The Recall Desk

Hazard

Functional Defect recalls

293 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
293
Critical
0
Severe
2
Most recent
2026-08-26

Of the 293 functional defect recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2 (1%) are Severe.

Which agencies issued them

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all functional defect recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

201–225 of 293

  • HighFDA (Devices)·Z-0196-2015·2014-11-19

    Steris 5085 Surgical Tables Recalled for Damaged Column Shrouds

    Steris is recalling 5085 and 5085SRT surgical tables because column shrouds may become damaged, potentially preventing the table from raising or lowering.

    Product
    The 5085 is a general surgical table with high patient weight capacity, extended width capability, and lower minimal table top elevation.
    Category
    Medical Device
    Distribution
    36 states
  • ModerateFDA (Devices)·Z-0201-2015·2014-11-19

    Integra Licox Pt02 Monitor Recalled for USB Data Extraction Issues

    Integra LifeSciences is recalling 60 Licox Pt02 monitors because the USB port may not allow users to extract trend data as described in the manual.

    Product
    Integra Licox Pt02 Monitor, Rx Only, Manufacturer: Integra LifeSciences (Ireland) Limited, IDA Business and Technology Park, Sragh, Tullamore, County Offaly, Ireland, Distributed by: Integra LifeSciences Corporation, 311 Enterprise Drive, Plainsboro, NJ 08536
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-0098-2015·2014-10-29

    DeRoyal SafeLiner Suction Canister Kit Recalled for Insufficient Seal

    DeRoyal Industries is recalling 5,112 units of SafeLiner Suction Canister Kits due to an insufficient seal under low or intermittent suction conditions.

    Product
    DeRoyal(R) SafeLiner Suction Canister Kit, SEMI-RIGID, 1000cc, REF 71-6518, NON-STERILE, Rx Only, general hospital
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0113-2015·2014-10-29

    Vygon Recalls Bionector Needleless Connectors Due to Membrane Elasticity Issues

    Vygon is voluntarily recalling Bionector Needleless connectors due to potential problems with membrane elasticity. The recall affects 42,250 units distributed worldwide.

    Product
    Bionector Needleless connector. Bionector is a multi-purpose catheter accessory; a closed needle-less system permitting blood sampling, intermit ant injection and continuous infusion of fluids or medications to patients in a hospital or homecare situation.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0108-2015·2014-10-29

    St. Jude Medical Recalls Fast-Cath Trio Hemostasis Introducer Due to Dilator Defect

    St. Jude Medical is voluntarily recalling 220 units of the Fast-Cath Trio Hemostasis Introducer because the dilator is too small to allow guidewire advancement, potentially causing procedural delays.

    Product
    St Jude Medical, 10F Fast-Cath Trio" Hemostasis Introducer, REF # 406308, Sterile EO. The Fast-Cath Trio" Hemostasis Introducer consists of the following components: Port hemostasis adapter (3), Sheath (10F Cath-Lock"), dilator (10F) and 0.038 guidewire. See product labelin
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2569-2014·2014-10-01

    Siemens Artis zee and zeego X-ray Systems Recalled for Radiation Release Issue

    Siemens is recalling 206 Artis zee and Artis zeego X-ray systems because radiation release can become blocked unnecessarily under certain circumstances.

    Product
    Artis zee and Artis zeego systems. x-ray, angiographic system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2214-2014·2014-08-20

    Ortho-Clinical VITROS Chemistry Calibration Modules Recalled for Calibration Failure

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products CDM PROM Calibration Data Modules because they prevent the calibration and use of specific ammonia test slides.

    Product
    VITROS¿ Chemistry Products CDM PROM Calibration Data Module Rev. No. 0168 and 0169 (Product Code 1999077) are used in conjunction with VITROS Chemistry Products NH3 DT Slides (Product Code 1532589) GEN 59 and VITROS¿ Chemistry Products DT Calibrator Kit lot 44 (Product Code 1957
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2022-2014·2014-07-16

    B. Braun Stopcock Extension Sets Recalled for Reverse Assembly Defect

    B. Braun Medical is recalling 10,835 Stopcock Extension Sets because some stopcocks are assembled in reverse, causing them to close when set to open.

    Product
    STOPCOCK EXT. SET W/ 3-WAY STOPCOCK WITH INJ. SITE AND SPINLOCK CONNECTOR, 22 inches and 37 inches
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1803-2014·2014-06-25

    Biomet Recalls EZPass Suture Passer Due to Wire Buckling

    Biomet, Inc. is recalling 102 EZPass Suture Passers because the nitinol wire may buckle and become kinked, making the instrument difficult to use.

    Product
    EZPass Passer, Sterile single use arthroscopic instrument utilized in conjunction with a nitinol wire to aid in passing suture through soft tissue. Part numbers 904050, 904051, 904052, 904053, 904054, 904055, and 904056.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1790-2014·2014-06-25

    Roche MODULAR ANALYTICS EVO Serum Work Area Filter Recall

    Roche Diagnostics is recalling 462 Serum Work Area filters for the MODULAR ANALYTICS EVO analyzer due to potential loose components that may cause discrepant results and system alarms.

    Product
    Roche MODULAR ANALYTICS EVO Serum Work Area (SWA), Operator's Manual Software Version 08-02; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N). Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1801-2014·2014-06-25

    Biomet Recalls EZPass Suture Retriever Due to Nitinol Wire Buckling

    Biomet is recalling 100 units of EZPass Suture Retriever instruments because the nitinol wire may buckle and become kinked, making the device difficult to use.

    Product
    EZPass Suture Retriever, Nitinol, Single Pack, Part number 10007380. Orthopedic Manual Surgical Instrument, Sterile, single use arthroscopic instrument utilized in conjunction with a nitinol wire to aid in passing suture through soft tissue.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1802-2014·2014-06-25

    Biomet Recalls EZPass Nylon Monofilament Suture Passers Due to Buckling

    Biomet is recalling 100 units of EZPass Nylon Monofilament Suture Passers because the internal wire may buckle, making the instrument difficult to use.

    Product
    EZPass Nylon Monofilament Single Pack, Part number 110007379, Orthopedic Manual Surgical Instrument Sterile, single use arthroscopic instrument utilized in conjunction with a nitinol wire to aid in passing suture through soft tissue.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1712-2014·2014-06-11

    Microport Recalls PATH Thread Cup Adaptors Due to Removal Difficulty

    Microport Orthopedics is recalling 140 units of PATH Thread Cup Adaptors because they may be difficult to remove from the impaction handle during surgery.

    Product
    PATH(R) THREAD CUP ADAPTOR, REF 2007-0013, Wright Medical Technology, Inc. Orthopaedic surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1710-2014·2014-06-11

    Leica CD15 Antibody Recalled for Reduced Function Before Expiration

    Leica Microsystems is recalling 145 units of CD15 antibody that may not function as intended before the expiration date due to age-related staining issues.

    Product
    Liquid Mouse Monoclonal Antibody CD15 (NCL-L-CD15), a liquid tissue culture supernatant containing 15 mM sodium azide as a preservative. For in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1698-2014·2014-06-11

    Leica Monoclonal Antibody Recalled for Reduced Functionality

    Leica Microsystems is recalling Novocastra Liquid Mouse Monoclonal Antibody Glutathione S-Transferase pi because it does not function as intended up to the expiry date.

    Product
    Novocastra Liquid Mouse Monoclonal Antibody Glutathione S-Transferase pi (NCL-L-GSTpi-438), a liquid tissue culture supernatant. For in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1449-2014·2014-04-16

    Roche Cobas c502 Analyzer Recall Due to Inactive Volume Check

    Roche Diagnostics is recalling 76 Cobas c502 clinical chemistry analyzers because the Initial Cassette Volume Check feature fails to activate when specific reagent packs are loaded.

    Product
    Cobas c8000 Modular Analyzer Series Cobas c502, Part Number 5964067001, a clinical chemistry analyzer intended for the in vitro quantitative / qualitative determination of analytes in body fluids.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1324-2014·2014-04-09

    Teleflex Medical Recalls Weck Vista Cannulas Due to Gas Leakage

    Teleflex Medical is recalling 55,521 units of 10mm and 12mm Weck Vista Cannulas because they may leak insufflation gas.

    Product
    10mm Weck Vista Cannula-only, Catalog No. 405910C, 12mm Weck Vista Cannula-only, Catalog No. 405912C. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1241-2014·2014-03-26

    Convatec Latex Foley Catheters Recalled Due to Blocked Lumen

    Convatec Inc. is recalling 4,760 SLC 3-way standard latex Foley catheters because the drainage lumen was found to be blocked by excess lubricious coating material.

    Product
    SLC 3-way standard Lubricious Coated 20Ch/Fr 30 mL/cc Product Usage: Latex Lubricous Coated Foley Catheters The standard catheter essentially consists of a flexible lubricous coated latex tube which incorporates one major drainage lumen and one or two minor lumens constructed
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1237-2014·2014-03-26

    Convatec Recalls Latex Foley Catheters Due to Blocked Lumen

    Convatec Inc. is recalling Curion CuriStay Nelaton latex Foley catheters because the drainage lumen was found blocked by excess lubricious coating material.

    Product
    Curion CuriStay Nelaton CH - 14 2-W Hydrogel Coated (Latex) 5- 10 mL Product Usage: Latex Lubricous Coated Foley Catheters The standard catheter essentially consists of a flexible lubricous coated latex tube which incorporates one major drainage lumen and one or two minor
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1142-2014·2014-03-12

    KCI Recalls Prevena Customizable Dressing Due to Connector Difficulty

    KCI USA is recalling 20,850 units of Prevena Customizable Dressing 5-Packs because the tubing connector is difficult to attach to the canister.

    Product
    PRE2055US: Prevena Customizable Dressing 5-Pack (US-ONLY) Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and remo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1072-2014·2014-03-05

    GE Healthcare Recalls Giraffe and Panda Infant Warmers Due to Reversed Fittings

    GE Healthcare is recalling Giraffe and Panda iRes Infant Warmers because oxygen and air wall inlet fittings were reversed during assembly.

    Product
    GE Healthcare - Giraffe¿ and Panda¿ iRes Infant Warmer Product Usage: The infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Infant radiant warmers may be used to facilitate the ne
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1063-2014·2014-02-26

    Implantech Recalls Gelzone Shoulder Sleeves Due to Velcro Closure Defect

    Implantech Associates Inc is voluntarily recalling Gelzone Shoulder Sleeves because the Velcro closure may not meet robustness requirements.

    Product
    Gelzone Shoulder Sleeve, Catalog Number SLV634, Lot Number 852766. Product Usage: To be used where limb support and/or elevation is considered necessary.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0866-2014·2014-02-05

    Medtronic Set Screw Retaining Driver Recalled Due to Component Sizing Issue

    Medtronic is recalling seven Set Screw Retaining Drivers because oversized retaining tabs may prevent proper mating with set screws.

    Product
    SET SCREW RETAINING DRIVER, REF 9010000820, QTY: 1 EA, Medtronic Sofamor Danek, USA, Inc. Screwdriver - orthopedic manual surgical instrument.
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-0900-2014·2014-02-05

    Boston Scientific Recalls 1068 Peripheral Imaging Catheters Due to Guidewire Issues

    Boston Scientific is recalling 1,068 units of the Atlantis PV 8.5F Peripheral Imaging Catheter because physicians reported an inability to pass a guidewire through the device.

    Product
    Atlantis PV, 8.5F, 15 MHz Peripheral Imaging Catheter: Sterile, R; Sterilized using irradiation. Product Usage: This catheter is a 15 MHz ultrasound imaging catheter intended to operate with an IVUS instrument for diagnostic imaging. It is used with an 8.5F-introducer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0710-2014·2014-01-22

    Boston Scientific Recalls Extractor Pro XL Retrieval Balloon Catheters

    Boston Scientific is recalling 39 units of Extractor Pro XL Retrieval Balloon Catheters due to potential incorrect skive hole location or balloon size.

    Product
    Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 9-12 mm Injects Above UPN: M00547100 The Extractor Pro XL Retrieval Balloon Catheter is used endoscopically to 1) remove stones from the biliary system; or 2) to facilitate injection of contrast medium while occludin
    Category
    Medical Device
    Distribution
    Distributed nationwide