The Recall Desk

Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

19551–19575 of 50413

  • HighFDA (Devices)·Z-2276-2021·2021-08-18

    Automated diagnostic analyzer from Abbott recalled for waste pressure buildup

    Abbott is recalling 260 Alinity s System analyzers due to a design defect allowing waste pressure to build up and spray operators. No injuries reported.

    Product
    Alinity s System REF 06P16-01. An automated immunoassay analyzer for In Vitro diagnostic use in blood donor screening, plasma and plasmapheresis screening, and organ donor centers, hospitals, and reference laboratories.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2253-2021·2021-08-18

    Medical imaging software displays anatomical orientation tags incorrectly

    Simpleware ScanIP medical imaging software contains a bug where anatomical orientation tags display incorrectly. This could lead to operator misunderstanding and errors during image resampling and realignment.

    Product
    Simpleware ScanIP 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-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-2205-2021·2021-08-18

    Transport Stretcher 747 distributed to home users without professional training

    Stryker's Transport Stretcher 747, designed for healthcare facilities, was distributed to home users who may not understand its intended-use instructions. The recall addresses risks from improper use by untrained consumers.

    Product
    Transport Stretcher 747 - a non-powered, wheeled device designed to support patients in a horizontal position, Part Number 0747000000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2217-2021·2021-08-18

    TruRize Clinical Chair distributed to home users who may misuse it

    Stryker's TruRize Clinical Chair was distributed to residential customers despite being designed for healthcare facility use only. Home users may not understand safety instructions intended for trained professionals.

    Product
    TruRize Clinical Chair - support structure that places human occupants in upright, seated, recline, supine, and trend positions, Model Number: 3333, Part #¿3333000000
    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-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
    47 states
  • 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-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
  • HighCPSC·21187·2021-08-18

    Nordstrom Tucker & Tate Children's Socks Recalled for Choking Hazard

    Nordstrom is recalling Tucker & Tate children's socks because the pom pom attached to the ankle can detach, posing a choking hazard to young children. About 370 units were sold nationwide from May through June 2021.

    Product
    Tucker & Tate children's socks
    Category
    Consumer Product
    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-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 (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 (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-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
  • HighNHTSA·21T012000·2021-08-18

    Bridgestone Recalls Specific Tires Due to Sidewall Pinhole Defect

    Bridgestone is recalling specific tire models with DOT code 2821 because a pinhole in the sidewall may cause slow air leaks, increasing the risk of a vehicle crash.

    Product
    TIRES:SIDEWALL recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • 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-2229-2021·2021-08-18

    Shent USA Grasper/Retriever Endoscopic Instruments Recalled for Mislabeling

    Shent USA is recalling Grasper/Retriever endoscopic instruments (lot 020377208) due to mislabeling. Products bearing one catalog number may contain different devices with different jaw specifications, potentially resulting in wrong instrument selection.

    Product
    Grasper/Retriever, Alligator Jaw 2.4 mm x 5 mm x 230 cm Catalog Number: 7208 Intended use: single use accessory devices used through the working channel of a GI endoscope
    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-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-2211-2021·2021-08-18

    Stryker Proform pressure ulcer support surface distributed to home users

    Stryker Proform pressure ulcer support surfaces designed for healthcare facility use were distributed to residential customers. The device labeling is correct but home users may not understand professional-level instructions.

    Product
    Proform- support surface is used to assist in the prevention and treatment of all categories/stages of pressure ulcers, Model Number: 2710, Part #¿2710000027¿¿¿¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0850-2021·2021-08-18

    5000 Years Foods Julrado Whole Cabbage Kimchi Recall for Listeria

    5000 Years Foods is recalling Julrado Whole Cabbage Kimchi in multiple sizes due to potential Listeria monocytogenes contamination. The product was distributed in Illinois and potentially nationwide through retail distributors.

    Product
    5000 Years Foods JULRADO WHOLE CABBAGE KIMCHI in 5GAL plastic tubs, and 128 oz and 64 oz glass jars
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2251-2021·2021-08-18

    Exactech hip prosthesis femoral head labeling and marking discrepancy

    Exactech BIOLOX delta Femoral Head prosthesis components were labeled as one size but marked as a different size. This labeling discrepancy could result in implantation of the incorrect component.

    Product
    Exactech BIOLOX delta Femoral Head, 36m O.D. + 3.5mm, REF 170-36-03. Hip prosthesis component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2270-2021·2021-08-18

    Biomet Arcos Hip Implant Revision Bodies Recalled for Corrosion Risk

    Biomet is recalling specific Arcos hip implant components due to potential fretting corrosion of the inner taper that could lead to device failure and require surgical intervention.

    Product
    Arcos Modular Revision Hip System High Offset Cone Prox Body, Size A, 70 MM Item Number: 11-301331
    Category
    Medical Device
    Distribution
    Distributed nationwide