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.

451–475 of 1441

  • HighFDA (Devices)·Z-2067-2023·2023-07-12

    LinkSymphoKnee Knee Augment Recalled for Incorrect Screw Orientation

    Waldemar Link GmbH & Co. KG recalled LinkSymphoKnee Distal Femoral Augments due to incorrect screw orientation during manufacturing. The fixation screw may be inserted through the wrong side of the augment, affecting 20 units distributed across seven US states.

    Product
    LinkSymphoKnee Distal Femoral Augment - Tilastan - Size. 7-8, Lateral-Right/Medial-Left, 5mm-Intended for primary and revision total knee replacement in skeletally mature patients. Product Code: 880-307/21
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2105-2023·2023-07-12

    Stryker Infinity Alignment Frame Distal Sub-Assembly Recalled for Manufacturing Defect

    Wright Medical Technology is recalling the Stryker Infinity Alignment Frame Distal Sub-Assembly due to manufacturing defects that prevent proper assembly. The pin sleeve holes were manufactured too narrow, preventing insertion of pin sleeves and proper device configuration.

    Product
    Stryker Infinity Alignment Frame Distal Sub-Assembly, Catalog #33600020, non-sterile.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2066-2023·2023-07-12

    LinkSymphoKnee Distal Femoral Augment Recalled for Improper Screw Placement

    The LinkSymphoKnee Distal Femoral Augment is being recalled because fixation screws were inserted in the wrong direction during manufacturing. The improper placement could affect the implant's structural stability.

    Product
    LinkSymphoKnee Distal Femoral Augment - Tilastan - Size 7-8, Medial-Right/Lateral Left, 5mm- Intended for primary and revision total knee replacement in skeletally mature patients. Product Code: 880-307/11
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0888-2023·2023-07-05

    FDA Recalls StellaLife VEGA Oral Care Spray for Manufacturing Practice Violations

    The FDA is recalling StellaLife VEGA Oral Care Spray due to current Good Manufacturing Practice (cGMP) deviations. The product was distributed nationwide.

    Product
    StellaLife VEGA Oral Care Spray, 1 fl oz (30 ml) bottles, Distributed by: StellaLife, Inc., Aventura, FL NDC 69685-101-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2010-2023·2023-07-05

    Limacorporate Prima TT Orthopedic Baseplate Recalled for Manufacturing Defect

    Limacorporate is recalling 13 units of the Prima TT Genoid Modular Reverse TT Baseplate due to a manufacturing issue that may cause peripheral holes to be out of specification. Healthcare facilities should contact the manufacturer.

    Product
    REF 1975.14.800, Prima TT Genoid Modular Reverse TT Baseplate, Sterile R
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2048-2023·2023-07-05

    Knee prosthesis femoral segment recalled for specification non-compliance

    Waldemar Link is recalling 16 units of a knee prosthesis femoral segment due to specification non-compliance discovered through customer complaints. Patients and healthcare facilities should contact the manufacturer for guidance.

    Product
    LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 4, Right
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-2009-2023·2023-07-05

    Orthopedic Baseplate Recall: Manufacturing Defect in Peripheral Holes

    Limacorporate is recalling Prima TT Genoid Monoblock Reverse TT Baseplates due to a manufacturing issue that may result in peripheral holes being out of specification.

    Product
    REF 1975.14.500, Prima TT Genoid Monoblock Reverse TT Baseplate, STERILE R
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0885-2023·2023-07-05

    Drug Recall: SnoreStop Naso Spray Bulk for cGMP Manufacturing Deviations

    Homeocare Laboratories is recalling SnoreStop Naso Spray Bulk due to current Good Manufacturing Practice (cGMP) deviations. This voluntary recall affects product distributed nationwide in 55-gallon drums.

    Product
    SnoreStop Naso Spray Bulk, liquid, Distributed by Green Pharma, NDC 61152-199-99
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0887-2023·2023-07-05

    OTC Oral Care Rinse Recalled for Manufacturing Process Deviations

    StellaLife VEGA Oral Care Rinse (Coconut, Lot #2396) was recalled due to manufacturing process deviations. About 16,587 bottles were distributed nationwide.

    Product
    STELLALIFE VEGA ORAL CARE COCONUT — STELLALIFE VEGA ORAL CARE COCONUT (RISNE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0890-2023·2023-07-05

    Drug Oral Care Spray Recalled for Manufacturing Practice Deviations

    StellaLife VEGA Oral Care Spray is being recalled for manufacturing deviations. The product was distributed nationwide; consumers should discontinue use of affected lots.

    Product
    STELLALIFE VEGA ORAL CARE — STELLALIFE VEGA ORAL CARE (SPRAY)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0881-2023·2023-07-05

    Drug: Arnica 7 Cream Recalled for Manufacturing Standards Deviations

    Homeocare Laboratories is recalling Arnica 7 Cream due to manufacturing standards deviations. The recall affects 2,376 bottles with lot number 2446.

    Product
    Arnica 7 Cream, net wt 2 oz (56.7g), Manufactured for: Brazmedics, LLC, New York, NY 10021 UPC 8 60208 00181 6
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1728-2023·2023-06-28

    Implantable Defibrillators Recalled for Potential Therapy Delivery Failure

    Medtronic is recalling certain ICD and CRT-D devices that may fail to deliver high-voltage therapy due to a manufacturing defect in the device feedthrough. The recall affects 2,018 units distributed nationwide and worldwide.

    Product
    ICD CROME DR MRI IS1 DF4, Model Number DDPC3D4; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1789-2023·2023-06-28

    Implantable Cardioverter Defibrillators May Fail to Deliver Therapy

    Medtronic implantable defibrillators with certain feedthroughs may fail to deliver high-voltage therapy when needed. This rare malfunction could prevent life-saving electrical treatment.

    Product
    ICD-VR DVAB1D1 VISIA AF US IS1/DF1, Model Number DVAB1D1; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1787-2023·2023-06-28

    Medtronic Implantable Defibrillators Risk Failing to Deliver Electrical Therapy

    Medtronic is recalling 404 units of implantable cardioverter defibrillators and cardiac resynchronization devices due to a rare risk of reduced or absent energy output during therapy. The defect involves a specific manufacturing feedthrough component.

    Product
    CRTD CROME HF QUAD MRI IS4 DF1, Model Number DTPC2Q1; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1699-2023·2023-06-14

    Magic3 Go Intermittent Urinary Catheters Recalled for Packaging Defect

    C.R. Bard is recalling Magic3 Go Intermittent Urinary Catheters because the clear resealing label can separate from the pouch, potentially compromising sterility. The recall affects devices distributed worldwide.

    Product
    Magic3 Go Intermittent Urinary Catheters, male Catalog Numbers: a) REF 50810G, b) REF 50812G, c) REF 50814G, d) REF 50816G, e) REF 50818G, f) REF 53810G, g) REF 53812G, h) REF 53814G, i) REF 53816G, j) REF 53818G, k) REF 53820G
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-1696-2023·2023-06-14

    Abbott Alinity i Anti-TPO Reagent Kit Recalled for Fill Volume Error

    Abbott is recalling Alinity i Anti-TPO Reagent Kit (Lot 46009FN00) due to a manufacturing error resulting in marginally lower fill volume than specified in the Instructions for Use. Approximately 110 kits were distributed nationwide across 17 US states.

    Product
    Alinity i Anti-TPO Reagent Kit, List Number 09P3521
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0800-2023·2023-06-07

    Diuril Injectable Drug Recalled Due to Manufacturing Quality Deviations

    Akorn, Inc. is recalling all lots of Diuril (chlorothiazide sodium) Injection, 500mg/vial, distributed nationwide, due to manufacturing deviations. The manufacturer went out of business and was unable to complete required stability studies.

    Product
    Diuril (chlorothiazide sodium) Injection, 500mg/vial, Single-Dose Vial, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0774-2023·2023-06-07

    Pin-Away Pyrantel Pamoate Recalled for Non-Food-Grade Lubricant Use in Manufacturing

    Denison Pharmaceuticals recalls Pin-Away Pyrantel Pamoate pinworm treatment nationwide due to CGMP deviation: non-food-grade lubricant used in the manufacturing mixing vessel.

    Product
    Pin-Away PYRENTAL PAMOATE (Pyrantel base 50 mg / mL) Pinworm Treatment, 2 FL OZ (60 mL) bottle, Distributed by: Cara Incorporated, 333 Strawberry Field Road, Warwick, RI 05886. NDC 70309-080-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1663-2023·2023-06-07

    Teleflex HORIZON Titanium ligating clips recalled for missing cartridge safety feature

    Teleflex LLC is recalling approximately 146,606 units of HORIZON Microclip Titanium Ligating Clips because a safety feature is missing from the clip cartridge. Without this step feature, clips may be positioned variably and applied inadequately to blood vessels during surgery.

    Product
    Teleflex HORIZON Microclip Titanium Ligating Clips w/tape, REF 005200; for use in general surgical procedures that require vessel or tissue ligation
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Drugs)·D-0859-2023·2023-06-07

    Akorn Midazolam Injection Recalled Due to Incomplete Stability Studies

    Akorn, Inc. is recalling all lots of Midazolam Injection nationwide due to manufacturing practice deviations. The company ceased operations and could not complete stability studies to verify the drug's safety and efficacy.

    Product
    Midazolam Injection, USP, 50 mg/10mL (5mg/mL), For Intramuscular or Intravenous Use Only, 10 mL vials, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0818-2023·2023-06-07

    Levofloxacin Injection Nationwide Recall Due to Manufacturing Deviations

    Akorn, Inc. has recalled all lots of Levofloxacin Injection nationwide due to manufacturing process violations and inability to complete required stability studies.

    Product
    Levofloxacin Injection 500mg/20 mL (25 mg/mL), For Intravenous Infusion, packaged in a) 20mL vials and b) 30 mL vials, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0849-2023·2023-06-07

    Timolol Maleate Ophthalmic Solution Recalled for Manufacturing and Stability Testing Defects

    Akorn, Inc. has recalled all lots of Timolol Maleate Ophthalmic Solution 0.5% nationwide due to manufacturing quality deviations and inability to complete stability studies.

    Product
    Timolol Maleate Ophthalmic Solution, USP 0.5%, packaged in a) 2.5mL bottles, b) 5mL bottles, c) 10 mL bottles, and d)15mL bottles, Rx only, Manufactured by: Akorn , Inc, Lake Forest, IL 60045. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1615-2023·2023-05-31

    ViziShot 2 Aspiration Needle recalled for manufacturing angle defect

    ViziShot 2 Aspiration Needles are being recalled because the needle angle does not meet specifications and remains unbent, causing resistance during use. No illnesses or injuries have been reported.

    Product
    ViziShot 2 Single Use Aspiration Needle, 21G- To be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree and the gastrointestinal tract. Model: NA-U401SX-4021, NA-U401SX-4021-A
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1616-2023·2023-05-31

    Olympus Fine Needle Aspiration Needles Recalled for Angle Non-Conformance

    Olympus is recalling 1,297 boxes of fine needle aspiration needles due to a manufacturing defect where the needle angle does not meet specifications, resulting in slight resistance during needle advancement and retraction.

    Product
    To be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree and the gastrointestinal tract Models: NA-U401SX-4022, NA-U401SX-4022-A
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0757-2023·2023-05-31

    Nationwide Recall of Glimepiride Tablets for Manufacturing Practice Deviations

    Amerisource Health Services LLC recalls 63,335 bottles of Glimepiride Tablets nationwide due to manufacturing practice deviations identified during FDA inspection.

    Product
    Glimepiride Tablets, USP, 1 mg, RX, Packaged as a)100-count bottle, NDC# 68001-177-00; b) 500-count bottle, NDC# 68001-177-03; Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213. INDIA. For BluePoint Laboratories
    Category
    Drug
    Distribution
    Distributed nationwide