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

12001–12025 of 40095

ModerateFDA (Devices)·Z-1596-2022·2022-08-31
FDA Recalls Heparin Sodium Prefilled Syringes Due to Heat Damage
Mckesson Medical-Surgical Inc. is recalling Excelsior Heparin Sodium prefilled syringes that may have been damaged by temperature excursions during manufacturing, potentially affecting their effectiveness. The recall covers lots received between June and September 2021.
Product
Excelsior Heparin Sodium, Porcine, Preservative Free 100 U / mL Solution Prefilled Syringe, Partial Fill 5 mL Fill in 10 mL Syringe Model Number: 513604
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1611-2022·2022-08-31
IV Securement Kit Recall Due to Storage Temperature Damage
McKesson is recalling Medline Centurion IV Securement Kits that were exposed to high temperatures during storage, which may have impacted product effectiveness. No illnesses have been reported.
Product
MEDLINE INDUSTRIES Centurion IV Securement Kit Model Number: IVSSTK3
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1612-2022·2022-08-31
Fischer Cone Biopsy Excisor recalled for potential temperature damage
McKesson is recalling Fischer Cone Biopsy Excisor Model 900-157 units because temperature excursions during storage may have compromised product effectiveness.
Product
Fischer Cone Biopsy Excisor EXCISOR, CONE FISCHER BIOPSY WD ANGL SM (5/BX) Model Number: 900-157
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1619-2022·2022-08-31
McKesson Medefil Normal Saline IV Flush Syringes Recalled for Temperature Exposure
McKesson is recalling Medefil Normal Saline IV Flush Syringes (Models MIS-1130 and 191-MIS-1130) due to facility temperature excursions between June and August 2021. Products received through September 30, 2021 may have impaired effectiveness from temperature exposure prior to delivery.
Product
a. Medefil Normal Saline IV Flush Syringe NORMAL SALINE FLUSH, SYR 10ML/12ML (60/BX 16BX/CS), Model Number: MIS-1130. b. MEDEFIL INC McKesson SALINE IV FLUSH, SYR NORMAL 10ML/12ML .9% (60/BX 16BX/CS) Model Number: 191-MIS-1130.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1624-2022·2022-08-31
Fisher Scientific Sure-Vue Pipette Recall Due to Temperature Exposure
Mckesson Medical-Surgical is recalling Fisher Scientific Sure-Vue RPR Dispensing Pipettes due to temperature excursions during storage from June to August 2021. Exposure to higher temperatures may have impacted product effectiveness.
Product
FISHER SCIENTIFIC Sure-Vue PIPETTE, RPR DISPENSING (500/PK) Catalog # 23038015
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1614-2022·2022-08-31
McKesson and Metrex Research Glutaraldehyde Disinfectants Recalled Due to Temperature Excursion
McKesson and Metrex Research are recalling glutaraldehyde disinfectants due to facility temperature excursions from June to August 2021 that may have reduced product effectiveness. Affected lots were distributed nationwide between June 1 and September 30, 2021.
Product
a. McKesson DISINFECTANT, GLUTARALDEHYDE 28DAY (4GL/CS) MGM68, Model Number: 68-102800. b. METREX RESEARCH McKesson 14-Day Glutaraldehyde Solution DISINFECTANT, GLUTARALDEHYDE 14DAY (4GL/CS) MGM68 Model Number: 68-101400. c. METREX RESEARCH McKesson SOLUTION, GLUT 2.5%…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1569-2022·2022-08-31
Anatomical Model Recalled for Wrong Product Shipped in Packaging
Materialise USA LLC is recalling ProPlan CMF Anatomical Model units where packages labeled MU22-INA-DUQ contained the wrong anatomical model inside. Recipients should verify their package contents match the label.
Product
ProPlan CMF Anatomical Model, Maxilla-Cranium, Clear Identification number SD900.208
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1634-2022·2022-08-31
Dynarex Lemon Glycerin Swabs recalled due to temperature exposure
Dynarex lemon glycerin swabs distributed nationwide may have reduced effectiveness due to temperature excursions prior to delivery. All lots received between June 1 and September 30, 2021 are affected.
Product
Dynarex SWAB, LEMON GLYCERIN (3/PK 25PK/BX 10BX/CS) DYNREX Catalog # 1216
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1567-2022·2022-08-31
Stryker SWANSON Finger Joint Implant Incorrect Sizing Label on Carton
Wright Medical Technology is recalling 17 Stryker SWANSON Finger Joint Implants (size 00) due to incorrect sizing labels applied to carton packaging. Devices with lot numbers 1728375 and 1728376 were distributed across multiple US states and internationally.
Product
Stryker SWANSON Flexspan Finger Joint Implant W/O Grommets Silicone, Size: 00, REF 4700020, Sterile.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1635-2022·2022-08-31
Dynarex DynaLube Lubricating Jelly Recalled Due to Temperature Excursions
Mckesson is recalling Dynarex DynaLube lubricating jelly due to facility temperature excursions from June-August 2021 that may have degraded product effectiveness. Recall affects 17.5 boxes distributed nationwide between June-September 2021.
Product
DYNAREX DynaLube LUBRICATING JELLY, STR 2.7GM (144/BX 12BX/CS) Catalog #1250
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1572-2022·2022-08-31
SteriSpine PS surgical screws recalled for patient label mislabeling
FDA recalls 8 SteriSpine PS multi-axial fenestrated screw kits distributed in Maryland due to incorrect labeling on patient documentation. The patient labels list the wrong screw type, though other labeling and the devices themselves are correct.
Product
SteriSpine PS kit of 2 Multi-Axial Fenestrated Screws, model numbers/REF numbers KITM640, KITM645, and KITM740.
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-1603-2022·2022-08-31
DisCide Ultra Surface Disinfectant Recalled Due to Temperature Exposure
McKesson Medical-Surgical's DisCide Ultra Surface Disinfectant Cleaner is being recalled because temperature excursions may have reduced product effectiveness. The recall affects all lots distributed nationwide between June and September 2021.
Product
Palmero Healthcare, LLC DisCide Ultra Surface Disinfectant Cleaner Quaternary Based Manual Pour Liquid 1 gal. Jug Herbal Scent NonSterile Model Number: 3565G
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1576-2022·2022-08-31
Baxter Syringe Tip Caps Recalled Due to Sterile Packaging Barrier Failure
Baxter Healthcare is recalling DISCPAC Syringe Tip Caps due to potential packaging defects that may not maintain sterile barriers. The recall affects approximately 63,190 units distributed worldwide.
Product
Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Orange: a) 25 pack, REF H93867025, b) 100 pack, REF H93867100
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1573-2022·2022-08-31
Mizuho OSI Femoral Hooks Recalled for Incorrect Model Etching
Mizuho OSI is recalling one batch of regular femoral hooks that were etched with an incorrect model designation. The recalled batch contains 13 devices distributed in the United States and Canada.
Product
HANA/PROFx CLASSIC FEMORAL HOOK RIGHT REF 6850-144
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1609-2022·2022-08-31
Medline Catheter Insertion Tray Recalled for Temperature Exposure During Manufacturing
Mckesson Medical-Surgical is recalling Medline catheter insertion trays (Model DYND10160) due to temperature excursions at the manufacturing facility that may have affected product effectiveness. Affected units were distributed nationwide between June and September 2021.
Product
MEDLINE INDUSTRIES Medline Catheter Insertion Tray Medline Foley Without Catheter Without Balloon Model Number: DYND10160
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1605-2022·2022-08-31
Hydrogen Peroxide Disinfectant Recalled for Potential Loss of Effectiveness
Revital-Ox Resert hydrogen peroxide disinfectant 4-liter containers may have reduced effectiveness due to temperature exposure during storage. McKesson is recalling affected lots distributed June-September 2021.
Product
STERIS CORP Revital-Ox Resert Hydrogen Peroxide High-Level Disinfectant Revital-Ox RESERT RTU Liquid 4 Liter Container Max 21 Day Reuse Model Number: 4455AW
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1627-2022·2022-08-31
Medical device swab recall: Fisherbrand SWAB TRANS STUARTS
Mckesson Medical-Surgical initiated a voluntary nationwide recall of Fisherbrand SWAB TRANS STUARTS swabs. The specific reason for the recall is not documented in the FDA notice.
Product
FISHER SCIENTIFIC Fisherbrand SWAB TRANS STUARTS DBL 50BX Catalog #1490721
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1616-2022·2022-08-31
B. Braun Anesthesia Support Tray Temperature Excursion Recall
B. Braun Medical Inc. is recalling Anesthesia Support Trays distributed between June and September 2021 due to temperature excursions during storage that may have affected product effectiveness.
Product
B. BRAUN MEDICAL INC. Anesthesia Support Tray SUPPORT TRAY, +EXT SET(10/CS)ST200E Model Number: 332116
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1574-2022·2022-08-31
Vanta Clinician Programmer Software Cannot Connect with Multiple Implants
The Vanta Clinician Programmer Application may fail to connect with Vanta neurostimulators when a patient has multiple devices implanted. This prevents programming of pain therapy settings in patients with multiple implants.
Product
Vanta Clinician Programmer Application, Model A71200. For programming of the Medtronic Model 977006 Vanta implantable neurostimulators for pain therapy.
Category
Medical Device
Distribution
50 states
ModerateFDA (Devices)·Z-1622-2022·2022-08-31
Dynarex Nail Polish Remover Pads Recalled for Reduced Effectiveness from Heat Exposure
Mckesson Medical-Surgical Inc. is recalling Dynarex Nail Polish Remover Pads due to facility temperature excursions in summer 2021 that may have reduced product effectiveness. All lots received between June 1 and September 30, 2021, nationwide are affected.
Product
Dynarex¿ PAD, NAIL POLISH REMOVER (100/BX 10BX/CS) DYNREX Catalog # 1501
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1587-2022·2022-08-31
McKesson Pregnancy Test Kits Recalled for Temperature Exposure During Storage
McKesson recalls hCG pregnancy test kits nationwide due to facility temperature excursions that may have compromised product effectiveness. Affected lots were received between June and September 2021.
Product
a. McKesson Rapid Test Kit McKesson Consult Fertility Test hCG Pregnancy Test Serum / Urine Sample 25 Tests. Model Number: 5002. b. McKesson Consult Rapid Test Kit McKesson Consult Fertility Test hCG Pregnancy Test Urine Sample 25 Tests Model Number: 5000. c.…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1610-2022·2022-08-31
Medline Catheter Plugs Recalled for Potential Temperature Exposure Impact
Mckesson Medical-Surgical is recalling Medline catheter plugs (Model DYND12200) due to temperature excursions that may have impacted effectiveness. All lots received between June 1 and September 30, 2021 are affected.
Product
MEDLINE INDUSTRIES Medline Plug, Catheter Medline Plastic, with Cover Model Number: DYND12200
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1633-2022·2022-08-31
Dynarex Cotton Swabs Recalled Due to Temperature Exposure
Mckesson Medical-Surgical is recalling Dynarex cotton swabs (197 boxes) received June 1–September 30, 2021, due to temperature excursions during storage that may have reduced product effectiveness.
Product
DYNAREX Dynarex SWABSTICK, PVP (3/PK 25/BX 10BX/CS) Catalog #1202
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1631-2022·2022-08-31
Cooper Surgical Milex Pessary Recalled for Temperature Exposure During Storage
Mckesson Medical-Surgical is recalling Cooper Surgical Milex Pessary Ring products stored at elevated temperatures from June through August 2021, which may have degraded product effectiveness.
Product
COOPER SURGICAL Milex PESSARY, RING MILEX INCONT FLEXIBLE SZ6 1 3/4" Catalog # MXPCON06
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1600-2022·2022-08-31
Temno Soft Tissue Biopsy Device Recalled for Temperature Exposure
Merit Medical Systems Temno soft tissue biopsy devices may have lost effectiveness due to storage temperature excursions between June and August 2021. The recall affects all lots received between June 1 and September 30, 2021.
Product
MERIT MEDICAL SYSTEMS Temno Soft Tissue Biopsy Device Temno 14 Gauge 6 cm Length Beveled Sharp Tip Model Number: T146
Category
Medical Device
Distribution
Distributed nationwide

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12001–12025 of 40095