The Recall Desk

Hazard

Functional Failure recalls

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

What the numbers show

Total
127
Critical
0
Severe
3
Most recent
2026-04-29

Of the 127 functional failure recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 3 (2%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all functional failure 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.

1–25 of 127

  • HighFDA (Devices)·Z-1874-2026·2026-04-29

    AccuVu Angiographic Catheter, Omni Flush, Non-Braided Defect Recall

    Angiodynamics recalls AccuVu Angiographic Catheters due to a manufacturing defect that may prevent guidewires from passing through the catheter hub. The affected devices were distributed worldwide.

    Product
    AccuVu Angiographic Catheter, Omni Flush, Non-Braided, With 21 R/O Markers; ACCU-VU OF 4F X 70CM 035 NB 6SH 21 R/O 1CM; Catalog No.: 13709704; Product/UPN No.: H787137097045 (Box), H787137097040 (Pouch); Box Quantity: 5 pouches;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1422-2025·2025-04-02

    Software Malfunction Disables Back Control on Baxter TruSystem 7500

    Baxter TruSystem 7500 medical devices are affected by a software issue that prevents the upper back section from operating when emergency mode is enabled. Approximately 1,709 units have been recalled nationwide.

    Product
    Baxter TruSystem 7500, Product Code 4091000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1417-2025·2025-04-02

    Baxter TruSystem 7500 Hybrid software issue disables upper back adjustment

    Baxter TruSystem 7500 Hybrid affected by software issue that prevents the upper back section from being operable or adjustable when emergency mode is enabled. Affects 10 units distributed nationwide.

    Product
    Baxter TruSystem 7500 Hybrid (FC), Product Code 1854085
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1643-2024·2024-05-22

    Cardiac catheters recalled due to polyurethane layer delamination defects

    Boston Scientific is recalling Expo 5F Selective Angiographic Catheters due to polyurethane layer defects that prevent proper guidewire insertion. Affected devices may experience material detachment in the catheter lining.

    Product
    Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR4 MOD (5PK), REF H74908526052; cardiac catheter
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0795-2024·2024-01-31

    Bard PreVent Anti-Reflux Filter with ENFit Recall for Reduced Suction

    C.R. Bard is recalling Bard PreVent Anti-Reflux Filters with ENFit connectors due to user reports of inadequate or reduced suction, decompression, and drainage during use.

    Product
    Bard¿ PreVent¿ Anti-Reflux Filter with ENFit, REF EN0046000
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1102-2023·2023-02-15

    Smart Correction External Fixation Struts: Collar Release Pin May Back Out

    The collar release pin on affected Smart Correction Dual Joint Express Struts may back out, preventing proper length adjustment and potentially delaying surgical correction.

    Product
    WishBone Medical Smart Correction Dual Joint Express Struts, external skeleton fixation device Type Part Number XXS 10-702-080095-0 XS 10-702-095115-0 Short 10-702-115150-0 Medium 10-702-140200 Long 10-702-190300-0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1588-2022·2022-08-31

    Drug screening tablets affected by temperature exposure during storage

    McKesson is recalling Alere Toxicology drug screening tablets due to temperature excursions during facility storage that may have reduced product effectiveness. Affected units were received between June and September 2021.

    Product
    Alere Toxicology TABLET, INSTANT BLUING F/DRUGSCREEN Model Number: 7875
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1391-2022·2022-07-27

    Surgical knee implant instrument key may become nonfunctional during assembly

    Aesculap is recalling the ENDURO SPECIAL KEY TIB.LOCK.RING (product code NP462R) used in knee replacement surgery because the key pins may be damaged during assembly, causing the instrument to become nonfunctional.

    Product
    ENDURO SPECIAL KEY TIB.LOCK.RING F1/10MM product code NP462R used with EnduRo Total Knee System. instrument used during orthopedic implant surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0398-2022·2021-12-29

    VirtuTRAX Instrument Navigator devices may not tighten properly

    Civco Medical Instruments is recalling VirtuTRAX Instrument Navigator devices due to a potential mechanical failure that could prevent proper securing of instruments. The device may not tighten onto the instrument as intended.

    Product
    VirtuTRAX Instrument Navigator, 10 17 GA VirtuTRAX
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2601-2021·2021-10-06

    Patient lift devices may lose ability to maintain horizontal positioning during transfers

    Hill-Rom LikoStretch Mod 600 IC patient lift devices may fail to maintain patients in a horizontal position while lifting, potentially causing patients to slide or fall.

    Product
    LikoStretch Mod 600 IC Model Number: 3156065 LikoStretch Mod 600 IC, Wide Model Number: 3156065B (obsolete since 12JUN2020) - The combination of this products allows the user to easily adjust/control the center of gravity during lift of patient.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1436-2021·2021-04-28

    Stryker DirectInject Bone Cement Recalled Due to Injection Failure

    Stryker is recalling 321 units of DirectInject bone cement because the paste cannot be injected from the syringe into the target location.

    Product
    DirectInject consists of a sterile dual paste system which is calcium phosphate based. Upon injection through the Mixer-Cannula, the two pastes form a cement paste which is moldable. The injected cement paste will harden under normal body conditions to form hydroxyapatite.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0071-2021·2020-10-14

    Skytron VGA to Fiber Converter Recall for Video Signal Failure

    Skytron is recalling 11 VGA to Fiber Converter units for the SkyVision Linx 300 system due to faceplate failures that cause video signal loss on secondary displays.

    Product
    VGDF-SKY (R4-010-06) VGA TO FIBER CONVERTER-Single Format Faceplate, a component of the SkyVision Linx 300 Integration Control System Model: VGDF-SKY (version 2). For communication and visual image management in the operating room suite.
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-2904-2020·2020-09-02

    Neurovision Cobra EMG ET Tube Recalled for Insulating Material Softening

    Neurovision Medical Products Inc. is recalling Cobra x5 1-Ch EMG ET Tubes because the electrode insulating material may soften, potentially damaging the device and stopping signal transmission.

    Product
    Cobra x5 1-Ch EMG ET Tube, 7.0mm, REF LTE700M-5, Rx Only, Sterile EO CE UDI: B006LTE700M52/$$7061418C - Product Usage: For continuous EMG monitoring and status assessment of the nerves supplying the laryngeal musculature as well as providing an open airway for patient ventilation
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2902-2020·2020-09-02

    Neurovision Nerveana x5 RLN Monitoring Kit Recalled for Insulation Softening

    Neurovision is recalling Nerveana x5 RLN Monitoring Kits because the electrode insulating material may soften, potentially damaging the device and stopping EMG signal transmission.

    Product
    Nerveana x5 RLN Monitoring Kit with Cobra 1-Ch EMG ET Tube, 8.0 mm, REF NVTKIT-C8-5, Rx Only, Sterile UDIB006NVTKITC852/$$7062118C - Product Usage: For continuous EMG monitoring and status assessment of the nerves supplying the laryngeal musculature as well as providing an open
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2821-2020·2020-08-26

    Arjo Huntleigh Recalls Citadel Plus Bariatric Bed Frames Due to Melting Cables

    Arjo Huntleigh is recalling 145 Citadel Plus Bariatric Bed Frame Systems because Modular Junction Box cables can melt, potentially affecting bed functionality.

    Product
    Bariatric Bed Frame System The Citadel Plus Bariatric Bed Frame System is intended for the acute and post-acute care environments. It is not intended for use in the home care environment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2811-2020·2020-08-26

    Philips Charging Station Recalled Due to Battery Charging Failure

    Philips is recalling charging stations for the Expression MR400 MRI system because the battery fails to charge due to poor electrical contact.

    Product
    Phillips Charging Station, Product #: 989803191021 - Product Usage: This charging station is used in the Expression MR400 MRI Patient Monitoring System (Model MR400) is intended to monitor vital signs for patients undergoing MRI procedures and to provide signals for synchronizati
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2192-2020·2020-06-10

    Abbott Afinion 2 Power Supply Recall for Electrostatic Discharge Risk

    Abbott is recalling Afinion 2 and Alere Afinion AS100 power supplies due to a risk of electrostatic discharge and sparking that can render the unit non-functional.

    Product
    Power supply provided with Afinion 2, Catalog numbers 1116553, 1116554, 1116556, 1116557, 1116597, 1116598, 1116663, 1116679, 1116680, 1116681, 1116682, 1116684, 1116770, 1116771, 1116772, 1116777, 1116778, 1116970, 1116971, 1116985, 1116986, IVD. The firm name on the label is A
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2072-2020·2020-05-27

    Clinical Innovations Recalls Kiwi Vacuum Delivery System Due to Vacuum Failure

    Clinical Innovations, LLC is recalling 2,340 units of the Kiwi Complete Vacuum Delivery System because the device may fail to generate or maintain vacuum during use.

    Product
    Kiwi Complete Vacuum Delivery System, Model No. VAC-6000MTE - Product Usage: The Kiwi is a disposable vacuum-assisted fetal delivery system.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1954-2020·2020-05-20

    Cardiac Assist Recalls TandemLung Kits Due to Assembly Error

    Cardiac Assist, Inc. is recalling two TandemLung Kit units because an assembly error may prevent the pump from priming.

    Product
    TandemHeart pump is assembled into kits: TandemLung Kit - DL31, Product: 5730-3118 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally deliver an anticoagulant through the infusion system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1486-2020·2020-03-25

    Philips Allura Exper FD Series X-Ray Generator Recall

    Philips is recalling Allura Exper FD Series X-ray generators because a capacitor may fail after electrical surges, preventing image acquisition.

    Product
    Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1489-2020·2020-03-25

    Philips MultiDiagnost Eleva X-ray System Recalled for Capacitor Failure

    Philips is recalling 534 MultiDiagnost Eleva X-ray systems because a capacitor may fail after electrical surges, preventing image acquisition.

    Product
    MultiDiagnost Eleva, System codes 722030 722016 722017 708032 708036 708034 708037 708038
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1494-2020·2020-03-25

    Philips Allura Centron X-ray System Recalled for Capacitor Failure

    Philips is recalling 87 Allura Centron X-ray systems because a capacitor may fail after electrical surges, preventing image acquisition.

    Product
    Cardio Vascular-Allura Centron, system code 722400
    Category
    Medical Device
    Distribution
    Distributed nationwide