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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10951–10975 of 13717

  • ModerateFDA (Devices)·Z-0028-2023·2022-10-19

    Medical Device Retrieval Basket Recalled for Incorrect Expiration Date

    Hobbs Medical is recalling Helical Retrieval Baskets with incorrect expiration dates on labels. The labeled shelf life extends beyond the actual safe duration for device use.

    Product
    Hobbs Helical Retrieval Basket Catalog Number: 4814
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0063-2023·2022-10-19

    Pancreatic stent recall due to incorrect expiration date on device labels

    Hobbs Medical is recalling Freeman Pancreatic Flexi-Stent devices distributed between March 2018 and September 2020 due to incorrect expiration dates on product labels. The mislabeled devices display extended shelf-life information that does not reflect actual product safety.

    Product
    Freeman Pancreatic Flexi-Stent Catalog Number: 6568
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0085-2023·2022-10-19

    Prismaflex HF20 Medical Device Recall Due to Mistranslated Instructions

    Baxter Healthcare recalls the Prismaflex HF20 Set due to a mistranslation in device instructions that creates contradictory information about patient weight restrictions. The issue affects 29,764 devices distributed nationwide.

    Product
    Prismaflex HF20 Set (product code 109841). For use in providing continuous fluid management and renal replacement therapies.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0080-2023·2022-10-19

    Clip COVID Rapid Antigen Test Kit Recalled for Unapproved Shelf-Life Extension

    LUMINOSTICS recalled Clip COVID test kits because the manufacturer extended shelf life and expiration dates without FDA approval. The extended expiration dates lack FDA validation.

    Product
    Clip COVID Rapid Antigen Test Kit (25-pack), Catalog Number: MDL002
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1783-2022·2022-10-12

    Wisp and Wisp Youth nasal masks recalled for missing implanted device warnings

    Philips Respironics is recalling Wisp and Wisp Youth nasal masks because they lack warnings about magnetic components that could interfere with implanted medical devices or cause eye injuries from metallic splinters.

    Product
    Wisp and Wisp Youth Nasal Mask
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1780-2022·2022-10-12

    CPAP Full-Face Mask Recalled for Missing Implantable Device Warnings

    Philips Respironics Amara View Full-Face Mask lacks critical safety warnings about magnetic components for patients with implantable medical devices. The Class I recall affects 5.6 million units worldwide.

    Product
    Philips Respironics Amara View Minimal Contact Full-Face Mask
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1782-2022·2022-10-12

    DreamWisp CPAP mask recalled for missing implant safety warnings

    Philips Respironics is recalling 930,813 DreamWisp Nasal Masks worldwide due to missing warnings about magnetic components that could interfere with implantable medical devices or cause metallic splinters.

    Product
    DreamWisp Nasal Mask with Over the Nose Cushion
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0006-2023·2022-10-12

    Orthopedic implant recall due to labeling mismatch on Stryker EVOLVE Proline Stem

    Wright Medical Technology recalls 32 units of Stryker EVOLVE Proline Stem due to labeling mismatch: outer packages are labeled with one stem size but contain a different size. Surgeons should verify device size before implantation.

    Product
    stryker EVOLVE, Proline Stem, CoCr, Size: +4, OD: 9.5mm, REF 496S275, Wright s EVOLVE Proline Plus Radial Head and Repair System is a set configuration designed to address radial head fractures. It combines parts of two systems: EVOLVE Proline and EVOLVE TRIAD.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1858-2022·2022-10-12

    Hologic BioZorb LP Implant Markers Recalled Due to Mislabeled Expiration Date

    Hologic recalls 233 BioZorb LP Markers nationwide due to removable labels showing incorrect expiration dates. Implants labeled with January 2022 dates may be mistakenly used after their actual July 2024 expiration.

    Product
    The BioZorb LP Marker is an implantable radiopaque marker used to facilitate visualization of a soft tissue site. The BioZorb LP Marker is comprised of a bioabsorbable PLA (polylactic acid) component which resorbs completely in 1 year or more and a permanent component (titanium).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1784-2022·2022-10-12

    [pending] Therapy Mask 3100 NC/SP

    Pending LLM rewrite. Source: FDA_DEVICE Z-1784-2022.

    Product
    Therapy Mask 3100 NC/SP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0009-2023·2022-10-12

    Introcan Safety Catheter Recalled for Potential Leakage at Hub

    B. Braun is recalling 94,000 Introcan Safety FEP 14G catheters due to potential leakage at the catheter hub. Affected units were distributed in the US and Canada.

    Product
    Introcan Safety FEP 14G, 2.2x32MM-US, Product Code 4251890-02. A passive anti-needle device to provide venous or arterial access.
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-0003-2023·2022-10-12

    Handheld UV-C Germicidal Wand Recalled for Excessive Radiation Exposure

    IN MY BATHROOM LLC is recalling 485 units of the Seago SG-153 handheld UV-C germicidal wand nationwide due to excessive ultraviolet-C radiation. Consumers should stop using the device and contact the manufacturer for instructions.

    Product
    The product is a handheld ultraviolet-C germicidal wand and contains two, narrow-diameter, tubular lamps with a peak emission wavelength in the 254 nm range.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0005-2023·2022-10-12

    [pending] stryker EVOLVE, Proline Stem, CoCr, Size: +2, O: 705mm, REF 496S275, Wright s EVOLVE Proline Plus R

    Pending LLM rewrite. Source: FDA_DEVICE Z-0005-2023.

    Product
    stryker EVOLVE, Proline Stem, CoCr, Size: +2, O: 705mm, REF 496S275, Wright s EVOLVE Proline Plus Radial Head and Repair System is a set configuration designed to address radial head fractures. It combines parts of two systems: EVOLVE Proline and EVOLVE TRIAD.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0004-2023·2022-10-12

    Philips MR Patient Care Portal 5000 Units Recalled for Intermittent Audio Failure

    Philips has recalled MR Patient Care Portal 5000 desktop units (Model 453564792561) due to intermittent audio failure. The device may fail to produce audio, and standard troubleshooting does not reliably resolve the issue.

    Product
    MR Patient Care Portal 5000 (Desktop Unit), Model Number 453564792561 This is a component of product number 866162.
    Category
    Medical Device
    Distribution
    25 states
  • SevereFDA (Devices)·Z-1763-2022·2022-10-05

    TANDEM LIFE controller software failures affecting cardiopulmonary bypass equipment nationwide

    FDA recalls TANDEM LIFE LivaNova LIFESPARC Controllers due to critical software failures that cause the device to freeze, crash, or stop displaying data. The controllers are used in cardiopulmonary bypass procedures.

    Product
    TANDEM LIFE LivaNova LIFESPARC Controller; Controller and Accessories Model 5900-0000; Controller Only Model 5900-0001. For circulatory or cardiopulmonary bypass.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1779-2022·2022-10-05

    SunMed Pulset Syringes Recalled Due to Non-Sterile Spare Needles

    SunMed Holdings is recalling Pulset 3cc syringes with non-sterile spare needles that could cause skin infection or sepsis if used. The recall affects 53,560 units distributed across ten US states.

    Product
    Full Kit Pulset 3cc Syringe 23g x 1 Safety Tip 25u BH, REF Number 3373-91
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-1846-2022·2022-10-05

    Cook Movable Core Wire Guide Guidewires Recall Due to Packaging Defect

    Cook Incorporated is recalling specific lots of Movable Core Wire Guide guidewires due to a potential breach of the packaging seal that may compromise device sterility.

    Product
    Movable Core Wire Guide (Tapered Tefcor) (OUS ONLY), Guidewire Reference Part Number/GPN TCMTNA-35-145-3 G01678
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1825-2022·2022-10-05

    Bentson Plus Guidewire Recall for Compromised Packaging Sterility Seal

    Cook Incorporated is recalling Bentson Plus Wire Guides due to potential packaging seal breaches that may compromise device sterility. Affected devices may not maintain proper sterility before use.

    Product
    Bentson Plus Wire Guide (Extra Body/20cm Distal Flexibility with Softened Tip), Guidewire; Reference Part Number: TSFBP-35-180 (GPN G09782) TSFBP-35-145 (GPN G09735)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1850-2022·2022-10-05

    Leica M530 Surgical Microscopes recalled for illumination adjustment defect

    Leica Microsystems is recalling 115 M530 surgical microscopes due to a photodiode component change that causes inaccurate illumination limit adjustment when using the BrightCare Plus feature with Luxmeter.

    Product
    Leica Surgical Operating Microscopes, M530 OHX, Part Number 10448737
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1856-2022·2022-10-05

    Medline suction catheters recalled due to connector separation risk

    Medline ClearPro Trach Double Swivel Closed Suction Catheters may have the green connector separate from the device during patient suctioning. The recall affects 34,920 units distributed nationwide and internationally.

    Product
    MEDLINE CLEARPRO TRACH DOUBLE SWIVEL CLOSED SUCTION CATHETER, flat peel pouch EA, 10 EA per Inner Carton (IC), 20 EA/2 Inner cartons per Case (CS). Labeled as follows: a. TRACH DOUBLE SWIVEL, 12 Fr, Item Number/REF: DYNCPDS12T b. TRACH DOUBLE SWIVEL, 14 Fr, Item Number/REF:
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1827-2022·2022-10-05

    Bentson Wire Guide Recalled for Packaging Defect Affecting Sterility

    Cook Incorporated is recalling Bentson Wire Guide guidewires due to packaging seal failures that may compromise sterility. The recall affects over 5,500 units distributed in the U.S. and internationally.

    Product
    Bentson Wire Guide (20cm Distal Flexibility with Softened Tip), Guidewire; Reference Part Number: TSFB-35-80 (GPN G01315) TSFB-35-145 (GPN G00691) TSFB-35-200 (GPN G01095)
    Category
    Medical Device
    Distribution
    Distributed nationwide