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.

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.

1176–1200 of 1441

  • ModerateFDA (Devices)·Z-0826-2017·2016-12-28

    Medtronic Recalls Affinity Fusion Oxygenators Due to Plastic Flash Defect

    Medtronic is voluntarily recalling specific lots of Affinity Fusion Oxygenators because of an out-of-specification condition involving additional plastic in the arterial sampling port.

    Product
    Affinity Fusion" Oxygenator with Integrated Arterial Filter, Affinity Fusion cardiotomy/Venous Reservoir, Perfusion Tubing Packs The Affinity Fusion Oxygenator with Integrated Arterial Filter with or without the Cardiotomy/Venous Reservoir with Balance¿1 Biosurface is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0647-2017·2016-12-14

    Centurion Multi-Med Single Lumen Catheters Recalled for Embolism Risk

    Centurion Medical Products is recalling 1,000 Multi-Med Single Lumen Catheter kits because excess material at the catheter tip may separate and cause an embolism.

    Product
    Multi-Med Single Lumen Catheters sold in Centurion convenience kits. The Multi-Med catheter is indicated for use in patients requiring administration of solutions, blood sampling, and central venous pressure monitoring.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0703-2017·2016-12-14

    DePuy Recalls LCS Knee Revision Insert Due to Manufacturing Defect

    DePuy Orthopaedics is recalling one lot of LCS Complete Knee Revision System VVC Inserts because they were manufactured outside of specifications, preventing proper seating in the tibial tray.

    Product
    LCS Complete Knee Revision System VVC Insert Product Usage: LCS VVC Insert is used in Knee Revision Surgery
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0669-2017·2016-12-07

    Terumo Recalls MISAGO RX Self Expanding Peripheral Stent

    Terumo Medical Corp is recalling 7,965 MISAGO RX Self Expanding Peripheral Stents nationwide because they do not conform to product specifications regarding diameter and shape.

    Product
    MISAGO RX Self Expanding Peripheral Stem
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0168-2017·2016-12-07

    Nationwide Laboratories Recalls Phenazopyridine Hydrochloride Tablets Due to CGMP Deviations

    Nationwide Laboratories LLC is recalling Phenazopyridine Hydrochloride Tablets, 200 mg, due to manufacturing deviations that may result in assay or content uniformity failures.

    Product
    Phenazopyridine Hydrochloride Tablets, USP, 200 mg, 100 count bottles, Rx only, Manufactured for: Nationwide Laboratories LLC, Iselin, New Jersey 08830, NDC 42937-702-10.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0336-2017·2016-11-09

    Stryker Neurovascular Recalls Guider Softip XF Guide Catheters

    Stryker Neurovascular is recalling 1,478 Guider Softip XF guide catheters due to a manufacturing defect that could cause hub leaks.

    Product
    Guider Softip XF; GUIDER/MP XF/6FR/90CM, Model number: H965100460. Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional devices into the neurovascular system.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0342-2017·2016-11-09

    Stryker Neurovascular Recalls Guider Softip XF Guide Catheters

    Stryker Neurovascular is recalling 1,478 Guider Softip XF guide catheters due to a manufacturing defect that could cause hub leaks.

    Product
    Guider Softip XF; GUIDER/40 DEG XF/7FR/100 cm, Model number: M003101430 . Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional devices into the neurovascular system.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0333-2017·2016-11-09

    Stryker Recalls Guider Softip XF Guide Catheters Due to Hub Leaks

    Stryker Neurovascular is recalling Guider Softip XF guide catheters because a manufacturing defect may cause hub leaks.

    Product
    Guider Softip XF; GUIDER/40DEG XF/7FR/90CM, Model number: H965100430 . Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional devices into the neurovascular system.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0346-2017·2016-11-09

    Stryker Recalls Guider Softip XF Guide Catheters Due to Hub Leaks

    Stryker Neurovascular is recalling 1,478 Guider Softip XF guide catheters worldwide due to a manufacturing defect that could cause hub leaks.

    Product
    Guider Softip XF; GUIDER STRAIGHT XF 5F 100CM, Model number: M003101640. Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional devices into the neurovascular system.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0340-2017·2016-11-09

    Stryker Recalls Guider Softip XF Guide Catheters Due to Hub Leaks

    Stryker Neurovascular is recalling 1,478 Guider Softip XF guide catheters worldwide due to a manufacturing defect that could cause hub leaks.

    Product
    Guider Softip XF; GUIDER/40 DEG XF/6FR/100 cm, Model number: M003101420. Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional devices into the neurovascular system.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0339-2017·2016-11-09

    Stryker Neurovascular Recalls Guider Guide Catheters Due to Hub Leaks

    Stryker Neurovascular is recalling 1,478 Guider Guide Catheters worldwide due to a manufacturing defect that could cause hub leaks.

    Product
    Guider Softip XF; GUIDER MPXF 5F 100CM, Model number: M003101630. Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional devices into the neurovascular system.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0341-2017·2016-11-09

    Stryker Recalls Guider Softip XF Guide Catheters Due to Hub Leaks

    Stryker Neurovascular is recalling 1,478 Guider Softip XF guide catheters worldwide due to a manufacturing defect that may cause hub leaks.

    Product
    Guider Softip XF; GUIDER/40XF/8FR/90CM, Model number: H965100440 . Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional devices into the neurovascular system.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0350-2017·2016-11-09

    Smith & Nephew Recalls Tandem Hip Shells With Out-of-Specification Grooves

    Smith & Nephew is recalling 2,352 Tandem hip shells manufactured with out-of-specification retainer grooves. The recall covers units distributed nationwide and in 23 other countries.

    Product
    TANDEM (TM) COCR SHELL UHMWPE LINER BIPOLAR, REF NUMBERS: 71322040, 71322041, 71322042, 71322043, 71322044, 71322045, 71322046, 71322047, 71322048, 71322049, 71322050, 71322051, 71322052, 71322053, 71322054, 71322055, 71322057
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0351-2017·2016-11-09

    Smith & Nephew Recalls Tandem Hip Shells With Out-of-Specification Grooves

    Smith & Nephew is recalling 5,806 Tandem hip shell units manufactured with out-of-specification retainer grooves. The recall covers distribution in the US and 23 other countries.

    Product
    TANDEM (TM) INTL COCR SHELL UHMWPE LINER BIPOLAR, REF NUMBERS: 71324038, 71324039, 71324040, 71324041, 71324042, 71324043, 71324044, 71324045, 71324046, 71324047, 71324048, 71324049, 71324050, 71324051, 71324052, 71324053, 71324054, 71324055, 71324057, 71324059, 71325039…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0343-2017·2016-11-09

    Stryker Neurovascular Recalls Guider Softip XF Guide Catheters

    Stryker Neurovascular is recalling 1,478 Guider Softip XF guide catheters due to a manufacturing defect that could cause hub leaks.

    Product
    Guider Softip XF; GUIDER/ST XF/6FR/100 cm, Model number:M003101500 . Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional devices into the neurovascular system.
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0338-2017·2016-11-09

    Stryker Neurovascular Recalls Guider Softip XF Guide Catheters

    Stryker Neurovascular is recalling 1,478 Guider Softip XF Guide Catheters due to a manufacturing defect that could cause hub leaks.

    Product
    Guider Softip XF; GUIDER/40DEG XF/6FR/90CM, Model number: H965100420. Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional devices into the neurovascular system.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0053-2017·2016-10-26

    Vascular Solutions Recalls Twin-Pass Catheters Due to Manufacturing Material

    Vascular Solutions is recalling Twin-Pass dual access catheters because excess manufacturing material may remain at the tip or in the distal lumen.

    Product
    Vascular Solutions Twin-Pass Dual Access Catheter, models 5200, 5210, and 5230. Sterilized with Ethylene Oxide. The Twin-Pass dual access catheter is a dual lumen catheter designed for use in the coronary and/or peripheral vasculature. The Twin-Pass catheter (Models 5200…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0091-2017·2016-10-26

    Triceutical Recalls Super Natural Children's Growth Formula Due to Manufacturing Issues

    Triceutical Inc. is recalling Super Natural Children's Growth Formula dietary supplements because they were not produced according to good manufacturing practices.

    Product
    Super Natural Children's Growth Formula Dietary Supplement, 90 Tablets, Manufactured for GW Biotech Greenwood Biotech, LLC New York. Made in USA.
    Category
    Food
    Distribution
    3 states
  • LowFDA (Food)·F-0095-2017·2016-10-26

    Triceutical Recalls Joint Lubrica Rebuilds Dietary Supplements for Manufacturing Issues

    Triceutical Inc. is recalling Joint Lubrica Rebuilds dietary supplements due to a lack of good manufacturing practices. The product was distributed in Florida, New York, Pennsylvania, and China.

    Product
    Joint Lubrica Rebuilds, 120 Capsules, Dietary Supplement, Distributed by: GW Biotech Greenwood Biotech, LLC Staten Island, NY 10305. Made in USA.
    Category
    Food
    Distribution
    3 states
  • LowFDA (Food)·F-0097-2017·2016-10-26

    Triceutical Recalls Super Lecithin Complex Soft Gels for Manufacturing Issues

    Triceutical Inc. is recalling Super Lecithin Complex soft gels due to a lack of good manufacturing practices. The recall covers 1,450 bottles distributed in Florida, New York, Pennsylvania, and China.

    Product
    Super Lecithin Complex soft gels
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Drugs)·D-0024-2017·2016-10-19

    Teva Recalls Amikacin Sulfate Injection Due to Manufacturing Deviations

    Teva Pharmaceuticals USA is voluntarily recalling 11,844 vials of Amikacin Sulfate Injection due to Current Good Manufacturing Practice (CGMP) deviations.

    Product
    Amikacin Sulfate Injection, USP, 1 gm/4 mL (250 mg/mL) Rx Only, Manufactured in Hungary For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0703-9040-01 (individual pack), NDC 0703-9040-03 (shelf-pack carton of 10 vials).
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0003-2017·2016-10-12

    Zimmer Biomet Recalls Vanguard 360 Knee Prostheses Due to Bolt Defect

    Zimmer Biomet is recalling 454 Vanguard 360 Revision Knee System prostheses because a manufacturing defect in the tibial augment bolts may prevent them from being fully tightened during surgery.

    Product
    Vanguard 360 Revision Knee System Knee prostheses
    Category
    Medical Device
    Distribution
    9 states