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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3526–3550 of 5038

  • SevereFDA (Devices)·Z-0144-2018·2017-11-29

    Exactech Recalls Optetrak Offset Tibial Tray Due to Design Incompatibility

    Exactech is recalling 317 Optetrak Offset Tibial Trays because a design incompatibility exists with certain offset spine stiffener screws and constrained condylar tibial inserts.

    Product
    Optetrak Offset Tibial Tray and Screws, Size 5F/5T, Alpha, Ref 208-04-53, Sterile, RX.
    Category
    Medical Device
    Distribution
    11 states
  • SevereFDA (Devices)·Z-0135-2018·2017-11-29

    Exactech Recalls Optetrak Offset Tibial Tray Due to Design Incompatibility

    Exactech, Inc. is recalling 733 Optetrak Offset Tibial Tray and Screws units due to a design incompatibility with certain offset spine stiffener screws and constrained condylar tibial inserts.

    Product
    Optetrak Offset Tibial Tray and Screws, Size 3F/2T, Alpha, Ref 208-04-31, Sterile, RX.
    Category
    Medical Device
    Distribution
    11 states
  • SevereFDA (Devices)·Z-0143-2018·2017-11-29

    Exactech Recalls Optetrak Offset Tibial Tray Due to Design Incompatibility

    Exactech is recalling 333 Optetrak Offset Tibial Tray and Screws units due to a design incompatibility with certain offset spine stiffener screws and constrained condylar tibial inserts.

    Product
    Optetrak Offset Tibial Tray and Screws, Size 5F/4T, Beta, Ref 208-04-52, Sterile, RX.
    Category
    Medical Device
    Distribution
    11 states
  • SevereFDA (Devices)·Z-0167-2018·2017-11-29

    Zimmer Biomet ROSA Brain 3.0.0 Software Recall for Communication Errors

    Zimmer Biomet is recalling 18 units of ROSA Brain 3.0.0 software due to communication errors between software components and the controller.

    Product
    ROSA Brain 3.0.0 Usage: The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments (biopsy needle, stimulation or recording electrode, endoscope). The device i
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0140-2018·2017-11-29

    Exactech Recalls Optetrak Offset Tibial Tray Due to Design Incompatibility

    Exactech is recalling 547 Optetrak Offset Tibial Tray and Screws units due to a design incompatibility with certain offset spine stiffener screws and constrained condylar tibial inserts.

    Product
    Optetrak Offset Tibial Tray and Screws, Size 4F/4T, Alpha, Ref 208-04-43, Sterile, RX.
    Category
    Medical Device
    Distribution
    11 states
  • SevereFDA (Devices)·Z-0141-2018·2017-11-29

    Exactech Recalls Optetrak Offset Tibial Trays Due to Design Incompatibility

    Exactech is recalling 537 Optetrak Offset Tibial Trays and Screws due to a design incompatibility with certain offset spine stiffener screws and constrained condylar tibial inserts.

    Product
    Optetrak Offset Tibial Tray and Screws, Size 4F/4T, Beta, Ref 208-04-44, Sterile, RX. .
    Category
    Medical Device
    Distribution
    11 states
  • SevereFDA (Devices)·Z-0160-2018·2017-11-29

    FDA Recalls Zimmer Biomet ROSA Surgical Devices Due to Sensor Failure

    The FDA is recalling 31 Zimmer Biomet ROSA Surgical Devices because a force feedback sensor may fail, causing the operating arm to continue moving instead of stopping.

    Product
    ROSA Surgical Device 2.5.8, a computer-controlled electromechanical arm to guide standard neurosurgical instruments.
    Category
    Medical Device
    Distribution
    5 states
  • SevereFDA (Devices)·Z-0069-2018·2017-11-15

    Windstone Medical Recalls Custom Surgical Kits Due to Sterile Barrier Breach

    Windstone Medical Packaging is recalling 60 custom surgical kits containing a recalled catheter component due to a potential sterile barrier breach.

    Product
    AMS, ALIGNED MEDICAL SOLUTIONS, T&A Pack, AMS6357, STERILE EO.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0059-2018·2017-11-08

    Teleflex Percuvance Percutaneous Surgical System Recalled for Tool Tip Breakage

    Teleflex is recalling specific Percuvance surgical instruments because the tool tip jaws may break, causing fragments to fall off during use.

    Product
    Teleflex(R) Percuvance(TM) Percutaneous Surgical System, Components: (a) 5 mm Atraumatic Johans Grasper, Catalog Number PCVJG5 (b) 5 mm Maryland Dissector, Catalog Number PCVMD5 (c) 5 mm Hem-o-lok Clip Applier, Catalog Number PCVHCA5 (d) 5 mm Traumatic Gripper Grasper, Catalo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0058-2018·2017-11-08

    Biosense Webster Recalls THERMOCOOL SF NAV Catheters Due to Display Error

    Biosense Webster is recalling THERMOCOOL SF NAV catheters because a system alert may cause physicians to ablate in unintended areas.

    Product
    THERMOCOOL SF NAV Catheters Model Numbers - BNI35FJCT, BNI35DFCT, D-131503-S, D-131504-S
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0056-2018·2017-11-08

    Biosense Webster Recalls THERMOCOOL SMARTTOUCH Navigation Catheters

    Biosense Webster is recalling 64 THERMOCOOL SMARTTOUCH catheters because they may trigger a false magnetic distortion alert on the CARTO 3 System, potentially leading to unintended ablation.

    Product
    THERMOCOOL SMARTTOUCH Bi-Directional Navigation Catheter (D-132704-S, D-132705-S)
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0057-2018·2017-11-08

    Biosense Webster Recalls THERMOCOOL Catheters Due to Navigation System Alert

    Biosense Webster is recalling 19 THERMOCOOL catheters because they trigger a false magnetic distortion alert on the CARTO 3 System, potentially leading to unintended ablation.

    Product
    THERMOCOOL SMARTTOUCH Uni-Directional Navigation Catheter (D133602S)
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0021-2018·2017-11-01

    OriGen Reinforced Dual Lumen Catheter Recalled for Tube Separation

    OriGen Biomedical is recalling 180 units of Reinforced Dual Lumen Catheters because the extension tube may separate from the hub, causing patient injury.

    Product
    The OriGen Reinforced Dual Lumen catheter (RDLC) is a duel lumen catheter with a wire reinforcement layer on the tip of the device. A thin sheath is used to cover and secure the wire layer and is heat shrunk into a permanent position.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0043-2018·2017-11-01

    MicroPort Orthopedics Recalls 48 Schanz Screws Due to Seal Defect

    MicroPort Orthopedics is recalling 48 sterile Schanz screws due to an inadequate pouch seal that could compromise sterility and lead to infection.

    Product
    MicroPort Orthopedics SCHANZ SCREW SELF DRILL, SIZE 4mm, REF 20070057, STERILE R Product Usage: MPO Total Hip Systems are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3175-2017·2017-10-04

    Zimmer Biomet Recalls Straight Shank Drill Bits Due to Fracture Risk

    Zimmer Biomet is recalling 62 units of 4.0 mm Straight Shank Drill Bits because raw material anomalies may increase the risk of instrument fracture during use.

    Product
    Straight Shank Drill Bits 4.0 mm Diameter, Item Number/EDI 00231804006, Nonsterile. orthopedic surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3164-2017·2017-10-04

    Zimmer Biomet Recalls ECT Internal Fracture Fixation Drills

    Zimmer Biomet is recalling 4,423 ECT Internal Fracture Fixation Drills because raw material anomalies may increase the risk of instrument fracture during use.

    Product
    ECT Internal Fracture Fixation Drill 2.0 mm Diameter (.079 Inch), Item Number/EDI 00231802000, Nonsterile. orthopedic surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3150-2017·2017-10-04

    Zimmer Biomet Recalls ECT Internal Fracture Fixation Quick-Connect Drills

    Zimmer Biomet is recalling 4 units of ECT Internal Fracture Fixation Quick-Connect Drills due to raw material anomalies that may increase the risk of instrument fracture.

    Product
    ECT Internal Fracture Fixation Quick-Connect Drill, 1.5 mm Diameter, 85mm Length, Item Number/EDI 00241001500, Nonsterile. orthopedic surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3178-2017·2017-10-04

    Zimmer Biomet Recalls Orthopedic Screw Taps Due to Material Anomaly

    Zimmer Biomet is recalling 198 nonsterile orthopedic screw taps because raw material anomalies may increase the risk of instrument fracture during use.

    Product
    Zimmer Periarticular Locking Plate System, Locking Screw Tap Standard Quick-Connect 3.5 mm Diameter, Item Number/EDI 00236015335, Nonsterile. orthopedic surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3188-2017·2017-10-04

    Zimmer Biomet Recalls ECT Internal Fracture Fixation Quick-Connect Drill Bits

    Zimmer Biomet is recalling 10 units of ECT Internal Fracture Fixation Quick-Connect Drills due to a raw material anomaly that may increase the risk of instrument fracture during use.

    Product
    ECT Internal Fracture Fixation Quick-Connect Drill 4.0 mm Diameter 20cm Length, Item Number/EDI 00241004000, Nonsterile. orthopedic surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3199-2017·2017-10-04

    Zimmer Biomet Recalls Orthopedic Drill Bits Due to Fracture Risk

    Zimmer Biomet is recalling 15 nonsterile orthopedic drill bits because raw material anomalies may increase the risk of instrument fracture during use.

    Product
    Drill Bit Quick-Connect 3-Fluted 4.5 mm Diameter 195 mm Length, Item Number/EDI 00480719545, Nonsterile. orthopedic surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3158-2017·2017-10-04

    Zimmer Biomet Recalls M/DN Intramedullary Fixation Distal Drill Pilot Tips

    Zimmer Biomet is recalling 182 M/DN Intramedullary Fixation Distal Drill Pilot Tips due to raw material anomalies that may increase the risk of instrument fracture.

    Product
    M/DN Intramedullary Fixation Distal Drill Pilot Tip 3.2 mm Diameter, Item Number/EDI 00225503332, Nonsterile. orthopedic surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3191-2017·2017-10-04

    Zimmer Biomet Recalls Orthopedic Drill Bits Due to Fracture Risk

    Zimmer Biomet is recalling specific orthopedic drill bits and screw taps because raw material anomalies may cause the instruments to fracture during use.

    Product
    Drill Bit Jacobs Chuck 3.2 mm Diameter 130 mm Length, Item Number/EDI 00480513032, Nonsterile. orthopedic surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide