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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9151–9175 of 27393

  • HighFDA (Devices)·Z-0124-2023·2022-11-02

    Medline Pre-Op CHG Bathing Kit recalled for incorrect expiration dates

    Medline is recalling 460 Pre-Op CHG Bathing Kits because the CHG solution and blood culture bottles have expiration dates that don't match the kit label. Expired components could compromise effectiveness.

    Product
    MEDLINE PRE-OP CHG BATHING KIT Reorder #: P164756
    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, CORA2015
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-0118-2023·2022-11-02

    AutoPulse Resuscitation System Battery Recalled for Increased Li-ion Failures

    ZOLL Circulation is recalling 6,353 AutoPulse Li-ion Batteries used in the AutoPulse Resuscitation System Model 100 CPR device due to an increase in battery failures. Affected users should contact the manufacturer for replacement guidance.

    Product
    AutoPulse Li-ion Battery used on the AutoPulse Resuscitation System Model 100. used as an adjunct to manual CPR
    Category
    Medical Device
    Distribution
    48 states
  • HighFDA (Devices)·Z-0138-2023·2022-11-02

    CorVocet Biopsy System recall due to potential unintended needle ejection

    Merit Medical Systems is recalling 2,894 CorVocet Biopsy Systems because misaligned components may cause the needle to eject unexpectedly when triggered outside the body, risking needle stick injuries.

    Product
    CorVocet Biopsy System, Catalog Code: CORA1410/B, CORA1410S/B, CORA1415/B, CORA1615S/B, CORA2010S/B, CORCA1410S/B, CORCA1410S/CNB, CORCA1415S/B, CORCA1610/CNB, CORCA1615S/CNB, CORCA1810SB/CNB, CORCA1815SB/CNB, CORCA1820SB/CNB, CORCA2015SB/CNB, CORCA2020SB/CNB
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-0133-2023·2022-11-02

    da Vinci Surgical Robot Systems Risk of Unintended Energy Delivery

    Intuitive Surgical's da Vinci X and Xi surgical systems can inadvertently deliver electrical energy to patients under specific instrument and pedal combinations, creating a risk during surgery.

    Product
    da Vinci X (IS4200) and Xi (IS4000) systems, which consists of finished devices Surgeon Console (SSC), Patient Cart (PSCART), Vision System (VSS)
    Category
    Medical Device
    Distribution
    27 states
  • HighFDA (Devices)·Z-0140-2023·2022-11-02

    Stryker INBONE Tibial Tray recalled for oversized lock detail defect

    Wright Medical Technology is recalling one Stryker INBONE Tibial Tray due to an oversized tibial tray lock detail that exceeds product specifications and could affect device functionality.

    Product
    Stryker INBONE Tibial Tray, Left Plasma Spray Ti6Al4V, CPti, Use w/ 18mm Stem Base, REF 200252904, Size 4
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-0122-2023·2022-11-02

    Medline Blood Culture Kits recalled due to mismatched component expiration dates

    Medline Industries is recalling 1,600 blood culture kits (Reorder # DYNDH1592) because component expiration dates don't match the kit label. Affected components include CHG Solution and Bactec bottle plastic.

    Product
    MEDLINE BLOOD CLUTURE KIT, Reorder #: DYNDH1592
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-0130-2023·2022-11-02

    ConvaTec Ostomy Pouch Recalled for Impaired Release Liner Functionality

    ConvaTec is recalling 2,611 units of its Active Life ostomy pouch due to impaired release liner functionality. The defect may affect product performance and seal integrity.

    Product
    ConvaTec Active Life, One-Piece Drainable Pouch, 3/4-2 1/2 in., 19-64mm, REF 400599. For the management of stoma output following a colostomy or ileostomy procedure.
    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
  • HighFDA (Devices)·Z-0128-2023·2022-11-02

    ConvaTec Esteem+ Durahesive Plus Ostomy Pouch Release Liner Defect

    ConvaTec recalled 182 units of Esteem+ Durahesive Plus ostomy pouches nationwide due to impaired release liner functionality. The defect affects pouches with batch number 2A02671 and UDI 768455115334.

    Product
    ConvaTec Esteem+ Durahesive Plus, Drainable Pouch, 3/4-2 1/4 in., 19-64mm, REF 416975. For the management of stoma output following a colostomy or ileostomy procedure.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0127-2023·2022-11-02

    ConvaTec Esteem+ Durahesive Plus ostomy pouches recalled for release liner defect

    ConvaTec is recalling 5,284 units of Esteem+ Durahesive Plus ostomy pouches due to impaired release liner functionality. The defect may affect proper device operation for patients managing colostomy or ileostomy output.

    Product
    ConvaTec Esteem+ Durahesive Plus, Drainable Pouch, 3/4-2 1/2 in., 19-64mm, REF 416976. For the management of stoma output following a colostomy or ileostomy procedure.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0119-2023·2022-11-02

    ARTIS pheno interventional x-ray system software defect prevents treatment continuation

    Siemens is recalling ARTIS pheno x-ray systems with VE10B software due to three potential software issues that may prevent continued treatment on the affected system, potentially requiring use of an alternate system.

    Product
    ARTIS pheno, Interventional fluoroscopic x-ray system, Model No. 10849000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0134-2023·2022-11-02

    ARIES SARS-CoV-2 Assay Recalled Due to Syringe Defect

    Luminex is recalling certain lots of the ARIES SARS-CoV-2 Assay because a defect in the wash 1 syringe could cause incomplete sample extraction and produce false negative test results.

    Product
    ARIES SARS-CoV-2 Assay, REF: 50-10047
    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-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-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-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
  • 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
  • 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-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
  • 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