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.

21351–21375 of 88183

  • HighFDA (Drugs)·D-0078-2023·2022-12-21

    FDA Recalls Fentanyl Citrate Injection Cassettes Due to Underfilling

    OurPharma LLC is recalling 691 fentanyl citrate injection cassettes due to underfilled units. The recall affects lots distributed in Missouri with expiration dates between December 2022 and January 2023.

    Product
    FentaNYL Citrate 2.5 mg/50 mL (50mcg/ml) Injection Solution, Preservative Free, Single Use 50 ml Cassette, Rx Only, Repackaged by OurPharma, LLC. 2512 S. City Lake Rd. Fayetteville, AR 72701, 1-833-290-2654, NDC 73013-001-01
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-0516-2023·2022-12-21

    Stradis Healthcare Major Extremity Surgical Kits Recalled for Potential Sterility Breach

    Stradis Healthcare is recalling Henry Schein Major Extremity surgical kits due to incomplete outer bag sealing that could compromise kit sterility. Affected kits were distributed nationwide in the US and Canada.

    Product
    HENRY SCHEIN, MAJOR EXTREMITY PACK, Item No.570-2783,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0686-2023·2022-12-21

    Medical Device Recall: DeRoyal HAND PACK Kit Lot 57685848

    DeRoyal Industries Inc is voluntarily recalling DeRoyal HAND PACK kits (Lot 57685848) distributed across 23 US states. The reason for recall has not been publicly disclosed.

    Product
    DeRoyal HAND PACK, REF 89-10314.03
    Category
    Medical Device
    Distribution
    23 states
  • HighFDA (Devices)·Z-0720-2023·2022-12-21

    Cordis Angiographic Catheter Extensions Recalled for Male Connector Separation Risk

    Cordis angiographic catheter extensions may experience separation at the male connector during use. Approximately 2,915 US units were distributed; users should verify affected lot numbers.

    Product
    Cordis Angiographic Catheter Extensions. Used to transport fluid from the power injector to the catheter for injection into the patient.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0475-2023·2022-12-21

    Surgical microscope power supply may overheat and cause unexpected shutdown

    Leica Microsystems is recalling 43 Proveo 8 surgical microscopes nationwide due to a potential power supply defect that may cause device overheating and unexpected shutdown during use.

    Product
    Leica MICROSYSTEMS Proveo 8, Part Number 10449058, surgical microscope system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0506-2023·2022-12-21

    General Surgery Procedure Kit Recalled for Sterility Concerns

    Stradis Medical is recalling surgical procedure kits with potentially incomplete outer bag seals that may compromise sterility. The recall affects 35 units distributed nationwide in the US and Canada.

    Product
    HENRY SCHEIN, PROCEDURE KIT, Item No.570-1508, general surgery tray
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0560-2023·2022-12-21

    DeRoyal Minor Oral and ENT Procedure Packs Recalled for Defective Steri Drapes

    DeRoyal procedure packs distributed across multiple U.S. states are being recalled because they contain previously recalled 3M Steri Drapes. Affected healthcare facilities should stop using the packs and contact the manufacturer.

    Product
    DeRoyal MINOR ORAL / ENT PACK, REF 89-2576.15
    Category
    Medical Device
    Distribution
    23 states
  • HighFDA (Devices)·Z-0670-2023·2022-12-21

    Surgical Spinal Fusion Device Recalled Across 23 US States

    DeRoyal is recalling its Posterior Lumbar Fusion Pack medical device across 23 states. The voluntary recall affects specific lot numbers; patients should consult their healthcare provider.

    Product
    DeRoyal POSTERIOR LUMBAR FUSION PACK, REF 89-10060.02
    Category
    Medical Device
    Distribution
    23 states
  • HighFDA (Devices)·Z-0607-2023·2022-12-21

    FDA Recalls DeRoyal BASIC EYE PACK Medical Device Kits

    The FDA has issued a recall of 50 kits of DeRoyal BASIC EYE PACK, a medical device distributed across 23 U.S. states. The specific reason for the recall is not provided in available source information.

    Product
    DeRoyal BASIC EYE PACK, REF 89-8337.09
    Category
    Medical Device
    Distribution
    23 states
  • HighFDA (Devices)·Z-0574-2023·2022-12-21

    FDA Class II recall: DeRoyal surgical procedure pack distributed to multiple states

    DeRoyal Industries voluntarily recalled 3 kits of its OPEN SHOULDER PROCEDURE PACK RF (Lot 56391733, expiring 3/1/2024) starting November 2022. The recall affects multiple U.S. states.

    Product
    DeRoyal OPEN SHOULDER PROCEDURE PACK RF, REF 89-6629.07
    Category
    Medical Device
    Distribution
    23 states
  • HighFDA (Devices)·Z-0530-2023·2022-12-21

    Single-shot epidural kits recalled due to incomplete outer bag sealing

    Stradis Medical is recalling 80 Henry Schein single-shot epidural kits due to potentially incomplete outer bag sealing that could compromise sterility. The recall affects units distributed nationwide in the US and Canada.

    Product
    HENRY SCHEIN, SINGLE SHOT EPIDURAL, Item No.570-3089
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0538-2023·2022-12-21

    Stradis Healthcare Thoracic Surgery Kits Recalled for Sterility Risk

    Thoracic Phleb procedure kits from Stradis Healthcare are being recalled due to incomplete outer bag sealing during manufacturing, which may compromise kit sterility.

    Product
    STRADIS HEALTHCARE, Thoracic Phleb, Item No.682-1228,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0514-2023·2022-12-21

    ENT Surgical Kits Recalled for Potential Sterility Loss

    Stradis Medical is recalling HENRY SCHEIN ENT surgical kits distributed nationwide due to defective outer bag sealing that may compromise sterility. Affected kits were distributed across the US and Canada.

    Product
    HENRY SCHEIN, ENT SET UP PACK, Item No.570-2742
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0667-2023·2022-12-21

    DeRoyal ACDF surgical implant kit recall, Class II, reason undisclosed

    DeRoyal is recalling 63 ACDF surgical implant kits distributed to 23 US states. This is a voluntary, Class II recall announced November 2022, with no reported illnesses or injuries.

    Product
    DeRoyal ACDF PACK PGYBK A PACK / B PACK, REF 89-9997.06
    Category
    Medical Device
    Distribution
    23 states
  • HighFDA (Devices)·Z-0493-2023·2022-12-21

    Stradis Healthcare Dental Implant Trays Recalled Due to Incomplete Sealing

    Stradis Healthcare is recalling dental implant trays with incomplete outer bag seals that may compromise sterility. Affected units were distributed in the US and Canada.

    Product
    STRADIS HEALTHCARE, Implants, Item No.41015NSI, dental tray
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0597-2023·2022-12-21

    DeRoyal Spinal Fusion Packs Recalled for Containing Affected 3M Steri Drapes

    DeRoyal procedure kits for spinal fusion are being recalled because they contain 3M Health Care Steri Drapes that have been recalled by 3M. The affected 16 kits were distributed to healthcare facilities in 23 US states.

    Product
    DeRoyal SPINAL FUSION PACK, REF 89-7515.13
    Category
    Medical Device
    Distribution
    23 states
  • HighFDA (Devices)·Z-0508-2023·2022-12-21

    Surgical Procedure Trays Recalled for Potential Sterility Breach

    Stradis Medical recalls surgical procedure trays due to incomplete outer bag sealing that may compromise sterility. The affected products were distributed nationwide in the US and Canada.

    Product
    HENRY SCHEIN, Basin Set, Item No.570-1803
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0548-2023·2022-12-21

    Stradis Healthcare Surgical Procedure Kits Recalled for Incomplete Sealing

    Stradis Medical recalls Vein & Laser surgical procedure kits due to incomplete outer bag sealing that may compromise sterility. The recall affects 10 units distributed in the US and Canada.

    Product
    STRADIS HEALTHCARE, Vein & Laser, Item No.682-334R1,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0676-2023·2022-12-21

    Medical Device Kit Recall: DeRoyal CRANI PACK Lot 56705261

    DeRoyal Industries is recalling 16 units of the DeRoyal CRANI PACK (Lot 56705261, expiring 6/1/2025) distributed across multiple U.S. states. The specific reason for this Class II recall is not disclosed in the source notice.

    Product
    DeRoyal CRANI PACK, REF 89-10202.03
    Category
    Medical Device
    Distribution
    23 states
  • ModerateFDA (Devices)·Z-0649-2023·2022-12-21

    DeRoyal Endovascular Tracepack Medical Device Recall, FDA Class II

    DeRoyal Industries initiated a Class II recall of 495 endovascular tracepack kits distributed across 23 U.S. states due to an unspecified manufacturing concern.

    Product
    DeRoyal ENDOVASCULAR TRACEPACK, REF 89-9350.03
    Category
    Medical Device
    Distribution
    23 states
  • ModerateFDA (Devices)·Z-0650-2023·2022-12-21

    Medical Device Shoulder Pack Recall Initiated by Manufacturer

    DeRoyal Industries initiated a voluntary recall of 32 kits of its Shoulder Pack medical device distributed across 23 U.S. states. The specific reason for the recall was not provided in the source documentation.

    Product
    DeRoyal SHOULDER PACK, REF 89-9449.12
    Category
    Medical Device
    Distribution
    23 states
  • ModerateFDA (Devices)·Z-0620-2023·2022-12-21

    FDA Recalls GEO-MED Podiatry Pack Medical Device Kit

    DeRoyal Industries voluntarily recalls GEO-MED Podiatry Pack medical device kits distributed across 23 US states. The specific reason for recall is not detailed in available source materials.

    Product
    GEO-MED PODIATRY PACK PGYBK, REF 89-8700.02
    Category
    Medical Device
    Distribution
    23 states
  • ModerateFDA (Devices)·Z-0663-2023·2022-12-21

    Medical Device Recall: DeRoyal Breast Augmentation Pack Class II

    DeRoyal Industries initiated a voluntary Class II recall of 70 kits of its Breast Augmentation Pack distributed across 23 US states. The specific reason for the recall is not stated in available FDA materials.

    Product
    DeRoyal BREAST AUGMENTATION PACK, REF 89-9618.05
    Category
    Medical Device
    Distribution
    23 states
  • ModerateFDA (Devices)·Z-0577-2023·2022-12-21

    GEO-MED PLASTIC HAND PACK RF Medical Device Recall

    DeRoyal Industries Inc is recalling 102 kits of the GEO-MED PLASTIC HAND PACK RF. The reason for the recall is not publicly specified. The recall affects 23 US states and was voluntarily initiated by the manufacturer.

    Product
    GEO-MED PLASTIC HAND PACK RF, REF 89-6667.10
    Category
    Medical Device
    Distribution
    23 states
  • ModerateFDA (Devices)·Z-0652-2023·2022-12-21

    FDA Class II: DeRoyal Trauma Pack Voluntary Recall

    DeRoyal Industries initiated a voluntary recall of EMERGENT TRAUMA PACK kits (18 units) distributed to hospitals and medical facilities across 23 US states. The specific reason for the recall was not disclosed in the FDA notification.

    Product
    DeRoyal EMERGENT TRAUMA PACK, ref 89-9453.12
    Category
    Medical Device
    Distribution
    23 states