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.

851–875 of 1434

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
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-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-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
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 bradycar
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 inserte
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 needl
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-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 c
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-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-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-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-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 pa
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 c
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1501-2021·2021-05-05
Nextremity Solutions Recalls InCore Lapidus Disposable Kits Due to Drill Bushing Defect
Nextremity Solutions is recalling 123 units of InCore Lapidus Disposable Kits because a drill bushing defect may prevent surgeons from completing the intended procedure.
Product
InCore Lapidus Disposable Kit 28mm Right, Part Number: IC-LAP-28R - Product Usage: Intended as a three-part construct intended for internal fixation for First Metatarsocuneiform arthrodesis.
Category
Medical Device
Distribution
16 states
SevereFDA (Devices)·Z-1473-2021·2021-04-28
Smiths Medical Recalls LogiCal Left Heart Kits Due to Weld Defects
Smiths Medical ASD Inc. is recalling specific lots of LogiCal Left Heart Kits and related components due to insufficient or incomplete welds.
Product
LogiCal Left Heart Kit, Model Number M20553. for blood pressure monitoring.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1471-2021·2021-04-28
Smiths Medical Recalls Medex High Pressure Adaptors and LogiCal Kits
Smiths Medical ASD Inc. is recalling specific lots of Medex High Pressure Adaptors and LogiCal Kits due to insufficient or incomplete welds.
Product
Mark 910 LogiCal, Model Number DPS567201. for blood pressure monitoring and blood sampling.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1475-2021·2021-04-28
Smiths Medical Recalls Medex High Pressure Adaptors and LogiCal Kits
Smiths Medical is recalling specific lots of Medex High Pressure Adaptors and LogiCal Kits due to potential manufacturing defects in welds.
Product
ANGIOGRAPHIC KIT W/MX123-3MR MANIFOLD, Model Number MX1030. for use during angiography and other special procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1411-2021·2021-04-21
FDA Recalls 59,828 Covidien Surgiwand II Suction and Irrigation Devices
The FDA is recalling 59,828 units of the Covidien Surgiwand II Suction and Irrigation Device due to a manufacturing defect that generates particulate matter inside the tubing.
Product
Covidien Surgiwand" II Suction and Irrigation Device: Electrosurgical, cutting & coagulation & accessories22 Product Number/CFN: 178083, 178093, 178094
Category
Medical Device
Distribution
36 states
ModerateFDA (Devices)·Z-1301-2021·2021-03-31
Cardinal Health Recalls In-View Clear Leggings Due to Manufacturing Variance
Cardinal Health is recalling In-View Clear Leggings because a manufacturing variance causes the product to stick, preventing proper application.
Product
In-View Clear Leggings Sterile Non-Sterile
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1303-2021·2021-03-31
Cardinal Health Recalls Sterile Femoral Angiography Drapes Due to Sticking Defect
Cardinal Health is recalling 936 units of sterile femoral angiography drapes because a manufacturing variance causes the plastic film to stick, preventing proper application.
Product
Femoral Angiography Drape Sterile
Category
Medical Device
Distribution
Distributed nationwide