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 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.

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11601–11625 of 40095

  • HighFDA (Devices)·Z-0139-2023·2022-11-02

    Stryker INBONE Tibial Tray Recalled Due to Oversized Lock Detail

    Stryker INBONE Tibial Trays are being recalled due to an oversized lock detail that could affect proper component assembly and implant function. Affected units were distributed in New York.

    Product
    Stryker INBONE Tibial Tray, Left Plasma Spray Ti6Al4V, CPti, Use w/ 16mm Stem Base, REF 200252903, Size 3
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0137-2023·2022-11-02

    CorVocet Biopsy System recalled for needle ejection risk from component misalignment

    Merit Medical Systems is recalling CorVocet Biopsy Systems due to manufacturing defects that may cause the needle to eject when triggered outside the body, risking needle stick injuries to users or patients.

    Product
    CorVocet Biopsy System/Catalog Code: CORA1610/B, CORA1610S/B, CORA1615/B, CORA1810/A, CORA1810/B, CORA1810S/B, CORA1815/A, CORA1815/B, CORA1815S/A, CORA1815S/B, CORA1820/A, CORA1820/B, CORA1820S/A, CORA1825/A, CORA1825/B, CORA1825S/A, CORA2010/A, CORA2010/B, CORA2010S/A…
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-0125-2023·2022-11-02

    Hip Liner Implants Mixed with Knee Inserts in Packaging

    Encore Medical is recalling EMPOWR hip liner implants because boxes may contain knee inserts instead. This packaging error could delay surgeries. Four units affected in six US states.

    Product
    EMPOWR Acetabular System, Liner, 10 deg Hooded, HXe+ 40H, REF: 942-01-40H. Orthopedic implant component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0131-2023·2022-11-02

    LINEAR Intra-Aortic Balloon Catheter Recalled for Incorrect Volume Labeling

    Datascope's LINEAR intra-aortic balloon catheter has an incorrect balloon volume label on internal instructions that may delay critical therapy in unstable patients.

    Product
    LINEAR 7.5Fr. 40cc IAB with Accessories (APA), Model No. 0684-00-0480-02. intra-aortic balloon catheter.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0121-2023·2022-11-02

    Medline Peripheral Blood Culture Draw Kit Recall: Incorrect Expiration Dates

    Medline is recalling 1,020 peripheral blood culture draw kits due to incorrect expiration dates on kit components. The CHG solution and Bactec bottle plastic have expiration dates that do not match the date listed on the kit.

    Product
    MEDLINE PHERIPHERAL BLOOD CULTURE DRAW, Reorder #: DYNDH1561
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0120-2023·2022-11-02

    Medline Blood Culture Collection Kits Recalled for Incorrect Expiration Dates

    Medline recalls Adult Blood Culture Collection Kits due to incorrect expiration dates on kit components. The expiration dates on the CHG Solution and Bactec bottle plastic do not match the dates listed on the kit packaging.

    Product
    MEDLINE ADLT BLOOD CLUTURE COLLECT KIT, Reorder #: DYNDH1245
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0123-2023·2022-11-02

    Blood Culture Collection Kit Distributed with Mismatched Component Expiration Dates

    Medline is recalling 760 blood culture kits because the expiration dates printed on the kit do not match the expiration dates on the CHG Solution and Bactec bottle components inside.

    Product
    MEDLINE 24 BLOOD CLUTURE KIT, Reorder #: DYNDH1632
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0129-2023·2022-11-02

    ConvaTec Active Life Stoma Pouch Recalled for Release Liner Malfunction

    ConvaTec is recalling 3,209 units of its Active Life One-Piece Drainable Pouch due to impaired functionality of the release liner. Contact the manufacturer with your batch number.

    Product
    ConvaTec Active Life, One-Piece Drainable Pouch, 3/4-2 1/2 in., 19-64mm, REF 400598. For the management of stoma output following a colostomy or ileostomy procedure.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0135-2023·2022-11-02

    LumiraDx SARS-CoV-2 Quality Control Kit: Incorrect Lot Numbers

    LumiraDx is recalling 83 SARS-CoV-2 Antigen Liquid Quality Control Kits (batch 2002204017) with incorrect vial lot numbers. The kits contain Flu A/B lot numbers instead of SARS-CoV-2 Ag numbers, causing error messages and preventing device use.

    Product
    LumiraDx SARS-CoV-2 Antigen (Ag) Liquid Quality Control Kit Catalog #: L016080109002 (EUA) The LumiraDx SARS-CoV-2 Quality Controls are intended for liquid quality control testing performed on the LumiraDx Instrument when used with the LumiraDx SARS-CoV-2 Ag Test Strip.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0126-2023·2022-11-02

    EMPOWER 3D Knee Tibial Insert Recall Due to Packaging Mix-Up

    Hip and knee implant boxes from Encore Medical may contain the wrong product, potentially causing surgery delays. The FDA is recalling affected units to prevent unavailability of correct implants.

    Product
    EMPOWER 3D Knee Tibial Insert, REF: 341-14-708. Orthopedic implant component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0132-2023·2022-11-02

    Vortex MP Port Titanium Recalled for Missing Printed Instructions

    Angiodynamics is recalling 11 Vortex MP Port Titanium implantable ports because printed Instructions for Use were not shipped with the devices. Missing instructions could lead to improper implantation or post-operative care.

    Product
    Vortex MP Port Titanium Low Profile Implanted Port with 5F attached Silicone Catheter and Tray. Indicated for central venous placement (either peripheral or chest placement) when patient therapy requires repeated venous access for injection or infusion therapy and/or venous…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0075-2023·2022-10-26

    Iso-Gard Filter S Medical Gas Filters Recalled Due to Device Splitting Risk

    TELEFLEX is recalling 355 units of Iso-Gard Filter S medical gas filters nationwide due to incidents of device splitting or detaching during use. The FDA classified this as a Class I recall.

    Product
    Iso-Gard Filter S, with Expandi-Flex, Tethered Cap, REF: a) 19261T, OUS only; b) 19262T, OUS only; c) 19272T, OUS only; Microbial medical gas filter, single-use,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0074-2023·2022-10-26

    Medical Gas Filter Devices Recalled Due to Splitting and Detachment Risk

    Teleflex is recalling Iso-Gard Filter S microbial medical gas filters that may split or detach during use. The recall affects 164 units distributed nationwide.

    Product
    Iso-Gard Filter S, Tethered Cap, REF: a) 19211T, OUS only; b) 19212T, OUS only; Microbial medical gas filter, single-use
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0076-2023·2022-10-26

    Medical gas filter recalled due to splitting and detachment risk

    TELEFLEX LLC is recalling Iso-Gard Filter S medical gas filters due to incidents of device splitting or detaching during use. The affected filters may compromise patient safety.

    Product
    Iso-Gard Filter S with Expandi-Flex/Elbow: a) REF 19012, OUS only, b) REF 19012T with Tethered Cap, OUS only; Microbial medical gas filter, single-use
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0077-2023·2022-10-26

    Teleflex Catheter Mount and Filter May Split or Detach During Use

    Catheter mounts with filters (REF 191667-000100) used to connect endotracheal tubes or masks to breathing circuits may split or detach during patient use. Teleflex is recalling affected units distributed nationwide.

    Product
    Filter + Catheter Mount, REF 191667-000100, OUS only. Catheter mount for circuit-patient connection (Endotracheal tube and mask)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0072-2023·2022-10-26

    Iso-Gard Filter S Recalled for Device Splitting or Detachment During Use

    Teleflex is recalling Iso-Gard Filter S microbial filters (60,500 units) due to incidents of device splitting or detaching during use. The filters protect patients and equipment from bacterial and viral contamination in breathing systems.

    Product
    Iso-Gard Filter S, REF : a) 19211, OUS only; b) 19212; Microbial medical gas filter, single-use. Bacterial/viral filters for use in breathing system for the protection of patient and equipment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0073-2023·2022-10-26

    Iso-Gard Filter S Medical Gas Filter Recall Due to Splitting or Detachment

    TELEFLEX LLC is recalling Iso-Gard Filter S microbial medical gas filters due to incidents where the device may split or detach during use. The FDA classified this as a Class I recall.

    Product
    Iso-Gard Filter S, with Expandi-Flex, REF: a) 19261, OUS only; b) 19272, OUS only; Microbial medical gas filter, single-use
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0094-2023·2022-10-26

    N Antiserum to Human IgG Fails High-Dose Hook Effect Performance Standards

    Siemens N Antiserum to Human IgG reagent batches are not meeting performance standards for high-dose immunoassay testing. The issue affects 10,201 packs distributed nationwide and may result in inaccurate diagnostic test results.

    Product
    N Antiserum to Human IgG, 5mL Variant for BN II System and BN ProSpec System- IVD Siemens Material Number (SMN): 10446299
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0106-2023·2022-10-26

    Chest Tube Insertion Tray Recalled Due to Over-Sterilization of Suture Component

    Medline recalls CENTURION SnagFree Chest Tube insertion trays because a silk suture component was sterilized twice instead of once, potentially compromising its integrity. The affected lot contains 18 kits distributed in California and Texas.

    Product
    CENTURION SnagFree Chest Tube insertion Tray, Reorder CHT545
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0116-2023·2022-10-26

    Abbott MitraClip and TriClip Clip Delivery Systems: Locking Malfunction Risk

    Abbott is recalling MitraClip and TriClip Clip Delivery Systems due to clip locking malfunctions. Failed procedures may result in mitral regurgitation recurrence, device embolization, or tissue injury.

    Product
    Product/Part: MitraClip NTR Clip Delivery System US/CDS0601-NTR, MitraClip NTR Clip Delivery System CE/CDS0602-NTR, MitraClip XTR Clip Delivery System CE/CDS0602-XTR, MitraClip G4 Clip Delivery System NT CE/CDS0702-NT, MitraClip G4 Clip Delivery System NTW CE/CDS0702-NTW…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0115-2023·2022-10-26

    MitraClip Clip Delivery System Recalled for Locking Malfunctions

    Abbott Vascular is recalling MitraClip Clip Delivery System devices due to observed increases in clip locking malfunctions that can lead to recurrence of mitral regurgitation, device embolization, or tissue injury.

    Product
    Product/Part: MitraClip XTR Clip Delivery System US/CDS0601-XTR, MitraClip G4 Clip Delivery System NT US/CDS0701-NT, MitraClip G4 Clip Delivery System NTW US/CDS0701-NTW, MitraClip G4 Clip Delivery System XT US/CDS0701-XT, MitraClip G4 Clip Delivery System XTW…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0099-2023·2022-10-26

    Surgical Implant Kit Recall: Incorrect Drill Guide Included

    Synthes surgical implant kits are being recalled because they contain an incorrect size drill guide that cannot properly prepare the bone for the implant, creating a risk of bone damage during surgery.

    Product
    SPEED 15X12X12mm Continuous Compression Implant, Product No. SE-1512
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0100-2023·2022-10-26

    Synthes SPEED implant recall: drill guide size mismatch in surgical kit

    Synthes is recalling SPEED 9X10X10mm surgical implant kits nationwide due to an incorrect-size drill guide that will not properly prepare bone for the implant, creating potential for bone damage.

    Product
    SPEED 9X10X10mm Continuous Compression Implant, Product No. SE-0910
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0112-2023·2022-10-26

    Medicina Reusable Oral Syringe Recalled for Unapproved Plunger Material

    Medicina Uk Ltd is recalling Medicina Reusable Oral syringes because the plunger was manufactured with polyethylene instead of the required polypropylene material. The 11,100 affected syringes do not meet raw material specifications.

    Product
    Medicina Reusable Oral syringe 1ml Code: OTH01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0113-2023·2022-10-26

    Reusable Oral Syringe Recalled for Unapproved Plunger Material

    Medicina UK Ltd is recalling Reusable Oral Syringes because plungers were manufactured from unapproved polyethylene instead of the specified polypropylene material.

    Product
    Medicina Reusable Oral syringe 5ml Code: OTH05
    Category
    Medical Device
    Distribution
    Distributed nationwide