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.

1326–1350 of 1434

ModerateFDA (Devices)·Z-1932-2014·2014-07-09
Zimmer Recalls NexGen Knee Components Due to Thread Specification Issues
Zimmer is voluntarily recalling specific lots of NexGen Complete Knee Solution stemmed tibial components because the threads may be out of specification.
Product
NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 2. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1939-2014·2014-07-09
Zimmer Recalls NexGen Knee Components Due to Thread Specification Issues
Zimmer, Inc. is voluntarily recalling specific lots of NexGen Complete Knee Solution stemmed tibial components because the threads may be out of specification.
Product
NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 8. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1925-2014·2014-07-02
Biomet Recalls Discovery Elbow Prosthesis Due to Surface Finish Defect
Biomet, Inc. is recalling one unit of a Discovery Elbow prosthesis because the surface finish differs from specifications, potentially causing pain requiring surgery.
Product
DISCOVERY ELBOW prosthesis, 4 MM X 100 MM RIGHT HUMERAL FLANGED I BOND COAT Tl 6AL 4V ALLOY. Elbow joint replacement prostheses are intended for primary and revision joint arthroplasty for use in cemented applications.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1876-2014·2014-07-02
Anspach Modified Arthroscopic Knotless Suture Anchor Deployment Tool Recalled
The Anspach Effort, Inc. is recalling Modified Arthroscopic Knotless Suture Anchor Deployment Tools because they were not manufactured consistently with Quality System requirements.
Product
ANSPACH***REF 98-0020***Modified Arthroscopic Knotless Suture Anchor Deployment Tool with Suture Puller***Rx Only*** This device is intended to be used with Anspach Systems
Category
Medical Device
Distribution
14 states
HighFDA (Devices)·Z-1798-2014·2014-06-25
Boston Scientific Recalls IntellaTip MiFi XP Temperature Ablation Catheters
Boston Scientific is recalling 968 IntellaTip MiFi XP Temperature Ablation Catheters because some units were not manufactured according to specification.
Product
IntellaTip MiFi XP Temperature Ablation Catheter; 10m x 8F (2.67mm) Large Curve. The BSC Controller and Accessories are indicated for use in conjunction with standard and high power catheters for cardiac ablation procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1796-2014·2014-06-25
Boston Scientific Recalls IntellaTip MiFi XP Temperature Ablation Catheters
Boston Scientific is recalling 968 IntellaTip MiFi XP Temperature Ablation Catheters because some units were not manufactured according to specification.
Product
IntellaTip MiFi XP Temperature Ablation Catheter; 8mm x 8F (2.67mm); Asymmetric Curve. The BSC Controller and Accessories are indicated for use in conjunction with standard and high power catheters for cardiac ablation procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1794-2014·2014-06-25
Boston Scientific Recalls IntellaTip MiFi XP Temperature Ablation Catheters
Boston Scientific is recalling 968 IntellaTip MiFi XP Temperature Ablation Catheters because some units were not manufactured according to specification.
Product
IntellaTip MiFi XP Temperature Ablation Catheter; 8mm x 8F (2.67mm) Standard Curve. The BSC Controller and Accessories are indicated for use in conjunction with standard and high power catheters for cardiac ablation procedures.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1799-2014·2014-06-25
Boston Scientific Recalls IntellaTip MiFi XP Temperature Ablation Catheters
Boston Scientific is recalling 968 IntellaTip MiFi XP Temperature Ablation Catheters because some units were not manufactured according to specification.
Product
IntellaTip MiFi XP Temperature Ablation Catheter; 10m x 8F (2.67mm) Asymmetric Curve. The BSC Controller and Accessories are indicated for use in conjunction with standard and high power catheters for cardiac ablation procedures.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1797-2014·2014-06-25
Boston Scientific Recalls IntellaTip MiFi XP Temperature Ablation Catheters
Boston Scientific is recalling IntellaTip MiFi XP Temperature Ablation Catheters because some units were not manufactured according to specification.
Product
IntellaTip MiFi XP Temperature Ablation Catheter; 10m x 8F (2.67mm) Standard Curve. The BSC Controller and Accessories are indicated for use in conjunction with standard and high power catheters for cardiac ablation procedures.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1795-2014·2014-06-25
Boston Scientific Recalls IntellaTip MiFi XP Temperature Ablation Catheters
Boston Scientific is recalling 968 IntellaTip MiFi XP Temperature Ablation Catheters because some units were not manufactured according to specification.
Product
IntellaTip MiFi XP Temperature Ablation Catheter; 8mm x 8F (2.67mm); Large Curve. The BSC Controller and Accessories are indicated for use in conjunction with standard and high power catheters for cardiac ablation procedures.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1780-2014·2014-06-18
Stryker Neuro Drill Accessories Recalled for Missing Notches
Stryker is recalling 916 sterile neuro drill cutting accessories due to missing or partial notches that may affect device performance.
Product
Stryker 3.0mm x 3.8mm Neuro Drill Less Aggressive Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgic
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1757-2014·2014-06-18
Stryker 4.5mm Round Fluted Bur Recall for Missing Notches
Stryker is recalling 62 units of 4.5mm Round Fluted Bur Aggressive Sterile devices due to missing or partial notches.
Product
Stryker 4.5mm Round Fluted Bur Aggressive Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical appli
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1760-2014·2014-06-18
Stryker Round Fluted Bur Recall Due to Missing Notches
Stryker is recalling 301 sterile 6.0mm Round Fluted Bur Aggressive devices because some units have missing or partial notches.
Product
Stryker 6.0mm Round Fluted Bur Aggressive Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical appli
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1762-2014·2014-06-18
Stryker Zyphr Elite Round Fluted Bur Recall for Missing Notches
Stryker is recalling 39 sterile Zyphr Elite Round Fluted Burs because some units may have missing or partial notches, which could affect their use with Elite Attachments.
Product
Stryker 3.5mm Zyphr Elite Round Fluted Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical appl
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1749-2014·2014-06-18
Stryker 0.5mm Round Fluted Bur Recalled for Missing Notches
Stryker is recalling 27 sterile 0.5mm Round Fluted Burs because some units may have missing or partial notches, which could affect their use with Elite Attachments.
Product
Stryker 0.5mm Round Fluted Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications incl
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1766-2014·2014-06-18
Stryker 5.0mm Egg Bur Recall Due to Missing Notches
Stryker is recalling 144 units of 5.0mm Egg Bur sterile devices because some cutting accessories may have missing or partial notches.
Product
Stryker 5.0mm Egg Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including ma
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1772-2014·2014-06-18
Stryker 1.3mm Wire Pass Drill Recalled for Missing Notches
Stryker is recalling 176 sterile 1.3mm Wire Pass Drills because some units may have missing or partial notches.
Product
Stryker 1.3mm Wire Pass Drill Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications incl
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1751-2014·2014-06-18
Stryker 2.0mm Round Fluted Bur Recalled for Missing Notches
Stryker is recalling 252 sterile 2.0mm Round Fluted Burs because some units have missing or partial notches, which may affect their use with Elite Attachments.
Product
Stryker 2.0mm Round Fluted Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications i
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1774-2014·2014-06-18
Stryker Neuro Drill Accessories Recalled for Missing Notches
Stryker is recalling 41 sterile neuro drill accessories due to missing or partial notches that may affect compatibility with Elite attachments.
Product
Stryker 2.5mm x 3.6mm Neuro Drill Soft Touch Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical ap
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1758-2014·2014-06-18
Stryker 5.0mm Round Fluted Bur Recall Due to Missing Notches
Stryker is recalling 1,537 sterile 5.0mm Round Fluted Bur Aggressive devices because some units have missing, partial, or no notches.
Product
Stryker 5.0mm Round Fluted Bur Aggressive Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical appli
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1776-2014·2014-06-18
Stryker Neuro Drill Accessories Recalled for Missing Notches
Stryker is recalling 188 sterile neuro drill accessories because some units have missing or partial notches, which may affect their use with Elite attachments.
Product
Stryker 4.0mm x 5.1mm Neuro Drill Soft Touch Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical ap
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1679-2014·2014-06-11
Cincinnati Sub-Zero Recalls 115 V Blanketrol II Hyper-Hypothermia Systems
Cincinnati Sub-Zero is recalling seven 115 V Blanketrol II Hyper-Hypothermia Systems due to an incorrect voltage component that may prevent the device from maintaining patient temperature during cooling.
Product
115 V Blanketrol II, Model 222S Hyper-Hypothermia System . Used to lower or to raise a patients temperature and /or maintain a desired patient temperature through conductive heat transfer. Part number 86165.
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-1637-2014·2014-05-28
Smith & Nephew Recalls Trigen Intertan 1.5 Nails Due to Manufacturing Error
Smith & Nephew is recalling 1,253 units of Trigen Intertan 1.5 Nails because a manufacturing error caused set screws to be inserted too deep.
Product
TRIGEN INTERTAN 1.5 NAIL: (1) REF 71676515, 10 MM X 10 CM, 125 degree, LEFT, (2) REF 71676556, 11.5 MM X 36 CM, 125 degree, RIGHT, (3) REF 71676558, 11.5 MM X 38 CM, 125 degree, RIGHT, (4) REF 71676561, 11.5 MM X 42 CM, 125 degree, LEFT, Smith & Nephew, Inc. Ortho
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1497-2014·2014-04-30
Teleflex Medical Recalls Non-absorbable Steel Sutures for Diameter Defects
Teleflex Medical is recalling specific lots of non-absorbable steel sutures because they did not meet minimum diameter requirements.
Product
Monofilament and Multifilament Non-absorbable Steel Suture; Product Codes: 0520197-2, 29-727, 29-7270M4, 29-7281M4, E29-5553M4, E29-7270M4, E29-7272M4, E29-727A, EP4013P, EP4110N, X-2235, X29-7271M2, X-5667M8 and X-6730M5.
Category
Medical Device
Distribution
8 states
LowFDA (Drugs)·D-1247-2014·2014-04-30
GlaxoSmithKline Recalls Nicorette Lozenge and NicoDerm CQ Combination Pack
GlaxoSmithKline is recalling a specific lot of Nicorette Lozenge and NicoDerm CQ combination packs because the lozenges failed quality specifications.
Product
Nicorette Lozenge and NicoDerm CQ, nicotine polacrilex system. 189 2mg Mint Flavored Lozenges + 21 31 mg Patches. OTC Only. GlaxoSmithKlein, 1000 GSK Drive, Moon Township, PA 15108. UPC: 0-03-0766-1480-30-2.
Category
Drug
Distribution
Distributed nationwide