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.

1176–1200 of 1434

  • 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-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-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, 71
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-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-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-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
  • 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
  • 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
  • HighFDA (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 and
    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
  • ModerateFDA (Devices)·Z-2854-2016·2016-09-28

    EKOS Intelligent Drug Delivery Catheter Recalled for Potential Epoxy Defect

    EKOS Corporation is recalling 10 Intelligent Drug Delivery Catheters due to potential non-compliant manufacturing tests that may cause epoxy blisters.

    Product
    EkoSonic Endovascular Devices EKOS Intelligent Drug Delivery Catheter
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2757-2016·2016-09-14

    Sorin Coronary Artery Perfusion Cannula Recalled for Tip Angle Defect

    Sorin Group USA is recalling 1,205 units of Coronary Artery Perfusion Cannulas with Balloons because the tip angle is less than the required 45 or 90 degrees.

    Product
    Coronary Artery Perfusion Cannula with Balloon (part number CP-2200X). The Coronary Artery Perfusion Cannula with Balloon The Cannula consists of a single lumen vinyl tube provided for with a vinyl female luer connector bonded proximally and a vinyl cuff bonded distally. The cuff
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-2756-2016·2016-09-14

    Sorin Aortic Arch Cannula Recalled for Improper Tip Angle

    Sorin Group USA is recalling Aortic Arch Cannulas because the tip angle is less than the required 45 or 90 degrees.

    Product
    Aortic Arch Cannula and Coronary Artery Perfusion Cannula with Ballon (part number NA-55X6). The Aortic Arch Cannulae are designed to be used in the extracorporeal circuit during cardiopulmonary bypass surgery. The cannula consists of varying lengths of non-wire reinforced (flex
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Drugs)·D-1467-2016·2016-08-31

    Mylan Amlodipine Besylate Tablets Recalled for CGMP Deviations

    Mylan Institutional, Inc. is recalling Amlodipine Besylate Tablets, 5 mg, because they were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.

    Product
    Amlodipine Besylate Tablets, USP, 5 mg*, packaged in a) 100-count (10 x 10) unit dose blisters per carton, NDC 51079-451-20; b) 300-count (10 x 30) unit dose blisters per carton, NDC 51079-451-56, c) 25-count (25 x 1) Robot-Rx Ready Packages in a carton, NDC 51079-451-19; and d)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2635-2016·2016-08-31

    Medtronic Recalls Tibial Tray Components Due to Passivation Defect

    Medtronic is recalling three units of tibial tray components for total knee replacement because they may not have been passivated correctly.

    Product
    TIBIAL TRAY , SIZE 2, REF 90-SRK-200200, QTY: 1, STERILE R, total knee replacement .
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2634-2016·2016-08-31

    Medtronic Recalls Alpha Total Knee Replacement Components for Passivation Defect

    Medtronic Sofamor Danek USA Inc is recalling four units of Alpha total knee replacement femoral components that may not have been passivated according to requirements.

    Product
    RESPONSIVE, KNEE: FEMORAL total knee replacement COMPONENT CR/CS, SIZE 3L, REF 90-SRK-312300, QTY: 1, STERILE R,
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2638-2016·2016-08-31

    Medtronic Recalls Alpha Total Knee Replacement Tibial Tray Components

    Medtronic is recalling specific Alpha total knee replacement tibial trays that may not have been passivated according to manufacturing requirements.

    Product
    TIBIAL TRAY , SIZE 5, REF 90-SRK-200500, QTY: 1, STERILE R, Responsive Orthopedics, total knee replacement
    Category
    Medical Device
    Distribution
    3 states