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 the agency’s own highest classification or reported deaths or serious injuries, 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

22151–22175 of 90081

SevereFDA (Drugs)·D-0080-2023·2022-12-21
FDA Recalls Sodium Bicarbonate Injection Vials for Glass Breakage Risk
Exela Pharma Sciences is recalling Sodium Bicarbonate Injection vials due to defective containers that may break and release glass fragments when pressurized during preparation. The recall affects 37,320 vials distributed nationwide.
Product
8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, packaged in cartons of 20 vials, Rx Only, Mfd for: Civica, Inc. Lehi, Utah 84043, Mfd by: Exela Pharma Sciences, LLC, Lenoir, NC 28645, Carton NDC 72572-740-20, vial NDC 72572-740-1.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0086-2023·2022-12-21
Injectable iohexol syringes recalled for mislabeled iodine strength
BayCare Integrated Service Center is recalling 250 iohexol injection syringes mislabeled as 300 mg iodine/mL but actually containing 350 mg iodine/mL. The labeling error could result in dosing mistakes.
Product
Iohexol (300 mg Iodine/mL), 2.4 g Iodine/8 ml, Total Volume 8 ml in 10 ml syringe, 5-count syringes packaged in a bag labeled as Omnipaque (iohexol) 300 mg I/mL, 2.4g Iodine/8 mL in a 10 mL syringe, Compounded with GE Healthcare product, Each mL contains (647 mg) of iohexol as…
Category
Drug
Distribution
1 state
SevereFDA (Devices)·Z-0455-2023·2022-12-21
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump Recalled for Short Battery Run-Times
Arrow International is recalling Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump devices worldwide due to a potential issue with short battery run-times.
Product
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-05001 (IPN000333), cardiac pump
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-0426-2023·2022-12-21
Arrow AutoCAT2 Intra-Aortic Balloon Pump recalled for short battery run-times
Arrow International is recalling 1,394 units of the Arrow AutoCAT2 Intra-Aortic Balloon Pump worldwide due to a potential issue with short battery run-times.
Product
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT 2 IAPB, REF IAP-0400 (IPN000302), cardiac pump
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-0456-2023·2022-12-21
Intra-Aortic Balloon Pump Recalled for Potential Battery Run-Time Issue
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump devices are being recalled worldwide due to a potential issue with short battery run-times. Healthcare providers and patients should contact the manufacturer for guidance.
Product
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500J (IPN000334), cardiac pump
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-0432-2023·2022-12-21
Arrow AutoCAT2 Intra-Aortic Balloon Pump Battery Runtime Recall
The Arrow AutoCAT2 intra-aortic balloon pump has been recalled due to potential short battery run-times. This Class I recall affects devices distributed worldwide.
Product
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT2 WAVE REFURBISHED, REF IAP-0535X (IPN000329), cardiac pump
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-0427-2023·2022-12-21
Arrow AutoCAT2 Intra-Aortic Balloon Pump: Short Battery Run-Time Issue
Arrow International is recalling 6 refurbished Arrow AutoCAT2 intra-aortic balloon pumps worldwide due to a potential issue with battery run-times. The affected devices may not operate for sufficient duration during medical use.
Product
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 IAPB, REFURBISHED, REF IAP-0400X (IPN000311), cardiac pump
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-0433-2023·2022-12-21
Arrow AutoCAT2 Intra-Aortic Balloon Pump Recalled for Battery Run-Time Issue
Arrow International is recalling the AutoCAT2 Intra-Aortic Balloon Pump worldwide due to a potential issue with short battery run-times. All lot and serial numbers are affected.
Product
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/EMEA, REF IAP-0600 (IPN001108), cardiac pump
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-0453-2023·2022-12-21
Intra-Aortic Balloon Pump Recalled for Potential Short Battery Runtime
The Arrow AutoCAT2WAVE intra-aortic balloon pump is recalled due to a potential issue with short battery run-times. The FDA Class I recall affects 4 units distributed worldwide.
Product
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500NL (IPN000326), cardiac pump
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-0444-2023·2022-12-21
Arrow AutoCAT 2 Intra-Aortic Balloon Pump Short Battery Runtime Recall
Arrow International is recalling the Arrow AutoCAT 2 Intra-Aortic Balloon Pump (IABP) due to a potential issue with short battery run-times. The recall affects 29 units distributed worldwide.
Product
Arrow AutoCAT 2 Intra-Aortic Balloon Pump, Arrow AutoCAT 2 IABP, REF IAP-0400E (IPN000305), cardiac pump
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-0430-2023·2022-12-21
Arrow AutoCAT2 Intra-Aortic Balloon Pump short battery run-time issue
Arrow International is recalling 88 units of Arrow AutoCAT2 Intra-Aortic Balloon Pumps worldwide due to a potential issue with short battery run-times. Affected cardiac support devices may not operate reliably.
Product
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 WAVE REFURBISHED, REF IAP-0500X (IPN000328), cardiac pump
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-0441-2023·2022-12-21
Arrow AC3 Optimus Intra-Aortic Balloon Pumps recalled for short battery runtime
Arrow International is recalling Arrow AC3 Optimus Intra-Aortic Balloon Pumps worldwide due to a potential issue with short battery run-times. The pumps may not operate for the intended duration during critical cardiac care.
Product
Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/AJLA, REF IAP-0701 (IPN001113), cardiac pump
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0718-2023·2022-12-21
Siemens allergy test kits recalled for false mold allergen reactivity results
Siemens Healthcare Diagnostics is recalling 560 allergy diagnostic kits (Lot 565) due to potential for falsely elevated mold allergen reactivity, which may result in incorrect test results.
Product
IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests Japan Siemens Material Number (SMN): 10711939 For the quantitative measurement of allergen-specific IgE in human serum, as an aid in the clinical diagnosis of IgE mediated allergic disorders.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0557-2023·2022-12-21
Henry Schein Vas Reversal Pack Surgical Kit Recalled for Incomplete Seal
A surgical procedure kit is being recalled due to manufacturing conditions that may result in an incompletely sealed outer bag, potentially compromising sterility. Affected kits were distributed in the US and Canada.
Product
HENRY SCHEIN, Vas Reversal Pack, Item No.888-2549,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0510-2023·2022-12-21
Stradis Medical gynecological surgical kit recalled due to potential sterility breach
Stradis Medical is recalling Henry Schein GYN Pack surgical kits with potentially incompletely sealed outer bags that may compromise sterility. The affected kits were distributed nationwide in the US and Canada.
Product
HENRY SCHEIN, GYN PACK, Item No.570-2625
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0526-2023·2022-12-21
Surgical procedure kit recalled due to incompletely sealed outer bag
A HENRY SCHEIN extremity pack surgical kit is being recalled because its outer bag may not be completely sealed, which could compromise the sterility of the kit. Affected units were distributed nationwide in the US and Canada.
Product
HENRY SCHEIN, EXTREMITY PACK, Item No.570-2946
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0495-2023·2022-12-21
Dental surgical kits recalled due to incomplete outer bag sealing
Stradis Healthcare is recalling dental surgical procedure kits due to manufacturing issues that may result in incompletely sealed outer bags, potentially compromising kit sterility.
Product
STRADIS HEALTHCARE, DENTAL CUSTOM PACK, Item No.41137TDS,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0712-2023·2022-12-21
DeRoyal Cataract Pack Surgical Kit Class II Recall
DeRoyal Industries has recalled the DeRoyal CATARACT PACK (368 kits) in a voluntary Class II recall. Affected lot numbers are 55990451 and 56615717 with expiration 08/01/2024.
Product
DeRoyal CATARACT PACK, REF 89-9241.03
Category
Medical Device
Distribution
23 states
HighFDA (Devices)·Z-0651-2023·2022-12-21
Medical device shoulder pack recalled by DeRoyal Industries
DeRoyal Industries recalled 48 units of its shoulder pack medical device (Lot 57755295) on November 3, 2022. The specific reason for the recall was not disclosed in available documentation.
Product
DeRoyal SHOULDER PACK, REF 89-9449.13
Category
Medical Device
Distribution
23 states
HighFDA (Devices)·Z-0554-2023·2022-12-21
Angio Pack surgical trays recalled for incomplete sealing and sterility breach
Stradis Healthcare is recalling Angio Pack surgical trays due to manufacturing defects that may leave the outer bag incompletely sealed, compromising product sterility. Affected units were distributed nationwide in the US and Canada.
Product
STRADIS HEALTHCARE, Angio Pack, Item No.686-199,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0505-2023·2022-12-21
Surgical Pain Tray Outer Bag May Not Be Properly Sealed
Stradis Healthcare is recalling Henry Schein Surgical Pain Trays due to potential incomplete sealing of outer bags, which may compromise sterility. Healthcare providers and facilities should stop using affected trays and contact their supplier for replacement.
Product
HENRY SCHEIN, SURGICAL PAIN TRAY, Item No.570-1482
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0515-2023·2022-12-21
Medical and Surgical Procedure Trays Recalled Due to Incomplete Sealing
Stradis Medical is recalling medical and surgical procedure kits with potentially incompletely sealed outer bags that may compromise sterility. Affected healthcare facilities should stop using these kits immediately.
Product
HENRY SCHEIN, OMFS, Item No.570-2779,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0529-2023·2022-12-21
Surgical Procedure Kits Recalled Due to Incomplete Outer Bag Sealing
Stradis Healthcare is recalling Henry Schein Custom PK 2 surgical procedure kits due to manufacturing defects that may result in incomplete outer bag sealing, potentially compromising sterility. The recall affects 27 units distributed nationwide in the US and Canada.
Product
HENRY SCHEIN, CUSTOM PK 2, Item No.570-3072
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0503-2023·2022-12-21
Medical Trays Recalled for Potentially Compromised Sterility from Incomplete Sealing
Stradis Medical is recalling 800 units of HENRY SCHEIN Vein Clinics 1 surgical trays because the outer bag may be incompletely sealed, potentially compromising sterility. No infections have been reported.
Product
HENRY SCHEIN, Vein Clinics 1, Item No.570-1426
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0692-2023·2022-12-21
FDA Class II Recall of DeRoyal Posterior Spine Surgical Packs
DeRoyal Industries voluntarily recalled 1,196 posterior spine surgical packs distributed across 23 states. The specific reason for the recall was not documented.
Product
DeRoyal CMC POSTERIOR SPINE PACK, REF 89-10570.01
Category
Medical Device
Distribution
23 states

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22151–22175 of 90081