The Recall Desk

Hazard

Manufacturing Error recalls

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

What the numbers show

Total
65
Critical
1
Severe
12
Most recent
2026-06-24

Of the 65 manufacturing error recalls we have scored against our rubric, 1 (2%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 12 (18%) are Severe.

Which agencies issued them

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all manufacturing error 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 65

  • ModerateFDA (Devices)·Z-1576-2020·2020-04-01

    BardPort M.R.I. Implantable Port Recall Due to Incorrect Catheter Tip

    Bard Peripheral Vascular Inc is recalling BardPort M.R.I. Implantable Ports because they may contain an incorrect catheter tip, potentially prolonging surgical operations.

    Product
    BardPort M.R.I. Implantable Port with Attachale 9.6 F Open-Ended Single-Lumen Venous Catheter, REF: 0602680, UDI:(01)00801741025679 Product Usage: Bard implantable ports are indicated for patient therapies requiring repeated access to the vascular system. The port system can be
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1571-2020·2020-04-01

    Bard PowerPort M.R.I. Implantable Port Catheter Recall for Incorrect Tunneler Tip

    Bard Peripheral Vascular Inc is recalling 878 PowerPort M.R.I. Implantable Port catheters because they may contain a tunneler with an incorrect barb tip, potentially prolonging surgical operations.

    Product
    1. PowerPort M.R.I. Implantable Port with Attachable 9.6 F Open-Ended Single-Lumen Venous Catheter with Suture Plugs, REF: 1809600, UDI: (01)00801741027130 ; 2. PowerPort M.R.I. Implantable Port with Attachable 9.6 F Open-Ended Single-Lumen Venous Catheter Without Suture Plugs,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0588-2020·2019-12-18

    Cook CrossCath Support Catheter Recalled for Manufacturing Error

    Cook Inc. is recalling six CrossCath Support Catheters due to a manufacturing error that may cause radiopaque marker bands to be too loose or too tight.

    Product
    CrossCath Support Catheter, RPN CXC3.4-2.2-18-90-P-NS-0, Order Number G51575 For diagnostic and interventional vascular procedures.
    Category
    Medical Device
    Distribution
    20 states
  • SevereFDA (Devices)·Z-0587-2020·2019-12-18

    Cook CrossCath Support Catheter Recall Due to Manufacturing Error

    Cook Inc. is recalling 20 CrossCath Support Catheters because a manufacturing error may cause radiopaque marker bands to be too loose or too tight.

    Product
    CrossCath Support Catheter, RPN CXC3.0-1.9-14-90-P-NS-0, Order Number G51572 For diagnostic and interventional vascular procedures.
    Category
    Medical Device
    Distribution
    20 states
  • ModerateFDA (Drugs)·D-1315-2019·2019-06-05

    Inopak Recalls Antibacterial Hand Soap Due to Manufacturing Deviations

    Inopak Ltd is recalling specific batches of Healthcare 2000 antibacterial hand soap because they were not produced under current good manufacturing practices.

    Product
    Antibacterial Hand Soap, Healthcare 2000, labeled as a) DERMA System CARE SaniClenz Antimicrobial Skin Cleanser (Chlorhexidine Gluconate), 4 x (1 gallon containers), Reorder/REF #JSCG; Manufactured for Crosstex International, Inc.; b) MEDI-WASH CHG Anti-Microbial Hand Wash with C
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0076-2019·2018-10-17

    AngioDynamics BioFlo Port Recall Due to Incorrect Sterile Assembly

    AngioDynamics is recalling BioFlo Ports that were partially manufactured with the wrong sterile port assembly. The devices were distributed in Indiana.

    Product
    BioFlo Port with ENDEXO and PASV Technology-AngioDynamics BIOFLO 8F SINGLE PLASTIC NON-FILLED; VALVED PG UPN: H965440210 Catalog Number: 44-021 Box of 1 Port - Product Usage - Long-term access to the central venous system for administration of fluids including but not limited t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3179-2018·2018-09-26

    bioMerieux Recalls VITEK 2 AST-P640 Cards Due to Gentamicin Error

    bioMerieux is recalling VITEK 2 AST-P640 cards because some lots contain insufficient gentamicin, potentially affecting high-level resistance test results.

    Product
    VITEK(R) 2 AST-P640, For susceptibility testing of Staphylococcus spp. Enterococcus spp., ad S agalactiae against specified antimicrobials, REF 418579 Product Usage: VITEK¿ 2 is an automated system consisting of instruments, software and reagent cards designed for the identi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0824-2018·2018-05-30

    Mylan Recalls Loxapine Capsules Due to Manufacturing Deviations

    Mylan Pharmaceuticals is recalling 8,679 bottles of Loxapine Capsules 25 mg due to CGMP deviations. The product was distributed throughout the United States and Puerto Rico.

    Product
    Loxapine Capsules, USP 25 mg, Rx Only, 100-count bottles, NDC 0378-7025-01
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-0346-2018·2018-01-31

    Vyaire Medical Recalls AirLife Humidification Chambers Due to Overflow Risk

    Vyaire Medical is recalling 16,670 AirLife Humidification Chambers and circuits because a manufacturing error may cause water to back up into patient airways.

    Product
    Adult AirLife dual-limb, dual-heat circuit (Model AH280) with AirLife Humidification Chamber, Model Number AH290. The AH290 Humidification Chamber and Heated Breathing Circuit Kit(s) operate as part of a system for delivering health and humidified respirator gasses to patients
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0882-2017·2017-06-14

    Spectrum Chemical Recalls Levonorgestrel API Due to CGMP Deviations

    Spectrum Laboratory Products is recalling levonorgestrel active pharmaceutical ingredient due to manufacturing deviations found by the FDA.

    Product
    Levonorgestrel, U.S.P. active pharmaceutical ingredient, packaged in 1 kg container, Rx only, Spectrum Chemical Mfg. Corp, Gardena, CA 90248, New Brunswick, NJ 08901, Product code L1229.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0244-2017·2017-01-11

    Apotex Recalls Torsemide Tablets Due to Manufacturing Deviations

    Apotex Corp. is voluntarily recalling Torsemide Tablets 20 mg due to CGMP deviations. The recall covers 35,819 bottles distributed in the United States.

    Product
    Torsemide Tablets, 20 mg 100-count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9W, 6Y3, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-0234-01
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1466-2016·2016-08-31

    Mylan Amlodipine Tablets Recalled for CGMP Deviations

    Mylan Institutional, Inc. is recalling Amlodipine Besylate Tablets because they were not manufactured according to Good Manufacturing Practices.

    Product
    Amlodipine Besylate Tablets, USP, 2.5 mg*, packaged in a)100-count (10 x 10) unit dose blisters per carton, NDC 51079-450-20 and b) 30-count tablets per dosage card in a carton, NDC 51079-450-63, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505; Package
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0275-2016·2015-11-25

    Medacta Recalls GMK Hinge Knee Prosthesis Due to Incorrect Screws

    Medacta USA is recalling 4 units of GMK Hinge knee prostheses because they contain 5 mm screws instead of the required 10 mm screws.

    Product
    GMK Hinge knee prosthesis; Model Number: 02.09.TA410; Orthopedics and Orthopedic Surgery
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0239-2016·2015-11-18

    Beckman Coulter Recalls Access CEA Assay Reagent Packs for Filling Errors

    Beckman Coulter is recalling Access CEA Assay reagent packs because they were filled incorrectly. The recall covers 11,406 units distributed worldwide.

    Product
    Access CEA Assay, Part No. 33200. For the quantitative determination of Carcinoembryonic Antigen (CEA) levels in human serum.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0108-2016·2015-10-14

    Beckman Coulter Recalls MICroSTREP plus 1 and 2 Panels for Manufacturing Error

    Beckman Coulter is recalling MICroSTREP plus 1 and 2 panels because a manufacturing error may cause antimicrobial degradation and false resistant results.

    Product
    MICroSTREP plus 1 Panel, Part No. B1027-201 Product Usage: MicroScan MICroSTREP plus panels are designed for use in determining quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic streptococci, including Streptococcus
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0109-2016·2015-10-14

    Beckman Coulter Recalls MICroSTREP plus Panels Due to Manufacturing Error

    Beckman Coulter is recalling MICroSTREP plus 1 and 2 panels because a manufacturing error may cause antimicrobial degradation, leading to false resistant results.

    Product
    MICroSTREP plus 2 Panel, Part No. B1027-202 Product Usage: MicroScan MICroSTREP plus panels are designed for use in determining quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic streptococci, including Streptococcus
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0025-2016·2015-10-14

    Integra Recalls Universal Compact Head Ring Adapter Plate Due to Assembly Error

    Integra LifeSciences Corp. is recalling six Universal Compact Head Ring Adapter Plates that do not assemble properly due to a manufacturing drawing error.

    Product
    Universal Compact Head Ring Adapter Plate (UCHRAP), a component of the Universal Compact Head Ring Adapter, UCHRA. The UCHRA is a component of the Integra¿ CRW¿ Precision Arc Stereotactic System.
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Food)·F-2931-2015·2015-08-12

    Lil Critters Gummy Vites Recalled for Incorrect Bulk Ingredient Use

    Church & Dwight is recalling Lil Critters Gummy Vites Complete Multivitamin because two lots were produced using Adult Multivitamin bulk.

    Product
    Gummy Vites Complete Multivitamin L'il Critters 70 gummies Manufactured for Church & Dwight Co., Inc. Ewing, NJ 08628
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1526-2015·2015-05-06

    Cyberonics Recalls VNS Therapy DemiPulse Generators Due to Battery Defect

    Cyberonics is recalling 13 VNS Therapy DemiPulse Generators because they were left in an ON state during manufacture, causing lower battery longevity than specified.

    Product
    VNS Therapy DemiPulse Generator Model 103 and VNS Therapy DemiPulse Duo Generator Model 104; CYBERONICS, INC.
    Category
    Medical Device
    Distribution
    9 states
  • SevereFDA (Drugs)·D-0377-2015·2015-01-28

    Mylan Recalls Ciprofloxacin Tablets Due to Manufacturing Deviations

    Mylan Institutional, Inc. is recalling Ciprofloxacin Tablets 500 mg because they were produced with active ingredients not manufactured according to Good Manufacturing Practices.

    Product
    CIPROFLOXACIN TABLETS, USP, 500 mg, 100 Tablets (10 tablets per blister card. 10 blister cards per carton), Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV --- NDC 51079-182-20.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0238-2015·2014-11-12

    Nanophase Recalls Z-COTE HP 1 Zinc Oxide Powder Due to Manufacturing Error

    Nanophase Technologies is recalling Z-COTE HP 1 Transparent Zinc Oxide powder because an incorrect amount of raw material was added during manufacturing.

    Product
    Z-COTE HP 1 TRANSPARENT ZINC OXIDE, Zinc Oxide (and) Triethoxycaprylylsilane, Powder, NET: 22 KG, Packaged in double plastic liners in a single fiber carton, FOR MANUFACTURING, PROCESSING OR REPACKING, BASF Corporation, Florham Park, NJ
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1636-2014·2014-05-28

    Smith & Nephew Recalls Trigen Intertan Nails Due to Manufacturing Error

    Smith & Nephew is recalling 1,253 Trigen Intertan Nails because a manufacturing error caused set screws to be inserted too deep.

    Product
    TRIGEN INTERTAN NAIL: (1) REF 71675201, 10 MM X 18 CM, 125 degree, (2) REF 71675202, 11.5 MM X 18 CM, 125 degree, (3) REF 71675203, 13 MM X 18 CM, 125 degree, (4) REF 71675204, 10 MM X 20 CM, 125 degree, (5) REF 71675205, 11.5 MM X 20 CM, 125 degree, (6) REF 71675207,
    Category
    Medical Device
    Distribution
    0 states