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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6301–6325 of 27364

  • HighFDA (Devices)·Z-0898-2024·2024-02-07

    Knee Replacement Implant Component Recalled Due to Material Oxidation Risk

    The FDA is recalling SCORPIO U-DOME PATELLA knee replacement components because manufacturing used raw material over 5 years old that may have elevated oxidation levels affecting the implant's material properties.

    Product
    SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3910
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0884-2024·2024-02-07

    Knee replacement bearing insert recalled due to material degradation risk

    Howmedica Osteonics Corp. is recalling Scorpio-Flex knee bearing inserts made with material over 5 years old that may develop oxidation affecting performance. Affected patients should contact their physician if they experience knee problems.

    Product
    Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- -Intended for knee replacement Part Number: 72-16-0908
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0926-2024·2024-02-07

    Tibial Knee Replacement Implants Recalled Due to Material Oxidation

    Howmedica Osteonics is recalling tibial bearing inserts used in knee replacements manufactured from UHMWPE raw material over 5 years old. The material may develop elevated oxidation levels that could impact its structural properties.

    Product
    TIBIAL BEARING INSERT SERIES P-S I ASSY Intended for knee replacement Product Number: 7291-0324
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0909-2024·2024-02-07

    Knee replacement implant recall due to material oxidation risk

    Howmedica Osteonics is recalling knee replacement implants manufactured with aged UHMWPE raw material that may have elevated oxidation levels, which could degrade the material's mechanical properties.

    Product
    LEFT X-LARGE-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement. Product Number: 6637-0-328
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0845-2024·2024-02-07

    Surgical sutures recalled due to substandard gamma sterilization doses

    Covidien is recalling multiple surgical suture products because certain lots were sterilized with gamma doses exceeding approved levels. The excess radiation may reduce suture strength over time, potentially causing wound failure and bleeding.

    Product
    Sofsilk Braided Silk sutures: CS-211 SOFSILK* 4-0 BLK 45CM CVF21 X36 GS-831 SOFSILK* 4-0 BLK 75CM V20 X36 S-176 SOFSILK* 0 BLK 12X45CM PCT X24 S-182 SOFSILK* 5-0 BLK 12X45CM PCT X36 S-184 SOFSILK* 3-0 BLK 12X45CM PCT X36 S-185 SOFSILK* 2-0 BLK 12X45CM PCT X36 S-245 SOFSILK* 2-0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0925-2024·2024-02-07

    PS Lipped Tibial Insert Assy Duracon Knee Implant Oxidation Risk

    Howmedica Osteonics is recalling PS Lipped Tibial Insert knee replacement components manufactured with aged UHMWPE material that may develop oxidation, potentially affecting device properties and performance.

    Product
    PS LIPPED TIBIAL INSERT ASSY DURACON Intended for knee replacement Product Number: 6742-1-416
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0881-2024·2024-02-07

    SCORPIO TS Knee Implant Recall Due to Material Oxidation Risk

    Howmedica is recalling SCORPIO TS knee implants made with raw material over 5 years old due to potential oxidation that could degrade the device's mechanical properties.

    Product
    SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-7521
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0912-2024·2024-02-07

    Knee Replacement Implant Recalled Due to Potential Material Oxidation Risk

    Howmedica Osteonics Corp. is recalling certain knee replacement implants made with UHMWPE material over 5 years old that may have oxidized, potentially affecting implant performance.

    Product
    RGT.LARGE-PCA MOD.REV.- DUR.REV.INSERT Intended for knee replacement Product Number: 6637-0-928
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0873-2024·2024-02-07

    Series II Tibial Bear Insert Recalled for Potential Material Degradation

    Howmedica Osteonics Corp. is recalling the Series II Tibial Bear Insert for knee replacement because UHMWPE material over 5 years old may develop elevated oxidation that can affect the component's material properties.

    Product
    SERIES II TIBIAL BEAR INSERT-Intended for knee replacement Part Number: 3052-0515
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0829-2024·2024-02-07

    Obstetrical Labor and Delivery Kits Recalled for Potential Functionality Loss

    American Contract Systems has recalled Labor and Delivery Packs because certain components may have lost functionality or efficacy due to unvalidated sterilization exposure.

    Product
    Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as: a) LABOR & DELIVERY PACK, kit number HILD52F; b) LABOR & DELIVERY PACK, kit number HILD52G
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0828-2024·2024-02-07

    Obstetrical and Gynecological Surgical Kits Recalled for Sterilization Assessment Defects

    American Contract Systems is recalling 1,020 obstetrical and gynecological surgical kits because components were sterilized without documented assessment of their suitability to the process, potentially causing loss of functionality or drug efficacy.

    Product
    Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as: a) LOWER PELVIC PACK, kit number AGLP52L; b) OB/GYN DAVINCI PACK A RG BASIN, kit number HGOB98G; c) DAVINCI GYN PACK, kit number HHDV17; d) KIT, GYNE ROBOTIC, kit number MMGR44D;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0843-2024·2024-02-07

    FX SHOULDER Centered Glenosphere with Screw may contain eccentric component

    FX SHOULDER is recalling 4 units of a shoulder glenosphere implant component due to potential manufacturing defects that may result in eccentric product orientation rather than the intended centered design.

    Product
    Centered Glenosphere w/Screw, CoCr/TA6V/TiN 10-degrees Tilt 32 mm, REF: 115-3210
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0830-2024·2024-02-07

    Surgical kits for childbirth recalled for sterilization and functionality risks

    American Contract Systems is recalling C-section surgical kits that were sterilized without proper assessment. Components may have lost function or drug efficacy, or have excess sterilization residuals.

    Product
    Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as: a) C-SECTION PACK, kit number FDCS01AA; b) C-SECTION PACK, kit number FDCS01AB; c) C-SECTION STERILE PACK, kit number HGCS68J; d) C-SECTION PACK, kit number HICS50H; e) C-SECTION
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0932-2024·2024-02-07

    Volar Bearing Plate wrist fixation systems recalled for bearing dislodgement

    TriMed Inc. recalls Volar Bearing Plate wrist fixation systems because bearings may dislodge from distal peg holes during implantation, potentially compromising fracture fixation. Approximately 270 units distributed in five states.

    Product
    Volar Bearing Plate. REF: VBEAL-3-7N, VBEAL-5-7N, VBEAL-3-7S, VBEAL-5-7S, VBEAL-7-7S, VBEAL-3-7W, VBEAL-5-7W, VBEAR-3-7N, VBEAR-5-7-N, VBEAR-3-7S, VBEAR-5-7S, VBEAR-7-7S, VBEAR-3-7W, VBEAR-5-7W. Intended to be used as an aid to the treatment of certain types of fractures,
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-0824-2024·2024-02-07

    Custom Surgical Convenience Kits May Lack Proper Sterilization Validation

    American Contract Systems, Inc. recalls surgical convenience kits whose added components may lack proper sterilization validation, potentially resulting in loss of functionality or retained sterilant residue.

    Product
    Custom procedural convenience kits and trays, general & plastic surgery, labeled as: a) Breast Plastics Pack, kit number BBPL20D; b) MINOR PLASTIC, kit number WPMP16H
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0887-2024·2024-02-07

    Knee Replacement Implant Recalled Due to Potential Material Degradation

    Knee replacement components recalled due to potential oxidation in UHMWPE material that could affect durability. Approximately 76 units distributed in the US with additional international distribution.

    Product
    SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #5 -Intended for knee replacement Part Number: 73-0510
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0928-2024·2024-02-07

    Tank hose assembly recalled for incorrect material and missing perforations

    AtriCure recalls tank hose assemblies due to manufacturing defects. Certain lots have outer sheaths missing required pin perforations and inner tubes made of incorrect material.

    Product
    Packaged, Tank Hose Assembly CMA-US, Product Catalog Number A001056
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0972-2024·2024-02-07

    NovoTHOR Whole Body Light Pod Gen 3.0 Canopy Strut Ball Stud May Fail

    A ball stud on the gas strut may fail on NovoTHOR Whole Body Light Pod units, potentially causing injury if the canopy malfunctions while someone is using the device.

    Product
    NovoTHOR Whole Body Light Pod, Gen 3.0 (1) Product Code S2188 - Reg (2) Product Code S2189 - Reg PRX (3) Product Code S2190 - XL
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Devices)·Z-0885-2024·2024-02-07

    Knee Replacement Insert Recalled Due to Potential Material Oxidation

    Howmedica Osteonics is recalling Scorpio-Flex knee prosthesis inserts due to potential oxidation in UHMWPE raw material over 5 years old, which could impact material properties.

    Product
    Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- -Intended for knee replacement Part Number: 72-16-0910
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0872-2024·2024-02-07

    Knee replacement implant recalled for material oxidation risk

    Howmedica Osteonics is recalling SCORPIO RECESSED PATELLA knee replacement components due to potential oxidation of the UHMWPE material in units manufactured with raw material over 5 years of age.

    Product
    SCORPIO RECESSED PATELLA-Intended for knee repalcment Part Number: 3044-0032
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0890-2024·2024-02-07

    Knee replacement implant recalled due to material oxidation risk

    Howmedica Osteonics is recalling a knee replacement patellar component that may have been manufactured with oxidized raw material. Products using UHMWPE over 5 years old can develop elevated oxidation and degraded material properties.

    Product
    SCORPIO TOTAL KNEE CONCENTRIC DOME PATELLA-SZ #11 -Intended for knee replacement Part Number: 73-2110
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0867-2024·2024-02-07

    Aesculap Needle Holders Distributed With Incorrect Product Labels and Packaging

    Aesculap Inc. is recalling needle holder models that were distributed with incorrect product labels. The MB215R was labeled as MB362R and vice versa, which may cause procedural delays.

    Product
    MB215R - MILLS DUROGRIP TC Micro Needle Holder, straight, 8:, (203 mm), "TC MILLS NDLE HOLDRRND HNDLSTR203MM"
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0936-2024·2024-02-07

    EZDilate Endoscopic Balloon Devices Recalled for Malfunction and Foreign Body Risk

    Olympus is recalling EZDilate Fixed Wire Balloon devices used for esophageal stricture treatment due to reports of inflation/deflation failures, bursting, leaking, and foreign body retention in patients.

    Product
    EZDilate Fixed Wire Balloon 13.5-14.5-15.5. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Model: BD-400P-1580
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0836-2024·2024-02-07

    Medical sterilization chemical integrators recalled due to labeling discrepancy

    TERRAGENE S.A. is recalling over 36,000 chemical integrator strips used to verify sterilization in healthcare settings because the instructions distributed with the products don't match the FDA-cleared instructions for use.

    Product
    Terragene Integron IT26-C Terragene Integron IT26-C with extender Benco Dental Chemical Integrator [5726-583] Tuttnauer (WTL198-0082) Terragene Integron (PCD26-C) Terragene Bionova PCD (PCD222-C)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0799-2024·2024-01-31

    Bard Nasogastric Sump Tube Recalled for Reduced Suction and Drainage

    C.R. Bard is recalling 51,750 Bard Nasogastric Sump Tubes with PreVent Anti-Reflux Filter due to reports of inadequate suction and drainage during use.

    Product
    Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit, 16Fr., 48in Long, REF EN0046160
    Category
    Medical Device
    Distribution
    0 states