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.

26–50 of 299

ModerateFDA (Devices)·Z-1500-2021·2021-05-05
Nextremity Solutions Recalls InCore Lapidus Disposable Kits Due to Drill Bushing Defect
Nextremity Solutions is recalling 111 units of the InCore Lapidus Disposable Kit 28mm Left because a drill bushing defect may prevent surgeons from completing the intended procedure.
Product
InCore Lapidus Disposable Kit 28mm Left, Part Number: IC-LAP-28L - Product Usage: Intended as a three-part construct intended for internal fixation for First Metatarsocuneiform arthrodesis.
Category
Medical Device
Distribution
16 states
ModerateFDA (Devices)·Z-1304-2021·2021-03-31
Cardinal Health Recalls Femoral Angiography Drapes Due to Sticking Defect
Cardinal Health is recalling non-sterile femoral angiography drapes because a manufacturing defect causes them to stick, preventing proper application.
Product
Femoral Angiography Drape Bulk Non-Sterile
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1300-2021·2021-03-31
Cardinal Health Recalls In-View Clear Leggings Due to Manufacturing Variance
Cardinal Health is recalling In-View Clear Leggings Sterile because a manufacturing variance causes the plastic film to stick, potentially preventing proper application.
Product
In-View Clear Leggings Sterile
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1302-2021·2021-03-31
Cardinal Health Recalls In-View Clear Leggings Due to Sticking Defect
Cardinal Health is recalling In-View Clear Leggings because a manufacturing variance causes the plastic film to stick, preventing proper application.
Product
In-View Clear Leggings Bulk Non-Sterile
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1255-2021·2021-03-24
R&D Systems Recalls Quantikine IVD Human sTfR Immunoassay Kits
R&D Systems is recalling 156 Quantikine IVD Human sTfR Immunoassay kits due to low standard signals and out-of-specification controls.
Product
Quantikine IVD Human sTfR Immunoassay (Human sTransferrin ELISA Kit (sTfR immunological test system)). An enzyme linked immunosorbent assay (ELISA) for the quantitative determination of Soluble Transferrin Receptor (sTfR) concentration in human serum and plasma as an aid in the…
Category
Medical Device
Distribution
4 states
ModerateFDA (Devices)·Z-1172-2021·2021-03-10
Barco Diagnostic Radiology Display Recalled for Lack of DICOM Compliance
Barco N.V. is recalling MDNC-3421 diagnostic radiology displays because they were shipped without being DICOM-compliant. These units will not pass required acceptance tests.
Product
Barco MDNC-3421 DISPLAY, DIAGNOSTIC RADIOLOGY
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1118-2021·2021-02-24
Baxter Gambro Cartridge Blood Set Prime Line Recalled for Kinked Lines
Baxter Healthcare is recalling Gambro Cartridge Blood Set Prime Line units because kinked access lines were observed during hemodialysis treatments.
Product
Gambro Cartridge Blood Set Prime Line, product code 101025 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0641-2021·2020-12-30
GA Health Recalls 11,000 Stopcon Disposable Endoscope Valve Sets
GA Health Company Limited is recalling 11,000 Stopcon Disposable Endoscope Valve Sets because the suction button may be sticky or broken, potentially prolonging medical procedures.
Product
STOPCON Disposable Endoscope Valves Set-Single Use Valves Olympus R (Air-Water-/Suction) DISTRIBUTED BY: KEY SURGICAL 8101 WALLACE ROAD / EDEN PRAIRIE, MN 55344 / USA Product Code: EN10229.2
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0645-2021·2020-12-30
GA Health Recalls Andorate Disposable Endoscope Valves Due to Suction Button Defect
GA Health Company Limited is recalling 50 units of Andorate Disposable Endoscope Valves because the suction button may be sticky or broken, potentially prolonging procedures.
Product
Andorate Disposable Endoscope Valves Set-5-piece Valve, Connector and Cleaning Adapter Kit for Olympus Product Code: GAR3846
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-3027-2020·2020-10-07
Greiner Bio-One Recalls VACUETTE Blood Collection Tubes Due to Separation Issues
Greiner Bio-One is recalling VACUETTE blood collection tubes because they experienced an issue with separation and clotting.
Product
VACUETTE TUBE 5 mL CAT Serum Separator Clot Activator, Item Number: 456018P - Product Usage: are used to collect, transport, and process blood for testing serum, plasma or whole blood in the clinical laboratory.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2911-2020·2020-09-09
C.A. Greiner HOLDEX Plastic Cannula Recalled for Sample Leakage
C.A. Greiner & Sohne is recalling 390,000 units of HOLDEX Plastic Cannulas (Lot A19073FK) because sample may leak from the sleeve covering the needle.
Product
Plastic Cannula HOLDEX Item # 450216 - Product Usage: - Product Usage: It is intended for use in routine specimen withdrawal from specimen collection bags or bottles through needleless cannula ports.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2702-2020·2020-08-05
Smith & Nephew T-F1X0 RCG Drill Pac Recalled for Missing Sleeve
Smith & Nephew is recalling T-F1X0 RCG Drill Pacs because some sterile packages contain only one sleeve instead of two, preventing the device from performing as intended for the second bone tunnel.
Product
Smith & Nephew T-F1X0 RCG Drill Pac, 2 mm Drill & (2) Sleeves - Product Usage: indicated for use in surgical arthroscopic rotator cuff repair procedures. REF/ Catalog Number : 014771
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2435-2020·2020-07-08
Westmed Recalls Neo-Vent Infant T-Piece Resuscitation Circuits Due to Fit Issues
Westmed, Inc. is recalling Neo-Vent Infant T-Piece Resuscitation Circuits because a mold repair resulted in non-compliant 15mm OD connections that prevent use with compatible infant resuscitators.
Product
Neo-Vent Infant T-Piece Resuscitation Circuit With Infant Mask; Circuit for use on compatible Infant Resuscitators. 15mm OD x 10mm ID connector; REF 0420, Qty:10, Length: 60" (1.5cm), Rx Only.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2434-2020·2020-07-08
Westmed Recalls Neo-Vent Infant T-Piece Resuscitation Circuits Due to Fit Issues
Westmed, Inc. is recalling Neo-Vent Infant T-Piece Resuscitation Circuits because a manufacturing error resulted in non-compliant 15mm OD connections, preventing use with compatible infant resuscitators.
Product
Neo-Vent Infant T-Piece Resuscitation Circuit;Circuit for use on compatible Infant Resuscitators. 15mm OD x 10mm ID connector; REF 0415, Qty:10, Length: 60" (1.5cm), Rx Only.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2436-2020·2020-07-08
Westmed Neo-Vent Infant T-Piece Resuscitation Circuit Recall for Non-Compliant Connections
Westmed is recalling Neo-Vent Infant T-Piece Resuscitation Circuits because a mold repair resulted in non-compliant 15mm OD connections, preventing use with compatible infant resuscitators.
Product
Neo-Vent Infant T-Piece Resuscitation Circuit With Neonatal Mask; Circuit for use on compatible Infant Resuscitators. 15mm OD x 10mm ID connector; REF 0421, Qty:10, Length: 60" (1.5cm), Rx Only.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2422-2020·2020-07-01
Coltene Recalls Dental Dam Forceps Due to Pin Size Defect
Coltene Whaledent Inc is recalling 7,206 HYGENIC Wingless Fiesta Kit forceps because a pin size defect may prevent them from fitting dental dam clamps.
Product
HYGENIC Wingless Fiesta Kit, Model no. H02790 - Product Usage: The dental dam forceps are intended to be used in conjunction with the rubber dental dam and the dental dam clamps. The forceps are used to place and remove the dental dam clamps from the rubber dental dam.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2419-2020·2020-07-01
Coltene Recalls HYGENIC Dental Dam Forceps Due to Pin Size Defect
Coltene Whaledent Inc is recalling 7,206 HYGENIC Dental Dam Forceps because a pin size defect may prevent them from fitting properly with dental dam clamps.
Product
HYGENIC Dental Dam Forceps, Model no. H01262 - Product Usage: The dental dam forceps are intended to be used in conjunction with the rubber dental dam and the dental dam clamps. The forceps are used to place and remove the dental dam clamps from the rubber dental dam.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2420-2020·2020-07-01
Coltene Recalls HYGENIC Simple Dam Kit Forceps Due to Fit Issues
Coltene Whaledent Inc is recalling 7,206 HYGENIC Simple Dam Kit forceps because a pin size defect may prevent them from fitting properly with dental dam clamps.
Product
HYGENIC Simple Dam Kit, Model no. 60019066 - Product Usage: The dental dam forceps are intended to be used in conjunction with the rubber dental dam and the dental dam clamps. The forceps are used to place and remove the dental dam clamps from the rubber dental dam.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2421-2020·2020-07-01
Coltene Recalls Dental Dam Forceps Due to Pin Size Defect
Coltene Whaledent Inc is recalling 7,206 dental dam forceps because a pin size defect may prevent them from fitting properly with dental dam clamps.
Product
HYGENIC Winged Fiesta Kit, Model no. H02778 - Product Usage: The dental dam forceps are intended to be used in conjunction with the rubber dental dam and the dental dam clamps. The forceps are used to place and remove the dental dam clamps from the rubber dental dam.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2108-2020·2020-06-03
Siemens ARTIS Pheno X-Ray Systems Recalled for Drivetrain Faults
Siemens is recalling 105 ARTIS Pheno X-ray systems because a drivetrain fault may prevent the C-arm from moving, requiring field service to restore operation.
Product
ARTIS Pheno - Interventional Fluoroscopic X-Ray System Model: 10849000 - Product Usage: is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1998-2020·2020-05-20
ICU Medical Recalls Central Venous Catheters Due to Guidewire Issue
ICU Medical is recalling 10 Central Venous Catheters because the included guidewire cannot pass through the needles.
Product
Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients. Model # 41401-25.
Category
Medical Device
Distribution
19 states
ModerateFDA (Devices)·Z-1999-2020·2020-05-20
ICU Medical Recalls Central Venous Catheters Due to Guidewire Issue
ICU Medical is recalling 60 units of Model 41406-23 Central Venous Catheters because the included guidewires cannot pass through the needles.
Product
Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients. Model # 41406-23
Category
Medical Device
Distribution
19 states
ModerateFDA (Devices)·Z-2002-2020·2020-05-20
ICU Medical Recalls Central Venous Catheters Due to Guidewire Issue
ICU Medical is recalling 15 units of Central Venous Catheters because the included guidewire cannot pass through the needles.
Product
Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients. Model # 50456-01
Category
Medical Device
Distribution
19 states
ModerateFDA (Devices)·Z-2000-2020·2020-05-20
ICU Medical Recalls Central Venous Catheters Due to Guidewire Defect
ICU Medical is recalling 10 Central Venous Catheters because the included guidewire cannot pass through the needles. The defect prevents proper use of the device.
Product
Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients. Model # 41411-25
Category
Medical Device
Distribution
19 states
ModerateFDA (Devices)·Z-2001-2020·2020-05-20
ICU Medical Recalls Central Venous Catheters Due to Guidewire Issue
ICU Medical is recalling 235 Central Venous Catheters because the included guidewire cannot pass through the needles.
Product
Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients. Model # 41414-23
Category
Medical Device
Distribution
19 states