The Recall Desk

Hazard

Mechanical Defect recalls

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

What the numbers show

Total
283
Critical
2
Severe
11
Most recent
2026-07-22

Of the 283 mechanical defect recalls we have scored against our rubric, 2 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 11 (4%) 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 mechanical 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.

126–150 of 283

  • HighFDA (Devices)·Z-2662-2018·2018-08-15

    Smiths Medical Recalls Medfusion Syringe Infusion Pumps with Defective Barrel Clamp Guides

    Smiths Medical ASD Inc. is recalling 276 Medfusion Syringe Infusion Pumps because a ridge in the Barrel Clamp Guide may cause spring slippage, preventing the pump from recognizing or correctly identifying loaded syringes.

    Product
    Medfusion Syringe Infusion Pump, containing the Barrel Clamp Guide mechanism
    Category
    Medical Device
    Distribution
    26 states
  • LowFDA (Devices)·Z-2598-2018·2018-08-08

    BD FACS Universal Loader Recalled for Insufficient Locking Mechanism

    Becton, Dickinson and Company is recalling 8 BD FACS Universal Loader devices because the solenoid plunger tip is too short to lock securely during use.

    Product
    BD FACS Universal Loader (Optional) to the BD FACSLyric Clinical System, Model 662879 (Universal Loader), Rx Only. The firm name on the label is Becton, Dickinson and Company, BD Biosciences, San Jose, CA. The Loader offers various settings to resuspend and mix samples. It c
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-2488-2018·2018-07-25

    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 Single Spike and no Probe, Ref ASC1220, packaged 1/box, 12 boxes/case, single use, RX, Sterile.
    Category
    Medical Device
    Distribution
    34 states
  • ModerateFDA (Devices)·Z-2496-2018·2018-07-25

    Philips Ingenuity Digital PET/CT System Recall for Pallet Assembly Defect

    Philips is recalling 32 Ingenuity Digital PET/CT Systems because a block connecting the patient pallet to the couch may be assembled incorrectly, potentially causing a misaligned screw.

    Product
    Ingenuity Digital PET/CT System, Model 882446 with the following UDI's: (01)00884838059559(21)900004 (01)00884838059559(21)900005 (01)00884838059559(21)900006 (01)00884838059559(21)900007 (01)00884838059559(21)900008 (01)00884838059559(21)900009 (01)00884838059559(21)9000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2176-2018·2018-06-20

    Philips Brilliance 16 P CT Systems Recalled for Head Holder Contact Risk

    Philips is recalling 20 Brilliance 16 P CT systems because the patient support head holder may contact the back ISO shelter wall, posing a risk of serious injury.

    Product
    Brilliance 16 P with DEPMED HARDENING KIT 12NC: 453567400741, Model Number 728246. Computed Tomography X-ray system
    Category
    Medical Device
    Distribution
    6 states
  • SevereFDA (Devices)·Z-2174-2018·2018-06-20

    Philips Brilliance 64 CT System Recalled for Patient Support Head Holder Hazard

    Philips is recalling three Brilliance 64 CT systems because the patient support head holder could contact the back ISO shelter wall, posing a risk of serious injury.

    Product
    Brilliance 64 with DEPMED HARDENING KIT 12NC: 459800191351, Model Number 728231. Computed Tomography X-ray system
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-2155-2018·2018-06-20

    Sun Med Recalls Adult Manual Resuscitators Due to Port Detachment Risk

    Sun Med, LLC is recalling 60 cases of Medline Adult Manual Resuscitators because the patient port retaining ring may not fully seat, allowing the port to detach and impact air delivery.

    Product
    MEDLINE ADULT MANUAL RESUSCITATOR WITH LARGE ADULT MASK, TUBE RESERVOIR, FILTER AND 7 FT. OXYGEN TUBING, REF CPRM1126FL
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1555-2018·2018-05-16

    Vyaire Medical Recalls AirLife Pediatric Resuscitation Devices Due to Mask Sticking

    Vyaire Medical is recalling 24 AirLife Pediatric Resuscitation devices because the mask may stick to the elbow, making it difficult to disconnect.

    Product
    AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, filter Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathin
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1573-2018·2018-05-16

    Vyaire Medical Recalls AirLife Infant Resuscitation Devices Due to Mask Sticking

    Vyaire Medical is recalling 900 AirLife Infant Resuscitation Devices because the mask may stick to the elbow, making it difficult to disconnect.

    Product
    AirLife Resuscitation, Infant, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, PEEP valve Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1552-2018·2018-05-16

    Vyaire Medical Recalls AirLife Resuscitation Devices Due to Mask Sticking

    Vyaire Medical is recalling 305,136 AirLife Resuscitation devices because the mask may stick to the elbow, making it difficult or impossible to disconnect.

    Product
    AirLife Resuscitation, Adult, with mask, 40" oxygen reservoir tubing 6/cs Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1581-2018·2018-05-16

    Vyaire Medical Recalls AirLife Infant Resuscitation Devices Due to Mask Sticking

    Vyaire Medical is recalling 180 AirLife Infant Resuscitation devices because the mask may stick to the elbow, making it difficult to disconnect.

    Product
    AirLife Resuscitation, Infant, with mask, oxygen reservoir bag, pressure-relief valve, PEEP valve Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cann
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1556-2018·2018-05-16

    Vyaire Medical Recalls AirLife Infant Resuscitation Devices Due to Mask Sticking

    Vyaire Medical is recalling 180 AirLife Infant Resuscitation devices because the mask may stick to the elbow, making it difficult to disconnect.

    Product
    AirLife Resuscitation, Infant, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, manometer Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathin
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1554-2018·2018-05-16

    Vyaire Medical Recalls Pediatric AirLife Resuscitation Devices Due to Mask Sticking

    Vyaire Medical is recalling 8,058 pediatric AirLife resuscitation devices because the mask may stick to the elbow, making it difficult or impossible to disconnect.

    Product
    AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, pressure-relief valve Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or can
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1485-2018·2018-05-02

    Keystone Dental Recalls Genesis Surgical Cassettes Due to Burr Wobble

    Keystone Dental Inc is recalling 19 Genesis Surgical Cassettes because extra-large grommets cause dental burrs to wobble.

    Product
    Genesis Surgical Cassette Tapered Implants are intended for placement following natural tooth loss or for immediate placement into an extraction socket
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1411-2018·2018-04-25

    Philips Brilliance Big Bore CT Systems Recalled for Emergency Stop Defect

    Philips is recalling 119 Brilliance Big Bore CT systems because closing the Emergency Stop may disable the horizontal motor, allowing the couch to move during patient load or unload.

    Product
    Brilliance Big Bore (Radiology) - Model no. 728244, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and pla
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1404-2018·2018-04-25

    Philips Ingenuity Flex CT Scanner Recall for Emergency Stop Defect

    Philips is recalling 151 Ingenuity Flex CT scanners because closing the Emergency Stop may disable the horizontal motor, allowing the couch to move during patient loading.

    Product
    Ingenuity Flex - Model no. 728317, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1266-2018·2018-04-04

    Deerfield Imaging Recalls IMRIS ORT300 Operating Room Tables Due to Drift Risk

    Deerfield Imaging is recalling 13 IMRIS ORT300 operating room tables because they may drift during use, potentially causing unintended movement.

    Product
    IMRIS ORT300, Removable Operating Room Table, Part Numbers: (a) 114093-000 (b) 114093-600
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1009-2018·2018-03-21

    Zimmer Biomet Recalls Nondegradable Soft Tissue Fixation Fasteners

    Zimmer Biomet is recalling 429 units of nondegradable soft tissue fixation fasteners because the implant shaft may shift and fall out during device opening.

    Product
    fastener, fixation, nondegradable, soft tissue
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-0703-2018·2018-03-07

    Oakworks Medical Imaging Table Foot Controls Recalled for Lodging Hazard

    Oakworks Inc. is recalling foot controls for specific medical imaging tables because they can become lodged under the table base or column.

    Product
    Foot Controls impacted for the following devices: OAKWORKS¿ Medical CFPM 300 Imaging Table OAKWORKS¿ Medical CFPM 301 Imaging Table OAKWORKS¿ Medical CFPM 400 Imaging Table OAKWORKS¿ Medical CFPM 401 Imaging Table OAKWORKS¿ Medical CFPMB 301 Bariatric Imaging Table OAKWOR
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0739-2018·2018-03-07

    Ventana ultraView SISH DNP Detection Kit Recalled for Leaking Reagent Dispensers

    Ventana Medical Systems Inc is recalling 358 units of the ultraView SISH DNP Detection Kit due to increased reports of leaking and sticking reagent dispensers.

    Product
    ultraView SISH DNP Detection Kit, Ventana Part Number 800-098, Roche GMMI 05907136001 in vitro diagnostic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0735-2018·2018-03-07

    Ventana Recalls CINtec PLUS Cytology Kits Due to Leaking Reagent Dispensers

    Ventana Medical Systems is recalling 18 units of the CINtec PLUS Cytology Kit due to increased reports of leaking and sticking reagent dispensers.

    Product
    CINtec PLUS Cytology Kit (Canada/Japan), Ventana Part Number 805-100, Roche GMMI 06889549001 in vitro diagnostic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0579-2018·2018-02-21

    GE Carestation 600 Series Recalled for Possible Incomplete CO2 Seal

    GE Medical Systems is recalling 5,148 Carestation 600 Series anesthesia machines due to a possible incomplete seal between the CO2 absorber and the breathing circuit.

    Product
    Carestation 620 A1, Carestation 650 A1, and Carestation 650c A1
    Category
    Medical Device
    Distribution
    39 states
  • HighFDA (Devices)·Z-0452-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a set screw and sleeve assembly may have shifted during rework, potentially preventing proper product assembly.

    Product
    Affixus Hip Fracture Nail, RH 125 DEG 13MM X 260MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0423-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a set screw and sleeve assembly may have shifted, potentially preventing proper product assembly.

    Product
    Affixus Hip Fracture Nail, 130 DEG 9MM X 180MM
    Category
    Medical Device
    Distribution
    Distributed nationwide