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.

826–850 of 1441

  • ModerateFDA (Drugs)·D-0826-2021·2021-09-29

    Zonisamide Capsules Recalled by Glenmark Due to CGMP Deviations

    Glenmark Pharmaceuticals Inc., USA is voluntarily recalling Zonisamide Capsules USP 100 mg nationwide due to CGMP (Current Good Manufacturing Practice) deviations. The recall affects multiple lot numbers distributed from August 2021.

    Product
    ZONISAMIDE — ZONISAMIDE (ZONISAMIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0803-2021·2021-09-22

    MIC+Methyl B12 Injection Recalled for Lack of Processing Controls

    Promise Pharmacy is recalling MIC+Methyl B12 injection (57 vials, Lot# 06152021@2) distributed across five states due to lack of processing controls that may affect product quality and safety.

    Product
    MIC+Methyl B12 injection Methionine Inositol Choline+Methylcobalamin 25 mg/50 mg/50 mg/1 mg/mL, 10 mL vial sterile, Rx only, Promise Pharmacy 31818 US Hwy 19N Palm Harbor FL 34684 1-888-3PROMIS
    Category
    Drug
    Distribution
    5 states
  • HighFDA (Devices)·Z-2450-2021·2021-09-22

    Diagnostic reagent kits recalled for incorrect chemical composition

    Gibson Bioscience is recalling Potassium Hydroxide 10% diagnostic reagent kits (Lot 21137116, 11 units) manufactured with Hydrogen Peroxide 3% instead of the intended chemical. The wrong solution could cause inaccurate laboratory test results.

    Product
    Potassium Hydroxide 10% (KOH 10%), Cat. No. 300145 Potassium Hydroxide 10% (KOH 10%) is intended for use in the demonstration of yeast and fungal elements in wet clinical preparations. Potassium Hydroxide digests the proteinaceous material in the specimen, leaving the fungal…
    Category
    Medical Device
    Distribution
    7 states
  • HighNHTSA·21V702000·2021-09-10

    2022 GMC Acadia air bag system defect due to inactive safety module

    General Motors is recalling certain 2022 GMC Acadia vehicles with an unactivated sensing diagnostic module that prevents air bag deployment. The two affected units remain in dealer inventory.

    Product
    GMC — GMC ACADIA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2333-2021·2021-09-01

    BD Mouse IgG2a Antibody Reagent Recalled for Manufacturing Contamination

    This antibody reagent was recalled due to manufacturing contamination that may produce false positive staining results in laboratory tests. The affected lot was distributed worldwide.

    Product
    BD" Mouse IgG2a Isotype Control APC X39 ASR
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2329-2021·2021-08-25

    Triathlon orthopaedic implant baseplate recalled for assembly defect

    Howmedica Osteonics is recalling the Triathlon Prim CEM baseplate (Lot JHS2H) due to a manufacturing defect that may prevent the insert from locking properly on the implant.

    Product
    Triathlon Prim CEM FXD BPLT 7, Catalog No. 5520B700
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2309-2021·2021-08-25

    Dual Balloon Angioplasty Catheter Recalled for Balloon Deflation Difficulty

    Ostial Corporation is recalling the FLASH Ostial System dual balloon angioplasty catheter due to a manufacturing issue that may prevent proper balloon deflation, potentially causing access site complications.

    Product
    FLASH Ostial System, Dual Balloon Angioplasty Catheter, REF: OAB6014BA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2228-2021·2021-08-18

    Medtronic StimLoc Burr Hole Cover Recalled for Excess Nylon Flash on Clip

    Medtronic is recalling StimLoc Burr Hole Cover neurosurgical devices and related components due to excess nylon flash on the clip. The defect could affect device function during implantation or use.

    Product
    Medtronic StimLoc Burr Hole Cover, Part Numbers: a) 3387S-40 b) 3389S-28 c) 3389S-40 d) 3391S-40 e) 3550S-01 f) 924256 g) DB-5000
    Category
    Medical Device
    Distribution
    47 states
  • HighFDA (Devices)·Z-2245-2021·2021-08-18

    FDA Recalls Blood Culture Identification Panel for False Negative Results

    BioFire Diagnostics is recalling 29 FilmArray Blood Culture Identification Panel kits distributed nationwide due to false negative test results caused by a pouch manufacturing error.

    Product
    FilmArray Blood Culture Identification (BCID) Panel Product Pouch Label: FilmArray BCID Panel Part No: RFIT-ASY-0126 Part No: RFIT-ASY-0127
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2240-2021·2021-08-18

    Covidien Sonicision Surgical Generator Recalled for Manufacturing Defect Risk

    Covidien recalls 96 units of its Sonicision Reusable Generator surgical device due to a manufacturing assembly error that may cause device malfunction, thermal burns, or tissue damage. The defect may also disable the audio indicator that signals device activation.

    Product
    Covidien Sonicision Reusable Generator-converts electrical power from the battery pack to ultrasonic energy to drive the active blade. Product Number: SCGAA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0720-2021·2021-08-18

    Zyprexa Intramuscular Injection Recalled for Manufacturing Defects

    Eli Lilly is recalling 36,540 vials of Zyprexa (olanzapine) 10 mg intramuscular injection due to manufacturing deviations affecting the drug product's appearance, size, and color.

    Product
    Zyprexa Intramuscular, Olanzapine for Injection, 10 MG per Single Use Vial, Rx only, Marketed by: Lilly USA, LLC, Indianapolis, IN 46285, NDC# 0002-7597-01
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0721-2021·2021-08-18

    Nystatin Oral Suspension Recalled Due to CGMP Violation

    PAI Holdings is recalling Nystatin Oral Suspension nationwide due to a lack of Current Good Manufacturing Practice (CGMP) controls that could allow carryover of Senna Syrup into the product.

    Product
    NYSTATIN — NYSTATIN (NYSTATIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0696-2021·2021-08-04

    Azelaic Acid 99.0+% Micro 500G Drug Recalled for cGMP Deviations

    API Solutions Inc. is voluntarily recalling Azelaic Acid 99.0+% Micro 500 Grams (Lot #AZA181105, Exp 11/09/2021) distributed in five states due to current Good Manufacturing Practice (cGMP) deviations identified during manufacturing.

    Product
    Azelaic Acid 99.0+% Micro 500 Grams, Distributed By: A.P.I. Solutions Daphne Alabama Manufactured by: Yicheng Chemicals Corp. China Distributed by: Syntec Pharma Corp New York
    Category
    Drug
    Distribution
    5 states
  • HighFDA (Devices)·Z-2072-2021·2021-07-21

    HeartWare HVAD Pump Implant Kit Impeller Defect Recall

    HeartWare HVAD Pump Implant Kit (REF MCS1705PU) recalled because the pump's impeller shroud height does not meet the lower control limit. The device is used for hemodynamic support in patients with advanced heart failure.

    Product
    HeartWare, HVAD Pump Implant Kit, REF MCS1705PU - Product Usage: indicated for hemodynamic support in patients with advanced, refractory left ventricular heart failure; either as a Bridge to Cardiac Transplantation (BTT), myocardial recovery, or as Destination Therapy (DT) in…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0659-2021·2021-07-21

    Durisan Hand Sanitizing Wipes Recalled for CGMP Deviations

    Sanit Technologies, LLC is recalling Durisan Antimicrobial Solutions Hand Sanitizing Wipes (benzalkonium chloride, 0.13%) due to manufacturing deviations that could result in contaminated product.

    Product
    Durisan Antimicrobial Solutions (benzalkonium chloride) Hand Sanitizing Wipes, 0.13%, packaged in 80-count canister (UPC 8 52379 00632 5), b) 160-count canister (UPC 8 52379 00631 8), and c) 240-count canister (UPC 8 52379 00633 2); Sanit Technologies, LLC, 7810 25th Court East…
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2034-2021·2021-07-14

    Nonsterile Radial/Femoral Angiography Drapes Recalled for Sticking Defect

    Cardinal Health is recalling 13,426 units of Nonsterile Radial/Femoral Angiography Drape (Catalog #29529N) due to a manufacturing defect where plastic film causes the drapes to stick, preventing proper unfolding and application in surgical settings.

    Product
    Nonsterile Radial/Femoral Angiography Drape, Catalog Number 29529N - 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-2027-2021·2021-07-14

    Atellica IM 1300 Analyzer Valves Recalled Due to Manufacturing Defect

    Siemens is recalling Atellica IM 1300 diagnostic analyzer valves due to a manufacturing defect that may cause leaking and affect test result accuracy.

    Product
    Atellica IM 1300 Analyzer - multi-component system for in vitro diagnostic testing of clinical specimens SMN 11066001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2026-2021·2021-07-14

    Siemens Atellica Analyzer Valves Recalled for Manufacturing Defect Risk

    Siemens Healthcare Diagnostics has recalled Atellica CH 930 Analyzer valves that may malfunction due to a manufacturing defect. The affected valves may wear and leak over time, potentially impacting diagnostic test accuracy.

    Product
    Atellica CH 930 Analyzer - multi-component system for in vitro diagnostic testing of clinical specimens SMN 11067000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2036-2021·2021-07-14

    Cesarean Birth Drapes recalled due to defective plastic film causing sticking

    Cardinal Health is recalling Cesarean Birth Drapes due to a plastic film defect. The defect causes the drapes to stick, preventing proper unfolding and application during surgery.

    Product
    Nonsterile Sterile Cesarean Birth Drape with Dual Layer Anesthesia Screen, Catalog Number 29442N - 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-2028-2021·2021-07-14

    Atellica analyzer valves recalled for manufacturing defect affecting diagnostic accuracy

    Siemens recalls Atellica analyzers (CH 930, IM 1300, IM 1600) due to valve manufacturing defects that may cause leaking and affect clinical test result accuracy.

    Product
    Atellica IM 1600 Analyzer- multi-component system for in vitro diagnostic testing of clinical specimens SMN 11066000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1951-2021·2021-06-30

    LEGION Knee Prosthesis Component Recalled for Manufacturing Surface Damage

    Smith & Nephew is recalling 5 units of a knee prosthesis component due to surface damage from a manufacturing error. The affected lot was distributed in specific U.S. states.

    Product
    LEGION Posterior Stabilized OXINIUM Femoral Component, REF 71421216, Size 6, Left, Nonporous Femoral Component, A/P 65.5 MM, M/L 73 MM, For Cemented Use Only, ZR-2.5NB,Sterile. Knee prosthesis component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1945-2021·2021-06-30

    Medical Action Industries Hemostats Recalled for Flaking Metal Defects

    Medical Action Industries is recalling Mosquito Hemostats due to potential flaking metal and brown spots on the devices. The recall affects 23 boxes of surgical instruments distributed nationwide.

    Product
    Medical Action INDUSTRIES INC., Disposable Instrument Pack Mosquito Hemostat, REF 56220
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1852-2021·2021-06-23

    Hydrodissection Cannula Recall Due to Residue at Tip

    Anodyne Surgical has recalled hydrodissection cannulas due to a possible yellowish-brown or greenish-brown residue on the tip. The affected devices were distributed in multiple US states and Canada.

    Product
    Hydrodissection Cannula (Chang), 27g, labeled as: anodynesurgical, REF 7018 ASICO, REF AS-7638 anodynesurgical, REF 7018NS katena, REF K20-3168 anodynesurgical, REF 104910 MSI, REF CA7800 ACCUTONE, REF AX14784-BULK Walcott Rx Products, REF RX2300NS Walcott Rx Products…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1883-2021·2021-06-23

    Medtronic Perfusion System Tubing Packs Recalled for Incomplete Welds

    Medtronic is recalling 14 tubing packs of its HY10J00R12 perfusion system due to insufficient or incomplete welds. The affected lot is 221227814 with a use-by date of August 28, 2022.

    Product
    Medtronic HY10J00R12, Custom Pack HY10J00R12 ECC Small CA, Custom Perfusion System,
    Category
    Medical Device
    Distribution
    Distributed nationwide