes in a 900g ( 32 ounce), clear plastic package marked with UPC # 425404904110. Ingredients: White Radish, Mushrooms, Fried Dried shallot, White Rice Flour. Event 92987Southern Taiwan LLCFoodClass II1
25 Aug 2023WEFUN Capsules 825 mg, 1x10 blister pack per carton, Manufactured by WEFUN Brooklyn NY 11204 www.eshoponlineusa.com Bar Code X00358V0O5 Event 92979Hua Da Trading, Inc. dba Wefun Inc.DrugClass I1
25 Aug 2023BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Sterile Solution, 0.03mL (1 ml) each, 60 applicators in carton, applicator is sterile if package is intact. CareFusion 213, LLC, El Paso, TX 79912, subsidiary of Becton, Dickinson and Co., NDC 54365-400-31 REF 930480 Product…CareFusion 213, LLCDrugClass II1
25 Aug 2023Digoxin Tablets, USP 0.125mg, 100-count bottles, Rx Only, Manufactured for/Distributed by: Marlex Pharmaceuticals, Inc. New Castle, DE NDC# 10135-0747-01Marlex Pharmaceuticals, Inc.DrugClass I2
25 Aug 2023TODRGANIC Natural Products, NUEZ DE LA INDIA, Natural Products, 12 Seeds 12 Semillas Event 92934Todorganic Inc.FoodClass I1
25 Aug 2023Somebody's Mother's White Chocolate, Net Wt 9.5 oz (270g), UPC 5803100102Somebody's Mother's Chocolate SauceFoodClass II2
24 Aug 2023Philips Tempus Pro Patient Monitor, REF: 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R, 00-1004, and 00-1007, when Used With Tempus Pro Video Laryngoscope, REF 01-2044Remote Diagnostic Technologies Ltd.DeviceClass II1
23 Aug 2023MINISCAV (tm) Vacuum Pump Event 92929R A Medical ServicesDeviceClass II1
23 Aug 2023Clindamycin Phosphate Topical Solution USP, 1%, 60 mL bottle, Rx only, Manufactured by: Contract Pharmaceuticals Limited Canada, Mississauga, Ontario, Canada, Manufactured for: Glasshouse Pharmaceuticals Limited Canada, Mississauga, Ontario, Canada, NDC# 71428-003-60 Event 92922Contract Pharmaceuticals Limited CanadaDrugClass III1
21 Aug 2023Cassano's The Pizza King Premium Pizza Dough on Parchment: packaged as 16in (regular)Cassanos IncFoodClass II2
21 Aug 2023Texas Tamale Black Bean Tamales 18 oz, (1 lb. 2 oz), 510 g Event 92924TEXAS TAMALE COMPANYFoodClass I1
18 Aug 2023Humanrace Suncare, Ozone Face Protection Daily Moisturizer, Broad Spectrum Sunscreen SPF 30, packaged as a 53mL (1.8 fl oz.) bottle, 100% mineral, Active Ingredient: Zinc oxide 15%, Snow Mushroom, Dist. By: @Humanrace 2022 Beverly Hills, CA 90210, USA, NDC 82779-01HUMANRACEDrugClass II2
18 Aug 2023Individually Quick Frozen (IQF) Corn distributed in BULK TOTES (1650lbs and 1750lbs) to consignees for further processing. Bulk tote labels have cooking instructions. Individually Quick Frozen (IQF) Super Sweet Corn, foodservice item, packaged in 32oz. plastic bag, 12 bags per case. The poly bag is stamped with lot…Twin City Foods, Inc.FoodClass II4
17 Aug 2023Patient Information Center iX with Software Version Number 4.x in the following: (1) Patient Information Center iX Product Number: 866389; (2) Patient Information Center iX Expand Product Number: 866390; (3) PIC iX Essentials Product Number: 867093; (4) PIC iX Essentials Expand Product Number: 867154Philips North America LlcDeviceClass II1
17 Aug 2023Sabril (vigabatrin) for Oral Solution, 500 mg, 50 Packets, Rx only, Manufactured by: Patheon, Cincinnati, OH 45237, NDC 67386-211-65 Event 92894Lundbeck LLCDrugClass III1
17 Aug 2023CARDIOPLEGIA SOLUTION, 20 mEq K, Maintenance 4:1, Low Potassium, Total Volume = 810 mL, EVA Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-0103-1Central Admixture Pharmacy Services, Inc.DrugClass II32
17 Aug 2023Mellow Mallow packaged in 7oz cellophane wrappers.Name withheldFoodClass II3
16 Aug 2023Gallant VR Implantable Cardioverter Defibrillator: VR ICD REF CDVRA500Q Gallant DR Implantable Cardioverter Defibrillator: DR ICD REF CDDRA500Q Neutrino VR Implantable Cardioverter Defibrillator: NxT VR ICD REF CDVRA600Q Neutrino DR Implantable Cardioverter Defibrillator: NxT DR ICD REF CDDRA600Q Entrant VR…Abbott MedicalDeviceClass II2
16 Aug 2023Nexlizet (bempedoic acid and ezetimibe), 180ng/18mg, 30 tablets, Rx only, Manufactured for: Esperion Therapeutics, Inc, Ann Arbor, MI 48108, NDC 72426-818-03 Event 92897EsperionDrugClass III1
16 Aug 2023Power Snacks Honey Roasted Sunflower Kernels, Net Wt 1 oz; UPC 076500722025Mount Franklin Foods LLC DBA Azar Nut Co.FoodClass II5
16 Aug 2023Asmus Seasonings Asian Spice Blend 18oz clear plastic bottle, UPC 7 18122 95603 6, item number 233944, 12 bottle per wholesale case Event 92891Asmus Seasoning, Inc.FoodClass II1
15 Aug 2023Philips Allura Xper, Allura Centron, Allura CV, Azurion, UNIQ Clarity, and MultiDiagnost-Eleva systemsPHILIPS MEDICAL SYSTEMS NEDERLAND B.V.DeviceClass II1
15 Aug 2023Trader Joe's Multigrain Crackers with Sunflower and Flax Seeds, 10oz (283g) box, UPC 000000761567, 24 retail boxes per wholesale caseTreehouse FoodsFoodClass II1
14 Aug 2023remel TODD HEWITT W. CNA (LIM BROTH), REF R064810; used to isolate Group B Streptococci form clinical specimens containing mixed bacterial floraRemel, IncDeviceClass II1
14 Aug 2023KWIK-STIK, ANA (3 Strains) QC Set, REF 5065P; Microbiological testingMicrobiologics IncDeviceClass III1
14 Aug 2023Milrinone Lactate Injection, USP 20mg/20 mL (1mg/mL), packaged in 10 x 20 mL vials per carton, NDC 72485-502-01 (single vial), Rx only, Distributed by: Armas Pharmaceuticals, Inc. Freehold, NJ 07728(USA) Manufactured by: Caplin Steriles Limited, India, NDC 72485-502-10 Event 92900Caplin Steriles LimitedDrugClass III1
14 Aug 2023Stonewall Kitchen brand Peanut Butter Maltballs packaged in 6oz clear plastic packagingStonewall Kitchen, LLCFoodClass I1
14 Aug 2023Southern Belle Seafood Crabmeat Stuffing, Packed: 2/25 lb. Bag, Net Weight: 50 lb. (22.68 kg), Use By: 08/23/2023 Event 92890Shaw's Southern Belle Frozen Foods, Inc.FoodClass II1
11 Aug 2023DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution 1.5% Dextrose, packaged in a) 2000 mL AMBU-FLEX II Container bag, Product Code L5B4825, NDC 0941-0409-06; b) 5000 mL AMBU-FLEX II Container bag, Product Code L5B4826, NDC 0941-0409-07; and c) 6000 mL AMBU-FLEX II Container bag, Product Code L5B9770, NDC…Baxter Healthcare CorporationDrugClass II2
11 Aug 2023Sodium Fluoride 1.1%, SODIUM FLUORIDE Prescription Dental Toothpaste, 5000 ppm Fluoride Plus Mild Cleaning System Spearmint NET WT. 1.8 OZ. (51g), Rx only, NDC 42291-741-51, Manufactured for: AvKARE Pulaski, TN 38478AVKARE LLCDrugClass II2
11 Aug 2023Lyons Grape Juice packaged in 4 fl oz opaque white plastic cup 96 cups per caseLyons Magnus LLCFoodClass II3
11 Aug 2023La Reyna Diablo Salsa. Red Diablo Salsa, Hot. Product Code 1782. Net Wt 8 oz. UPC 7 52830-92710 0. Ingredients: Dried Red Peppers, Tomatoes, Onion, Salt, Sesame Seed, Garlic, Olive Oil. Keep Refrigerated. La Reyna, 202 4th, Vinton IA 42349Twin Cities Co-Op Partners Inc.FoodClass III5
11 Aug 2023Cheese Spread Pasteurized Process packaged under the following brands and sizes: 1. bowl & Basket, A Shoprite Brand, Net Wt 32 oz (2lb)907g. UPC 0 41190-46935 2. Refrigerate after Opening. Distributed by: Wakeforn Food Corp, 5000 Riverside Drive, Keasbey, NJ 08832 2. Lucerne Dairy Farms, Family Size, American Style ,…Great Lakes Cheese, Inc.FoodClass III11
10 Aug 2023PDS Plus Antibacterial (polydioxanone) Suture, Product Numbers PDP072H40, PDP259H50, PDP416H50, PDP441H50, PDP442H50, PDP489G50, PDP489H40, PDP497G51, PDP497H16, PDP497H40, PDP498H40, PDP502V05, PDP507V05, PDP510V05, PDP515V05, PDP662H50, PDP663H50, PDP684H40, PDP9615H40, PDP9625H40, PDP9626H40, PDP9631H40,…ETHICON, LLCDeviceClass II2
10 Aug 2023Arrow ErgoPack Pressure Injectable One-Lumen PICC, REF CDC-05541-HPK1A; catheter, intravascularARROW INTERNATIONAL Inc.DeviceClass II2
10 Aug 2023Welch Allyn Connex Spot MonitorBaxter Healthcare CorporationDeviceClass II1
10 Aug 2023Knorr Estrellitas con Tomate Tomato Based Star Pasta Soup Mix 3.5 oz UPC: 048001716193Conopco DBA UnileverFoodClass II3
10 Aug 2023Nestle Toll House, Chocolate Chip Cookie Dough, 16.5 oz. Cookie dough in bar form packaged in paperboard tray with plastic overwrap, 12 packages per case, Keep RefrigeratedNestle-USA, Inc. (Corporate Office)FoodClass II1
9 Aug 2023FLUIDSHIELD 3 N95 Particulate Filter Respirator and Surgical Mask with SO SOFT* Lining, Orange, size small, Product Code 46827O&M HALYARD, INC.DeviceClass II1
8 Aug 2023Oculus Pentacam AXL Wave, Ref 70020, CE 0123Oculus Optikgeraete GMBHDeviceClass II3
8 Aug 2023Prucka 3 Amplifiers, Model P1801PA, and Field Replaceable Units (FRUs), Model 5875569, used with CardioLab AltiX and ComboLab AltiX.GE Medical Systems Information Technologies IncDeviceClass II1
8 Aug 2023Mallinckrodt One-Way Valve, 22F x 22M, a) Part #91346 (1 piece) and b) Part #50412 (pack of 5) Used with ventilators. Event 92799Mallinckrodt Manufacturing LLCDeviceClass I1
8 Aug 2023Zespri Organic Green Kiwi, product of New Zealand, perishable, packaged in plastic clamshell, net wt. 1lb. UPC 818849020093. Distributed by The Oppenheimer Group, 180 Nickerson Street, Suite 211 Seattle WA. Zespri Organic Green Kiwi, product of New Zealand, perishable, packaged in plastic clamshell, net wt. 3lb, item…David Oppenheimer & Company I LLCFoodClass I2
7 Aug 2023Stryker ACM (Advanced Cement Mixing) System: Break-Away Femoral Nozzle-, Allows the user to mix bone cement with a constant high vacuum through the process. Catalog number: 0206-512-000.Stryker CorporationDeviceClass II7
5 Aug 2023VITROS XT Chemistry Products TBIL-ALKP SlidesOrtho-Clinical Diagnostics, INc.DeviceClass II2
4 Aug 2023DJO Surgical: Empowr Knee, Universal Tibia Baseplate, 6R, REF: 352-02-106Encore Medical, LPDeviceClass II5
4 Aug 2023HUDSON RCI Addipak, UNIT DOSE VIALS, 5mL Sterile 0.9% NaCl Solution for Inhalation USP. REF RHUD59UMEDLINE INDUSTRIES, LP - NorthfieldDeviceClass I1
3 Aug 2023Upper roller bracket (part number 1088370) for the Gen2 gantry enclosure for the Radixact Treatment Delivery System.Accuray IncorporatedDeviceClass II1
3 Aug 2023Liquid Assayed Chemistry Control Premium Plus Level 3, Catalog Number LAE4215Randox Laboratories Ltd.DeviceClass II1
3 Aug 2023MEDLINE STERILE IRIS SCISSORS CVD/STD, REF DYNJ04049MEDLINE INDUSTRIES, LP - NorthfieldDeviceClass II1
3 Aug 2023Vegetal Vigra, 200mg capsules, 8-count bottle, Manufacturer: Hand-shaking (Int'l) Corp. USA ADD: Hand-shaking Mansion, the 5th Ave., Stanford, USA. UPC 8 931028 556885 Event 92892APG SEVEN, INCDrugClass I1
2 Aug 2023Rasagiline Tablets 0.5mg, 30-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A., NDC 0378-1270-93Aurobindo Pharma USA Inc.DrugClass II1
1 Aug 2023COOLIEF RF Generator is an 80-watt Radio-Frequency (RF) Generator with four independent RF channels, allowing all RF channels to be activated individually or altogether. The system is controlled via a touch screen interface display that includes user controls, alarm messages, and on-screen selection of lesioning…Avanos Medical, Inc.DeviceClass II1
1 Aug 2023GS70 Salus Surgical Table, Product Code 18-070-70Skytron, LLCDeviceClass II2
1 Aug 2023Ruby Mountain Spring Water 3 and 5 gallon plastic water jugs Event 92809RUBY MOUNTAIN SPRING WATERFoodClass III1
31 Jul 2023Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-UC-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-UC-0800-52, 0998-00-0800-53, 0998-UC-0800-53, 0998-00-0800-55, 0998-UC-0800-55,…Datascope Corp.DeviceClass I2
31 Jul 2023Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-UC-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-UC-0800-52, 0998-00-0800-53, 0998-UC-0800-53, 0998-00-0800-55, 0998-UC-0800-55, 0998-00-0800-65Datascope Corp.DeviceClass I2
31 Jul 2023Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-UC-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-UC-0800-52, 0998-00-0800-53, 0998-UC-0800-53, 0998-00-0800-55, 0998-UC-0800-55, 0998-00-0800-65Datascope Corp.DeviceClass II2
31 Jul 2023Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-UC-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-UC-0800-52, 0998-00-0800-53, 0998-UC-0800-53, 0998-00-0800-55, 0998-UC-0800-55, 0998-00-0800-65Datascope Corp.DeviceClass I2
31 Jul 2023Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-UC-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-UC-0800-52, 0998-00-0800-53, 0998-UC-0800-53, 0998-00-0800-55, 0998-UC-0800-55, 0998-00-0800-65Datascope Corp.DeviceClass I2
31 Jul 2023Perifix / Epidural anesthesia set, medicatedB. Braun Medical, Inc.DeviceClass II1
31 Jul 2023Magnifuse Bone Graft, Large, Size: 14mm x 25mm, REF 7509014, Human Tissue, Demineralized Bone Matrix, sterile.Medtronic Sofamor Danek USA IncDeviceClass II1
28 Jul 2023Moore Family Farms and Creamery Cheddar Cheese Curds, 1 lb plastic bag.Name withheldFoodClass II4
27 Jul 2023Olympus Distal Attachment (in Olympus Disposable EMR Kit)- Designed to be attached to the distal end of the endoscope. Disposable EMR Kit: K-001, K-002, K-003, K-004, K-011, K-012Aomori Olympus Co., Ltd.DeviceClass II2
27 Jul 2023EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190VOlympus Corporation of the AmericasDeviceClass II1
27 Jul 2023Olympus Bronchovideoscope, Models BF-1T150, BF-1T60, BF-MP60, BF-P150, BF-P60, BF-PE2, BF-TE2, BF-XT160.Olympus Corporation of the AmericasDeviceClass II15
27 Jul 2023PASCAL Precision Transcatheter Valve Repair System, Models: 20000ISM and 20000ISEdwards Lifesciences, LLCDeviceClass II1
26 Jul 2023M/L Taper Hip Prosthesis Extended Offset, Reduced Neck Length, Size 4 (Item Number 00771100640) and Size 6 (Item Number 00771100440)Zimmer, Inc.DeviceClass II1
26 Jul 2023Link OptiStem Rasp Handle-Used with the OptiStem Rasp to prepare the femoral medullary canal for a knee prosthesis implant during a total knee arthroplasty surgical procedure Item Number: 17-5220/01Waldemar Link GmbH & Co. KG (Mfg Site)DeviceClass II1
26 Jul 2023Hamilton-C1, REF: 161001, Portable Intensive Care VentilatorHamilton Medical, Inc.DeviceClass I6
25 Jul 2023Membrane Changer Single-Use, REF MC, each package contains 3 changers; Membrane Changer Reloadable, REF MC-R, each package contains 3 changers; and Membrane Changer Insert, REF MC-I, each package contains 5 inserts. All are components of the Sentec Digital Monitoring System (SDMS).SenTec AGDeviceClass II1
25 Jul 2023ZVU Functional GI Software, REF: ZVU-3Diversatek HealthcareDeviceClass III1
24 Jul 2023Cook Lead Clipper- An auxiliary tool indicated for use in patients requiring percutaneous retrieval of cardiac leads. Order Number (GPN): G20003 Reference Part Number (RPN): LR-CLP001 Event 92791Cook Vandergrift, Inc.DeviceClass II1
24 Jul 2023Trader Joe's Almond Windmill Cookies Buttery, tender cookies topped with crunchy almonds. Net Wt. 15 oz.Fantasy Cookie CorporationFoodClass II2
21 Jul 2023Keystone Bosworth Copaliner Cavity Varnish .5oz (14 ml)- Intended to provide a marginal seal between the dentin and amalgam which helps to protect against penetration of amalgam into the dentina Item No. 0921526Keystone IndustriesDeviceClass II1
21 Jul 2023Cooperstown Cheese Company 1. Jersey Girl 2. Toma Celena 3. Abbie 4. SK 5. Jersey Girl with garlic/rosemary 6.Jersey Girl spring onion 7. Bobby s got the Blues 8.Toma Torino 9. Jersey Gold with garlic 10. Abbie. 11. Jersey Gold 12. Marielle Event 92753Cooperstown Cheese Company, LLCFoodClass II1
20 Jul 2023Visera Hysterovideoscope Olympus HYF Type VOlympus Corporation of the AmericasDeviceClass II1
20 Jul 2023PHOROPTOR VRX DIGITAL REFRACTION SYSTEM-Digital refractor intended for the subjective measurement of the refractive error of the eye. MODEL NUMBER: 16242 [Model 16241 is the base model. Model 16242 includes an additional prism feature used for the measurement of ocular deviation in patients with latent or manifest… Event 92805Reichert, Inc.DeviceClass II1
20 Jul 2023For intraventricular indications mainly used for operations within the brain ventricles. Product Code: FF399RAesculap Implant Systems LLCDeviceClass II1
20 Jul 2023Mehlenbacher's Taffy, 1.25 oz per piece, 36 pieces/box, cello wrapped. Watermelon UPC 022099174004. Storage in a cool dry place.Name withheldFoodClass II3
19 Jul 2023Allura Xper seriesPhilips Medical Systems Nederland B.V.DeviceClass II3
19 Jul 2023The following items sold at Stop & Shop stores located in the New York Metro Region: Natures Promise Lemonade Natures Promise Orange Natures Promise Tangerine Harmless Harvest Coconut Water Organic Natalies Guava Lemonade Natalies Lemonade Natalies Guava Lemonade Natalies Strawberry Lemonade So Good Grapefruit So…C & S Wholesale Grocers Inc.FoodClass II8
19 Jul 2023Sodium Nitrite, Granular Super Free-Flowing Food Grade, 50lb polyethylene and paper bags - 50 per pallet Event 92733Chemtrade Solutions, LLCFoodClass II1
18 Jul 2023PORTEX 0.5u HYDROPHOBIC DISC FILTER, REF 002291 - Bacterial/Viral filterSmiths Medical ASD Inc.DeviceClass II1
18 Jul 2023Proclaim XR 5 Implantable Pulse Genterator REF 3660 (previously known as Proclaim" 5 Elite IPG) Model 3660 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with up to 16 electrodes total. It is powered by a hermetically…Abbott MedicalDeviceClass I7
18 Jul 2023Fosfomycin Tromethamine Granules for Oral Solution, 3 g single- dose sachet, Rx only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC# 67877-749-57Ascend Laboratories, LLCDrugClass III1
17 Jul 2023RayCare software, include version number 5A, 5B, 6A, including service packs-An oncology information system used to support workflows and scheduling, as well as clinical information, planning and treatment management for oncology care. Model Numbers: 5.0.0, 5.0.1, 5.1.1,5.1.2, 5.1.3, 6.0.0RAYSEARCH LABORATORIES ABDeviceClass II1
14 Jul 2023COPAN REF: 2U045S01 300uL Transfer Pipette Individually wrapped pipettes, 1000 pcs. Event 92832Copan Diagnostics IncDeviceClass II1
13 Jul 2023The Chevalier Valvulotome is a device used to disrupt the valves of veins which are to be used as grafts in the in situ or non-reversed bypass procedure. The Chevalier Valvulotome consists of a 70 cm stainless steel shaft with two tips: 1) the cutting tip is shaped like an inverted tulip with four teeth at its base.…LeMaitre Vascular, Inc.DeviceClass II1
13 Jul 2023ACL TOP Family 50 Series Models as follows: In vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis (1) ACL TOP 550 CTS Model Number: 00000280045; (2) ACL TOP 750 CTS Model Number: 00000280055; (3) ACL TOP 350 CTS…Instrumentation LaboratoryDeviceClass II1
13 Jul 2023ACUSON Redwood 2.0 ultrasound systems, REF: 11503314Siemens Medical Solutions USA, Inc.DeviceClass II1
12 Jul 2023Beckman Coulter, IVD, REF: OSR61171, IgA, 4 x 14 mL R1, 4 x 11 mL R2Beckman Coulter Inc.DeviceClass II1
12 Jul 2023nanoDot D2DNS, for custom calibrate, OTO, Model Number 03033-OTO; radiation monitoring dosimeter used with the microSTAR readersLandauerDeviceClass II38
10 Jul 2023SurgiCount+ Software Application-indicated as an adjunctive technology for augmenting the manual process of counting, displaying and recording the number of RFID-tagged absorbent articles used during surgical procedures Product Code: 0694-002-090;Stryker CorporationDeviceClass II1
10 Jul 2023Atellica CH Total Bilirubin_2 -In vitro diagnostic use in the quantitative determination of total bilirubin in human serum and plasma (lithium heparin) of adults and neonates Test Code: TBil_2 Siemens Material Number (SMN): 11097531Siemens Healthcare Diagnostics, Inc.DeviceClass II4
7 Jul 2023LIF AMP, Adjustable Awl, REF 117-165, Part of the AMP System. Used with Spine Lateral Interbody Systems, IdentiTi LIF, Transcend LIF and Battalion LLIF,Alphatec Spine, Inc.DeviceClass II1
7 Jul 2023Five S 5 3x65, REF: 0915612-06, sterile for single use, Sterile EO, Rx Only Event 92796Name withheldDeviceClass II1
7 Jul 2023ASG-001; Ultrasound gelAdvance Medical Designs, Inc.DeviceClass II6
6 Jul 2023APK2 Pressure-Sensing Wheelchair CushionsAquila CorporationDeviceClass II2
30 Jun 20233D9-3v Transducer, accessory to Philips Ultrasound Systems: EPIQ Elite; Affiniti 30, 50, and 70; ClearVue 850; HD15; iU22; and Compact 5000Philips Ultrasound, Inc.DeviceClass II1
30 Jun 2023Wireless Foot Switch distributed with Philips Allura Xper and Azurion Interventional Fluoroscopic X-Ray SystemsPHILIPS MEDICAL SYSTEMS NEDERLAND B.V.DeviceClass II1
30 Jun 2023LifeSPARC Pump (part number 5800-0000) contained within TandemLife LifeSPARC Priming Tray part number: 5800-1000. Note: The 5800-1000 model number is an individually packaged component contained within the Kit numbers: 5830-2916 LS TANDEMLIFE KIT DL29 5840-2417 LS TANDEMLIFE KIT - V24, A17Cardiac Assist, IncDeviceClass II1
26 Jun 2023ISee Ortho-K LensPARAGON VISION SCIENCES, IncDeviceClass II2
26 Jun 2023Cream Cheese Rangoon NET WT: 5.00 LB. (2.26 KG) CT/CS: 100 PS (5 TRAYS X 20 PCS UPC: (01)10664383187016(15)112823(10)0601233A1W package in corrugated cardboard case. Event 92665Pegasus Foods, Inc.FoodClass II1
16 Jun 2023Parent's Choice brand Sensitivity Premium Infant Formula, 638g, packaged in plastic tubs; and Tippy Toes brand Sensitivity Premium Infant Formula, 942g, packaged in composite cansPBM Nutritionals, LLCFoodClass III1
7 Jun 2023BeamAdjust software Version 2.3.3 Ref: S080032 The following devices are affected when a relative calibration is performed using ArrayCal (module from BeamAdjust S080032, UDI-DI: EPTWS0800320 ): " OCTAVIUS Detector 1600 SRS (T10056) (UDI-DI: EPTWT100560) " OCTAVIUS Detector 1600 MR (T10057) (UDI-DI: EPTWT100570) "…PTW-FREIBURGDeviceClass II1
1 Jun 2023epoc BGEM BUN Test Card with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1Siemens Healthcare Diagnostics IncDeviceClass II3
25 Apr 2023FILMARRAY Gastrointestinal (GI) Panel (Part No.: RFIT-ASY-0104 & RFIT-ASY-0116) Pouch Module SoftwareBioFire Diagnostics, LLCDeviceClass II1
10 Apr 2023Henry Schein Hard Line Chairside Reline kit-Resilient Acrylic Denture Relining Material KI Item No.: 0921940HS Henry Schein Item No.: 570-0718Keystone IndustriesDeviceClass II1
28 Feb 2023Omnipod 5 Automated Insulin Delivery SystemInsulet CorporationDeviceClass II1
27 Jan 2023Atellica CH LDL Cholesterol Direct (DLDL)-In vitro diagnostic quantitative determination of LDL cholesterol in human serum and plasma (lithium heparin) using the Atellica CH Analyzer. SMN: 11097632Siemens Healthcare Diagnostics, Inc.DeviceClass II4
5 Oct 2020TyTek Tension Pneumothorax Access Kit TPAK 14 gauge 3.25 inch- Intended for introduction into the body to facilitate removal of air from the pleural cavity in patients with a tension pneumothorax Model Number: TM-303Tytek Medical IncDeviceClass II3

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

Sources

NHTSA recall file through
29 Sep 2026
Newest CPSC recall on the register
24 Sep 2026
openFDA export date
28 Sep 2026

How the register is made. Data sources and licences.

Questions

Which NHTSA campaign of September 2023 has the most units?
Campaign 23V652000, with 1,730,192 units. NHTSA received the report on 25 Sep 2023.
Which CPSC recall of September 2023 has the most units?
CPSC recall 23294, with about 680,000 units. The CPSC title is: Shimano Recalls Cranksets for Bicycles Due to Crash Hazard
How many FDA recalls of September 2023 are in Class I?
17 of the 122 FDA enforcement events with a report date in September 2023.
Which date puts a recall in September 2023?
For NHTSA, the date NHTSA received the report. For CPSC, the recall date. For FDA, the first report date of the event.