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.

8326–8350 of 88183

  • ModerateFDA (Devices)·Z-1565-2025·2025-04-23

    Welch Allyn Spot Vital Signs 4400 Device Blood Pressure Cuff Recall

    Baxter Healthcare Corporation is recalling certain Welch Allyn Spot Vital Signs 4400 blood pressure cuff devices due to undeclared natural rubber bands in the packaging, which poses an allergy risk.

    Product
    Welch Allyn Spot Vital Signs 4400 Device, Product Code/Part Numbers: 1) 44WT-2; 2) 44WT-3; 3) 44WT-4; 4) 44WT-6; 5) 44WT-B; 6) 44XT-2; 7) 44XT-4; 8) 44XT-6; 9) 44XT-B.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0366-2025·2025-04-23

    Chlorpromazine Hydrochloride Tablets Recalled Due to Impurity

    The FDA is recalling Chlorpromazine Hydrochloride Tablets, 10 mg, due to the presence of N-Nitroso-Desmethyl Chlorpromazine impurity above recommended limits. The affected lot was distributed nationwide.

    Product
    ChlorproMAZINE Hydrochloride Tablets, USP, 10 mg, packaged in cartons of 100 TABLETS (10x10), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-7129-61
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1575-2025·2025-04-23

    ID NOW Influenza A/B 2 24T Nucleic Acid Assay Kits Recalled

    Abbott Diagnostics is recalling ID NOW Influenza A/B 2 24T test kits (Model 427-000) nationwide because affected lots have a higher occurrence of invalid test results than stated in the product instructions.

    Product
    Brand Name: ID NOW Influenza A/B 2 24T Product Name: ID NOW Influenza A/B 2 24T Model/Catalog Number: 427-000 Software Version: N/A Product Description: Influenza A And Influenza B Multiplex Nucleic Acid Assay; Real Time Nucleic Acid Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1603-2025·2025-04-23

    Medline Convenience Kits Recalled for Potentially Weak Breather Pouch Seals

    Medline Industries is recalling select sterile convenience kits with Model Number MNS12590 due to potential open or weak seals on breather pouches used in packaging. The affected lot is 24IBH166.

    Product
    Medline Convenience kits used for various procedures: 1) PRECIP TRAY, Model Number: MNS12590
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1606-2025·2025-04-23

    Medline Convenience Kit Skin Lesion Set Potential Seal Defect

    Medline is recalling its Skin Lesion Set convenience kits due to potential open or weak seals on breather pouches used for packaging. The compromised seals may affect the sterility of the kits.

    Product
    Medline Convenience kits used for various procedures: 1) SKIN LESION SET, Model Number: MNS6270
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1573-2025·2025-04-23

    ID NOW RSV 24T Respiratory Virus Assay System Higher Invalid Result Rates

    Abbott Diagnostics is recalling certain lots of the ID NOW RSV 24T respiratory virus assay system due to higher-than-expected invalid result rates compared to the product instructions.

    Product
    Brand Name: ID NOW RSV 24T Product Name: ID NOW RSV 24T Model/Catalog Number: 435-000 Software Version: N/A Product Description: Respiratory virus panel nucleic acid assay system Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0712-2025·2025-04-23

    Lemon Plum product recall due to undeclared cyclamates

    Rong Shing Trading NY Inc is recalling Lemon Plum (228g) because the product contains cyclamates, which are not declared on the label.

    Product
    LEMON PLUM; NET WT: 228G (8oz); INGREDIENTS: Plum, sugar, salt, lemon juice, food additives (citric acid, sodium benzoate, potassium sorbate, ethyl maltol, FD&C YELLOW#6, vanillin, saccharin sodium, sodium metabisulfite), food flavoring; DISTRIBUTED BY RONG SHING TRADING NY INC…
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Drugs)·D-0363-2025·2025-04-23

    Testosterone Cypionate Injection Recalled for Insoluble Crystals

    Eugia US LLC is recalling Testosterone Cypionate Injection due to complaints that crystals do not redissolve into solution after warming and shaking. The defect may affect product safety and efficacy.

    Product
    TESTOSTERONE CYPIONATE — TESTOSTERONE CYPIONATE (TESTOSTERONE CYPIONATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1619-2025·2025-04-23

    Medline Sterile Convenience Kits Recalled for Open Breather Pouches

    Medline Industries is recalling three models of sterile convenience kits used for arthroscopy procedures due to potential open or weak seals on the breather pouches used for packaging.

    Product
    Medline Convenience kits used for various procedures: 1) ARTHROSCOPIE DU GENOU-LF, Model Number: DYNJ40229A; 2) ARTHROSCOPY PACK-LF, Model Number: OPK382N; 3) ARTHROSCOPY NEW TEGH-LF, Model Number: DYNJ46723B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0714-2025·2025-04-23

    Tony's Chocolonely Dark Chocolate Almond Sea Salt recalled for foreign objects

    Tony's Chocolonely Dark Chocolate Almond Sea Salt is being recalled nationwide because some units contain stones. Consumers who have purchased affected lots should not consume the product.

    Product
    Tony's Chocolonely Dark Chocolate Almond Sea Salt
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1563-2025·2025-04-23

    Welch Allyn Connex Spot Monitor blood pressure cuffs undeclared natural rubber

    Baxter Healthcare is recalling certain Welch Allyn Connex Spot Monitor reusable blood pressure cuffs worldwide because packaging contains an undeclared natural rubber band that may trigger allergic reactions in sensitive individuals.

    Product
    Welch Allyn Welch Allyn Connex Spot Monitor, Product Code/ Part Numbers: 1) 73WT-B; 2) 74CE-B; 3) 74CT-B; 4) 74CX-B; 5) 74ME-B; 6) 74MT-B; 7) 74MX-B; 8) 74RE-B; 9) 74RT-B; 10) 75CE-B; 11) 75CT-B; 12) 75CT-BR; 13) 75CX-B; 14) 75-HCA-CTB; 15)…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1577-2025·2025-04-23

    Maquet VH-3010 Power Supply Recalled for Inadequate Heating Function

    Maquet Cardiovascular is recalling 110 units of the VH-3010 Power Supply due to an incorrect resistor that may prevent the HemoPro 2 harvesting tool jaws from heating adequately.

    Product
    Maquet VH-3010 Power Supply. Used to deliver power to the harvesting tool of the Vasoview Hemopro EVH System (HemoPro 2).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1609-2025·2025-04-23

    Medline Hernia Repair Convenience Kit Recalls Due to Weak Seals

    Medline is recalling Hernia Repair Tote convenience kits (Model DYNJ908337C) because purchased breather pouches used for packaging may have open or weak seals, which could compromise product sterility.

    Product
    Medline Convenience kits used for various procedures: 1) HERNIA REPAIR TOTE, Model Number: DYNJ908337C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1613-2025·2025-04-23

    Medline Convenience Kits Recalled for Potentially Open Breather Pouches

    Medline Industries is recalling 706 units of various sterile convenience kits used for gynecological and other procedures due to potential open or weak seals on breather pouches. The packaging defect could affect product sterility.

    Product
    Medline Convenience kits used for various procedures: 1) STANDARD D&C, Model Number: DYNJ69733; 2) NHS - LAP BOWEL GNG, Model Number: DYNJ39904A; 3) LAPAROSCOPY GYN SURGERY PA, Model Number: DYNJ64651A; 4) GYNE - LITHOTOMY MAJOR-LF, Model Number: DYNJ49250F; 5) ENS.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0711-2025·2025-04-23

    Legally Addictive O.G. Cookies recalled for rancid taste

    Legally Addictive Foods is recalling Legally Addictive The O.G. Cookies in two sizes due to consumer complaints of rancid taste. The cookies were distributed in Illinois and Pennsylvania.

    Product
    LEGALLY ADDICTIVE THE O.G. COOKIES MADE FROM CRACKERS+TOFFEE+CHOCOLATE+SEA SALT NET WT. 4.7OZ (133G) UPC 8 54766 00802 8 & 1.34OZ (38G) UPC 8 54766 02800 4
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1605-2025·2025-04-23

    Medline Convenience Kit NAIL PACK Sterile Packaging Seal Defect Recall

    Medline is recalling select NAIL PACK sterile convenience kits (Model SUT15830A, Lot 24IBR642) due to potential open or weak seals on breather pouches used for product packaging.

    Product
    Medline Convenience kits used for various procedures: 1) NAIL PACK, Model Number: SUT15830A;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0362-2025·2025-04-23

    Unisom SleepMinis diphenhydramine capsules recalled for nitrosamine impurity

    Chattem Inc. is recalling Unisom SleepMinis 25 mg diphenhydramine capsules due to detection of nitrosamine impurity above FDA limits. Affected lots are 22L603 (exp. Oct 2025) and 378999 (exp. Feb 2027).

    Product
    Unisom, SleepMinis, Diphenhydramine HCl, Mini-Capsules, 25 mg, 60 Mini-Capsules bottles, Dist. by Chattem, Inc., P.O. Box 2219, Chattanooga, TN 37409-0219, USA, UPC 0 41167 00670 2
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1578-2025·2025-04-23

    Rover Mobile X-ray System Recalled for Potential Early Tube Failure

    Micro-X Ltd. is recalling 31 Rover Mobile X-ray Systems (Model MXU-RV71) due to potential early life failure of the x-ray tube caused by excessive thermal load on the anode. The systems were distributed nationwide in California, New Jersey, and Puerto Rico.

    Product
    Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV71 Product Description: Rover Mobile X-rays System ("Rover") is a mobile imaging system that incorporates a self-contained X-ray generator, imaging display and software for acquiring medical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1597-2025·2025-04-23

    Medline Convenience Kits Recalled for Potentially Open Breather Pouches

    Medline Industries is recalling select sterile convenience kits because purchased breather pouches used for packaging may have open or weak seals, potentially compromising the sterility of the kits.

    Product
    Medline Convenience kits used for various procedures: 1) T A PACK, Model Number: DYNJ67791A; 2) NASAL PACK, Model Number: DYNJ66514; 3) ENT PACK, Model Number: DYNJ67775A; 4) T/A ENDO PACK, Model Number: DYNJ83158; 5) T & A PACK, Model Number: DYNJ0634878I; 6)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1571-2025·2025-04-23

    ID NOW COVID-19 2.0 Point-of-Care Test Device Recall

    Abbott is recalling certain lots of the ID NOW COVID-19 2.0 24T test device due to higher invalid result rates than stated in product instructions. The affected lots were distributed worldwide.

    Product
    Brand Name: ID NOW COVID-19 2.0 24T Product Name: ID NOW COVID-19 2.0 24T Model/Catalog Number: 192-000 Software Version: N/A Product Description: Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1572-2025·2025-04-23

    ID NOW Influenza A/B 2 24T Diagnostic Assay Invalid Result Rates

    Abbott Diagnostics is recalling certain lots of the ID NOW Influenza A/B 2 24T diagnostic assay due to higher-than-expected invalid test result rates. Affected lots were distributed worldwide.

    Product
    Brand Name: ID NOW Influenza A/B 2 24T Product Name: ID NOW Influenza A/B 2 24T Model/Catalog Number: 427-000 Software Version: N/A Product Description: Influenza A And Influenza B Multiplex Nucleic Acid Assay; Real Time Nucleic Acid Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1601-2025·2025-04-23

    Medline Convenience Kits Recalled for Potential Weak Breather Pouch Seals

    Medline Industries is recalling select sterile convenience kits due to potential open or weak seals on breather pouches used for packaging. The issue affects 116 units distributed worldwide.

    Product
    Medline Convenience kits used for various procedures: 1) MINOR BASIN -SMH, Model Number: DYNJ907733B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1576-2025·2025-04-23

    ID NOW RSV 24T Respiratory Virus Panel Has Higher Invalid Test Rates

    Abbott Diagnostics is recalling specific lots of the ID NOW RSV 24T respiratory virus assay due to higher-than-expected invalid test rates. The affected lots were distributed nationwide.

    Product
    Brand Name: ID NOW RSV 24T Product Name: ID NOW RSV 24T Model/Catalog Number: 435-000 Software Version: N/A Product Description: Respiratory virus panel nucleic acid assay system Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1598-2025·2025-04-23

    Medline Sterile Convenience Kits Recalled for Defective Breather Pouches

    Medline Industries is recalling select sterile convenience kits due to the potential for open or weak seals on breather pouches used in packaging. Affected units were distributed nationwide and internationally.

    Product
    Refer to RES
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1574-2025·2025-04-23

    ID NOW COVID-19 2.0 24T Point-of-Care Device Recall

    Abbott Diagnostics is recalling certain lots of the ID NOW COVID-19 2.0 24T test device due to higher-than-expected rates of invalid test results. The affected devices were distributed nationwide.

    Product
    Brand Name: ID NOW COVID-19 2.0 24T Product Name: ID NOW COVID-19 2.0 24T Model/Catalog Number: 192-000 Software Version: N/A Product Description: Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide