The Recall Desk

Hazard

Manufacturing Defect recalls

1,434 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
1,434
Critical
7
Severe
107
Most recent
2026-09-09

Of the 1,434 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 107 (7%) 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.

1051–1075 of 1434

  • ModerateFDA (Drugs)·D-1741-2019·2019-08-21

    US Pharmaceuticals Recalls CRYO-273 Cold Pain Gel Due to Water Quality Issues

    US Pharmaceuticals is recalling CRYO-273 Cold Pain Relieving Gel because the purified water used in manufacturing failed quality tests for microbial count or organic carbon.

    Product
    CRYO-273 Cold Pain Relieving Gel 128 FL. OZ. Distributed By: CRYO-273.com Tampa, FL 33629. UPC 8 15290 01550 2
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2286-2019·2019-08-21

    Luminex ARIES Group A Strep Assay Recalled for Seal Defects

    Luminex is recalling ARIES Group A Strep Assay kits because side cassette seals may not meet specifications, potentially affecting test sensitivity and stability.

    Product
    ARIES Group A Strep Assay , REF 50-10041, UDI # 00840487101469
    Category
    Medical Device
    Distribution
    34 states
  • ModerateFDA (Drugs)·D-1737-2019·2019-08-21

    US Pharmaceuticals Recalls CRYO-273 Cold Pain Gel Due to Water Quality Issues

    US Pharmaceuticals is recalling CRYO-273 Cold Pain Relieving Gel Roll-On because the purified water used in manufacturing failed quality tests for microbial count or organic carbon.

    Product
    CRYO-273 Cold Pain Relieving Gel Roll-On 3 FL. OZ. (89 mL) Distributed By: CRYO-273.com Tampa, FL 33629. UPC 8 15290 01529 6
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1730-2019·2019-08-21

    US Pharmaceuticals Recalls Adult Glycerin Suppositories for Water Quality Issues

    US Pharmaceuticals is recalling 880 cases of Adult Glycerin Suppositories because purified water used in manufacturing failed quality tests for microbial count or organic carbon.

    Product
    Adult Glycerin Suppositories, Package Size 100-count suppositories, Distributed By: Walgreen Co. 200 Wilmot Rd. Deerfield, IL 60015. NDC#0363-0441-00
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1726-2019·2019-08-21

    US Pharmaceuticals Recalls CVS Therapeutic Menthol Gel Due to Water Quality Issues

    US Pharmaceuticals is recalling CVS Therapeutic Menthol Gel because the purified water used in manufacturing failed quality tests for microbial count or organic carbon.

    Product
    CVS Therapeutic Menthol Gel, 8 FL OZ (227 g) Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895. UPC 0 50428 48136 3
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2142-2019·2019-08-14

    Biomet 3i Recalls Certain Bellatek Titanium Abutments Due to Manufacturing Defect

    Biomet 3i is recalling 6 units of Certain Bellatek Titanium Abutments because a manufacturing defect causes the screw head to seat too deep without a positive stop.

    Product
    CERTAIN(R) BELLATEK(R) TITANIUM ABUTMENT 3.4MM, Item Number IIAT3 - Product Usage: BIOMET3i Restorative products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2138-2019·2019-08-14

    MED-EL PULSARci100 Cochlear Implant Recalled for Leak Test Failures

    MED-EL is recalling PULSARci100 Cochlear Implants because they failed helium-fine leak tests. Affected devices were distributed in the US and several international countries.

    Product
    MED EL Cochlear Implant System, PULSARci100 Standard - Product Usage: The PULSARci100 Implant is an implantable part of the MED EL Cochlear Implant System and can only be used together with compatible MED EL external components. The MED EL Cochlear Implant System is intended to e
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2143-2019·2019-08-14

    Biomet 3i Recalls Certain Bellatek Tin Abutments Due to Manufacturing Defect

    Biomet 3i is recalling 2 units of Bellatek Tin Abutments because a manufacturing defect causes the screw head to seat too deep without a positive stop.

    Product
    CERTAIN(R) BELLATEK(R) TIN ABUTMENT 3.4MM, Item Number ILDAN3 - Product Usage: BIOMET3i Restorative products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2144-2019·2019-08-14

    Biomet 3i Recalls Titanium Abutments Due to Manufacturing Defect

    Biomet 3i is recalling 49 units of Certain Bellatek Titanium Abutments because a manufacturing defect prevents the screw from seating correctly.

    Product
    CERTAIN(R) BELLATEK(R) TITANIUM ABUTMENT 3.4MM, Item Number ILDAT3 - Product Usage:BIOMET3i Restorative products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2208-2019·2019-08-14

    Abbott Recalls Alinity i Ferritin Reagent Kits Due to Manufacturing Defect

    Abbott Ireland Diagnostics Division is recalling 216 units of Alinity i Ferritin Reagent Kits due to a manufacturing issue that may cause bottle neck damage and instrument failure.

    Product
    Alinity i Ferritin Reagent Kit, List Number 07P6530 The Alinity i Ferritin assay is a chemiluminescent microparticle immunoassay (CMIA) used for the quantitative determination of ferritin in human serum and plasma on the Alinity i analyzer.
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-2141-2019·2019-08-14

    Biomet 3i Recalls Titanium Dental Abutments Due to Manufacturing Defect

    Biomet 3i is recalling 17 units of Certain Bellatek Titanium Abutments because a manufacturing defect prevents the screw from seating correctly.

    Product
    CERTAIN(R) BELLATEK(R) TITANIUM ABUTMENT 3.4MM, Item Number IEDAT3 - Product Usage: BIOMET3i Restorative products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2160-2019·2019-08-14

    Howmedica Serrato Polyaxial Screws Recalled for Incorrect Length

    Howmedica Osteonics Corp. is recalling 11 Serrato polyaxial screws because some 90mm and 100mm units were manufactured with the wrong length.

    Product
    Serrato 9.5mm X 90mm Polyaxial Screw Catalog Number 482619590 Serrato 9.5mm X 100mm Polyaxial Screw Catalog Number 4826195100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2036-2019·2019-07-31

    Cardinal Health Recalls Monoject Hypodermic Needles Due to Sterility Defect

    Cardinal Health is recalling specific lots of Monoject Standard Hypodermic Needles because a manufacturing defect in the cartridge component could compromise the product's sterility barrier.

    Product
    Monoject Standard Hypodermic Needle, 14 G x 1-1/2" Item code: 8881200011
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1502-2019·2019-07-31

    Pharma-Natural Recalls Lid O Creme Due to Manufacturing Violations

    Pharma-Natural Inc. is recalling Lid O Creme topical analgesic cream because it was manufactured with current good manufacturing practice violations, including lack of process validation.

    Product
    Lid O Creme (Lidocaine HCL 4% and Menthol 1%) Topical Analgesic Cream, 2.5 Oz (71 g) roll on bottle, Manufactured & Distributed by: Pharma Natural, Inc. Hialeah, FL 33016, NDC 63788-111-25.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1724-2019·2019-06-12

    Cook Inc. Recalls Pericardiocentesis Catheter Trays Due to Small Distal Hole

    Cook Inc. is recalling two Pericardiocentesis Catheter Trays because the catheter distal end hole may be too small. The affected units were distributed domestically and internationally.

    Product
    Pericardiocentesis Catheter Tray, RPN C-PCSY-850-LHSC-061096, Order # G10030
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1740-2019·2019-06-12

    Zimmer Biomet Recalls Oxford Partial Knee Drill Guides Due to Corrosion Risk

    Zimmer Biomet is recalling 14 units of Oxford Partial Knee Phase 3 Femoral Drill Guides because incorrect raw materials were used, potentially leading to corrosion.

    Product
    Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide: Item Number: 32-421060 Phase 3 Femoral Drill Guide Extra Small
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-1218-2019·2019-05-01

    Jelco ViaValve Safety Intravenous Catheters Recalled for Manufacturing Defect

    Smiths Medical ASD Inc. is recalling specific lots of Jelco ViaValve safety intravenous catheters due to a V-shaped puncture at the base of the catheter.

    Product
    Jelco(R) ViaValve(TM) safety intravenous (I.V.) catheters, 18G x 1 1/4", Model Number REF 3265, MOD 10 The Jelco(R) ViaValve(TM) safety I.V. catheter is a sterile, non pyrogenic, single use, radiopaque intravascular catheter device used for the administration of medically pre
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1130-2019·2019-04-17

    Philips Recalls Two Azurion FlexArm Units Due to Cable Damage

    Philips is recalling two Azurion FlexArm units because a manufacturing error caused damage to the 24V power cable of the detector.

    Product
    Azurion FlexArm, 722079
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0867-2019·2019-03-06

    Zimmer Biomet Recalls Vitality Spinal Fixation Set Screws

    Zimmer Biomet Spine Inc. is recalling Vitality Shear-off Set Screws because they do not thread properly with mating components due to a manufacturing issue.

    Product
    Vitality¿ Spinal Fixation System. Spinal Interlaminal, Appliance, Fixation, (non-sterile). Pedicle screw fixation is indicated for skeletally mature patients and for adolescent patients. For use in Orthopedic medical specialty area. Product Usage: The Vitality Shear-off Set Scre
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0866-2019·2019-03-06

    Zimmer Biomet Recalls Vitality Spinal Fixation Set Screws

    Zimmer Biomet is recalling Vitality Shear-off Set Screws because they do not thread properly with mating components due to a manufacturing issue.

    Product
    Vitality¿ Spinal Fixation System. Thoracolumbosacral pedicle screw system (non-sterile). Pedicle screw fixation is indicated for skeletally mature patients and for adolescent patients. For use in Orthopedic medical specialty area. Product Usage: The Vitality Shear-off Set Screw i
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0488-2019·2019-02-20

    Valeant Recalls Cardizem CD Capsules for Dissolution Failures

    Valeant Pharmaceuticals is recalling 206 bottles of Cardizem CD capsules because they failed to meet dissolution specifications, meaning the drug may not release properly.

    Product
    CARDIZEM CD — CARDIZEM CD (DILTIAZEM HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0818-2019·2019-02-13

    Bone Marrow Biopsy Needle Recall Due to Sterile Seal Manufacturing Issue

    Angiotech is recalling 1,404 Bone Marrow Biopsy Needles due to a manufacturing defect in the sterile seal on blister trays.

    Product
    Aguja de Aspiracion con Profundidad Ajustable Tipo I 16ga x 5 cm- Product Usage: Manual surgical instruments for Bone Marrow Biopsy and Aspiration.
    Category
    Medical Device
    Distribution
    Distributed nationwide