The Recall Desk

Hazard

Material Defect recalls

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

What the numbers show

Total
198
Critical
1
Severe
10
Most recent
2026-08-26

Of the 198 material defect recalls we have scored against our rubric, 1 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 10 (5%) 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 material 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.

176–198 of 198

  • ModerateFDA (Devices)·Z-1842-2014·2014-07-02

    Zimmer Recalls VerSys Hip Stems Due to Material Inspection Failures

    Zimmer, Inc. is recalling 147 VerSys Hip System stems because supplier forgings failed routine material inspections.

    Product
    VerSys¿ Hip System, Beaded Fullcoat Stems, Zimmer, Inc., Warsaw, IN 46581
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1781-2014·2014-06-18

    Synthes Mandible Plate Cutter Recalled for Potential Corrosion

    Synthes, Inc. is recalling 14 units of the Matrix Mandible Short Cut Plate Cutter due to potential discoloration and corroded material on the tool's face.

    Product
    Synthes Matrix Mandible Short Cut Plate Cutter Synthes Matrix Mandible Short Cut Plate Cutter is intended for oral, maxillofacial surgery.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-1516-2014·2014-05-07

    Acumed Recalls Tension Band Pins Due to Steel Specification Defect

    Acumed LLC is recalling specific lots of Tension Band Pins because they were manufactured with stainless steel that does not meet specifications.

    Product
    The Acumed Tension Band Pin is a fixation pin which is .0625" in diameter and is available in lengths between 35mm and 90mm. It is to be used in conjunction with commonly used orthopedic wire. 50.0 mm Tension Band Pin; Part Number 30-0097 70.0 mm Tension Band Pin; Part Num
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1515-2014·2014-05-07

    Acumed Osteo-Clage System Recalled for Non-Specification Stainless Steel

    Acumed LLC is recalling the Osteo-Clage System because the stainless steel used in manufacturing was not within specifications.

    Product
    The Osteo-Clage System consists of stainless steel cable/sleeves and compression plates. . 2.0 mm x 850mm SS Cable/Sleeve; Part Number 01-0020-S 2.0 mm SS Sleeve Only; Part Number 01-0022-S 8, 7 hole, SS compression plate; Part Number 02-2007-S 10, 9 hole, SS compression p
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1217-2014·2014-03-26

    Exactech Recalls Gibralt Spine System Polyaxial Screws Due to Material Error

    Exactech is recalling 242 Gibralt Spine System Polyaxial Screws because they contain springs made of type-304 stainless steel instead of the specified titanium alloy.

    Product
    Gibralt Spine System Polyaxial Screw Intended to promote fusion of the cervical spine, and the thoracic spine, (C3-T3), the Gibralt Spinal System is indicated for the following: DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiogra
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-1262-2014·2014-03-26

    Zimmer Recalls Natural-Knee II Poly Ultra Tibia Components Due to Discoloration

    Zimmer, Inc. is recalling 3,638 Natural-Knee II Poly Ultra Tibia components worldwide due to discoloration caused by premature oxidation during storage.

    Product
    Natural-Knee¿ II System: POLY ULTRA TIB LT SZ00/9M POLY ULTRA TIB LT SZ0/9MM POLY ULTRA TIB LT SZ0/19M POLY ULTRA TIB RT SZ0/13M POLY ULTRA TIB RT SZ0/16M ALL POLY ULTRA TIB LT SZ1 ALL POLY ULTRA TIB RT SZ1 ALL POLY ULTRA TIB LT SZ2 ALL POLY ULTRA TIB LT SZ2 ALL POLY UL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1248-2014·2014-03-26

    Zimmer Recalls Natural-Knee Flex System Components Due to Discoloration

    Zimmer, Inc. is recalling 3,638 units of the Natural-Knee Flex System due to discoloration caused by premature oxidation during storage.

    Product
    Gender Solutions" Natural-Knee¿ Flex System: N-K FLEX MBACK SZ 0 PAT N-K FLEX MBACK SZ 1 PAT N-K FLEX MBACK SZ 2 PAT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1051-2014·2014-03-05

    Medline Recalls Angiography Surgical Kits Due to Guidewire Coating Defect

    Medline Industries is recalling 120 surgical kits containing guidewires with a potential coating flaking defect.

    Product
    CATH PACK; REF: DYNJ41103; Packaged in Mexico by: Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform angiography medical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1062-2014·2014-02-26

    Bausch & Lomb Recalls AKREOS AO Micro Incision Lenses Due to Material Error

    Bausch & Lomb is recalling 336 AKREOS AO Micro Incision Lenses because they were manufactured with incorrect raw material. The lenses are intended for cataract surgery.

    Product
    Bausch & Lomb AKREOS AO Micro Incision Lens The Akreos IOL intended for primary implantation in the capsular bag of the eye for the visual correction of aphakia secondary to the removal of a cataractous lens in adult patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0526-2014·2013-12-25

    Karl Storz Recalls Flexible Intubation Fiberscopes Due to Material Issue

    Karl Storz Endoscopy America is recalling specific flexible intubation fiberscopes because the suction channel material is incompatible with STERRAD sterilization systems.

    Product
    Intubation Flexible Fiberscope, Models: 11301AA1, 11301BN1, 11302BD1, 11302BD2, 11304BC1, 11340BC1, 11301BND1, 11302BDD1, and 11302BDD2. " Transoral intubation " Transnasal intubation " Evaluation of placement of endotracheal and double lumen endotracheal tubes " Provide visua
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0393-2014·2013-12-04

    Synthes Material Mix Surgical Instruments Recalled Due to Material Error

    Synthes USA is recalling approximately 44 surgical instruments because a material batch was mixed with an incorrect material having lower hardness and corrosion resistance.

    Product
    Synthes Material Mix (Adjustable Cervical Distractor-Right, Matrix Distractor Rack, T-PAL Spacer Remover, Implant Inserter) Synthes Material Mix: Adjustable Cervical Distractor-Right is used to distract spine segment. Matrix Distractor Rack is used to distract the interbody di
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2187-2013·2013-09-18

    Spine Wave Recalls Lumbar Intervertebral Fusion Implants Due to Material Error

    Spine Wave, Inc. is recalling 17 units of the StaXx IB Convex Expandable Implant because the superior endplate was manufactured from a different polymer than specified.

    Product
    StaXx¿ IB Convex Expandable Implant (25 x 12 x 9 mm), Intervertebral Fusion Device, Lumbar; Catalog Number 11 -1902. Indicated for intervertebral body fusion procedures in skeletally mature patients.
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Devices)·Z-1693-2013·2013-07-17

    Fresenius Hemodialysis Machine O-Rings Recalled for Incorrect Material

    Fresenius Medical Care is recalling 725 replacement O-rings for hemodialysis machines because they were made of nitrile rubber instead of the required EPDM material.

    Product
    Fresenius Service Replacement 0-Ring. Used in as a service part in 4 sub-assemblies manufactured and/or refurbished Fresenius hemodialysis machines, models 2008K, 2008K2, 2008K@Home and 2008T
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1664-2013·2013-07-10

    SpineFrontier Recalls S-LIFT Instrument Cases Due to Peeling Coating

    SpineFrontier, Inc. is recalling 12 S-LIFT Instrument Cases because a bracket has a peeling nylon coating. The cases are used to hold surgical instruments for spinal fusion.

    Product
    BASE, S-LIFT Instrument Case Product Usage: System cases are designed to hold and secure all instrumentation to be used with a surgical system. Case and caddy components are used to contain implants intended for intervertebral body fusion and fixation of the spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1347-2013·2013-05-29

    Unimed Recalls Laparoscopic Electrode Hooks Due to Coating Material Changes

    Unimed Surgical Products is recalling 120,416 laparoscopic electrode hooks due to changes in PTFE coating materials. The devices were distributed in Missouri, Tennessee, and Pennsylvania.

    Product
    PROGRESSIVE MEDICAL Laparoscopic Electrode PTFE Coated L Hook 33cm. Intended for the cutting of soft tissue and coagulation.
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1247-2013·2013-05-15

    Spinal Elements Recalls Mercury Spinal System Rods Due to Raw Material Issue

    Spinal Elements, Inc. is recalling 68 units of Mercury Spinal System lordosed rods due to a raw material issue. The affected units were distributed in Ohio and Pennsylvania.

    Product
    Mercury Spinal System DIA 5.5 x 40 MM Lordosed Rod, Part Number: 60100-040. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
    Category
    Medical Device
    Distribution
    2 states
  • LowFDA (Devices)·Z-1266-2013·2013-05-15

    Spinal Elements Recalls Mercury Spinal System Rods Due to Raw Material Issue

    Spinal Elements, Inc. is recalling 68 units of the Mercury Spinal System straight rod due to a raw material issue. The affected units were distributed in Ohio and Pennsylvania.

    Product
    Mercury Spinal System DIA 5.5 x 400mm Straight Rod, Part Number: 60101-400. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
    Category
    Medical Device
    Distribution
    2 states
  • LowFDA (Devices)·Z-1258-2013·2013-05-15

    Spinal Elements Recalls Mercury Spinal System Straight Rods

    Spinal Elements is recalling 68 units of the Mercury Spinal System straight rod due to a raw material issue. The devices were distributed in Ohio and Pennsylvania.

    Product
    Mercury Spinal System DIA 5.5 x 50mm Straight Rod, Part Number: 60101-050. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
    Category
    Medical Device
    Distribution
    2 states
  • LowFDA (Devices)·Z-1265-2013·2013-05-15

    Spinal Elements Recalls Mercury Spinal System Rods Due to Raw Material Issue

    Spinal Elements is recalling 68 units of the Mercury Spinal System straight rod due to a raw material issue. The affected devices were distributed in Ohio and Pennsylvania.

    Product
    Mercury Spinal System DIA 5.5 x 120mm Straight Rod, Part Number: 60101-120. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1192-2013·2013-05-08

    Owens & Minor Recalls MediChoice OB/GYN Applicators Due to Rayon Defect

    Owens & Minor is withdrawing MediChoice OB/GYN applicators because the rayon tip may loosen or unravel during use.

    Product
    MediChoice¿ Rayon Tipped OB/GYN Applicator, 8 inch, Plastic Shaft, Non-Sterile, Item Numbers WOD5001 and WOD5002. Product Usage: Usage: An absorbent tipped applicator is a device intended for medical purposes that consists of an absorbent swab on a wooden, paper, or plastic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0536-2013·2012-12-26

    Biomet Polaris 5.5 Button Lock Screw Inserter Recalled for Hardness Defect

    Ebi, LLC is recalling 15 units of Biomet Polaris 5.5 Button Lock Screw Inserters because the hardness of broken units was found to be below acceptable limits.

    Product
    Biomet Polaris 5.5 Button Lock Screw Inserter. Catalog number 14-500178
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0462-2013·2012-12-12

    Terumo Recalls Sarns Aortic Cannulas Due to Plastic Flash Defect

    Terumo is recalling Sarns Aortic Cannulas because plastic flash at the tip may detach and harm patients during surgery.

    Product
    24 Fr 8mm Soft Flow Ang W/L The Sarns Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.
    Category
    Medical Device
    Distribution
    27 states
  • HighFDA (Devices)·Z-2017-2012·2012-07-25

    Kimberly-Clark Recalls MicroCool Surgical Gowns Due to Material Defects

    Kimberly-Clark is recalling specific lots of MicroCool surgical gowns because they pill, lint, or allow blood strikethrough, potentially compromising sterility.

    Product
    MicroCool Breathable Impervious Surgical Gown, (Large and X-Large), Sterile, Made in Honduras. The Kimberly Clark Micro COOL Surgical Gowns are sterile single use surgical apparel intended to be worn by heathcare professionals to help protect the patient and the healthcare wor
    Category
    Medical Device
    Distribution
    Distributed nationwide