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.

1426–1441 of 1441

ModerateFDA (Devices)·Z-0416-2013·2012-11-28
Zimmer Recalls Trilogy Acetabular System Shells Due to Missing Threads
Zimmer, Inc. is recalling 95 units of the Trilogy Acetabular System Shell with Cluster Holes because they are missing polar hole threads. No injuries were reported.
Product
The Trilogy Acetabular System Shell with Cluster Holes Porous 56 mm O.D. Sterile The Trilogy Acetabular System is indicated for either cemented or uncemented use In skeletally mature Individuals undergoing primary or revision surgery for rehabilitating hips damaged as a…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0279-2013·2012-11-21
Terumo HX2 Temperature Management System Recalled for Board Defect
Terumo is recalling 15 HX2 Temperature Management Systems because AC Control boards were manufactured with incorrect flux, which may cause premature failure.
Product
Tested AC Control BD, 120V, X2 The Terumo HX2 Temperature Management System is a selfcontained, dual channel system for supplying temperature controlled water to heat exchangers used in an extracorporeal circuit.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0207-2013·2012-11-14
OrthoPediatrics Recalls Trochar Scalpel Instruments for Design Defect
OrthoPediatrics Corp is recalling 78 trochar scalpel instruments that were not manufactured to design specifications and will not function as intended.
Product
Trochar Scalpel Instrument (Surgical Punch) OrthoPediatrics intramedullary rods (nails) are generally rod-shaped devices, with screw holes at either end for fixation to bone. This device is intended to be inserted into the medullary canal of the femur for fixation of…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2487-2012·2012-10-10
Stryker Orthopaedics Recalls Cone Body Trials Due to Metal Shavings
Stryker Howmedica Osteonics Corp. is recalling 10,983 Restoration Modular Cone Body Trials because metal shavings were found in the internal threaded portion.
Product
Stryker Orthopaedics Restoration Modular Cone Body Trials Stryker Ireland Carrigtwohill Industrial Estate Carrigtwohill County Cork, Ireland. The Cone Body Trials simulate the respective Cone Body implants and mate with the stem trials to assist the surgeon in assessing…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2421-2012·2012-09-26
Asahi Kasei Recalls REXEED Hemodialyzers Due to Adverse Event Trend
Asahi Kasei is recalling REXEED hemodialyzers after identifying a negative trend in adverse events potentially linked to a manufacturing change.
Product
Asahi KASEI, REXEED(TM)- 25 SX, HEMODIALYZER dialysis filter
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2423-2012·2012-09-26
Asahi Kasei Recalls REXEED 15 LX Hemodialyzers Due to Adverse Event Trend
Asahi Kasei is recalling 24 units of REXEED 15 LX hemodialyzers due to a negative trend in adverse events potentially linked to manufacturing changes.
Product
Asahi KASEI, REXEED(TM)- 15 LX, HEMODIALYZER dialysis filter
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2422-2012·2012-09-26
Asahi Kasei Recalls REXEED Hemodialyzers Due to Adverse Event Trend
Asahi Kasei is recalling 1,536 REXEED hemodialyzers because of a negative trend in adverse events potentially linked to a manufacturing change.
Product
Asahi KASEI, REXEED(TM)- 13 LX, HEMODIALYZER dialysis filter
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2419-2012·2012-09-26
Asahi Kasei Recalls REXEED Hemodialyzers Due to Adverse Event Trend
Asahi Kasei is recalling 152,016 REXEED hemodialyzers after identifying a negative trend in adverse events potentially linked to a manufacturing change.
Product
Asahi KASEI, REXEED(TM)- 18 SX, HEMODIALYZER dialysis filter
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2418-2012·2012-09-26
Asahi Kasei Recalls REXEED Hemodialyzers Due to Adverse Event Trend
Asahi Kasei is recalling 55,632 REXEED hemodialyzers because of a negative trend in adverse events potentially linked to a manufacturing change.
Product
Asahi KASEI, REXEED(TM)- 15 SX, HEMODIALYZER dialysis filter
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2420-2012·2012-09-26
Asahi Kasei Recalls REXEED Hemodialyzers Due to Adverse Event Trends
Asahi Kasei is recalling 30,408 REXEED hemodialyzers due to a negative trend in adverse events potentially linked to manufacturing changes.
Product
Asahi KASEI, REXEED(TM)- 21 SX, HEMODIALYZER dialysis filter
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2424-2012·2012-09-26
Asahi Kasei Recalls REXEED Hemodialyzers Due to Adverse Event Trend
Asahi Kasei is recalling REXEED hemodialyzers because of a negative trend in adverse events potentially linked to a manufacturing change.
Product
Asahi KASEI, REXEED(TM)- 18 LX, HEMODIALYZER dialysis filter
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-2199-2012·2012-08-22
SenTec Recalls V-Sign 2 Sensors Due to Configuration Parameter Writing Errors
Sentec AG is recalling V-Sign 2 Sensors because of a problem with configuration parameter writing during manufacturing.
Product
SenTec, V-Sign"2 Sensors The SenTec Digital Monitoring System (SMDS) is used for continuous and noninvasive real-time monitoring of ventilation (tcPCO2) and oxygenation (SpO2).
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2028-2012·2012-07-25
Integra Jarit Take-Apart Endoscopic Instruments Recalled for Component Defect
Integra Limited is recalling 108 Take-Apart Endoscopic Instruments because internal shaft components were out of specification.
Product
Integra(TM) Jarit(R) Take-Apart Endoscopic Instruments. Integra(TM) Jarit(R) Take-Apart Endoscopic Instruments are intended for use in laparoscopic gynecological surgery and other operative procedures under endoscopic observations. For use when a rigid endoscopic instrument…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2008-2012·2012-07-25
DeRoyal Recalls Surgical Kits Due to Missing Protective Tape
DeRoyal Industries is recalling 303 custom surgical kits and trays because clear protective tape was not applied during manufacturing.
Product
Custom surgical kits and trays: GEO-MED TOTAL KNEE PACK PGYBK, REF 89-6664.04 GEO-MED TOTAL HIP PACK, REF 89-6664.03 surgical kits
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1927-2012·2012-07-11
Thayer Medical Recalls AirLife MiniSpacer MDI Adapters Due to Molding Defect
Thayer Medical is recalling 19,340 AirLife MiniSpacer MDI adapters due to a molding defect that may result in incomplete filling of the aerosol dispensing pathway.
Product
AirLife¿ MiniSpacer¿ MDI Dispenser Adapter. Dual-Spray MiniSpacer¿ Metered Dose Inhaler (MDI) Dispenser/Adapter with 15 mm connections. The 15 mm Dual Spray MiniSpacer¿ is a Metered Dose Inhaler (MDI) Dispenser. It is a non-sterile, single-use item, intended to dispense…
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-1810-2012·2012-06-20
Stryker T4-Hytrel Zipper Toga Recall Due to Missing Tape
Stryker is recalling T4-Hytrel Zipper Togas because clear tape was not applied during manufacturing, allowing bodily fluids to bleed through the sleeve seam.
Product
T4-Hytrel Zipper Toga Product Usage - The togas are intended to provide a barrier between the operating room and the members of the surgical team in order to help protect against contamination and/or exposure of infectious body fluids and harmful microorganisms.
Category
Medical Device
Distribution
Distributed nationwide