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.

1376–1400 of 1434

ModerateFDA (Devices)·Z-0354-2014·2013-11-27
Restoration Robotics Recalls ARTAS Disposable Kits Due to Pin Discoloration
Restoration Robotics is recalling ARTAS Disposable Kits because skin tensioner pins have discoloration from insufficient cleaning during manufacturing.
Product
ARTAS Disposable Kit ( Contains Skin Tensioner FP-45384; Inner Needle with Vacuum Tube FP-45385; Dissection Punch 4.0mm FP-23304; Saline Nose Cone FP-45387; Follicle Trap - FP-23306 and Non-sterile Disposable Clinical Kit FP -23267): and ARTAS Disposable Kits, 18 Gauge Epsilon
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0045-2014·2013-10-30
Merit Medical Recalls Performa Angiographic Catheters Due to Tip Shape Variation
Merit Medical Systems is recalling 200 units of Performa Angiographic Catheters because four lots contain a catheter with a slight variation in tip shape.
Product
Merit Medical Performa Angiographic Catheter 5F Multipack. Part numbers 7560-43 and 7560-G3.
Category
Medical Device
Distribution
3 states
ModerateFDA (Devices)·Z-2208-2013·2013-09-25
Biomet 3i Recalls Dental Implants Lacking Internal Hex and Thread Features
Biomet 3i, LLC is recalling 178 Osseotite Parallel Walled dental implants because some units are missing the internal hex and internal thread features.
Product
Osseotite Parallel Walled Certain 4mm(D)X 15mm (L) Dental Implant Product Usage: Surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth utiliz
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2207-2013·2013-09-25
Biomet 3i Recalls Dental Implants Lacking Internal Hex and Thread Features
Biomet 3i is recalling 215 Osseotite 2 Certain Prevail dental implants because some units lack the internal hex and thread features required for proper prosthetic attachment.
Product
Osseotite 2 Certain Prevail 5mm(D)X 4.1mm (P) X X 11.5mm (L) Dental Implant Product Usage: Surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single te
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2064-2013·2013-09-04
Waldemar Link Recalls Trial Stems for Hip Reconstruction Prosthesis
Waldemar Link is recalling five trial stems for the MP Reconstruction Prosthesis because they were manufactured using the wrong design. The units were distributed only to Tennessee.
Product
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/20, Stem size 004, prox. Stem dia. 20 mm, Length 210 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2065-2013·2013-09-04
Waldemar Link Recalls Trial Stems for Hip Reconstruction Prosthesis
Waldemar Link is recalling five trial stems for hip reconstruction prostheses because they were manufactured using the wrong design.
Product
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/22, Stem size 005, prox. Stem dia. 22.5 mm, Length 210 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2076-2013·2013-09-04
Waldemar Link Recalls Trial Stems for Hip Reconstruction Prosthesis
Waldemar Link is recalling six trial stems for hip reconstruction prostheses because they were manufactured using the wrong design. The units were distributed only to Tennessee.
Product
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/16, Stem size S-2, prox. Stem dia. 16 mm, Length 180 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2073-2013·2013-09-04
Waldemar Link Recalls Trial Stems for Hip Reconstruction Prosthesis
Waldemar Link is recalling five trial stems for the MP Reconstruction Prosthesis because they were manufactured using the wrong design. The units were distributed only in Tennessee.
Product
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/25, Stem size 06, prox. Stem dia. 25 mm, Length 250 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2072-2013·2013-09-04
Waldemar Link Recalls Trial Stems for Hip Reconstruction Prosthesis
Waldemar Link is recalling four trial stems for a hip reconstruction prosthesis because they were manufactured using the wrong design.
Product
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/22, Stem size 05, prox. Stem dia. 22.5 mm, Length 250 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2063-2013·2013-09-04
Waldemar Link Recalls Trial Stems for Hip Reconstruction Prosthesis
Waldemar Link is recalling five trial stems for a hip reconstruction prosthesis because they were manufactured using the wrong design.
Product
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/18, Stem size 003, prox. Stem dia. 18 mm, Length 210 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2075-2013·2013-09-04
Waldemar Link Recalls Trial Stems for Hip Reconstruction Prosthesis
Waldemar Link is recalling six trial stems for the MP Reconstruction Prosthesis because they were manufactured using the wrong design. The units were distributed only in Tennessee.
Product
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/14, Stem size S-1, prox. Stem dia. 14 mm, Length 180 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2086-2013·2013-09-04
Alphatec Recalls Illico Ti Cannulated Polyaxial Screws Due to Manufacturing Defect
Alphatec Spine is recalling specific lots of Illico Ti Cannulated Polyaxial Screws because an off-center hole may prevent guide wires from passing through during surgery.
Product
Illico Ti Cannulated Polyaxial Screw 7.5mm X 40mm. The Illico MIS Posterior Fixation System is intended to facilitate the surgical correction of noncervical spinal deformities by providing temporary internal fixation and stabilization during bone graft healing and/or fusion mass
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2068-2013·2013-09-04
Waldemar Link Recalls Trial Stems for Hip Reconstruction Prosthesis
Waldemar Link is recalling 7 trial stems for hip reconstruction prostheses because they were manufactured using the wrong design. The units were distributed only to Tennessee.
Product
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/14, Stem size 01, prox. Stem dia. 14 mm, Length 250 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-2100-2013·2013-09-04
3M ESPE Recalls Unitek Primary Stainless Steel Crowns for Defective Edges
3M ESPE is recalling Unitek Primary Stainless Steel Crowns because they were manufactured with the incorrect marginal contour edge.
Product
3M ESPE Unitek Primary Stainless Steel Crowns (First Primary UL4), Product code 902150 (Kit- 112 crowns/kit) and 900114 (Refill- 5 crowns/box). Product Usage: Stainless Steel Crowns are designed to fill the need for long term provisional coverage on adult molars and bicuspids
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2060-2013·2013-09-04
Waldemar Link Recalls Trial Stems for Reconstruction Prosthesis
Waldemar Link is recalling four trial stems for a reconstruction prosthesis because they were manufactured using the wrong design.
Product
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/12, Stem size 00, prox. Stem dia. 12 mm, Length 210 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-2070-2013·2013-09-04
Waldemar Link Recalls Trial Stems for Reconstruction Prosthesis
Waldemar Link is recalling five trial stems for a reconstruction prosthesis because they were manufactured using the wrong design. The units were distributed only to Tennessee.
Product
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/18, Stem size 03, prox. Stem dia. 18 mm, Length 250 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-1935-2013·2013-08-21
Synthes Recalls 5.0mm Stainless Steel Spinal Rods Due to Process Error
Synthes USA is recalling 492 units of 5.0mm stainless steel spinal rods because they were produced using a finishing process not identified in the manufacturing specification.
Product
5.0mm Unit Rod 270mm 5.0mm Unit Rod 290mm 5.0mm Unit Rod 310mm 5.0mm Unit Rod 330mm 5.0mm Unit Rod 350mm 5.0mm Unit Rod 370mm 5.0mm Unit Rod 390mm 5.0mm Unit Rod 410mm 5.0mm Unit Rod 430mm 5.0mm Unit Rod 450mm pedicle screw spinal system; Intended to provide immobil
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-605-2013·2013-06-26
Sagent Recalls Vecuronium Bromide Injection Due to Manufacturing Deviations
Sagent Pharmaceuticals is recalling Vecuronium Bromide for Injection because it was not manufactured under current good manufacturing practices, resulting in failed impurity specifications.
Product
VECURONIUM Bromide for Injection, 10 mg* per vial, *1 mg per mL when reconstituted to 10 mL, for IV single use only, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195 (USA); Mfd. by MN Pharmaceuticals; Made in Turkey, NDC 25021-657-10.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1548-2013·2013-06-26
Biomet Recalls Superior Approach Resection Guide Assembly Due to Slot Offset
Biomet is recalling 17 units of the Superior Approach Resection Guide Assembly because a manufacturing defect may prevent the guide from securing properly to bone during surgery.
Product
Superior Approach Resection Guide Assembly. Indicated for primary, fracture, or revision total shoulder replacement for the relief of pain.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1553-2013·2013-06-26
Prism Medical Recalls BC Hammock Mesh Slings Due to Incorrect Size
Prism Medical Services USA is recalling 5 BC Hammock Mesh Slings (Large) because they were produced in the incorrect size.
Product
BC Hammock Mesh Sling (Large), product number, 537030. Product Usage: The fabric sling is used for the transfer of a patient, for example from a bed to a wheelchair.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1522-2013·2013-06-19
StarDental Classique Diamond Dental Bur Recall for Coating Adhesion Issues
Dental EZ Stardental Division is recalling 3,560 StarDental Classique Diamond Dental Burs because a manufacturing issue prevented the diamond coating from adhering properly to the shank.
Product
StarDental Classique(TM) Diamond Dental Bur. Used for specific applications in dental procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1376-2013·2013-06-05
Zimmer Recalls NEXGEN Complete Knee Solution Tibial Drills
Zimmer, Inc. is recalling 69 units of NEXGEN Complete Knee Solution Tibial Drills because the outside diameter may be oversized, preventing them from passing through the drill guide.
Product
NEXGEN Complete Knee Solution Monoblock Tibial Drill with stop 10.7 mm. Used to prepare cylindrical holes in the native tibia.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1377-2013·2013-06-05
Anspach Effort 3mm Diamond Ball Burrs Recalled for Grit Size Defect
The Anspach Effort, Inc. is recalling 1,827 3mm Diamond Ball burrs because three batches may have diamond grit larger than intended.
Product
***REF S-3D*** 3mm Diamond Ball. Used for cutting and shaping bone.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1408-2013·2013-06-05
Merit Medical Recalls Performa Cardiac Multipacks Due to Tip Shape Variation
Merit Medical Systems is recalling specific lots of Performa Cardiac Multipacks containing a JR4.0 catheter due to a slight variation in tip shape.
Product
Merit Medical PerfOrma Anglographic Catheter 5F Multipack Product Usage: Angiographic catheters are designed to be used for delivering radiopaque media to selected sites in the vascular system in conjunction with routine diagnostic procedures.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0975-2013·2013-04-03
Orthohelix Intraosseous Fixation System Drill Bits Recalled for Manufacturing Defect
Orthohelix Surgical Designs Inc is recalling specific lots of Intraosseous Fixation System drill bits because a burr prevents them from fitting over the guide wire.
Product
Intraosseous Fixation System (IFS) 1.7 mm, 2.0 mm & 2.5 mm Cannulated Drill Bit. Intended to stabilize and aid in fixation of fractures.
Category
Medical Device
Distribution
Distributed nationwide