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.

226–250 of 283

  • ModerateFDA (Devices)·Z-2169-2014·2014-08-20

    Abbott 5 mL Reaction Vessels Recalled for Insufficient Rim Defect

    Abbott Molecular is recalling 5 mL Reaction Vessels for the m2000sp system because an insufficient rim may cause the vessels to drop through the carrier.

    Product
    5 mL Reaction Vessels (a consumable of the Abbott m2000sp Automated Fluid Handling System). The Abbott m2000 RealTime System is intended for use in performing nucleic acid amplification testing by polymerase chain reaction in clinical laboratories. The system is comprised of the
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2083-2014·2014-07-30

    DePuy Orthopaedics Recalls RECLAIM Distal Tapered Surgical Instruments

    DePuy Orthopaedics is recalling RECLAIM Distal Tapered surgical instruments because they can be difficult to remove from the Distal Stem.

    Product
    RECLAIM DISTAL TAPERED, Angled Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.
    Category
    Medical Device
    Distribution
    49 states
  • ModerateFDA (Devices)·Z-1765-2014·2014-06-18

    Stryker Recalls Zyphr Elite Round Fluted Bur Due to Missing Notches

    Stryker is recalling four sterile Zyphr Elite Round Fluted Burs because some units may have missing or partial notches, potentially affecting their use with Elite Attachments.

    Product
    Stryker 2.0mm Zyphr Elite Round Fluted Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical appl
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1753-2014·2014-06-18

    Stryker 6.0mm Round Fluted Bur Recalled for Missing Notches

    Stryker is recalling 256 units of 6.0mm Round Fluted Bur due to missing or partial notches that may affect compatibility with Elite Attachments.

    Product
    Stryker 6.0mm Round Fluted Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications incl
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1763-2014·2014-06-18

    Stryker Recalls Four Zyphr Elite Round Fluted Bur Units

    Stryker is recalling four sterile Zyphr Elite Round Fluted Bur units due to missing or partial notches that may affect compatibility with Elite attachments.

    Product
    Stryker 5.0mm Zyphr Elite Round Fluted Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical appl
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1770-2014·2014-06-18

    Stryker 6.0mm Acorn Bur Recalled for Missing Notches

    Stryker is recalling 59 sterile 6.0mm Acorn Burs because some units have missing or partial notches, which may affect their use with Elite Attachments.

    Product
    Stryker 6.0mm Acorn Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1722-2014·2014-06-11

    Philips CT Scanners Recalled for Disengaged Service Latch

    Philips Medical Systems is recalling 6,839 CT scanners worldwide because a service latch may disengage, causing the table top to become free-floating.

    Product
    Philips Medical Systems Computed Tomography X-ray systems (Brilliance CT series, iCT, iCT SP, Ingenuity CT, Ingenuity Core, Ingenuity Core128, Ingenuity Flex, and the MX8000 Dual v. EXP scanners)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1445-2014·2014-04-16

    Alcon LenSx Ophthalmic Laser Recalled for Gantry Motion Defect

    Alcon LenSx is recalling 75 ophthalmic lasers used in cataract surgery due to reports of unexpected downward motion of the gantry.

    Product
    Alcon LenSx Ophthalmic Laser, for use in cataract surgery for the creation of corneal cuts/incisions, anterior capsulotomy and laser phacofragmentation.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1314-2014·2014-04-09

    Allesee Orthodontic Jet Appliances Recalled Due to Missing Screw Collar

    Allesee Orthodontic Appliances is recalling 411 Jet appliances because a missing screw collar may prevent intended tooth movement.

    Product
    AOA Distalizer Lock Nut Screw, found in products listed as: Distal Jet, Spring Jet, Mesial Jet, and Uprighter Jet. Removable functional orthodontic appliances that are to modify the growth of the jaws in a prescribed growth pattern.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1187-2014·2014-03-19

    Smiths Medical Recalls Arterial Blood Sampling Syringes Due to Plunger Tip Issue

    Smiths Medical ASD, Inc. is recalling specific Arterial Blood Sampling Line Draw Syringes due to an issue with the plunger tip. The devices are sterile, single-use, and used for drawing arterial blood.

    Product
    4043E: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device (for sale in Europe only) Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices used for the drawing of arterial blood v
    Category
    Medical Device
    Distribution
    40 states
  • HighFDA (Devices)·Z-1185-2014·2014-03-19

    Smiths Medical Recalls Arterial Blood Sampling Syringes Due to Plunger Tip Issue

    Smiths Medical ASD, Inc. is recalling Portex Arterial Blood Sampling Line Draw Syringes due to an issue with the plunger tip.

    Product
    4042LH: 3 mL Line Draw, Luer lock syringe (heparin concentration: 7 I.U. per mL)with Filter-Pro¿ device Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices used for the drawing of arterial blood via an arterial line. The p
    Category
    Medical Device
    Distribution
    40 states
  • HighFDA (Devices)·Z-1186-2014·2014-03-19

    Smiths Medical Recalls Arterial Blood Sampling Syringes Due to Plunger Tip Issue

    Smiths Medical ASD, Inc. is recalling specific arterial blood sampling syringes due to an issue with the plunger tip. The devices are sterile, single-use diagnostic tools used for drawing arterial blood.

    Product
    4042E: 3 mL Line Draw, Luer lock syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device (for sale in Europe only) Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices used for the drawing of arterial blood
    Category
    Medical Device
    Distribution
    40 states
  • HighFDA (Devices)·Z-1189-2014·2014-03-19

    Smiths Medical Recalls Arterial Blood Sampling Syringes Due to Plunger Tip Issue

    Smiths Medical ASD, Inc. is recalling Portex Arterial Blood Sampling Line Draw Syringes due to an issue with the plunger tip. The sterile, single-use devices are distributed worldwide.

    Product
    G1725: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device and 1 mL Line Draw Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device Arterial Blood Sampling Line Draw Syringes are sterile, single-use
    Category
    Medical Device
    Distribution
    40 states
  • HighFDA (Devices)·Z-1181-2014·2014-03-19

    Smiths Medical Recalls Arterial Blood Sampling Syringes Due to Plunger Tip Issue

    Smiths Medical ASD, Inc. is recalling specific arterial blood sampling syringes due to an issue with the plunger tip. The devices are used for in-vitro diagnostic blood sampling.

    Product
    4042-2: 3 mL Line Draw, Luer lock syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices used for the drawing of arterial blood via an arterial line. The
    Category
    Medical Device
    Distribution
    40 states
  • HighFDA (Devices)·Z-1188-2014·2014-03-19

    Smiths Medical Recalls Arterial Blood Sampling Syringes Due to Plunger Tip Issue

    Smiths Medical ASD, Inc. is recalling specific arterial blood sampling syringes due to a reported issue with the plunger tip. The devices are sterile, single-use, in-vitro diagnostic tools used for drawing arterial blood.

    Product
    G1469J: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device (for sale in Japan only) Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices used for the drawing of arterial blood
    Category
    Medical Device
    Distribution
    40 states
  • ModerateFDA (Devices)·Z-1184-2014·2014-03-19

    Smiths Medical Recalls Arterial Blood Sampling Line Draw Syringes

    Smiths Medical ASD, Inc. is recalling Portex Arterial Blood Sampling Line Draw Syringes due to an issue with the plunger tip.

    Product
    4043W-2: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device, syringe tip cap and 6 mL Luer slip syringe Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices used for the drawin
    Category
    Medical Device
    Distribution
    40 states
  • ModerateFDA (Devices)·Z-1191-2014·2014-03-19

    Smiths Medical Recalls Arterial Blood Sampling Syringes Due to Plunger Tip Issue

    Smiths Medical ASD, Inc. is recalling Portex Arterial Blood Sampling Line Draw Syringes due to an issue with the plunger tip.

    Product
    G1777: Umbilical (2) 3 mL Line Draw, Luer lock syringes (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ devices and (2) Needle-Pro¿ Devices with 22G x 1¿needles Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices
    Category
    Medical Device
    Distribution
    40 states
  • ModerateFDA (Devices)·Z-1180-2014·2014-03-19

    Smiths Medical Recalls Arterial Blood Sampling Syringes Due to Plunger Tip Issue

    Smiths Medical ASD, Inc. is recalling specific lots of Portex Arterial Blood Sampling Line Draw Syringes due to an issue with the plunger tip.

    Product
    4040-2: Umbilical 3 mL Line Draw, Luer lock syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device, 22g x 1¿ needle, and Point-Lok¿ needle safety device Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices u
    Category
    Medical Device
    Distribution
    40 states
  • ModerateFDA (Devices)·Z-1141-2014·2014-03-12

    KCI Recalls Prevena Incision Management System Due to Connector Difficulty

    KCI USA is recalling 20,850 units of the Prevena Incision Management System because the tubing connector is difficult to attach to the canister.

    Product
    PRE2001US: Prevena Incision Management Customizable System Box (US-ONLY) Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed envir
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1138-2014·2014-03-12

    KCI Recalls Prevena Dressing Kits Due to Connector Connection Difficulty

    KCI USA is recalling 20,850 Prevena Dressing kits because the tubing connector is difficult to connect to the canister.

    Product
    PRE1055US: Prevena Dressing, 5 Pack (US-ONLY) Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudate
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1135-2014·2014-03-12

    KCI Prevena Peel and Place System Kit Recalled for Connector Issues

    KCI USA is recalling Prevena Peel and Place System Kits because the male tubing connector is difficult to connect to the female canister connector.

    Product
    PRE1001: Prevena Peel and Place System Kit Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1136-2014·2014-03-12

    KCI USA Recalls Prevena Peel and Place System Kits

    KCI USA is recalling Prevena Peel and Place System Kits because the tubing connector is difficult to connect to the canister.

    Product
    PRE1001US: Prevena Peel and Place System Kit (US-ONLY) Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1139-2014·2014-03-12

    KCI Recalls Prevena Incision Management System Kits Due to Connector Issues

    KCI USA is recalling Prevena Incision Management System kits because the male tubing connector is difficult to attach to the female canister connector.

    Product
    PRE2001: Prevena Incision Management Customizable System Box Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and r
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1140-2014·2014-03-12

    KCI USA Recalls Prevena Customizable Dressing 5-Pack Due to Connector Issue

    KCI USA is recalling 20,850 units of the Prevena Customizable Dressing 5-Pack because the male connector on the tubing is difficult to connect to the female connector on the canister tubing.

    Product
    PRE2055: Prevena Customizable Dressing 5-Pack Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudate
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1137-2014·2014-03-12

    KCI Recalls Prevena Dressing Kits Due to Connector Connection Issues

    KCI USA is recalling 20,850 Prevena Dressing kits because the male tubing connector is difficult to connect to the female canister connector.

    Product
    PRE1055: Prevena Dressing, 5 Pack Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the ap
    Category
    Medical Device
    Distribution
    Distributed nationwide