Hazard

Device Failure recalls

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

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all device 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 240

ModerateFDA (Devices)·Z-2213-2026·2026-05-27
OneLIF Interbody Cage Inserter Attachment Failure Recall
Novapproach Spine is recalling OneLIF Interbody Cages because the straight inserter may fail to properly attach to the cages, potentially causing procedural delays or the need to use an alternative implant.
Product
OneLIF Interbody Cage (REF/Description): 010-107-1007/Small 7 Degree 10mm X 7mm, 010-107-1007-2/Small 7 Degree 10mm X 7mm - Oblique, 010-107-1209/Small 7 Degree 12mm X 9mm, 010-107-1411/Small 7 Degree 14mm X 11mm, 010-107-1613/Small 7 Degree 16mm X 13mm, 010-113-1006/Small,
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2159-2026·2026-05-20
NextStep Hemodialysis Catheters with Defective Sheath Introducer
Arrow International is recalling NextStep Antegrade and Retrograde Hemodialysis Catheters worldwide because an included 16F dual-valved splittable sheath introducer may not split as intended, potentially causing pain, bleeding, hematoma, and tissue injury.
Product
NextStep Antegrade Chronic Hemodialysis Catheter, REF: AC-15192-SFX, AC-15232-SFX, CS-15192-SFX, CS-15232-SFX, CS-15272-SFX, CS-15312-SFX, CS-15422-SFX, CS-15502-SFX; NextStep Antegrade Hemodialysis Catheter with Arrow Simplicity Micro-Introducer, REF: CS-15192-SFXM, CS-1523
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1979-2026·2026-05-13
Halyard VA Detroit Cath Lab Pack Kit Syringe Adaptor Disconnection Risk
Halyard VA Detroit Cath Lab Pack kits (Model VMCD029) are being recalled due to a potential risk that the Medline syringe rotating adaptor may unwind during use, causing a loose or full disconnection between the syringe and manifold.
Product
Halyard VA DETROIT CATH LAB PACK kit. Model Numbers: VMCD029.
Category
Medical Device
Distribution
7 states
SevereFDA (Devices)·Z-1976-2026·2026-05-13
Halyard NEURO IR PERIPHERAL kit syringe adapter may disconnect
AVID Medical is recalling the Halyard NEURO IR PERIPHERAL (PS 64405) kit because the Medline syringe rotating adapter may unwind during use, causing a loose or full disconnection between the syringe and manifold.
Product
Halyard NEURO IR PERIPHERAL (PS 64405) kit. Model Number: UINR44-01.
Category
Medical Device
Distribution
7 states
SevereFDA (Devices)·Z-1975-2026·2026-05-13
Halyard HEART CATH SELF REGIONAL kit syringe adapter disconnection hazard
AVID Medical is recalling the Halyard HEART CATH SELF REGIONAL kit (Model SELF131-05) because the Medline syringe rotating adaptor may unwind during use, causing a loose or full disconnection between the syringe and manifold.
Product
Halyard HEART CATH, SELF REGIONAL kit. Model Number: SELF131-05.
Category
Medical Device
Distribution
7 states
CriticalFDA (Devices)·Z-2031-2026·2026-05-06
Insulin Pump Batteries Recalled After Sudden-Shutdown Reports
OmniDose is recalling 23,000 lithium battery packs used in its X4 insulin pumps after reports of unexpected shutdown.
Product
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: GENERAL KIT, Medline Kit Number/SKU DYNJ905664I
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1907-2026·2026-04-29
OER-ELITE Endoscope Reprocessor Connecting Tubes Lock Failure Recall
Olympus Corporation of the Americas is recalling OER-ELITE Endoscope Reprocessor Connecting Tubes (Model MAJ-2119) due to potential premature failure of the Version 2 reprocessor connecting tube lock levers.
Product
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2119.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1689-2026·2026-04-08
Jiffy Composite Polisher Cups may crumble and disrupt dental treatment
The Jiffy Original Composite Polisher Cups (REF 7011) may crumble and break apart, potentially delaying patient treatment. Ultradent Products is recalling 2,508 units from 30 US states and Puerto Rico.
Product
Jiffy Original Composite Polisher Cups (Coarse) 12pk, REF 7011.
Category
Medical Device
Distribution
31 states
CriticalFDA (Devices)·Z-1568-2026·2026-04-01
Flexible surgical cryoprobes recalled due to potential rupture during use
Erbe USA Inc is recalling 3,603 flexible cryoprobes (REF: 20402-411) nationwide. The devices may rupture during use, posing patient safety risks.
Product
Flexible Cryoprobe (OD 2.4mm, L1.15mm) REF: 20402-411. For surgical use
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1567-2026·2026-04-01
Flexible Cryoprobes May Rupture During Surgical Activation
Erbe USA Inc recalls 8,284 flexible cryoprobes used in surgical procedures. The devices may rupture or burst during activation, posing a risk to patient safety.
Product
Flexible Cryoprobe (OD 1.7mm, L1.15mm) REF: 20402-410. For surgical use
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1566-2026·2026-04-01
Flexible Cryoprobe Surgical Instruments Recalled for Potential Rupture During Use
Erbe USA Inc is recalling 64,216 Flexible Cryoprobes used in surgery because they may rupture or burst during activation. Affected units were distributed nationwide.
Product
Flexible Cryoprobe (OD 1.1mm, L1.15mm) w/ oversheath (OD2.6mm, L817mm) REF: 20402-401 STERILE EO. For surgical use
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1521-2026·2026-03-18
Endo-Model Replacement Plateau orthopedic implant: bushing detachment risk
Waldemar Link is recalling Endo-Model Replacement Plateau implants due to the potential for bushing detachment from the screw shaft caused by longitudinal fracture. Affected units were distributed in the US and worldwide.
Product
Endo-Model Replacement Plateau; Item Number: 15-0027/11;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1509-2026·2026-03-18
Exactech Equinoxe Ergo Impactor Handles Recalled for Missing Cross-Pin
Exactech is recalling 120 units of Equinoxe Ergo Modular Impactor Handles (Model 321-09-05) because the handle may be missing a cross-pin, a structural component that could compromise surgical function.
Product
Brand Name: Equinoxe Ergo Product Name: Ergo Modular Impactor Handle Model/Catalog Number: 321-09-05
Category
Medical Device
Distribution
25 states
HighFDA (Devices)·Z-1441-2026·2026-03-04
Olympus Resection Sheath Ceramic Tip Breaking Defect Recall
Olympus Corporation is recalling the Resection Sheath, 24 Fr (Model A22041A) nationwide due to complaints that the ceramic tip can break during urologic procedures.
Product
Olympus Resection Sheath, 24 Fr; Model No. A22041A. Resection sheath for urologic applications.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1439-2026·2026-03-04
Olympus Resection Inner Sheath Recalled for Ceramic Tip Breakage
Olympus Corporation is recalling the Olympus Resection Inner Sheath (Model A22040A) due to reports of the ceramic tip breaking. The recall affects 6,949 units distributed nationwide.
Product
Olympus Resection Inner Sheath, for 26 Fr. Outer Sheath. Model No. A22040A. Resection sheath for urologic applications.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1450-2026·2026-03-04
Olympus Inner Sheath Recalled for Ceramic Tip Breakage in Medical Procedures
Olympus is recalling the Inner Sheath, Long (Model WA22017A) used in urological and gynecological procedures due to complaints of ceramic tip breakage. Medical facilities should stop using the device and contact Olympus.
Product
Olympus Inner Sheath, Long; Model No. WA22017A. Inner sheath for urological and gynecological applications.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1440-2026·2026-03-04
Olympus Resection Inner Sheath recalled for ceramic tip fractures
Olympus Corporation of the Americas is recalling the Resection Inner Sheath (Model No. A22040T) used in urologic procedures due to complaints of ceramic tip breaking. Approximately 7,426 units were distributed nationwide.
Product
Olympus Resection Inner Sheath for 26 Fr. Outer Sheath. Model No. A22040T. Resection sheath for urologic applications.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1373-2026·2026-02-25
FDA Recalls Olympus Thunderbeat 5mm Surgical Instruments Due to Adverse Events
Olympus Corporation is recalling 4,181 units of the Olympus Thunderbeat 5mm surgical device due to continued reports of adverse events. The device was distributed across the U.S., Brazil, Canada, Germany, Mexico, and Japan.
Product
Olympus Thunderbeat 5 mm, 20 cm, Front-Actuated Grip Type S
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1276-2026·2026-02-11
Olympus Sphincterotome Devices Recalled for Deformation and Loss of Performance
Olympus is recalling over 17,600 3-Lumen Sphincterotome V devices because some units did not undergo proper thermoforming, which could cause them to deform and lose performance.
Product
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V431M-0730; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1279-2026·2026-02-11
Olympus Sphincterotome V Surgical Instrument Recalled for Deformation Risk
Olympus Corporation is recalling 10,257 units of Single Use 3-Lumen Sphincterotome V endoscopic instruments. Some devices did not undergo thermoforming during manufacturing and could deform and lose performance.
Product
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0730; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1196-2026·2026-02-04
Medline Medical Procedure Kits Recalled Due to Tubing Defect Risk
Medline recalled multiple medical procedure kits due to a defect causing butyrate tubing in MASTISOL liquid adhesive vials to crack during use. The affected kits are used in neurological and surgical procedures.
Product
Medline medical procedure convenience kits labeled as: 1) DEPAUL BASIC NEURO-LF, Kit SKU DYNJ20028L; 2) NEURO MINOR PACK, Kit SKU DYNJ46546M; 3) NEURO SHUNT PACK, Kit SKU DYNJ54396K; 4) NEURO PACK, Kit SKU DYNJ59397Q; 5) NEURO BASIC, Kit SKU DYNJ904052L; 6) PK NEURO
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1123-2026·2026-01-28
Merit Medical Inflation Device Handle May Detach During Procedures
Merit Medical Systems is recalling inflation device units because the handle may detach from the syringe during medical procedures. Affected units: 4,163,123 worldwide.
Product
Merit Medical Inflation Device.basixCOMPAK.30 atm/bar.20 mL Reference Numbers: ENDO-AN2030/B IN4130/CNK IN4130/H IN4130/JPH IN4130/K IN4130/KRK IN4130/L IN4130/T IN4230/JPH IN4230/K IN4330/CNK IN4330/K IN4352/K IN4430/K IN4530/CNK IN4530/K IN4530/T IN4802/K IN4802/T IN4852/K IN4
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1128-2026·2026-01-28
Custom Procedure Kit Inflation Device Handle Detachment Risk
Merit Medical custom procedure kits contain inflation devices whose handles may detach from the syringe during medical procedures, potentially compromising procedure execution.
Product
Merit Medical , Custom Procedure Kit Reference Numbers: K12T-04270A K12T-07956 K12T-10922B
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1032-2026·2026-01-14
Call Station Firmware Issue May Prevent Low Battery Alert Transmission
Certain Arial 900 MHz wireless call stations (Model CSK200-900MR) may fail to alert users about low battery conditions before the device loses power. Approximately 1,898 affected units were distributed in the US and Canada.
Product
Arial 900 MHz Call Station, Model Number CSK200-900MR, with Firmware version: 1.6.3
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0963-2026·2025-12-31
Stryker CranialMask Tracker software error prevents surgical activation
The Stryker CranialMask Tracker may display a software error during surgery that prevents device activation. This surgical tracking device is used in cranial procedures.
Product
The Stryker CranialMask Tracker is a single-use device consisting of a flexible printed circuit board (PCB) with 31 infrared (IR) light-emitting diodes (LEDs) as well as an electronics control unit for the LEDs which includes its own battery power supply. The measured LED positio
Category
Medical Device
Distribution
Distributed nationwide