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.

851–875 of 1441

  • HighFDA (Devices)·Z-1885-2021·2021-06-23

    Medtronic perfusion tubing packs recalled for manufacturing weld defects

    Medtronic recalls 11 packs of HY10Y54R4 Custom Perfusion System tubing manufactured with insufficient or incomplete welds. No injuries have been reported.

    Product
    Medtronic HY10Y54R4, Custom Pack HY10Y54R4 ECC PED 1/4, Custom Perfusion System, Sterile, Rx.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1880-2021·2021-06-23

    Medtronic Perfusion System Tubing Packs Recalled for Defective Welds

    Medtronic is recalling specific lots of Custom Pack HY8R62R13 E Pack perfusion system tubing due to manufacturing defects. Affected lots may have incomplete welds that could compromise device function during use.

    Product
    Medtronic HY8R62R13,Custom Pack HY8R62R13 E Pack, Custom Perfusion System, Sterile, Rx.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1892-2021·2021-06-23

    Medtronic Cardiac Perfusion Tubing Packs Recalled for Incomplete Welds

    Medtronic is recalling specific lots of BB8M63R5 adult cardiac perfusion tubing packs due to incomplete welds in the manufacturing process. These defects could compromise tubing integrity during cardiac surgery.

    Product
    Medtronic BB8M63R5, Custom Pack BB8M63R5 Adult ECC, Custom Perfusion system, Sterile, Rx.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1878-2021·2021-06-23

    Medtronic Perfusion System Tubing Packs Recalled for Weld Defects

    Medtronic is recalling specific lots of CB1H18R20 Custom Perfusion System tubing packs because they may have been manufactured with insufficient or incomplete welds. No injuries have been reported.

    Product
    Medtronic CB1H18R20, Custom Pack CB1H18R20 Accesory, Custom Perfusion System, Sterile, Rx.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1875-2021·2021-06-23

    Medtronic Custom Perfusion System Tubing Packs Recalled for Incomplete Welds

    Medtronic recalls Custom Perfusion System tubing packs due to incomplete welds in the manufacturing process that may affect device integrity.

    Product
    Medtronic HY7M07R6, Custom Pack HY7M07R6 E 1/4, Custom Perfusion System, Sterile, Rx.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0657-2021·2021-06-16

    Garlic Alfredo Sauce Recall Due to Non-Food Grade Anti-Foamer

    Kerry Inc. is recalling Garlic Alfredo Sauce (product code 20607981) because the product was manufactured with a non-food grade anti-foamer ingredient. The affected sauce was distributed to AZ, CO, OK, TX, and WI.

    Product
    Garlic Alfredo Sauce. Product code 20607981. Keep Frozen. Net Wt. 30 lb. (13.61KG) Distributed By: Kerry Inc., Beloit, WI 53511.
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1835-2021·2021-06-16

    Medical microscope slide stainer recalled due to defective pump tubing

    Hardy Diagnostics is recalling the Quickslide GramPro 1 Automated Gram Stanier due to defective tubing in the pump mechanism that could cause device malfunction.

    Product
    Quickslide GramPro 1 Automated Gram Stanier is a microscope slide stainer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1679-2021·2021-06-02

    Nobel Biocare Implant Crown Recalled for Manufacturing Specification Defects

    Nobel Biocare Procera LLC is recalling specific implant crown units because they were not manufactured to specification. The recall affects units distributed in the US and several international countries.

    Product
    NPr FCZ¿Imp Crwn ASC CC NP CAD 1-25¿ s4 - Product Usage: Implant Crown intended to be placed in the upper or lower jaw creating a prosthetic device (full contour crown), and to restore the patient s chewing function and esthetics. Material Number: 77363
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1681-2021·2021-06-02

    Nobel Biocare Procera LLC Recalls Implant Crowns Not Manufactured to Specification

    Nobel Biocare Procera LLC is recalling specific implant crowns because they were not manufactured to specification. The recall affects units distributed in the US and several international countries.

    Product
    NPr FCZ¿Imp Crwn ASC CC NP CAD 1-25¿ s6 - Product Usage: Implant Crown intended to be placed in the upper or lower jaw creating a prosthetic device (full contour crown), and to restore the patient s chewing function and esthetics. Material Number: 77387
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1678-2021·2021-06-02

    Nobel Biocare Procera Implant Crown Recall for Manufacturing Defects

    Nobel Biocare Procera LLC is recalling seven implant crown units because they were not manufactured to specification. The recall covers distribution in the US and several international countries.

    Product
    NPr FCZ¿Imp Crwn ASC CC RP CAD 1-25¿s3 - Product Usage: Implant Crown intended to be placed in the upper or lower jaw creating a prosthetic device (full contour crown), and to restore the patient s chewing function and esthetics. Material Number: 77352
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1680-2021·2021-06-02

    Nobel Biocare Procera Implant Crown Recalled for Manufacturing Defect

    Nobel Biocare Procera LLC is recalling specific implant crown units that were not manufactured to specification. The recall affects units distributed in the US and several international countries.

    Product
    NPr FCZ¿Imp Crwn ASC CC RP CAD 1-25¿ s4 - Product Usage: Implant Crown intended to be placed in the upper or lower jaw creating a prosthetic device (full contour crown), and to restore the patient s chewing function and esthetics. Material Number: 77364
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1677-2021·2021-06-02

    Nobel Biocare Procera Recalls Two Dental Implant Crowns for Specification Defects

    Nobel Biocare Procera LLC is recalling two dental implant crown units because they were not manufactured to specification. The affected units were distributed in the US and several international countries.

    Product
    NPr FCZ¿Imp Crwn ASC CC RP CAD 1-25¿ s2 - Product Usage: Implant Crown intended to be placed in the upper or lower jaw creating a prosthetic device (full contour crown), and to restore the patient s chewing function and esthetics Material Number: 77339
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1650-2021·2021-05-26

    Medtronic Recalls Two Defective Implantable Cardioverter Defibrillators

    Medtronic is recalling two Cobalt HF Quad MRI SureScan CRT-D devices due to a potential missing resistance spot weld.

    Product
    Cobalt HF Quad MRI SureScan Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D) - Product Usage: are multiprogrammable cardiac devices that monitor and regulate a patient s heart rate by providing single- or dual chamber rate responsive…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1593-2021·2021-05-26

    Gore Viabil Biliary Endoprosthesis Recalled for Length Discrepancy

    W.L. Gore & Associates is recalling 61 Gore Viabil Biliary Endoprosthesis devices because a complaint reported a device appeared shorter than its labeled length.

    Product
    GORE VIBIL Biliary Endoprosthesis: stents, drains and dilators for the biliary ducts. Catalogue numbers: VH1008040, VH1010040, VN1010040, VN0808200 - Product Usage: intended for palliation of malignant strictures in the biliary tree.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1584-2021·2021-05-19

    ICU Medical Recalls Sprios IV Adapters Due to Leakage Defect

    ICU Medical is recalling specific lots of Sprios IV adapters because a molding defect may cause leakage in the inactivated position.

    Product
    REF 034-H2629 Appx 1.0 ml, Adaptador universal para sistemas IV con Spiros" - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1582-2021·2021-05-19

    ICU Medical Recalls Sprios Male Luer Administration Sets Due to Leakage

    ICU Medical is recalling specific lots of Sprios male luer administration sets due to a molding defect that may cause leakage in the inactivated position.

    Product
    REF 011-H2864-HSR 180 cm (71 IN)APPX 11.5ml, PUR AMBR, Spiros, CAMERA, REG. FLUSSO, BCV, Y-Clave - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1569-2021·2021-05-19

    ICU Medical Recalls Spinning Spiros Closed Male Luer Due to Leakage

    ICU Medical is recalling certain lots of Spinning Spiros Closed Male Luer devices due to a molding defect that may cause leakage in the inactivated position.

    Product
    REF Spinning Spiros Closed Male Luer - Product Usage: provides access for the administration of fluids from a container to a patients vascular system through the administration sets needle or catheter (which is inserted into a vein).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1567-2021·2021-05-19

    ICU Medical Recalls Spiros Administration Sets Due to Molding Defect

    ICU Medical is recalling specific lots of Spiros administration sets because a molding defect may cause leakage in the inactivated position.

    Product
    REF 20124-01 30" (76 cm) Appx 3.2 ml, 20 Drop Admin Set w/Integrated Clave Drip Chamber, Spiros, Bag Hanger LOT 5142971 - Product Usage: provides access for the administration of fluids from a container to a patients vascular system through the administration sets needle or…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1581-2021·2021-05-19

    ICU Medical Recalls Admin Sets Due to Potential Leakage Defect

    ICU Medical is recalling specific lots of REF 011-CH3967 Admin Sets due to a molding defect that may cause leakage in the inactivated position.

    Product
    REF 011-CH3967 Admin Set w/ClaveTM, SpirosTM - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1580-2021·2021-05-19

    ICU Medical Recalls Smallbore Trifuse Extension Sets Due to Leakage Defect

    ICU Medical is recalling specific lots of Smallbore Trifuse Extension Sets because a molding defect may cause leakage in the inactivated position.

    Product
    REF CH3625 5" (13 cm) Appx 0.50 ml, Smallbore Trifuse Ext Set w/3 ChemoClave (Purple, Green Rings), Spiros w/Red Cap, 3 Clamps - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1578-2021·2021-05-19

    ICU Medical Recalls Sprios Administration Sets Due to Molding Defect

    ICU Medical is recalling specific lots of Sprios administration sets due to a molding defect that may cause leakage in the inactivated position.

    Product
    REF CH3011 30" (76 cm) Appx 3.3 mL, 20 Drop Admin Set w/Integrated ChemoClave Drip Chamber, Spiros w/Red Cap, Bag Hanger - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1572-2021·2021-05-19

    ICU Medical Recalls Oncology Kits Due to Molding Defect

    ICU Medical is recalling specific lots of REF CL3538 Oncology Kits because a molding defect may cause small amounts of leakage in the inactivated position.

    Product
    REF CL3538 Oncology Kit w/5" (13 cm) Add-On Set w/ChemoLock Additive Port, Vented Cap; ChemoLock , Spinning Spiros w/Red Cap - Product Usage: provides access for the administration of fluids from a container to a patients vascular system through the administration sets needle…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1586-2021·2021-05-19

    ICU Medical Recalls Spinning Spiros Male Luers Due to Molding Defect

    ICU Medical is recalling specific lots of Spinning Spiros male luers because a molding defect may cause small amounts of leakage in the inactivated position.

    Product
    REF 20130-01 Spinning Spiros¿ Closed Male Luer, Red Cap REF CH2000S-PC Spinning Spiros¿ Closed Male Luer, Purple Cap - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1590-2021·2021-05-19

    ICU Medical Recalls Spinning Spiros Male Luers Due to Leakage Defect

    ICU Medical is recalling specific lots of Spinning Spiros Closed Male Luers because a molding defect may cause leakage in the inactivated position.

    Product
    REF K7040-001 Spinning Spiros Closed Male Luer - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1574-2021·2021-05-19

    ICU Medical Recalls Oncology Kits Due to Potential Leakage Defect

    ICU Medical is recalling specific lots of Oncology Kits because a molding defect may cause small amounts of leakage in the inactivated position.

    Product
    REF CL3960 Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/w/ChemoLock Port, Clamp, Anti-Siphon Valve, Spiros ; w/ChemoLock; Syringe Transfer Set w/MicroClave, w/ChemoLock Port - Product Usage: provides access for the administration of fluids from a container to a…
    Category
    Medical Device
    Distribution
    Distributed nationwide