Hazard

Functional Defect recalls

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

What the numbers show

Total: 299
Critical: 0
Severe: 7
Most recent: 2026-10-21

Of the 299 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 7 (2%) 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 299

ModerateFDA (Devices)·Z-1115-2015·2015-02-18
Zimmer Dental Recalls GemLock Long Hex Driver Due to Fit Issues
Zimmer Dental Inc is recalling 627 GemLock Long Hex Drivers because they may not fit into the Fixture Mount Transfer or the implant's internal hex.
Product
GemLock Long Hex Driver, Catalog RHL2.5; Also distributed within the Tapered SwissPlus & SwissPlus Implant Systems Kits, Surgical, Complete, Catalog OPCST; Tapered Screw-Vent Implant System Surgical Kit, Complete, Catalog TSVKIT. Used as a manual delivery tool that engages…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0952-2015·2015-01-21
Medtronic Spinal Surgical Instrument Recall Due to Component Sizing Issue
Medtronic is recalling 24 units of the POWEREASE Set Screw Breakoff Instrument because oversized retaining tabs may prevent proper mating with the set screw.
Product
POWEREASE Instruments Set Screw Breakoff Instrument, REF 2346010, Medtronic Sofamor Danek, USA, Inc. Spinal surgical instrumrent.
Category
Medical Device
Distribution
16 states
ModerateFDA (Devices)·Z-0986-2015·2015-01-21
Stryker Recalls SurgiCounter Charging Cradles Due to Charging Defects
Stryker is recalling 3,625 SurgiCounter Charging Cradles because they may fail to charge the scanner or download data after surgical procedures.
Product
The SurgiCounter Charging Cradle Product Usage: SurgiCounter Charging Cradles are designed to be used with the SurgiCounter and are part of the SurgiCount Safety-Sponge System. The SurgiCount Safety-Sponge System is indicated for use in counting and recording the number…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0941-2015·2015-01-14
CSA Medical truFreeze System Recalled for Timer Sound Loss
CSA Medical is recalling 46 truFreeze cryogenic surgical devices because the timer may lose its audible sound, potentially affecting surgical procedures.
Product
CSA Medical truFreeze System; Model: CC3-01, a cryogenic surgical device ***The involved units are those with the newest version of a panel PC referred to as POC-127. These panels are identified by serial number. *** The truFreeze is intended for cryogenic destruction of…
Category
Medical Device
Distribution
25 states
ModerateFDA (Devices)·Z-0877-2015·2015-01-07
Perouse Medical Recalls Synthes Inflation System Due to Pressure Limitations
Perouse Medical is recalling 2,184 units of the Synthes Inflation System because the device may fail to raise pressure above 10 atm, potentially delaying procedures.
Product
Synthes Inflation System (03.804.4135) Product Usage: Inflation system is used during kyphoplasty or other interventional kyphoplasty or other interventional procedures, to create and monitor pressure In the balloon catheter and pressure In the balloon catheter and to to…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0851-2015·2014-12-31
Zimmer NexGen Knee Implant Drill Guide Recalled for Fit Issues
Zimmer Trabecular Metal Technology is recalling 8 units of NexGen Complete Knee Solution drill guides because two units did not fit the handle during cleaning.
Product
NexGen Complete Knee Solution Monoblock Tibial Provisional / Drill Guide Tibial Size 5 Femoral Size Green / CH Zimmer U.K. Ltd., SN3 4FP, UK Zimmer Trabecular Metal Technology, Inc 10 Pomeroy Road, Parsippany, NJ 07054 USA
Category
Medical Device
Distribution
0 states
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…
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…
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-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
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
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-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
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…
Category
Medical Device
Distribution
1 state