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.

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 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.

1351–1375 of 1434

  • HighFDA (Devices)·Z-1305-2014·2014-04-02

    Medtronic Recalls FiberNet Embolic Protection System Due to Manufacturing Defect

    Medtronic is recalling specific lots of the FiberNet Embolic Protection System because a yellow polyimide tube was not removed during manufacturing.

    Product
    FIBERNET Embolic Protection System: Recommended Vessel Diameter 6.0 -7.0 mm, Maximum Guidewire Diameter: 0.014 in (0.36mm) Rx only, Sterile; Manufactured in: Invatec S.P.A., Italy; Manufacturer: Medtronic Inc. Minneapolis, MN. The FiberNet Embolic Protection System is
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-1303-2014·2014-04-02

    Medtronic Recalls FiberNet Embolic Protection System Due to Manufacturing Defect

    Medtronic is recalling specific lots of the FiberNet Embolic Protection System because a yellow polyimide tube was not removed during manufacturing.

    Product
    FIBERNET Embolic Protection System: Recommended Vessel Diameter 3.5 0 5.0 mm, Maximum Guidewire Diameter: 0.014 in ( 0.36 mm) Rx only, Sterile; Manufactured in: Invatec S.P.A., Italy; Manufacturer: Medtronic Inc. Minneapolis, MN. The FiberNet Embolic Protection System i
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-1304-2014·2014-04-02

    Medtronic Recalls FiberNet Embolic Protection System Due to Manufacturing Defect

    Medtronic is recalling specific lots of the FiberNet Embolic Protection System because a yellow polyimide tube was not removed during manufacturing.

    Product
    FIBERNET Embolic Protection System: Recommended Vessel Diameter 5.0 -6.0 mm, Maximum Guidewire Diameter: 0.014 in (0.36mm) Rx only, Sterile; Manufactured in: Invatec S.P.A., Italy; Manufacturer: Medtronic Inc. Minneapolis, MN. The FiberNet Embolic Protection System is
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-1134-2014·2014-03-12

    DeRoyal Circumcision Clamps Recalled for Manufacturing Defects

    DeRoyal Industries is recalling three lots of circumcision clamps that may not clamp completely at the surgical site due to manufacturing errors.

    Product
    DeRoyal ST. Circumcision Clamp, REF 32-1622, Size 1.3 cm, 1 Per Pack, Rx Only STERILE EO, distributed by DeRoyal Industries.
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-0850-2014·2014-02-05

    Kimberly-Clark Radiofrequency Cannula Recalled for Incorrect Active Tip Length

    Kimberly-Clark is recalling Radiofrequency Cannulas where the active tip may be 5mm instead of the labeled 10mm, potentially affecting lesion creation in nervous tissue.

    Product
    Kimberly-Clark RadiOpaque Radiofrequency Cannula, Gauge 22, Length 100 mm, Active Tip 10 mm, Distributed in the US by Kimberly-Clark,Product code PMF22-100-10 The product is used to create lesions in nervous tissue when used with the Kimberly-Clark radiofrequency generator and
    Category
    Medical Device
    Distribution
    12 states
  • SevereFDA (Devices)·Z-0812-2014·2014-01-29

    Vital Signs Anesthesia Circuits Recalled Due to Occlusion Risk

    Vital Signs Colorado Inc. is recalling anesthesia and ventilator circuits where a blue port cap may be attached, causing gas flow occlusion.

    Product
    Vital Signs Anesthesia Circuits The Ventilator Circuit is intended for use as an interface between a ventilator dependent patient and a ventilator. The Anesthesia Circuit is intended to administer medical gases to a patient during anesthesia. The CPAP Circuit is intended to in
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0793-2014·2014-01-29

    Remel Recalls Oxoid Norfloxacin Antimicrobial Susceptibility Test Discs

    Remel Inc is recalling Oxoid Norfloxacin 10 mcg antimicrobial susceptibility test discs because some cartridges may contain discs not impregnated with the antibiotic.

    Product
    Oxoid Antimicrobial Susceptibility Test Discs, Norfloxacin 10 mcg., CT0434B, packaged in cartridges of 50 discs, 5 cartridges/pack. The firm name on the label is Oxoid Ltd., Basingstoke, Hampshire, England. Used in the semi-quantitative agar diffusion test method for in-vitro su
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0712-2014·2014-01-22

    Boston Scientific Extractor Pro XL Retrieval Balloon Catheter Recall

    Boston Scientific is recalling 34 units of Extractor Pro XL Retrieval Balloon Catheters due to potential incorrect skive hole location or balloon size.

    Product
    Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 12-15 mm Injects Below UPN :M00547140
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0604-2014·2014-01-08

    Advanced Sterilization Products Recalls STERRAD Cyclesure Biological Indicators

    Advanced Sterilization Products is recalling STERRAD Cyclesure Biological Indicators due to a microscopic flaw in the outer vial.

    Product
    STERRAD Cyclesure Biological Indicator (BI, Part No. 14324. Intended to be used as a standard method for frequent monitoring of the STERRAD Sterilization System cycles.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0550-2014·2013-12-25

    Qualigen Recalls FastPack Immunoassay Kits Due to Manufacturing Defect

    Qualigen Inc is recalling six FastPack immunoassay kits because a manufacturing defect may cause lower than expected test results.

    Product
    FastPack Free T4 Immunoassay FastPack Vitamin D Immunoassay Chemilunescence assay for the determination of Vitamin D The FastPack Vitamin D Immunoassay is intended for the quantitative determination of FastPack Total PSA Immunoassay Chemilunescence assay for the determinat
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Devices)·Z-0547-2014·2013-12-25

    Qualigen Recalls FastPack Total PSA Immunoassay Kits Due to Manufacturing Defect

    Qualigen Inc is recalling 182 units of the FastPack Total PSA Immunoassay because a manufacturing defect may cause lower than expected test results.

    Product
    FastPack Total PSA Immunoassay Chemilunescence assay for the determination of Total PSA. FastPack Total PSA Immunoassay is a paramagnetic particle immunoassay for the in vitro quantitative determination of prostate-specific antigen (PSA) in human serum and plasma as an aid i
    Category
    Medical Device
    Distribution
    16 states
  • ModerateFDA (Devices)·Z-0548-2014·2013-12-25

    Qualigen Recalls FastPack Testosterone Immunoassay Kits Due to Manufacturing Defect

    Qualigen Inc is recalling 18 FastPack Testosterone Immunoassay kits because a manufacturing defect may cause lower than expected test results.

    Product
    FastPack Testosterone Immunoassay Chemilunescence assay for the determination of Testosterone The FastPack Testo Immunoassay is a paramagnetic particle immunoassay for the in vitro quantitative determination of total testosterone in human serum and plasma. It is intended str
    Category
    Medical Device
    Distribution
    16 states
  • ModerateFDA (Devices)·Z-0544-2014·2013-12-25

    SpineFrontier Recalls PedFuse Reset Pedicle Screws Due to Assembly Error

    SpineFrontier, Inc. is recalling 35 PedFuse Reset pedicle screws because one unit was found assembled with the wrong size screw. The recall covers devices distributed to Virginia and Texas.

    Product
    PedFuse Reset Screw; Model: 01-80115-55 The PedFuse Reset pedicle screw implants intended to be used to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine.
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0549-2014·2013-12-25

    Qualigen Recalls FastPack Free T4 Immunoassay Kits Due to Manufacturing Defect

    Qualigen Inc is recalling 17 units of the FastPack Free T4 Immunoassay because a manufacturing defect may cause lower than expected test results.

    Product
    FastPack Free T4 Immunoassay Chemilunescence assay for the determination of Free T4 The FastPack free T4 Immunoassay is a paramagnetic particle immunoassay for the in vitro quantitative determination of FT4 in human serum. The FastPack free T4 Immunoassay is designed for u
    Category
    Medical Device
    Distribution
    16 states
  • ModerateFDA (Devices)·Z-0450-2014·2013-12-11

    CareFusion Recalls SmartSite Infusion Sets Due to Tubing Assembly Error

    CareFusion is recalling 480 units of SmartSite Low Sorbing Infusion Sets because they were not assembled with low-sorbing tubing.

    Product
    SmartSite Low Sorbing Infusion Set with Texium Close Male Luer, Model No. 24301-0007T The SmartSite Low Sorbing Infusion Sets with Texium Male Luer are used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein.
    Category
    Medical Device
    Distribution
    5 states
  • SevereFDA (Food)·F-0352-2014·2013-12-04

    Plum Organics Baby Food Recalled for Manufacturing Defect and Contamination

    Plum Inc is recalling Peach, Apricot & Banana Organic Baby Food due to a manufacturing defect leading to post-process contamination.

    Product
    Plum Organics Peach, Apricot & Banana Organic Baby Food, 4 oz. pouch. Flexible pouch with resealable spout. Packaged for individual sale in 6 count cartons and in 4 count packages. Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. DISTRIBUTED BY: NEST CO
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0365-2014·2013-12-04

    Plum Organics Baby Food Recalled for Manufacturing Defect and Contamination

    Plum Inc is recalling specific lots of Plum Organics Blueberry, Pear and Purple Carrot Organic Baby Food due to a manufacturing defect leading to post-process contamination.

    Product
    Plum Organics Blueberry, Pear and Purple Carrot Organic Baby Food, 4 oz. pouch.. Flexible pouch with Resealable spout. Packaged for individual sale in 6 count cartons and in 4 count packages. Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. DISTRIBU
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0376-2014·2013-12-04

    Plum Organics Baby Food Recalled for Manufacturing Defect

    Plum Inc is recalling specific lots of Plum Organics Mango, Carrot & Greek Yogurt Baby Food due to a manufacturing defect that led to post-process contamination.

    Product
    Plum Organics Mango, Carrot & Greek Yogurt Organics Baby Food- 3.5 oz. Pouch Flexible pouch with Resealable spout. Packaged for individual sale in 6 count cartons and in 4 count packages. Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. DISTRIBUTED
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0361-2014·2013-12-04

    Plum Organics Baby Food Recalled for Post-Process Contamination Risk

    Plum Inc is recalling specific lots of Plum Organics Raspberry, Spinach & Greek Yogurt Organic Baby Food due to a manufacturing defect that could lead to post-process contamination.

    Product
    Plum Organics Raspberry, Spinach & Greek Yogurt Organic Baby Food, 4 oz. pouch. Flexible pouch with Resealable spout. Packaged for individual sale in 6 count cartons and in 4 count packages. Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. DISTRIBUTE
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0359-2014·2013-12-04

    Plum Organics Baby Food Recalled for Manufacturing Defect and Contamination

    Plum Inc is recalling Cherry & Sweet Corn Organic Baby Food due to a manufacturing defect that led to post-process contamination.

    Product
    Plum Organics Cherry & Sweet Corn Organic Baby Food, 4 oz. pouch. Flexible pouch with Resealable spout. Packaged for individual sale in 6 count cartons and in 4 count packages. Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. DISTRIBUTED BY: NEST COLL
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0381-2014·2013-12-04

    Biomet Recalls Oversized Security Blades for Carpal Tunnel Surgery

    Biomet, Inc. is recalling 1,130 Security Blades for carpal tunnel surgery because they were manufactured oversized and may be difficult to advance through the mating clip.

    Product
    REF 200068 Security (TM) Enclosed Carpal Tunnel System Blade ( Single) ABS /Stainless Steel Sterile Device, Single Use Only. Designed to release the transverse carpal ligament.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0400-2014·2013-12-04

    Lanx Recalls Timberline MPF Straight Split Tip Driver Due to Sizing Defect

    Lanx, Inc. is recalling 25 units of the Timberline MPF Straight Split Tip Driver - Short because the tip is oversized.

    Product
    LANX Timberline MPF Lateral Modular Plate Fixation System Straight Split Tip Driver - Short ("Driver"). Model Number 8630-0107. The Timberline MPF device is an intervertebral body fusion device consisting of a PEEK intervertebral spacer, titanium plate, and screws. The PEEK sp
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0355-2014·2013-11-27

    Restoration Robotics Recalls Sterile Disposable Kits Due to Pin Discoloration

    Restoration Robotics is recalling sterile disposable kits used in hair restoration because skin tensioner pins have discoloration from insufficient cleaning.

    Product
    Sterile Disposable Kit ( Contains Skin Tensioner ASY-25067; Three Mark Needle Assembly ASY-25094; Nose Cone Assembly ASY-25098; Dissection 4 mm PRT-25117, follicle Trap PRT 23999): Product Usage: Skin Tensioner is applied to patients scalp during follicular harvesting dur
    Category
    Medical Device
    Distribution
    Distributed nationwide