Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

10876–10900 of 13748

HighFDA (Devices)·Z-0098-2023·2022-10-26
Synthes Orthopedic Implant Drill Kit Recall: Incorrect Drill Guide Size
Synthes (USA) Products LLC is recalling 81 SPEEDSHIFT20x20x20 Offset 10mm Implant Drill Kits nationwide due to incorrect drill guide sizing. The defect could result in bone damage and incorrectly placed drill holes during orthopedic surgery.
Product
SPEEDSHIFT20x20x20 Offset 10mm Implant Drill Kit, Product No. SE-2020-10. Used with DePuy Synthes SPEEDSHIFT Continuous Compression Staple Implants for bone fixation and management of fracture and reconstructive surgery.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0102-2023·2022-10-26
ARROW Midline Catheter Kit Mislabeled with Wrong Device Type
ARROW INTERNATIONAL Inc. is recalling an ARROW Pressure Injectable Arrowgard Blue Advance Midline Catheter Kit due to mislabeling. The package labels incorrectly specify a double-lumen 5.5 French catheter, but the kit contains a single-lumen 4.5 French catheter.
Product
ARROW Pressure Injectable Arrowg+ard Blue Advance Two-Lumen Midline Kit, 5.5 Fr, 15 cm, .018 Inch dia., REF ASK-41552-JHVA1. For peripheral access to the venous system for intravenous therapy, blood sampling, infusion, and pressure injection of contrast media.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0110-2023·2022-10-26
Oral Tip Syringes Recalled Due to Unapproved Plunger Material
Medicina Oral Tip Syringes are being recalled because the plunger component was made with polyethylene instead of the approved polypropylene material. No illnesses or injuries have been reported.
Product
Medicina Oral Tip Syringe 1ml Code: OT01
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0097-2023·2022-10-26
Medical Device Recall: Roche cobas 5800 False Results Due to Baseline Anomalies
Roche Molecular Systems recalls the cobas 5800 PCR testing instrument due to false positive and invalid results caused by anomalous baselines. This may lead to erroneous or delayed diagnoses.
Product
cobas 5800 instrument, Material No. 08707464001. Used for automated Polymerase Chain Reaction (PCR) based Nucleic Acid Testing (NAT) in laboratory settings.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0101-2023·2022-10-26
DePuy Synthes Hammertoe Implants Recalled for Incorrect Drill Guide Size
Synthes (USA) Products LLC is recalling 196 DePuy Synthes Hammertoe Continuous Compression Implants due to an incorrect drill guide size that will not properly prepare bone for the implant, creating potential for bone damage.
Product
DePuy Synthes Hammertoe Continuous Compression Implants, Product No. 46.239.001
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0113-2023·2022-10-26
Reusable Oral Syringe Recalled for Unapproved Plunger Material
Medicina UK Ltd is recalling Reusable Oral Syringes because plungers were manufactured from unapproved polyethylene instead of the specified polypropylene material.
Product
Medicina Reusable Oral syringe 5ml Code: OTH05
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0105-2023·2022-10-26
Medical device assay may report falsely elevated lithium levels
Siemens' Atellica CH Lithium diagnostic assay may falsely report elevated lithium levels, potentially leading to incorrect dose adjustments in patients on lithium therapy.
Product
Atellica CH Lithium (Li), Siemens Material Number 11097535. in vitro diagnostic assay
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0091-2023·2022-10-26
IV Extension Sets Recalled for Bonded Joint Failure and Leakage Risk
B. Braun extension sets (Product Code 470169) are recalled due to high probability of bonded joint failure, which may cause leakage or detachment during use, risking bloodstream infections and medication exposure.
Product
Extension Set, EXT SET W/CARESITE, 6IN., Product Code 470169, 50 units per carton. A6 Access Device is a valve intended for the aspiration, injection or gravity/pump flow of IV fluids and blood upon insertion of a male luer connector.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0103-2023·2022-10-26
Optima Coil System Pouch Labels Do Not Match Carton Labels
BALT USA is recalling Optima Coil System models OPTI0208CSS10 and OPTI0308CSS10 due to a labeling discrepancy where pouch labels do not match carton labels. These endovascular devices require verification before use.
Product
Optima Coil System Model Number OPTI0208CSS10, Model Number OPTI0308CSS10. Used in endovascular procedures.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0108-2023·2022-10-26
Medicina ENFit Enteral Syringes Recalled for Incorrect Plunger Material
Medicina Uk Ltd is recalling Medicina ENFit 5ml Reusable Enteral Syringes because the plunger component was manufactured with polyethylene instead of the specified polypropylene material.
Product
Medicina ENFit 5ml Reusable Enteral Syringe Code: LHE05
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0001-2023·2022-10-19
Jiangsu Well Biotech COVID-19 test kits distributed without FDA authorization
Approximately 620,000 COVID-19 rapid test devices were distributed in the U.S. without FDA Emergency Use Authorization or approval. Consumers should not use these unauthorized test kits.
Product
Jiangsu Well Biotech Co.,Ltd. AND SDI LABS COVID-19 Ag Rapid Test Device - Cat#: CO-02
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-0041-2023·2022-10-19
Hobbs Medical Recalls Biliary Stent Kits Due to Mislabeled Expiration Dates
Hobbs Medical, Inc. is recalling Biliary Pigtail Stent Kits with incorrect expiration dates displayed on device labels. Affected devices distributed from March 2018 through September 2020 may be used beyond their validated shelf life.
Product
Hobbs Biliary Pigtail Stent Kits (contains 3412) Catalog Number: 6027
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0036-2023·2022-10-19
Hobbs Retrieval Forceps Recalled for Incorrect Expiration Dates
Hobbs Medical is recalling Retrieval Forceps with incorrect expiration dates on device labels. Affected devices distributed between March 2018 and September 2020 may be used past their actual expiration.
Product
Hobbs Retrieval Forceps Catalog Number: 5018
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0055-2023·2022-10-19
Freeman Pancreatic Flexi-Stent Recalled for Incorrect Expiration Date
Hobbs Medical recalled Freeman Pancreatic Flexi-Stents due to incorrect expiration dates on device labels. The mislabeled dates extend shelf life, potentially allowing use of expired devices.
Product
Freeman Pancreatic Flexi-Stent Catalog Number: 6533
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0025-2023·2022-10-19
Hobbs Posi-Stop Injection Needle recalled for incorrect expiration date labeling
Hobbs Medical recalled Posi-Stop Injection Needles with incorrect expiration dates on labels, potentially allowing use of units past actual expiration. The recall affects 17 units distributed in the US and several countries.
Product
Hobbs Posi-Stop Injection Needle Catalog Number: 4722
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0024-2023·2022-10-19
Hobbs Posi-Stop Injection Needles Recalled for Incorrect Expiration Date Labeling
Hobbs Medical, Inc. is recalling Posi-Stop Injection Needles with lot numbers ending in 'R' due to incorrect expiration dates on device labels. The mislabeling extends the apparent shelf life, potentially allowing use of expired sterile devices.
Product
Hobbs Posi-Stop Injection Needle Catalog Number: 4720
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0031-2023·2022-10-19
Hobbs Helical Retrieval Basket recalled for incorrect expiration date
Hobbs Medical recalled 10 units of its Helical Retrieval Basket due to mislabeled expiration dates that extend the product's shelf life, affecting devices distributed in the US and select countries between 2018 and 2020.
Product
Hobbs Helical Retrieval Basket Catalog Number: 4824
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0053-2023·2022-10-19
Freeman Pancreatic Flexi-Stent Kits Recalled for Incorrect Expiration Dates
Hobbs Medical recalls Freeman Pancreatic Flexi-Stent Kits due to labeling errors showing incorrect expiration dates that extend the shelf life of affected devices.
Product
Freeman Pancreatic Flexi-Stent Kit (containing 6567) Catalog Number: 6519
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0087-2023·2022-10-19
PET/CT imaging system loses vital signs data in strong Wi-Fi environments
Certain PET/CT imaging systems may lose vital sign monitoring due to Wi-Fi interference, potentially requiring patient rescans.
Product
Positron Emission Tomography and Computed Tomography System, Model: uMI 550
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-0039-2023·2022-10-19
Hobbs Biliary Pigtail Stent Kits recalled for incorrect expiration date
Hobbs Medical recalls biliary stent kits with incorrect expiration dates that extend shelf life. The kits were distributed from 2018 to 2020 in the US and select countries.
Product
Hobbs Biliary Pigtail Stent Kits (containing 6105) Catalog Number: 6023
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0062-2023·2022-10-19
Freeman Pancreatic Flexi-Stent recalled for incorrect expiration date labeling
Hobbs Medical is recalling Freeman Pancreatic Flexi-Stent devices due to incorrect expiration dates on product labels. The labeling error extends the stated shelf life, potentially allowing use of degraded devices.
Product
Freeman Pancreatic Flexi-Stent Catalog Number: 6567
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0043-2023·2022-10-19
Hobbs Biliary Pigtail Stent Kits Recalled for Incorrect Expiration Dates
Hobbs Medical is recalling Biliary Pigtail Stent Kits due to incorrect expiration dates on device labels that extend shelf life, affecting 15 units distributed from March 2018 to September 2020.
Product
Hobbs Biliary Pigtail Stent Kits Catalog Number: 6104
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0081-2023·2022-10-19
Prismaflex M Set Recall for Mistranslated Weight Restriction Instructions
Baxter Healthcare is recalling Prismaflex M Sets (524,376 devices nationwide) due to a mistranslation in instructions for use that provides contradictory patient body weight restrictions for renal replacement therapy.
Product
Prismaflex M Set: M60 (product code 106696), M100 (product code 106697). For use in providing continuous fluid management and renal replacement therapies.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0034-2023·2022-10-19
Hobbs Medical Grasping Forceps Recalled for Incorrect Expiration Date Labeling
Hobbs Medical, Inc. is recalling Grasping Forceps due to incorrect expiration dates on device labels. Affected devices may be used beyond their safe shelf life if the mislabeled expiration dates are not corrected.
Product
Hobbs Medical Grasping Forceps Catalog Number:5004
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0084-2023·2022-10-19
Prismaflex ST Renal Therapy Sets Recalled for Mistranslated Safety Instructions
Baxter Healthcare is recalling 1,068,560 Prismaflex ST renal replacement therapy sets nationwide. The recall is due to a mistranslation in the Estonian instructions that contains contradictory information about patient weight restrictions.
Product
Prismaflex ST Set: ST60 (product code 107643), ST100 (product code 107636), ST150 (product code 107640). For use in providing continuous fluid management and renal replacement therapies.
Category
Medical Device
Distribution
Distributed nationwide

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10876–10900 of 13748