Hazard

Malfunction recalls

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

What the numbers show

Total: 229
Critical: 2
Severe: 20
Most recent: 2026-09-02

Of the 229 malfunction recalls we have scored against our rubric, 2 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 20 (9%) 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 malfunction 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.

76–100 of 229

ModerateFDA (Devices)·Z-1398-2019·2019-05-29
Boston Scientific Recalls Auriga 30 Laser Systems Due to Power Degradation
Boston Scientific is recalling specific Auriga 30 laser systems because a mechanical cooling issue may cause faster-than-normal power degradation and low power errors.
Product
AURIGA 30 GENERAL - DEMO SYSTEM UPN: M0068S30GD0 Product Usage: The Auriga XL 4007 Laser System and the Auriga 30 Laser System including a fiber optic delivery system is intended to be used in surgical procedures such as open, laparoscopic and endoscopic, to perform inci
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1290-2019·2019-05-15
Ortho-Clinical Diagnostics Recalls VITROS 3600 Immunoassay Systems Due to Luminometer Malfunction
Ortho-Clinical Diagnostics is recalling 28 VITROS 3600 Immunoassay Systems because a luminometer malfunction may prevent the processing of MicroWell assays.
Product
VITROS¿ 3600 Immunoassay System Refurbished-Software V3.3.2 & below Product Code: 6802914 For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1288-2019·2019-05-15
Ortho-Clinical VITROS 5600 Systems Recalled for Luminometer Malfunction
Ortho-Clinical Diagnostics is recalling VITROS 5600 Integrated Systems due to a luminometer malfunction that may prevent the processing of MicroWell assays.
Product
VITROS¿ 5600 Integrated System Refurbished-Software V3.3.2 & below Product Code: 6802915 For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1289-2019·2019-05-15
Ortho-Clinical VITROS 3600 Immunoassay System Software Recall
Ortho-Clinical Diagnostics is recalling VITROS 3600 Immunoassay System software versions 3.3.2 and below due to a luminometer malfunction that may prevent the processing of MicroWell assays.
Product
VITROS¿ 3600 Immunoassay System-Software V3.3.2 & below Product Code: 6802783 For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1293-2019·2019-05-15
Ortho-Clinical VITROS ECi Immunodiagnostic System Recalled for Luminometer Malfunction
Ortho-Clinical Diagnostics is recalling 25 refurbished VITROS ECi Immunodiagnostic Systems because a luminometer malfunction may prevent the processing of MicroWell assays.
Product
VITROS ECi Immunodiagnostic System Refurbished Product Code: 6801059 For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1139-2019·2019-04-24
Pintler Medical Recalls 24 Warming Pads Due to Malfunction
Pintler Medical LLC is recalling 24 warming pads used in operating rooms because they malfunction. The affected units were distributed to facilities in Wisconsin.
Product
A warming pad, a component of the PINTLER PEAK & PINTLER SUMMIT Heated OR pad. PPWS-001 indicated for use in any condition where patient warming is desired as determined by clinical personnel, in accordance with facility normo-thermia protocol
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-0973-2019·2019-03-13
Stryker Reprocessed Arthroscopic Shavers Recalled for Display and Function Errors
Stryker is recalling 14,265 reprocessed arthroscopic shavers that may display incorrect settings or error messages, preventing proper use during surgery.
Product
Stryker Sustainability Solutions (SSS) reprocessed Arthroscopic Shavers Arthroscopic shavers can be used to abrade, cut and excise tissue and bone; remove loose fragments; and, shave away debris in arthroscopic surgeries, as well as surgeries of the jaw and sinuses. Intended
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0228-2019·2018-10-31
bioMerieux Recalls BACT/ALERT VIRTUO Systems Due to Firmware Calibration Issue
bioMerieux is recalling 516 BACT/ALERT VIRTUO systems with R2.0 firmware because a service feature may leave calibration standards in incorrect locations, potentially causing anomalies.
Product
BACT/ALERT VIRTUO system, A Unit, with Version R2.0 Firmware Product Usage: The BacT/ALERT VIRTU Microbial Detection System is an automated microbial test system capable of incubating, agitating, and continuously monitoring for the detection of aerobic, facultative, and anaer
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2970-2018·2018-09-26
Pro-Med DORO LUCENT Headrest System Recalled for Malfunction Risk
Pro-Med Instruments is recalling 30 DORO LUCENT Headrest Systems because mixing design revisions may cause malfunction during surgery.
Product
DORO LUCENT Base Unit, REF 1101.021 Headrest System used in open and percutaneous craniotomies and spinal surgeries
Category
Medical Device
Distribution
7 states
SevereFDA (Devices)·Z-2972-2018·2018-09-26
Pro-Med DORO LUCENT Transitional Member Recall for Potential Malfunction
Pro-Med Instruments is recalling 31 DORO LUCENT Transitional Members because mixing design revisions may cause the headrest system to malfunction.
Product
DORO LUCENT Transitional Member, REF 1101.026 Component of headrest system used in open and percutaneous craniotomies and spinal surgeries
Category
Medical Device
Distribution
7 states
HighFDA (Devices)·Z-2971-2018·2018-09-26
Pro-Med Instruments Recalls DORO LUCENT Locking Transitional Member
Pro-Med Instruments is recalling 31 DORO LUCENT Locking Transitional Members because mixing design revisions may cause the headrest system to malfunction.
Product
DORO LUCENT Locking Transitional Member, REF 1101.031 Component of headrest system used in open and percutaneous craniotomies and spinal surgeries
Category
Medical Device
Distribution
7 states
HighFDA (Devices)·Z-2485-2018·2018-07-25
Cardinal Health Recalls Hydroline Trumpet Valves Due to Suction Defect
Cardinal Health is recalling Hydroline Trumpet Valves because the suction valve may not close properly, potentially causing continuous suction.
Product
Hydroline Trumpet Valve with Pulse Wave Cassette, Cassette Trumpet Valve with Bariatric Probe, Double Spike, Ref ABP1201, packaged 1/box, 12 boxes/case, single use, RX, Sterile.
Category
Medical Device
Distribution
34 states
HighFDA (Devices)·Z-2494-2018·2018-07-25
Cardinal Health Recalls Hydroline Trumpet Valves Due to Suction Defect
Cardinal Health is recalling Hydroline Trumpet Valves because the suction valve may not close properly, potentially causing continuous suction.
Product
Hydroline Trumpet Valve, Trumpet Valve, No Probe, Single Spike, Ref ASU1220, packaged 1/box, 12 boxes/case, single use, RX, Sterile.
Category
Medical Device
Distribution
34 states
HighFDA (Devices)·Z-2492-2018·2018-07-25
Cardinal Health Recalls Hydroline Trumpet Valves Due to Suction Defect
Cardinal Health 200, LLC is recalling Hydroline Trumpet Valves because the suction valve may not close properly, potentially causing continuous suction.
Product
Hydroline Trumpet Valve, Trumpet Valve, 5mm x 28cm Probe, Single Spike, Ref ASU1210, packaged 1/box, 12 boxes/case, single use, RX, Sterile. .
Category
Medical Device
Distribution
34 states
HighFDA (Devices)·Z-2491-2018·2018-07-25
Cardinal Health Recalls Hydroline Trumpet Valves Due to Suction Defect
Cardinal Health 200, LLC is recalling Hydroline Trumpet Valves because the suction valve may not close properly, potentially causing continuous suction.
Product
Hydroline Trumpet Valve, Trumpet Valve, 5mm x 33cm Probe, Double Spike, Ref ASU1201, packaged 1/box, 12 boxes/case, single use, RX, Sterile.
Category
Medical Device
Distribution
34 states
HighFDA (Devices)·Z-2490-2018·2018-07-25
Cardinal Health Recalls Hydroline Trumpet Valves Due to Suction Defect
Cardinal Health 200, LLC is recalling Hydroline Trumpet Valves because the suction valve may not close properly, potentially causing continuous suction.
Product
Hydroline Trumpet Valve, Trumpet Valve, 5mm x 33cm Probe, Single Spike, Ref ASU1200, packaged 1/box, 12 boxes/case, single use, RX, Sterile.
Category
Medical Device
Distribution
34 states
HighFDA (Devices)·Z-2487-2018·2018-07-25
Cardinal Health Recalls Hydroline Trumpet Valves Due to Suction Defect
Cardinal Health is recalling Hydroline Trumpet Valves because the suction valve may not close properly, potentially causing continuous suction.
Product
Hydroline Trumpet Valve with Pulse Wave Cassette, Trumpet Valve with Cassette, 5mm x 33cm Composite Probe, Double Spike, Ref ASC1201, packaged 1/box, 12 boxes/case, single use, RX, Sterile.
Category
Medical Device
Distribution
34 states
HighFDA (Devices)·Z-2495-2018·2018-07-25
Cardinal Health Recalls Hydroline Trumpet Valves Due to Suction Defect
Cardinal Health is recalling Hydroline Trumpet Valves because the suction valve may not close properly, potentially causing continuous suction.
Product
Hydroline Trumpet Valve, Trumpet Valve, No Probe, Double Spike, Ref ASU1221, packaged 1/box, 12 boxes/case, single use, RX, Sterile.
Category
Medical Device
Distribution
34 states
HighFDA (Devices)·Z-2486-2018·2018-07-25
Cardinal Health Recalls Hydroline Trumpet Valves Due to Suction Defect
Cardinal Health 200, LLC is recalling Hydroline Trumpet Valves because the suction valve may not close properly, potentially causing continuous suction.
Product
Hydroline Trumpet Valve with Pulse Wave Cassette, Trumpet Valve with Cassette, 5mm x 33cm Composite Probe, Single Spike, Ref ASC1200, packaged 1/box, 12 boxes/case, single use, RX, Sterile.
Category
Medical Device
Distribution
34 states
ModerateFDA (Devices)·Z-2484-2018·2018-07-25
Stryker Recalls Reprocessed Harmonic Ace Shears Due to Error Code
Stryker is recalling 180 reprocessed Harmonic Ace shears because they may display an error code preventing use.
Product
Reprocessed HARMONIC Ace¿ +7, 5mm Diameter Shears with Advanced Hemostasis (HARH), Item Number HARH36 Product Usage: The Reprocessed HARMONIC ACE¿+7, 5 mm Diameter Shears with Advanced Hemostasis are indicated for soft tissue incisions when bleeding control and minimal therma
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2379-2018·2018-07-18
Smiths Medical Recalls BCI Advisor Vital Signs Monitors Due to Printing Defects
Smiths Medical ASD Inc. is recalling 10 BCI Advisor Vital Signs Monitors because certain printing modes may not function properly.
Product
BCI Advisor Vital Signs Monitor, Model 9200, Reorder numbers 920654235, 920654235, 920654335A, and 920674235A. (The differences in the reorder numbers have to do with certain functions being installed or not installed.) Product Usage: The 9200 vital signs monitor is intended
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1798-2018·2018-05-16
Inpeco Laboratory Automation Systems Recalled for Module Freezing Risk
Inpeco S.A. is recalling 18 laboratory automation systems because a module may freeze without warning, potentially delaying patient test results.
Product
FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2), Laboratory Automation System
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-1645-2018·2018-05-16
Deerfield Imaging Recalls IMRIS Intraoperative MRI Systems Due to Malfunction
Deerfield Imaging is recalling 10 IMRIS intraoperative MRI systems because magnetic fields cause the IFOSS collision detector control panel to malfunction.
Product
IMRIS IMRI 1.5T AND 3T S System Product Usage: The IMRIS intraoperative MRI systems are traditional MRI systems that have been suspended on an overhead rail system. and is designated to operative inside an RF shielded room to facilitate intraoperative and multi room use.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1392-2018·2018-04-25
Philips Ingenuity TF PET/CT Recalled for Unresponsive Acquisition Console
Philips is recalling 12 Ingenuity TF PET/CT systems because the mass storage device may cause the acquisition console to become unresponsive, preventing image acquisition.
Product
Ingenuity TF PET/CT, Model No. 882442 Product Usage: The device is an integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) system suitable for a wide range of diagnostic applications. The device utilizes the CT technology to obtain anato
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1288-2018·2018-04-11
Southmedic Oxygen Masks Recalled Due to Potential CO2 Diffuser Issues
Southmedic, Inc. is recalling specific oxygen masks with EtCO2 sampling lines because loose or missing CO2 diffusers may render the masks non-functioning.
Product
Southmedic Oxygen Masks with EtCO2 sampling line part number OM-2125-8, 25 masks per case. Minimal contact, open oxygen delivery device for use with USP medical grade oxygen and for monitoring breathing by providing a means to sample exhaled CO2.
Category
Medical Device
Distribution
1 state