The Recall Desk

Hazard

Manufacturing Defect recalls

1,441 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
1,441
Critical
7
Severe
114
Most recent
2026-10-21

Of the 1,441 manufacturing defect recalls we have scored against our rubric, 7 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 114 (8%) 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 manufacturing 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.

1126–1150 of 1441

  • HighFDA (Devices)·Z-1363-2018·2018-04-18

    Orthofix Recalls Connector System Set Screws Due to Size Discrepancies

    Orthofix is voluntarily recalling specific lots of Connector System set screws because size discrepancies may prevent proper driver fit or cause stripping.

    Product
    ORTHOFIX, Connector System, SMALL SET SCREW, REF 79-2003
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1347-2018·2018-04-18

    ICU Medical Recalls Infusion Sets with Incorrect Spin Collars

    ICU Medical is recalling 7,600 sterile intravascular administration sets because they were manufactured with an incorrect spin collar. The sets were distributed in the US, Canada, and Japan.

    Product
    14 cm (5.5") Appx 0.27 ml, Smallbore Ext Set w/SURPLUG¿ Nano T-Connector, Clamp, Rotating Luer, 50 pouches per case, Item IR-NG31481B, Sterile, Rx. The firm name on the label is icumedical, San Clemente, CA. The Intravascular Administration Set is a single use, sterile…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1343-2018·2018-04-18

    ICU Medical Recalls Infusion Sets with Incorrect Spin Collars

    ICU Medical is recalling specific lots of sterile intravascular administration sets because they were manufactured with an incorrect spin collar.

    Product
    6.5" (17 cm) Appx. 0.57 ml, Trifuse Ext Set w/3 MicroClave¿ Clear, NanoClave¿ T-Connector, 4 Clamps, Rotating Luer, Item A1254, 50 pouches per case, Sterile, Rx. The firm name on the label is icumedical, San Clemente, CA. The Intravascular Administration Set is a single…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1342-2018·2018-04-18

    ICU Medical Recalls Smallbore Extension Sets with Incorrect Spin Collars

    ICU Medical is recalling 11,500 smallbore extension sets manufactured with incorrect spin collars. The affected units were distributed in the US, Canada, and Japan.

    Product
    6.5" (17 cm) Smallbore Ext Set w/Remv MicroClave¿ Clear, NanoClave¿ T-Connector, Clamp, Rotating Luer, Bulk Non-Sterile, 500 per case, Item A1009-NS, Rx. The firm name on the label is icumedical, San Clemente, CA. The Intravascular Administration Set is a single use…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1317-2018·2018-04-18

    Smith & Nephew Recalls D-RAD Self-Tapping Locking Screws

    Smith & Nephew is recalling D-RAD Self-Tapping Locking Screws because they were machined out of specification. The screws measured over tolerance within the head thread form.

    Product
    D-RAD Self-Tapping Locking Screw intended for the fixation of fractures involving the distal radius. smith&nephew D-RAD 2.4MM X 10MM S-T LOCKING SCREW, REF 74692410, QTY (1), STERILE R
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1345-2018·2018-04-18

    ICU Medical Recalls 7-inch Smallbore Infusion Sets with Incorrect Spin Collar

    ICU Medical is recalling 2,950 sterile 7-inch smallbore infusion sets because they were manufactured with an incorrect spin collar. The affected lots were distributed in the US, Canada, and Japan.

    Product
    7" Smallbore Ext Set w/MicroClave¿, Clave¿ T-Connector, Clamp, Rotating Luer, 50 pouches per case, Item B9900-629, Sterile, Rx. The firm name on the label is icumedical, San Clemente, CA. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1346-2018·2018-04-18

    ICU Medical Recalls Smallbore Extension Sets Due to Incorrect Spin Collar

    ICU Medical is recalling 100 pouches of 5-inch Smallbore Extension Sets because they were manufactured with an incorrect spin collar.

    Product
    5" (13 cm) Smallbore Ext Set w/MicroClave¿, Clave¿ T-Connector, Clamp, Rotating Luer, 50 pouches per case, Item B99066, Sterile, Rx. The firm name on the label is icumedical, San Clemente, CA. The Intravascular Administration Set is a single use, sterile, non-pyrogenic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1012-2018·2018-03-21

    DePuy Global Unite Shoulder System Recall Due to Inverted Screw Assembly

    DePuy Orthopaedics is recalling 85 units of the Global Unite Platform Shoulder System because an inverted screw may cause the humeral stem to sit proud, potentially delaying surgery.

    Product
    The GLOBAL UNITE Platform Shoulder System is intended for cemented or uncemented total shoulder or hemi-shoulder replacement procedures, Product labeling: LE¿O-1100-30-000 REV D.pdf.pdf, LE¿O-1100-40-000 REV D.pdf.pdf, LE¿O-110030100_REV D.pdf.pdf, LE¿O-110030110_REV D.pdf.pdf…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0892-2018·2018-03-14

    Bausch & Lomb Recalls LaserEdge Ophthalmic Knives Due to Dull Blade Complaints

    Bausch & Lomb Inc Irb is voluntarily recalling LASEREDGE Knives intended for ophthalmic surgery because of an atypical volume of complaints regarding dull blades.

    Product
    LASEREDGE Knives, 2.0MMX2.2MM TRAPEZOID ANGLED GUARDED (6/BOX), REF/PRODUCT CODE E7601G, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and they are available to surgeons for use in procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0831-2018·2018-03-07

    Cook Percutaneous Gastrojejunostomy Set Recalled for Backwards Wire Guides

    Cook Inc. is recalling Percutaneous Gastrojejunostomy Sets because wire guides may be loaded backwards into the holder.

    Product
    Percutaneous Gastrojejunostomy Set Product Usage: Intended for the percutaneous placement of a catheter for gastroenteric feeding
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0566-2018·2018-02-21

    Medtronic Recalls Two Angled Drills Due to Tip Extension Discrepancy

    Medtronic is recalling two units of the ANGLED DRILL (REF 6630902) because the drill tip extension is longer than the printed specification indicates.

    Product
    Medtronic ANGLED DRILL, REF 6630902, QTY: 1 EA Rx only
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0481-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a manufacturing rework error may have displaced internal components, potentially preventing proper assembly.

    Product
    Affixus Hip Fracture Nail, RH 130 DEG 9MM X 380MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0475-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a manufacturing rework process may have displaced internal components, potentially preventing proper assembly.

    Product
    Affixus Hip Fracture Nail, RH 130 DEG 13MM X 460MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0422-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a manufacturing rework error may have displaced internal components, potentially preventing proper assembly.

    Product
    Affixus Hip Fracture Nail, 130 DEG 11MM X 180MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0444-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Assembly Defect

    Zimmer Biomet is recalling 638 units of Affixus Hip Fracture Nails because a manufacturing defect may prevent proper assembly of the device.

    Product
    Affixus Hip Fracture Nail, LH 130 DEG 9MM X 340MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0471-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Assembly Defect

    Zimmer Biomet is recalling 638 units of the Affixus Hip Fracture Nail because a manufacturing rework process caused set screws and sleeves to shift, potentially preventing proper assembly.

    Product
    Affixus Hip Fracture Nail, RH 130 DEG 11MM X 440MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0457-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a manufacturing defect may prevent proper assembly of the device.

    Product
    Affixus Hip Fracture Nail, RH 125 DEG 9MM X 360MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0450-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a manufacturing rework error may have displaced internal components, potentially preventing proper assembly.

    Product
    Affixus Hip Fracture Nail, RH 125 DEG 11MM X 440MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0344-2018·2018-01-31

    Vyaire Medical Recalls Infant AirLife Humidification Chamber Due to Overflow Risk

    Vyaire Medical is recalling 16,670 Infant AirLife humidification chambers because a manufacturing error may cause water to overflow into the patient's airway.

    Product
    Infant AirLife Dual-,limb, dual-heat, high-flow circuit (Model AH265) with AirLife Humidification Chamber, Model Number AH290. The AH290 Humidification Chamber and Heated Breathing Circuit Kit(s) operate as part of a system for delivering health and humidified respirator…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0320-2018·2018-01-17

    Brainlab DrapeLink Adapter Recall Due to Manufacturing Error

    Brainlab AG is recalling DrapeLink Adapters because a supplier error caused some units to not meet specifications.

    Product
    Brainlab Navigation System Spine & Trauma 3D with component Brainlab DrapeLink Registration Kit for C-arm Zeihm Vision RFD: Adapter Left
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0279-2018·2017-12-27

    Zimmer Dental GemLock Hex Driver Recalled for Manufacturing Defect

    Zimmer Dental Inc. is recalling 356 GemLock RHD2.5 Hex Drivers because a manufacturing defect may prevent the tool from properly engaging dental fixtures.

    Product
    Zimmer Dental GemLock RHD2.5 Hex Driver. The label shows the product is Manufactured by Zimmer Dental Inc., Carlsbad, CA. Endosseous dental implant accessories are manually powered devices intended to aid in the placement or removal of endosseous dental implants and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0280-2018·2017-12-27

    Zimmer Dental Surgical Kits Recalled for Manufacturing Defect

    Zimmer Dental Inc. is recalling 30 surgical kits because a manufacturing defect may prevent the driver from properly engaging dental implants.

    Product
    Zimmer Dental Tapered SwissPlus & SwissPlus Implant Systems surgical kit, Ref OPCST. The label shows the product is Manufactured by Zimmer Dental Inc., Carlsbad, CA. Endosseous dental implant accessories are manually powered devices intended to aid in the placement or…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0282-2018·2017-12-27

    Zimmer Dental Tapered Screw-Vent Implant Surgical Kits Recalled for Geometry Defect

    Zimmer Dental Inc. is recalling 891 Tapered Screw-Vent Implant System surgical kits because a manufacturing defect in the driver's hex feature may prevent proper engagement with dental implants.

    Product
    Zimmer Dental Instrument Kit System, Tapered Screw-Vent Implant System surgical kit, Complete, Ref TSVKIT. The label shows the product is Manufactured by Zimmer Dental Inc., Carlsbad, CA. Endosseous dental implant accessories are manually powered devices intended to aid in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0281-2018·2017-12-27

    Zimmer Dental Implant Surgical Kits Recalled for Manufacturing Defect

    Zimmer Dental Inc. is recalling 166 surgical kits because a manufacturing defect may prevent the driver from properly engaging dental implants.

    Product
    Zimmer Dental Instrument Kit System, Tapered Screw-Vent Implant System surgical kit, starter, Ref STRKIT. The label shows the product is Manufactured by Zimmer Dental Inc., Carlsbad, CA. Endosseous dental implant accessories are manually powered devices intended to aid in…
    Category
    Medical Device
    Distribution
    Distributed nationwide