The Recall Desk

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.

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24926–24950 of 26084

  • HighFDA (Devices)·Z-2267-2021·2021-08-18

    Biomet Arcos Hip Implant Component Recalled for Potential Fretting Corrosion

    Biomet is recalling 11 units of Arcos Modular Revision Hip System Standard Cone Prox Body components due to potential fretting corrosion at the inner taper joint that could cause device failure and require revision surgery.

    Product
    Arcos Modular Revision Hip System Standard Cone Prox Body, Size A, 70 MM Item Number: 11-301321
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2249-2021·2021-08-18

    Bard Bone Marrow Aspiration Needles Recalled for Incomplete Packaging Seals

    Bard Peripheral Vascular is recalling Illinois Bone Marrow Aspiration/Intraosseous Infusion Needles due to incomplete or open packaging seals that could compromise sterility. Approximately 1,200 devices are affected.

    Product
    TIN3018 Illinois Bone Marrow Aspiration/Intraosseous Infusion Needle 18G x 79mm TIN3015 Illinois Bone Marrow Aspiration/Intraosseous Infusion Needle 15G x 79mm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2228-2021·2021-08-18

    Medtronic StimLoc Burr Hole Cover Recalled for Excess Nylon Flash on Clip

    Medtronic is recalling StimLoc Burr Hole Cover neurosurgical devices and related components due to excess nylon flash on the clip. The defect could affect device function during implantation or use.

    Product
    Medtronic StimLoc Burr Hole Cover, Part Numbers: a) 3387S-40 b) 3389S-28 c) 3389S-40 d) 3391S-40 e) 3550S-01 f) 924256 g) DB-5000
    Category
    Medical Device
    Distribution
    46 states
  • HighFDA (Devices)·Z-2254-2021·2021-08-18

    Simpleware ScanIP Medical Software Recall: Incorrect Anatomical Orientation Display

    Simpleware ScanIP medical software may display anatomical orientation tags incorrectly, potentially causing surgical planning errors. This FDA Class II recall affects versions from 2018–2021 distributed in the US and internationally.

    Product
    Simpleware ScanIP medical software. For transfer of imaging information from a medical scanner to an output file, and for simulating/evaluating surgical treatment options.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2231-2021·2021-08-18

    Medline Shoulder CDS Kits Recalled Due to Expired Irrigation Component

    Medline Industries is recalling 286 Shoulder CDS convenience kits that may contain an expired NaCl irrigation component. Users should stop using the kits and contact the manufacturer for return instructions.

    Product
    Medline Shoulder CDS convenience kits, REF DYNJ902837D and REF DYNJ902837F, containing expired component NaCl 3000mL Irrigation Bag (exp. date 08/01/2020).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2282-2021·2021-08-18

    Edwards PediaSat Oximetry Catheter Set recalled for potential internal leaks

    Edwards Lifesciences is recalling its PediaSat Oximetry Catheter Set due to potential for internal leaks within the device.

    Product
    Edwards PediaSat Oximetry Catheter Set, REF: XT358KTP, Exterior Diameter 5.5F, Usable Length 8 cm, Number of Lumens: 3, Recommended Guidewire Size: GW: 0.025" (0.64 mm), Rx Only, Sterile EO, UDI: (01)00690103197556
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-2271-2021·2021-08-18

    Biomet Hip Replacement Component Recalled Over Corrosion and Device Failure Risk

    Biomet is recalling Arcos Modular Revision Hip System components that may develop fretting corrosion in the inner taper, risking device failure and the need for revision surgery. Affected patients should contact their healthcare provider.

    Product
    Arcos Modular Revision Hip System High Offset Cone Prox Body, Size C, 70 MM Item Number: 11-301333
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0853-2021·2021-08-18

    5000 Years Foods Kimchi Recalled for Listeria Contamination Risk

    5000 Years Foods is recalling NO MSG Sliced Cabbage Kimchi sold in multiple container sizes due to potential Listeria monocytogenes contamination. The product was distributed in Illinois and may have reached customers nationwide through retail stores.

    Product
    5000 Years Foods NO MSG SLICED CABBAGE KIMCHI in 5GAL plastic tubs, and 128 oz, 64 oz, 32 oz, & 16 oz glass jars
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0852-2021·2021-08-18

    5000 Years Foods Whole Cabbage Kimchi Listeria Contamination Recall

    5000 Years Foods is recalling NO MSG Whole Cabbage Kimchi in 5-gallon plastic tubs and glass jars due to potential Listeria monocytogenes contamination. The product was distributed in Illinois and potentially nationwide through retail stores.

    Product
    5000 Years Foods NO MSG WHOLE CABBAGE KIMCHI in 5GAL plastic tubs, and 128 oz and 64 oz glass jars
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2242-2021·2021-08-18

    Smith & Nephew Orthopedic Nail May Detach During Surgery

    Smith & Nephew is recalling an orthopedic surgical nail (BHR SQUARE HEADED, catalog #999908) that may detach during surgery. Forty-seven affected units have been distributed worldwide.

    Product
    smith&nephew BHR SQUARE HEADED NAIL, REF CATALOG NUMBER 999908. For use during orthopedic surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2230-2021·2021-08-18

    Endoscope Grasper/Retriever Devices Mislabeled with Incorrect Catalog Numbers

    Shent USA recalls grasper/retriever endoscopy devices that are mislabeled with incorrect catalog numbers. Units labeled as catalog #7208 may actually be #7226 and vice versa, potentially causing use of the wrong jaw size.

    Product
    Grasper/Retriever, Alligator Jaw, Rat Tooth 2.4 mm x 8 mm x 230 cm Catalog Number: 7226 Intended use: single use accessory devices used through the working channel of a GI endoscope
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2226-2021·2021-08-18

    In Vitro Diagnostic Test Produces Incorrect Antibiotic Susceptibility Results

    Biomerieux's ETEST IMIPENEM RELEBACTAM diagnostic test produces major errors when testing Pseudomonas aeruginosa, incorrectly identifying resistant strains as susceptible. Approximately 1,431 units distributed worldwide.

    Product
    ETEST IMIPENEM RELEBACTAM. in vitro diagnostic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2213-2021·2021-08-18

    Stryker IsoGel Air Medical Device Distributed to Home Users Instead of Healthcare Facilities

    Stryker has recalled 3 IsoGel Air pressure ulcer support surfaces that were distributed to home users when designed for use only in healthcare facilities. Home users may not understand the professional healthcare instructions required for proper use.

    Product
    IsoGel Air - support surface assists in the prevention and treatment of all pressure ulcers stages, Model Number 2860, Part 2860000999
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2239-2021·2021-08-18

    Cardiac Sheath Introducer Devices Recalled Due to Size Mislabeling

    Merit Medical Systems recalls 760 units of Prelude SNAP Splittable Sheath Introducer (7F) due to packaging errors where devices are labeled as 10F instead of the correct 7F size.

    Product
    Prelude SNAP Splittable Sheath Introducer, REF: PLS-1007, size 7F, Standard Length: 13 cm, CE0344, STERILE EO, Rx Only, UDI:(01) 00884450467985. For the introduction of various types of pacing leads and catheters to the heart and coronary venous system.
    Category
    Medical Device
    Distribution
    29 states
  • HighFDA (Devices)·Z-2268-2021·2021-08-18

    Arcos Hip System Cones Recalled for Potential Inner Taper Corrosion

    Biomet recalled 11 Arcos Modular Revision Hip System proximal cones due to potential inner taper fretting corrosion and device failure that could require surgical intervention. Affected units distributed nationwide.

    Product
    Arcos Modular Revision Hip System Standard Cone Prox Body, Size B, 70 MM Item Number: 11-301322
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2214-2021·2021-08-18

    S3 MedSurg hospital beds recalled from residential sale due to misuse risk

    Stryker's S3 MedSurg hospital beds designed for healthcare facilities were distributed to home customers. The device labeling is correct but home users may not understand professional-use instructions, posing a risk of improper operation.

    Product
    S3 MedSurg Bed - intended to support and transport patients within the Med/Surg and Critical Care hospital environments, Model Number 3002, Part 3002S3CUSTOM, 3002S3EX, 3002S3PATRIOT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0854-2021·2021-08-18

    5000 Years Foods Kimchi Recalled for Listeria Contamination Risk

    5000 Years Foods is recalling NO MSG JULRADO WHOLE CABBAGE KIMCHI in 128 oz and 64 oz glass jars due to potential Listeria monocytogenes contamination. The affected product was distributed through Illinois and reached customers nationwide.

    Product
    5000 Years Foods NO MSG JULRADO WHOLE CABBAGE KIMCHI in 128 oz and 64 oz glass jars
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2273-2021·2021-08-18

    Biomet Hip Implant System Recalled Due to Potential Fretting Corrosion

    Biomet is recalling the Arcos Modular Revision Hip System component due to potential inner taper fretting corrosion that could lead to device failure requiring surgery. No injuries have been reported.

    Product
    Arcos Modular Revision Hip System Standard Cone Prox Body, Size B, 80 MM Item Number: 11-301342
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2257-2021·2021-08-18

    Beckman Coulter SARS-CoV-2 Antigen QC Reagent Recalled Due to False Positive Risk

    Beckman Coulter is recalling ACCESS SARS-CoV-2 Antigen QC reagent due to false positive test results that could lead to incorrect diagnoses. The Class II recall affects 544 units distributed nationally and internationally.

    Product
    ACCESS SARS-CoV-2 ANTIGEN QC, REF: C68670, CONTENTS: 3 X 6.0 mL QC1, 3 x 6.0 mL QC2, 1 QC VALUE CARD, IVD, Rx Only, UDI: (01)15099590742737;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2260-2021·2021-08-18

    Biomet Arcos Hip Prosthesis Recalled Due to Device Failure Risk

    Biomet is recalling certain Arcos Modular Revision Hip System components due to risk of device failure and fretting corrosion. Affected patients may require revision surgery.

    Product
    Arcos Modular Revision Hip System Standard Cone Prox Body, Size A, 60 MM Item Number: 11-301301
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2279-2021·2021-08-18

    Edwards PediaSat Oximetry Catheter Kit Recalled for Internal Leak Risk

    Edwards Lifesciences recalls PediaSat Oximetry Catheter Kits (REF: XT3515SP) due to potential for internal leaks that could affect oxygen saturation monitoring.

    Product
    Edwards PediaSat Oximetry Catheter Kit, REF: XT3515SP, Exterior Diameter 5.5F (1.83 mm), Usable Length 15 cm, Number of Lumens 3, Recommended Guidewire Size 0.025" (0.64 mm), Rx Only, Sterile EO, UDI: (01)00690103197532
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-2280-2021·2021-08-18

    Edwards PediaSat Oximetry Catheter Kits Recalled for Potential Internal Leaks

    Edwards Lifesciences is recalling PediaSat Oximetry Catheter Kits due to potential internal leaks within the devices. The recall involves 218 units distributed across multiple U.S. states and internationally.

    Product
    Edwards PediaSat Oximetry Catheter Kit, REF: XT358SJ, Usable Length 8 cm, Number of Lumens 3, Exterior Diameter 5.5F, Rx Only, Sterile EO, UDI: (01)00690103197495 *NOT DISTRIBUTED WITHIN THE US
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Food)·F-0846-2021·2021-08-18

    Solumeve Hydrolyzed Collagen Peptides Recalled for Undeclared Milk

    IHERB LLC is recalling Solumeve Hydrolyzed Collagen Peptides dietary supplements because the MCT ingredient contains undeclared milk, which poses a risk to consumers with milk allergies.

    Product
    Solumeve Hydrolyzed Collagen Peptides, Turmeric + MCT and Ginger; Dietary Supplement, NET Wt. 14.1 oz. (400g) Suggested usage: Simply add 1 scoop (15.38 g) to a 6-8 fl oz. of room temperature water or juice once daily. UPC 8 98220 01828 4 Manufactured for Madre Labs, LLC 301 N
    Category
    Food
    Distribution
    31 states
  • HighFDA (Devices)·Z-2237-2021·2021-08-18

    Advance Dx 100 Blood Collection Cards Recalled for Inaccurate Glucose Results

    Advance Dx, Inc. is recalling Advance Dx 100 Blood Collection Cards due to inaccurate blood glucose test results. The recall affects 179,750 cards distributed in Maryland and North Carolina.

    Product
    Advance Dx 100 Blood Collection Card Quantity 25 REF CMT01 Advance Dx 100 Blood Collection Card and Foil Bags Quantity 500 Cards and Foil Bags REF CMT01/F02 IFU: Advance Dx 100 SSE(Serum Separating Extraction) Technology BLOOD COLLECTION INSTRUCTIONS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2208-2021·2021-08-18

    Stryker Prime Big Wheel Stretcher distributed to home users may lack professional-only guidance

    The Prime Big Wheel Stretcher was distributed to home users, but is intended for professional healthcare facility use only. Home users may not understand the professional-only instructions, creating safety risks.

    Product
    Prime Big Wheel Stretcher-used as a short-term outpatient clinical evaluation, treatment, minor procedure, and short-term outpatient recovery platform, Model Number 1115, Part Number 1115000030
    Category
    Medical Device
    Distribution
    Distributed nationwide