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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20251–20275 of 27461

  • HighFDA (Devices)·Z-0680-2023·2022-12-21

    FDA recalls 90 DeRoyal pacemaker ICD device packs for defect

    DeRoyal Industries is recalling 90 kits of its Pacemaker ICD Pack (Lot 56705350, expiring June 1, 2026) distributed across 23 US states. The specific reason for this voluntary, firm-initiated recall is not disclosed in the FDA notice.

    Product
    DeRoyal PACEMAKER ICD PACK, REF 89-10216.03
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0715-2023·2022-12-21

    DeRoyal Cataract Surgery Packs Recalled for Defective Components

    DeRoyal cataract procedure packs containing recalled 3M Health Care Steri Drapes are being recalled. The recall includes 520 kits distributed to healthcare facilities.

    Product
    DeRoyal CATARACT PACK, REF 89-10086.05
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0598-2023·2022-12-21

    DeRoyal Spinal Fusion Procedure Packs Recalled for 3M Drape Issue

    DeRoyal spinal fusion procedure packs containing recalled 3M Health Care Steri Drapes are being recalled. Affected kits were distributed to healthcare facilities across 23 U.S. states.

    Product
    DeRoyal SPINAL FUSION PACK, REF 89-7515.14
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0540-2023·2022-12-21

    Surgical Procedure Trays with Potentially Compromised Sterile Packaging

    Stradis Healthcare is recalling surgical procedure trays due to potentially incomplete outer bag sealing that may compromise product sterility. Affected units were distributed nationwide in the US and Canada.

    Product
    STRADIS HEALTHCARE, Phleb, Item No.682-1425,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0542-2023·2022-12-21

    Stradis Healthcare surgical procedure kits recalled for incomplete outer bag sealing

    Stradis Healthcare has recalled surgical procedure kits due to incomplete outer bag sealing that may compromise sterility. Affected units (40 units, lot 22235489419) were distributed across the United States and Canada.

    Product
    STRADIS HEALTHCARE, Surgery PK, Item No.682-1728,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0466-2023·2022-12-21

    NexGen Stemmed Tibial Component Recalled Due to Higher Revision Rates

    Zimmer is recalling NexGen Option Stemmed Tibial Components due to higher revision rates when used with certain femoral components in knee replacements.

    Product
    NexGen Option Stemmed Tibial Component Size 3, Item Number 00-5986-037-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0480-2023·2022-12-21

    Ethicon PDS II Surgical Sutures Recalled for Deficient Knot Strength

    Ethicon recalls PDS II violet monofilament sutures due to significantly reduced knot tensile strength, posing risk of intra-operative breakage in surgical procedures. The affected lot was distributed internationally to Canada, Japan, Australia, and New Zealand.

    Product
    PDS II (polydioxanone) Suture- VIOLET MONOFILAMENT 27IN 0 S/A CT-1 Product Code: Z340H For use in soft tissue approximation, including use in pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0562-2023·2022-12-21

    DeRoyal Procedure Packs Recalled Due to Included 3M Steri Drapes

    DeRoyal Industries recalls EYE PACK procedure kits because they contain 3M Health Care Steri Drapes that have been recalled. The recall affects 156 kits distributed across 23 U.S. states.

    Product
    DeRoyal EYE PACK, REF 89-4051.09
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0567-2023·2022-12-21

    DeRoyal Total Knee Procedure Pack Recalled for Defective Steri Drapes

    DeRoyal Industries is recalling 79 units of GEO-MED TOTAL KNEE PACK A & B due to defective 3M Steri Drapes included in the procedure packs. The affected units were distributed across 23 states.

    Product
    GEO-MED TOTAL KNEE PACK A & B PGYK, REF 89-5796.13
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0695-2023·2022-12-21

    Hip replacement surgical kits recalled by DeRoyal Industries

    DeRoyal Industries Inc has recalled 19 anterior approach total hip replacement surgical kits distributed across 23 U.S. states. This Class II recall was initiated voluntarily by the manufacturer.

    Product
    DeRoyal ANTERIOR APPROACH TOTAL HIP A&B PGYBK, REF 89-10612.01
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0689-2023·2022-12-21

    Medical Device Recall: DeRoyal CNRV Peripheral VAS Pack

    DeRoyal Industries is recalling 68 kits of the CNRV Peripheral VAS Pack. The voluntary Class II recall affects healthcare facilities in 23 US states with specific lot numbers.

    Product
    DeRoyal CNRV PERIPHERAL VAS PACK, REF 89-10530.03
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0517-2023·2022-12-21

    Henry Schein Universal Tray Recall for Incomplete Sealing

    Stradis Medical recalls 675 Henry Schein Universal Trays due to incomplete outer bag sealing that may compromise sterility. The defect affects surgical procedures nationwide and in Canada.

    Product
    HENRY SCHEIN, UNIVERSAL TRAY, Item No.570-2787
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0536-2023·2022-12-21

    Stradis Healthcare Medical and Surgical Trays Recalled for Incomplete Bag Sealing

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

    Product
    STRADIS HEALTHCARE, Lipo, Item No.681-254,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0610-2023·2022-12-21

    FDA Recalls DeRoyal HEART PACK Medical Device Kits

    FDA is recalling 51 DeRoyal HEART PACK medical device kits (Lot 57893436) distributed across 23 US states. The specific reason for this Class II recall has not been disclosed.

    Product
    DeRoyal HEART PACK, REF 89-8351.13
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0456-2023·2022-12-21

    Intra-Aortic Balloon Pump Recalled for Potential Battery Run-Time Issue

    Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump devices are being recalled worldwide due to a potential issue with short battery run-times. Healthcare providers and patients should contact the manufacturer for guidance.

    Product
    Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500J (IPN000334), cardiac pump
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0472-2023·2022-12-21

    Linear accelerator software addresses potential wrong-site treatment risk

    Siemens linear accelerator systems may allow users to select the wrong treatment site, potentially delivering radiation to the wrong location. The FDA classified this Class II recall affecting 8 units across seven U.S. states.

    Product
    ARTISTE, ONCOR and PRIMUS with syngo RT Therapist with software version 4.3.1 MR3. Material Number: 8162815 Intended Use: Family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0633-2023·2022-12-21

    DeRoyal Laminectomy Spinal Fusion Pack Recalled by FDA (Class II)

    DeRoyal Industries voluntarily recalled 100 kits of its laminectomy spinal fusion pack after identifying a device defect. The recall affects medical facilities in 23 states.

    Product
    DeRoyal LAMINECTOMY SPINAL FUSION PACK, REF 89-9105.10
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0708-2023·2022-12-21

    DeRoyal recalls Class II TRACECART POSTEROR LAMI MICRODISC device

    DeRoyal Industries is recalling 72 kits of TRACECART POSTEROR LAMI MICRODISC TRACECART devices distributed across 23 U.S. states in a voluntary Class II recall initiated by the manufacturer.

    Product
    DeRoyal TRACECART POSTEROR LAMI MICRODISC TRACECART, REF 53-1960.02
    Category
    Medical Device
    Distribution
    0 states
  • 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
    0 states
  • HighFDA (Devices)·Z-0497-2023·2022-12-21

    Dental Surgical Pack Recalled Due to Incomplete Sterile Seal

    Stradis Medical is recalling a dental surgical pack because the outer bag may be incompletely sealed, potentially compromising sterility. Affected units should not be used.

    Product
    Surgical room, DENTAL SURGICAL PACK, Item No.41236SDSP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0535-2023·2022-12-21

    Stradis Healthcare Curved Tip Syringes Recalled Due to Incomplete Sterile Sealing

    Stradis Medical is recalling approximately 300 Curved Tip Syringes because manufacturing defects may result in incomplete sealing of the sterile kit, potentially compromising product sterility.

    Product
    STRADIS HEALTHCARE, CURVED TIP SYRINGE, Item No.60060GCTS,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0488-2023·2022-12-21

    Stradis Healthcare Oral Surgery Implant Packs Recalled for Incomplete Seal Defect

    Stradis Medical recalled 20 oral surgery implant packs with incomplete outer bag sealing that may compromise sterility. Affected lot numbers are 22228490663 and 22242491516, distributed in the US and Canada. No illnesses reported.

    Product
    STRADIS HEALTHCARE, Basic Implant Pack, Item No.40561BIP, oral surgery tray
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0645-2023·2022-12-21

    Medical Device Recall: DeRoyal TOTAL KNEE PACK surgical kit

    DeRoyal Industries recalled 48 kits of the TOTAL KNEE PACK surgical product in November 2022. The specific reason for the recall was not disclosed in the public notice.

    Product
    DeRoyal TOTAL KNEE PACK, REF 89-9300.08
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0635-2023·2022-12-21

    DeRoyal hip surgical pack recalled in voluntary Class II action

    DeRoyal Industries is recalling 8 kits of its TOTAL HIP PACK (Lot 57460930) distributed across 23 U.S. states in a voluntary Class II FDA recall.

    Product
    DeRoyal TOTAL HIP PACK, REF 89-9113.07
    Category
    Medical Device
    Distribution
    0 states