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.

26–50 of 198

  • HighFDA (Devices)·Z-1409-2023·2023-04-26

    Spinal implant screws recalled due to defective titanium material

    Medtronic is recalling 45 units of INFINITY Multi-Axial Screws (lot H5802983) worldwide because incorrect titanium was used, reducing the screw head's gripping strength. No illnesses or injuries have been reported.

    Product
    INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 24mm, REF 3604024; for immobilization and stabilization of spinal segment as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical unction, the cervical spine
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1411-2023·2023-04-26

    Spinal Implant Screws Recalled for Defective Titanium Material

    Medtronic is recalling INFINITY spinal implant screws manufactured with incorrect titanium material. The defect reduces the screw's gripping strength, risking implant performance in critical spinal fusion surgery.

    Product
    INFINITY Occipitocervical Upper Thoracic System, PARTIALLY THREADED MULTI AXIAL SCREW, Size: 4.0mm x 22mm, REF 360PT4022; for immobilization and stabilization of spinal segment as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical unctio
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1412-2023·2023-04-26

    Spinal fixation screws recalled for reduced titanium gripping strength

    Medtronic is recalling 90 INFINITY Multi-Axial Screws (Lot H5806345) due to incorrect titanium material that reduces screw head gripping strength. The defect affects 5 batches distributed in the US and Canada.

    Product
    INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 26mm, REF 3604026; for immobilization and stabilization of spinal segment as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical unction, the cervical spine
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1370-2023·2023-04-19

    Inflatable Penile Prosthesis Recalled Due to Risk of Premature Pump Failure

    Coloplast is recalling Titan Touch Scro Zero Ang 20cm penile prostheses due to decreased wall thickness that could cause premature pump failure. Patients should contact their healthcare provider for guidance.

    Product
    Titan Touch Scro Zero Ang 20cm, Catalog Number ES29202400; inflatable penile Prosthesis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0984-2023·2023-01-25

    Cardinal Health Jackson-Pratt Channel Drains recalled for multiple performance defects

    Cardinal Health is recalling 2,277 Jackson-Pratt Channel Drains due to performance issues including lack of radiopacity, dull trocars, reduced flexibility, and broken tips. These defects may affect the drain's function and clinical performance.

    Product
    Cardinal Health Jackson-Pratt Channel Drain, 10 Fr, REF JP-2226
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0112-2023·2022-10-26

    Medicina Reusable Oral Syringe Recalled for Unapproved Plunger Material

    Medicina Uk Ltd is recalling Medicina Reusable Oral syringes because the plunger was manufactured with polyethylene instead of the required polypropylene material. The 11,100 affected syringes do not meet raw material specifications.

    Product
    Medicina Reusable Oral syringe 1ml Code: OTH01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0107-2023·2022-10-26

    Medicina ENFit enteral syringe recall due to material specification defect

    Medicina is recalling ENFit 1ml enteral syringes because the plunger was manufactured with polyethylene instead of approved polypropylene. This material defect could affect plunger function and device safety.

    Product
    Medicina ENFit 1ml Reusable Low Dose Enteral Syringe Code: LHE01LD
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0109-2023·2022-10-26

    Medicina Oral Tip Syringe Recall Due to Unapproved Plunger Material

    Medicina Uk Ltd is recalling 12,000 Oral Tip Syringes (Code: OT005) because the plunger component was manufactured with polyethylene instead of the approved polypropylene material. The syringes do not meet raw material specifications.

    Product
    Medicina Oral Tip Syringe 0.5ml Code: OT005
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0110-2023·2022-10-26

    Oral Tip Syringes Recalled Due to Unapproved Plunger Material

    Medicina Oral Tip Syringes are being recalled because the plunger component was made with polyethylene instead of the approved polypropylene material. No illnesses or injuries have been reported.

    Product
    Medicina Oral Tip Syringe 1ml Code: OT01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0114-2023·2022-10-26

    Medicina Reusable Oral Syringe recalled for incorrect plunger material

    Medicina Uk Ltd is recalling Medicina Reusable Oral Syringe 2.5ml units because plunger components were manufactured with polyethylene instead of the specified polypropylene material.

    Product
    Medicina Reusable Oral syringe 2.5ml Code: OTH25
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0245-2022·2021-11-24

    Ilizarov Wire Tensioner Recalled Due to Manufacturing Defect

    Medicalplastic S.R.L. is recalling Ilizarov Wire Tensioners (Model 71070341) due to an internal washer made of incorrect material. The washer could wear and break during autoclave sterilization, causing the tensioner to malfunction.

    Product
    Ilizarov Wire Tensioner, Model 71070341, UDI (10)08033201842072(10)21HP02550(11)210831(21E434
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2032-2021·2021-07-14

    Nonsterile Femoral Angiography Drapes Recalled Due to Sticking Plastic Film Defect

    Cardinal Health is recalling 26,250 units of Nonsterile Femoral Angiography Drapes due to a manufacturing defect causing the drapes to stick and preventing proper application. This may compromise surgical site protection.

    Product
    Nonsterile Femoral Angiography Drape with Single Pouch, Catalog Number 29525N - Product Usage: intended to be used as protective patient coverings, such as to isolate the site of a surgical incision from microbial and other contamination.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1148-2021·2021-03-03

    Northgate Recalls Steris CO2MPACT Endoscopic Insufflator Systems Due to Tubing Material Error

    Northgate Technologies is recalling 45 Steris CO2MPACT Endoscopic Insufflator systems because an internal tubing component was made with incorrect, untested material.

    Product
    Steris CO2MPACT Endoscopic Insufflator system, Catalog Number 72-00310-0 / 710300 - Product Usage: designed to use CO2 as a distention media in the gastrointestinal tract when used in conjunction with a gastrointestinal endoscope.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1147-2021·2021-03-03

    Northgate Recalls ConMed Abdominal Insufflators Due to Incorrect Tubing Material

    Northgate Technologies is recalling 25 ConMed 50L abdominal insufflators because an internal tubing component was made with untested material.

    Product
    ConMed 50L abdominal insufflator, Catalog Number 72-00258-0 / GS2000 - Product Usage: The device will maintain an expanded cavity (pneumoperitoneum) to allow the insertion of a variety of surgical instruments through the abdominal wall for visual examination of the interior or fo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0960-2021·2021-02-17

    Cook Medical Kwart Retro-Inject Ureteral Stent Set Recalled for Material Defect

    Cook Inc. is recalling 42 units of Kwart Retro-Inject Ureteral Stent Sets because they were manufactured with incorrect material, which may cause the stent to be stiffer and susceptible to degradation, breakage, or fragmentation.

    Product
    Cook Medical Kwart Retro-Inject Ureteral Stent Set 7.0Fr. 22-32cm -Used for retrograde injection during Extracorporeal Shock Wave Lithotripsy (E.S.W.L.) and leaving an indwelling ureteral stent Reference Part Number (RPN): 003700 GPN: G14837
    Category
    Medical Device
    Distribution
    6 states
  • SevereFDA (Devices)·Z-2854-2020·2020-09-02

    Globus Medical Recalls ALTERA Spacers with Incorrect Stainless Steel Components

    Globus Medical is recalling specific lots of ALTERA Spacers because internal components may have been manufactured using stainless steel instead of the specified cobalt chromium molybdenum alloy.

    Product
    ALTERA Spacer ALTERA Spacer, 10x26, 12-16mm, 8¿
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2858-2020·2020-09-02

    Globus Medical Recalls Specific Lots of ALTERA Spacers Due to Material Error

    Globus Medical is recalling specific lots of ALTERA Spacers because internal components may have been manufactured using stainless steel instead of the specified cobalt chromium molybdenum alloy.

    Product
    ALTERA Spacer ALTERA Spacer, 10x31, 8-12mm, 8¿
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2856-2020·2020-09-02

    Globus Medical Recalls ALTERA Spacers Due to Incorrect Material Composition

    Globus Medical is recalling specific lots of ALTERA Spacers because internal components may be made of stainless steel instead of the specified cobalt chromium molybdenum alloy.

    Product
    ALTERA Spacer ALTERA Spacer, 10x26, 10-14mm, 15¿
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2850-2020·2020-09-02

    FDA Recalls Specific Lots of ALTERA Spacer Implants Due to Material Error

    Globus Medical is recalling specific lots of ALTERA Spacer implants because internal components may have been manufactured using stainless steel instead of the specified cobalt chromium molybdenum alloy.

    Product
    ALTERA Spacer ALTERA Spacer, 10x31, 8-12mm, 8¿ (sterile)
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2869-2020·2020-09-02

    FDA Recalls Specific Lots of ALTERA Spacers Due to Material Defect

    Globus Medical is recalling specific lots of ALTERA Spacers because internal components may have been manufactured using stainless steel instead of the specified cobalt chromium molybdenum alloy.

    Product
    ALTERA Spacer ALTERA Spacer, 10x36, 9-13mm, 15¿
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2864-2020·2020-09-02

    Globus Medical Recalls Specific Lots of ALTERA Spacers Due to Material Error

    Globus Medical is recalling specific lots of ALTERA Spacers because internal components may have been manufactured using stainless steel instead of the specified cobalt chromium molybdenum alloy.

    Product
    ALTERA Spacer ALTERA Spacer, 10x31, 12-16mm, 15¿
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2862-2020·2020-09-02

    FDA Recalls Specific Lots of ALTERA Spacers Due to Material Defect

    Globus Medical is recalling specific lots of ALTERA Spacers because internal components may have been made with stainless steel instead of the specified cobalt chromium molybdenum alloy.

    Product
    ALTERA Spacer ALTERA Spacer, 10x31, 9-13mm, 15¿
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2857-2020·2020-09-02

    Globus Medical Recalls Specific Lots of ALTERA Spacers Due to Material Error

    Globus Medical is recalling specific lots of ALTERA Spacers because internal components may have been manufactured using stainless steel instead of the specified cobalt chromium molybdenum alloy.

    Product
    ALTERA Spacer ALTERA Spacer, 10x26, 12-16mm, 15¿
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2853-2020·2020-09-02

    Globus Medical Recalls Specific Lots of ALTERA Spacers Due to Material Error

    Globus Medical is recalling specific lots of ALTERA Spacers because internal components may have been manufactured using stainless steel instead of the specified cobalt chromium molybdenum alloy.

    Product
    ALTERA Spacer ALTERA Spacer, 10x26, 10-14mm, 8¿
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2863-2020·2020-09-02

    Globus Medical Recalls Specific Lots of ALTERA Spacers Due to Material Error

    Globus Medical is recalling specific lots of ALTERA Spacers because internal components may have been manufactured using stainless steel instead of the specified cobalt chromium molybdenum alloy.

    Product
    ALTERA Spacer ALTERA Spacer, 10x31, 10-14mm, 15¿
    Category
    Medical Device
    Distribution
    0 states