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.

Filters

Agency

Category

Minimum severity

Clear filters

13251–13275 of 13802

  • HighFDA (Devices)·Z-2236-2021·2021-08-18

    Orthopedic drill bit recalled for corrosion particle contamination risk

    NEOSTEO cannulated drill bits are being recalled due to corrosion traces on the laser marking that could release particles into the surgical field. The recall affects Lot 243-20 distributed in New Jersey.

    Product
    Cannulated graduated drill bit 1.9 mm diameter, with AO QC system, REF: INS-114 for use in orthopedic surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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 (Devices)·Z-2256-2021·2021-08-18

    SARS-CoV-2 Antigen Calibrators May Produce False Positive Test Results

    Beckman Coulter is recalling Access SARS-CoV-2 Antigen Calibrators because the assay test may generate false positive results, potentially leading to incorrect diagnosis. Approximately 451 units were distributed nationwide and internationally.

    Product
    Access SARS-CoV-2 Antigen Calibrators, Catalog, REF: C68669, Contents: 1x2.5 mL C0, 1x2.5mL C1, 1x CAL CARD, UDI: (01)15099590742720;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2274-2021·2021-08-18

    FDA Recalls Biomet Hip Implant for Potential Fretting Corrosion

    Biomet is recalling its Arcos Modular Revision Hip System Standard Cone Prox Body due to risk of fretting corrosion and device failure in the inner taper. Affected patients should consult their surgeon.

    Product
    Arcos Modular Revision Hip System Standard Cone Prox Body, Size C, 80 MM Item Number: 11-301343
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2248-2021·2021-08-18

    Bard Jamshidi Evolve Bone Marrow Needle Recall Due to Open Packaging

    Bard recalls Jamshidi Evolve bone marrow needles due to incomplete packaging seals that could compromise sterility. The recall affects 560 devices distributed in the U.S. and internationally.

    Product
    EJM4011 Jamshidi Evolve" Bone Marrow Biopsy/Aspiration Needle with Specimen Cradle. 11G x 10cm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2238-2021·2021-08-18

    Prelude SNAP cardiac introducer sheath potentially mislabeled with wrong size

    Merit Medical Systems is recalling Prelude SNAP Splittable Sheath Introducers (10F size) because 7F sheaths may have been packaged with 10F labels. This error affects 760 units in lot I2067768.

    Product
    Prelude SNAP Splittable Sheath Introducer, REF: PLSX -1010, size 10F, Standard Length: 13 cm, CE0344, STERILE EO, Rx Only, (01) 00884450489611. 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-2261-2021·2021-08-18

    Arcos Modular Revision Hip System Cone Bodies Recalled for Device Failure Risk

    Biomet, Inc. is recalling 21 units of Arcos Modular Revision Hip System Standard Cone Prox Bodies due to risk of fretting corrosion and device failure that may require surgical intervention.

    Product
    Arcos Modular Revision Hip System Standard Cone Prox Body, Size B, 60 MM Item Number: 11-301302
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2259-2021·2021-08-18

    Arcos Modular Hip Implant Cone Bodies Recalled for Fretting Corrosion

    Biomet is recalling specific lots of Arcos Modular Revision Hip System cone bodies due to potential fretting corrosion and device failure that could require surgical intervention.

    Product
    Arcos Modular Revision Hip System Standard Cone Prox Body, Size A, 50 MM Item Number: 11-301300
    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-2247-2021·2021-08-18

    Jamshidi Bone Marrow Biopsy Needles Recalled for Packaging Seal Defects

    Bard Peripheral Vascular Inc. is recalling multiple models of Jamshidi bone marrow biopsy needles due to incomplete or open packaging seals that may compromise sterility. No illnesses or injuries have been reported.

    Product
    TJM6008 Jamshidi" Crown Bone Marrow Biopsy/Aspiration Needle with Marrow Acquisition Cradle. 8G x 15 cm; TJC3513 Jamshidi" Bone Marrow Biopsy/Aspiration Needle. 13G x 8.9 cm; TJM4011 Jamshidi" Crown Bone Marrow Biopsy/Aspiration Needle with Marrow Acquisition Cradle. 11G x 10cm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2246-2021·2021-08-18

    Mislabeled Cutting Electrode May Contain Wrong Electrode Type

    Richard Wolf's Cutting Electrode Bipo 24.5FR may be mislabeled and contain a BIVAP electrode instead. Affected lot 21002858 was distributed to healthcare facilities in five states.

    Product
    CUTTING ELECTRODE BIPO 24.5FR, REF 4653.1323
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2252-2021·2021-08-18

    Dutch Ophthalmic Vitrectomy Pack Contains Mismatched Infusion Line Gauge

    Dutch Ophthalmic USA is recalling TDC Vitrectomy Pack VGPC 25g surgical kits. The packages are labeled as containing 25-gauge infusion lines but actually contain 23-gauge lines instead.

    Product
    The device is a 25-gauge infusion line that is part of 25-gauge surgical pack labeled TDC Vitrectomy Pack VGPC 25g, Product Number 8525.201.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2223-2021·2021-08-18

    Stryker GoBed II Medical Bed Recalled for Improper Home Distribution

    Stryker's GoBed II MedSurg Bed was distributed to residential customers but is intended for healthcare facility use. Home users may not understand professional-level safety instructions, creating a risk of misuse.

    Product
    GoBed II MedSurg Bed, Model Number FL28, Part #FL28EX
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2225-2021·2021-08-18

    MYLA Laboratory Software: Potential Test Result Alteration from Software Anomaly

    BioMerieux is recalling MYLA microbiology software due to a software anomaly that could cause unwanted alterations to test results when using the BCI Connect scripting feature. 248 systems nationwide are affected.

    Product
    MYLA software. Used to manage microbiology test workflow from the reception of requests to the transmission of results by transferring, storing, and displaying medical device data.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2255-2021·2021-08-18

    Beckman Coulter SARS-CoV-2 Test Recalled for False Positive Risk

    Beckman Coulter is recalling its ACCESS SARS-CoV-2 Antigen test (REF C68668) because it may produce false positive results, potentially leading to incorrect diagnoses.

    Product
    ACCESS SARS-CoV-2 Antigen , REF: C68668, IVD, Rx only, UDI: (01) 15099590742713;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-2235-2021·2021-08-18

    Cordis SABER PTA Balloon Catheter Recalled for Foreign Material Contamination

    Cordis Corporation is recalling the SABER PTA Balloon Dilation Catheter due to potential contamination with foreign material from manufacturing. The contamination may transfer from the protective sheath to the balloon itself.

    Product
    Cordis SABER PTA Balloon Dilation Catheter, 4F, REF 48004010X
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2278-2021·2021-08-18

    Edwards PediaSat Oximetry Catheter Kit Recalled for Potential Internal Leaks

    Edwards Lifesciences is recalling the Edwards PediaSat Oximetry Catheter Kit (REF: XT3515KTP) due to potential for internal leaks. The recall affects 70 units distributed across the US and internationally.

    Product
    Edwards PediaSat Oximetry Catheter Kit, REF: XT3515KTP, 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)00690103197563
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-2272-2021·2021-08-18

    Hip Implant Component Recalled Due to Potential Fretting Corrosion and Device Failure

    Biomet is recalling hip replacement components that could develop fretting corrosion and fail inside the body, potentially requiring revision surgery.

    Product
    Arcos Modular Revision Hip System High Offset Cone Prox Body, Size E, 70 MM Item Number: 11-301335
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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 (Devices)·Z-2218-2021·2021-08-18

    Symmetry Plus Treatment Recliner distributed to home users instead of healthcare facilities

    A medical treatment recliner designed for healthcare facilities was distributed to home consumers. Home users may not understand the specialized instructions intended for healthcare professionals, creating a potential safety risk.

    Product
    Symmetry Plus Treatment Recliner - general hospital use as a convenient seating surface for patients or guests to sit, Model Number 3500, Part # 3500000710
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2207-2021·2021-08-18

    Stryker Prime Fifth Wheel Stretcher distributed to residential customers instead of healthcare facilities

    A medical stretcher designed for healthcare professionals was distributed to residential customers. The device labeling is appropriate for healthcare settings, but home users may not understand or follow the professional-use instructions.

    Product
    Prime Fifth Wheel Stretcher-stretcher may be used for minor procedures and short-term stay (treatment and recovery, Model 1105, Part Numbers 1105000026 and 1105000000X
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2216-2021·2021-08-18

    Hospital Bed Model 3005 Recalled for Distribution to Home Residents

    Stryker's S3 MedSurg hospital bed was distributed to home residents instead of healthcare facilities. The devices are designed for professional operation, and untrained home users may not understand safety instructions.

    Product
    S3 MedSurg Bed - intended to support and transport patients within the Med/Surg and Critical Care hospital environments, Model Number: 3005, Part # 3005S3EX
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2234-2021·2021-08-18

    Medline Arthroscopy Kit Recalled for Expired Irrigation Component

    Medline Industries is recalling 286 Arthroscopy Kits (REF DYNJ904304B) containing an expired NaCl irrigation bag component. The affected kits were distributed to Minnesota, Nebraska, and Pennsylvania.

    Product
    Medline Arthroscopy Kit, convenience kit, REF DYNJ904304B, containing expired component NaCl 3000mL Irrigation Bag (exp. date 08/01/2020).
    Category
    Medical Device
    Distribution
    Distributed nationwide