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 the agency’s own highest classification or reported deaths or serious injuries, 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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Any3+ (High and above)4+ (High and above)5+ (High and above)

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32251–32275 of 40325

  • HighFDA (Devices)·Z-2355-2015·2015-08-19

    Trumpf Ceiling Mounted Surgical Lighting Systems Recalled Due to Spring Arm Defect

    Trumpf Medical Systems is recalling 9,287 ceiling-mounted surgical lighting systems because the front joint of the spring arm may break at the monitor interface.

    Product
    Trumpf Ceiling Mounted Surgical Lighting Systems,Helion/Xenion S/M/L, User Manual #1441784. The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patient's body with a high intensity light.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2359-2015·2015-08-19

    Synthes Recalls 8.5mm Reamer Heads for Potential Intraoperative Breakage

    Synthes (USA) Products LLC is recalling 8.5mm Reamer Heads for Flexible Intramedullary Nailing Systems due to the possibility of intraoperative breakage and un-retrieved material fragments.

    Product
    8.5mm Reamer Head for Flexible Intramedullary Nailing System; An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue or for use with other devices in orthopedic surgery. This generic type of device includes…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2381-2015·2015-08-19

    Etac Relax Wall Mounted Shower Seat Recalled for Cracked Brackets

    Etac Supply Center Ab is recalling 13 units of the Etac Relax wall mounted shower seat due to reports of the wall bracket cracking or breaking.

    Product
    Etac Relax wall mounted shower seat The Etac Relax is a wall mounted shower seat designed as a seating and standing support for personal hygiene purposes for people with reduced mobility. The Etac Relax shower seat is used for sitting where space is restricted, and can be…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2353-2015·2015-08-19

    Trumpf Ceiling Mounted Surgical Lighting Systems Recalled for Spring Arm Defect

    Trumpf Medical Systems is recalling 9,287 surgical lighting systems because the front joint of the spring arm may break at the monitor interface.

    Product
    Trumpf Ceiling Mounted Surgical Lighting Systems,iLED 3/5, User Manual #1558932. The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patient's body with a high intensity light.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2354-2015·2015-08-19

    Trumpf Ceiling Mounted Surgical Lighting Systems Recalled for Spring Arm Defect

    Trumpf Medical Systems is recalling TruLight 3000/5000 surgical lights because the front joint of the spring arm could break at the monitor interface.

    Product
    Trumpf Ceiling Mounted Surgical Lighting Systems,TruLight 3000/5000, User Manual #1528403. The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patient's body with a high intensity light.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2364-2015·2015-08-19

    Cadence Recalls Perfectum Tuberculin Glass Syringes Due to Misaligned Marks

    Cadence Inc. is recalling 766 non-sterile Perfectum Tuberculin Glass Syringes because graduation marks are not centered with numeric position marks.

    Product
    Perfectum Tuberculin Glass Syringe, Non sterile Catalog numbers 5202, 5205, 5212
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2379-2015·2015-08-19

    Boston Scientific Recalls AngioJet Thrombectomy Sets Due to Incorrect Expiry Date

    Boston Scientific is recalling 9 AngioJet SOLENT Dista Thrombectomy Sets because they were labeled with an incorrect use-by date of December 2015 instead of November 2015.

    Product
    AngioJet SOLENT Dista Thrombectomy Set: UPN 111303-001, Catalog No. 111303, Sterilized Using Ethylene Oxide. For breaking apart and removing thrombus from vascular system, used with the AngioJet Ultra System in breaking apart and…
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-2377-2015·2015-08-19

    Boston Scientific Recalls AngioJet Spiroflex Thrombectomy Sets Due to Incorrect Expiry Date

    Boston Scientific is recalling nine AngioJet Spiroflex Thrombectomy Sets because they were labeled with an incorrect use-by date of December 2015 instead of November 2015.

    Product
    AngioJet Spiroflex Thrombectomy Set: Peripheral - UPN 106553-004, Catalog No.106553, Sterilized Using Ethylene Oxide. For breaking apart and removing thrombus from vascular system, used with the AngioJet Ultra System in breaking…
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-2351-2015·2015-08-19

    Remel Recalls PathoDx Strep B Grouping Latex Reagent

    Remel Inc is recalling PathoDx Strep B Grouping Latex because a reagent may cause weak reactions, potentially leading to failure to identify target species.

    Product
    PathoDx Strep B Grouping Latex, REF 62031, 3 ml packaged in plastic dropper bottle with a pink cap. Latex reagent for streptococcal group B; Identify beta-hemolytic streptococci of Lancefield Groups A, B, C, F and G from primary culture plates.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2375-2015·2015-08-19

    Advanced Sterilization Products Recalls STERRAD 100NX Wall Charts for Incorrect Instructions

    Advanced Sterilization Products is recalling 1,465 STERRAD 100NX wall charts because they contain incorrect instructions regarding instrument tray wrapping.

    Product
    Wall Chart for STERRAD 100NX System, P/N 10104. The STERRAD 100NX Sterilizer is designed for sterilization of both metal and nonmetal medical devices at low temperatures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2352-2015·2015-08-19

    Merit Medical Recalls ReSolve Locking Drainage Catheters Due to Labeling Discrepancy

    Merit Medical Systems is voluntarily recalling 950 ReSolve Locking Drainage Catheters because the unit labeling may not match the actual device in the package.

    Product
    ReSolve Locking Drainage Catheters The ReSolve Locking Catheters are intended for percutaneous drainage of fluids from body cavities.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2320-2015·2015-08-19

    GE Laser Centering Device Recalled for Regulatory Non-Compliance

    GE Inspection Technologies is recalling 25 laser centering devices for X-ray generators due to potential failure to comply with federal regulations.

    Product
    GE Optional Laser Centering Device X-ray generator.
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-2376-2015·2015-08-19

    Biotronik Recalls Unapproved Pacemaker Programmer Software Versions

    Biotronik is recalling specific pacemaker programmer software versions because they are not approved for use in the United States.

    Product
    PSW 1203.U/1, PSW 1301.U, PSW 1307.U, PSW 1403.U, and PSW 1501.U Pacemaker Programmer software. Software approved for use with BIOTRONIK device programmers (trade names: Renamic and ICS 3000). Allows physicians to program devices to pace exclusively in the left ventricle.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2380-2015·2015-08-19

    Boston Scientific Recalls AngioJet AVX Thrombectomy Sets Due to Incorrect Expiry Date

    Boston Scientific is recalling nine AngioJet AVX Thrombectomy Sets because they were labeled with an incorrect use-by date of December 2015 instead of November 2015.

    Product
    AngioJet AVX Thrombectomy Set: UPN 105039-001, Catalog No.105039, Sterilized Using Ethylene Oxide. For breaking apart and removing thrombus from vascular system, used with the AngioJet Ultra System in breaking apart and removing…
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-2363-2015·2015-08-19

    Stryker Recalls Mispackaged Orthopedic Shoulder Trial Instruments

    Stryker is recalling 21 units of a shoulder trial instrument because the package contained the wrong part number.

    Product
    ReUnion TSA Shoulder System, Standard SR Humeral Head Trial, 48X18, Catalog number 5901-S-4818. Orthopedic manual surgical instrument. Howmedica Osteonics Corp. A Subsidiary of Stryker Corp. Stryker France Non-sterile Made in Cork Ireland
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2361-2015·2015-08-19

    Abbott Recalls i-Stat PT/INR Cartridges Due to Test Delays

    Abbott Point Of Care Inc. is recalling specific lots of i-Stat PT/INR Cartridges because they may generate excessive star outs, potentially delaying patient results.

    Product
    i-Stat PT/INR Cartridges List number 03P89-24 The cartridges are packaged in sealed pouches, one per pouch. There are 24 cartridges packed in a box. a prothrombin time test useful in monitoring patients receiving oral anticoagulation therapy such as coumadin or warfarin.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2378-2015·2015-08-19

    Boston Scientific Recalls AngioJet Thrombectomy Sets Due to Incorrect Expiry Dates

    Boston Scientific is recalling 9 AngioJet SOLENT Omni Thrombectomy Sets because they were labeled with an incorrect use-by date of December 2015 instead of November 2015.

    Product
    AngioJet SOLENT Omni Thrombectomy Set: UPN 109681-004 & 109681-001, Catalog No 109681, Sterilized. For breaking apart and removing thrombus from vascular system, used with the AngioJet Ultra System in breaking apart and removing…
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-2360-2015·2015-08-19

    Stryker Recalls Mislabelled Triathlon Tibial Inserts for Knee Replacement

    Stryker Howmedica Osteonics is recalling 26 Triathlon tibial inserts because one unit was found in a package labeled for a different catalog number.

    Product
    Triathlon PS X3 Tibial Insert; No. 3 Triathlon TS Plus Tibial Insert X3 Poly 19 mm Product Usage: The Triathlon PS X3 (posterior stabilized), cat no 5532-G-xxx and X3 TS (total stabilizing) Plus, cat. no. 5537-G-XXX, Tibial Inserts are used in TKA surgeries. During surgery…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2319-2015·2015-08-12

    Cook Inc. Recalls Slip-Cath Beacon Tip Catheters Due to Tip Separation

    Cook Inc. is recalling Slip-Cath Beacon Tip Catheters because the tips may split or separate, potentially causing loss of function or complications.

    Product
    Slip-Cath Beacon Tip Catheter. Angiographic catheter. For use in angiographic procedures as a conduit for the delivery of contrast media and can help physicians diagnose occlusion or stenosis. The catheters are designed for percutaneous introduction into the vascular…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2318-2015·2015-08-12

    Cook Inc. Recalls Beacon Tip Royal Flush Plus High-Flow Catheters

    Cook Inc. is recalling Beacon Tip Royal Flush Plus High-Flow Catheters due to reports of tip splits or separation that may cause loss of function or complications.

    Product
    Beacon Tip Royal Flush Plus High-Flow Catheter. Angiographic catheter. For use in angiographic procedures as a conduit for the delivery of contrast media and can help physicians diagnose occlusion or stenosis. The catheters are designed for percutaneous introduction into…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2325-2015·2015-08-12

    Medtronic Passive Biopsy Needle Kit Recalled for Adhesive Defect

    Medtronic is recalling 1,415 Passive Biopsy Needle Kits because adhesive failure may cause the sphere assembly to move, leading to inaccurate navigation during brain biopsies.

    Product
    Medtronic Passive Biopsy Needle Kit, Part Number 9731754 - Passive Biopsy Fee Per Use (FPU) Kit. The image guided Passive Biopsy Needle is an accessory instrument with the StealthStation System. The Biopsy Needle is intended to be used for stereotaxy biopsy of brain tissue.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2326-2015·2015-08-12

    Aesculap S4C Occiput Torque Wrench Recalled Due to Reassembly Defect

    Aesculap is recalling 10 S4C Occiput Torque Wrenches because improper reassembly after reprocessing caused a screw to break during implantation.

    Product
    S4C Occiput Torque Wrench F/Set Screw; used to tighten the S4 Cervical Spinal System clamping screws with a defined torque 2.8 Nm for tightening the clamping screw in the screw head/hook head/occipital plate/transverse connector and other connectors.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2317-2015·2015-08-12

    Cook Inc. Recalls Beacon Tip Torcon NB Advantage Catheters

    Cook Inc. is recalling Beacon Tip Torcon NB Advantage Catheters due to reports of tip splits or separation, which may cause loss of function or complications.

    Product
    Beacon Tip Torcon NB Advantage Catheter. Angiographic catheter. For use in angiographic procedures as a conduit for the delivery of contrast media and can help physicians diagnose occlusion or stenosis. The catheters are designed for percutaneous introduction into the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2324-2015·2015-08-12

    Medtronic Passive Biopsy Needle Kit Recalled for Adhesive Defect

    Medtronic is recalling 1,415 Passive Biopsy Needle Kits because compromised adhesive may cause the sphere assembly to move, leading to inaccurate navigation during brain biopsies.

    Product
    Medtronic Passive Biopsy Needle Kit, Part Number 9733068 - Passive Biopsy Needle Kit. The image guided Passive Biopsy Needle is an accessory instrument with the StealthStation System. The Biopsy Needle is intended to be used for stereotaxy biopsy of brain tissue.
    Category
    Medical Device
    Distribution
    Distributed nationwide