The Recall Desk

Agency

U.S. Food and Drug Administration

The FDA regulates food, drugs, biologics, medical devices, and tobacco. We aggregate Class I, II, and III enforcement actions across its three recall streams.

Visit the official FDA site →

About FDA recalls

The FDA is the single biggest source of US product recalls by volume. Its enforcement workload splits into three streams — Foods (everything from infant formula to leafy greens to nutritional supplements), Drugs (prescription medicines, over-the-counter products, and active pharmaceutical ingredients), and Medical Devices (everything from implants to home blood-pressure monitors). The Recall Desk ingests all three from the openFDA enforcement endpoint every six hours.

FDA classifies every recall as Class I, II, or III. Class I means there is a reasonable probability that using the product will cause serious health consequences or death — these are the recalls you should treat as urgent. Class II means the product may cause temporary or medically reversible harm. Class III means the product is unlikely to cause adverse health consequences but still violates FDA rules. We map these classifications into our 1–5 severity score using the rubric on the methodology page.

Medical-device recalls are the highest-volume stream by far — software-update letters, calibration corrections, and IFU updates all show up in enforcement reports alongside genuine hazard recalls. We try to surface the severe ones first, but when in doubt, click through to the FDA notice itself for the clinical detail.

21951–21975 of 88183

  • 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-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 (Drugs)·D-0021-2023·2022-11-02

    Quinapril and Hydrochlorothiazide Tablets Recalled Due to Manufacturing Impurity

    Aurobindo Pharma USA Inc. is recalling Quinapril/Hydrochlorothiazide Tablets 20mg/12.5mg due to N-nitroso-quinapril impurity above acceptable limits from manufacturing deviations. Affected lots QE2021005-A and QE2021010-A were distributed nationwide.

    Product
    QUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDE — QUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDE (QUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0078-2023·2022-11-02

    The Chai Box Chai Concentrate Recalled for Potential Clostridium Botulinum Contamination

    The Chai Box is recalling chai concentrate due to potential Clostridium botulinum contamination. Product testing revealed a pH level of 4.9, which creates conditions supporting bacterial growth.

    Product
    THE CHAI BOX CHAI CONCENTRATE 16FL OZ/473ML glass bottles UPC 7 93611 81925 2 REGRIGERATE AFTER OPENING. USE WITHIN 14 DAYS and 64FL OZ/1892ML plastic bottles KEEP REFRIGERATED USE WITHIN 7 DAYS OF OPENING UPC 7 93611 81926 9. INGREDIENTS Water, Black Teas, Spices - Cardamom…
    Category
    Food
    Distribution
    50 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-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
  • HighFDA (Food)·F-0073-2023·2022-11-02

    Indian Gooseberry Extract Recalled for Elevated Lead Levels

    Secrets of the Tribe is recalling Indian Gooseberry Alcohol-Free Extract (2 oz and 4 oz bottles) distributed nationwide due to elevated lead levels. Consumers should stop using the product.

    Product
    Indian Gooseberry Alcohol-Free Extract, 2 oz. glass bottle, UPC 722267094379 and Indian Gooseberry Alcohol-Free Extract, 4 oz. glass bottle, UPC 722267094393, Secrets of the Tribe LLC, PO Box 5264, Denver, CO, 80217
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0016-2023·2022-11-02

    Proton Armor hand sanitizer recalled for methanol contamination

    Ultra Chem Labs Corp is recalling Proton Armor hand sanitizer nationwide due to trace amounts of methanol found in a manufacturing component. No illnesses have been reported.

    Product
    Proton Armor, Anti-Microbial Alcohol-Free Foaming Hand Sanitizer, kills 99.99% of germs, Odor Free, Family Safe, No Gels, Water Based, 24 Hour Germ Protection with Moisturizers for Sensitive Skin, a) 8 oz bottle, b) 32 oz bottle and c) 1.7 fl oz or 50 mL bottle, Supplier…
    Category
    Drug
    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
    48 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 (Drugs)·D-0017-2023·2022-11-02

    Proton Armor Hand Sanitizer Recalled Due to Methanol Contamination

    Ultra Chem Labs Corp is recalling Proton Armor Anti-Microbial Alcohol-Free Foaming Hand Sanitizer nationwide due to trace amounts of methanol found in product components during manufacturing. The recall affects multiple bottle sizes with batch number 20117206.

    Product
    Proton Armor, Anti-Microbial Alcohol-Free Foaming Hand Sanitizer, kills 99.99% of germs, Green Tea and Aloe, Family Safe, No Gels, Water Based, 24 Hour Germ Protection with Moisturizers for Sensitive Skin, a) 8 oz bottle, b) 32 oz bottle, and c) 1.7 fl oz or 50 mL bottle…
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0020-2023·2022-11-02

    Fondaparinux Sodium Injection Recalled Nationwide for Subpotent Formulation

    AuroMedics Pharma LLC is recalling 11,520 units of Fondaparinux Sodium Injection nationwide due to out-of-specification potency. Patients should contact their healthcare provider immediately.

    Product
    FONDAPARINUX SODIUM — FONDAPARINUX SODIUM (FONDAPARINUX SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0072-2023·2022-11-02

    Secrets of the Tribe Amla Alcohol-Free Extract recalled for elevated lead

    Secrets of the Tribe is recalling Amla Alcohol-Free Extract (2 oz and 4 oz bottles) distributed nationwide due to elevated lead levels.

    Product
    Amla Alcohol-Free Extract, 2 oz. glass bottle, UPC 041979376093 and Amla Alcohol-Free Extract, 4 oz. glass bottle, UPC 041979376116, Secrets of the Tribe LLC, PO Box 5264, Denver, CO, 80217
    Category
    Drug
    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-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 (Food)·F-0077-2023·2022-11-02

    Qassim Mix for Coffee Recalled Due to Undeclared Milk Allergen

    Tomoorona LLC is recalling Qassim Mix for Coffee due to undeclared milk in the label. The product contains sodium caseinate (a milk derivative) but does not warn consumers about milk allergen, risking harm to those with milk allergies.

    Product
    Qassim Mix for Coffee, Net Weight 125g, packaged in a plastic container (UPC 6-281103 300011). Each case contains 48-125g containers.
    Category
    Food
    Distribution
    4 states
  • 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 (Food)·F-0079-2023·2022-11-02

    The Chai Box Chai Concentrate Recalled for Botulinum Contamination

    The Chai Box Chai Concentrate is being recalled due to potential Clostridium botulinum contamination identified during testing. Affected products have best-by dates from September 2022 to March 2023.

    Product
    THE CHAI BOX CHAI CONCENTRATE UNSWEETENED 16FL OZ/473ML glass bottles UPC 7 93611 81925 2 REGRIGERATE AFTER OPENING. USE WITHIN 14 DAYS and 64FL OZ/1892ML plastic bottles KEEP REFRIGERATED USE WITHIN 7 DAYS OF OPENING UPC 7 93611 81926 9. INGREDIENTS Water, Black Teas, Spices…
    Category
    Food
    Distribution
    50 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