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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10826–10850 of 13748

  • HighFDA (Devices)·Z-0160-2023·2022-11-09

    Surgical Cataract Kits Recalled for Defective Breather Pouch Seals

    Medline has recalled Bausch + Lomb cataract surgical kits due to breather pouches with seal openings that could compromise sterility. Affected kits were distributed nationwide.

    Product
    BAUSCH + LOMB CATARACT TRAY, REF LYN023FACTB. Convenience kit used in surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0173-2023·2022-11-09

    BD Multitest 6-Color TBNK tubes recalled for partial label detachment

    BD Multitest 6-Color TBNK tubes are being recalled due to partial label detachment. The defect can cause tubes to stick together or lead to automation errors when used with the flow cytometer's automated loader.

    Product
    BD Multitest 6-Color TBNK with optional BD Trucount Tubes (Cat. No. 662995), for use with BD FACSLyric, BD FACSCanto II, and BD FACSCanto flow cytometers to determine the percentages and absolute counts of human lymphocyte subsets in peripheral whole blood for immunophenotyping.
    Category
    Medical Device
    Distribution
    43 states
  • 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-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-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-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-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-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-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
    46 states
  • 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
  • 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-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-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-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-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
  • 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-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. The
    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
  • 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-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
  • 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 bloo
    Category
    Medical Device
    Distribution
    Distributed nationwide