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.

1401–1425 of 1441

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-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-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-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
ModerateFDA (Devices)·Z-0905-2013·2013-03-13
Synthes Multi-Vector Distractor Recalled for Non-Conforming Shear Pin
Synthes USA is recalling 18 Multi-Vector Distractors because the shear pin may not meet product specifications.
Product
Synthes Multi-Vector Distractor - Multi-axial Mandible Distractor (Left), Part Number 487.967. For mandibular bone lengthening.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0903-2013·2013-03-13
Synthes Multi-Vector Distractor Body Recalled for Manufacturing Defect
Synthes USA HQ, Inc. is recalling two units of the Multi-Vector Distractor Body because the sheer pin may not meet product specifications.
Product
Synthes Multi-Vector Distractor Body, Part Number 487.931. For mandibular bone lengthening.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0904-2013·2013-03-13
Synthes Multi-Vector Distractor Recalled Due to Shear Pin Specification Issues
Synthes USA is recalling 24 Multi-Vector Distractors because the sheer pin may not meet product specifications. The devices are used for mandibular bone lengthening.
Product
Synthes Multi-Vector Distractor, Multi-axial Mandible Distractor (Right), Part Number 487.966. For mandibular bone lengthening.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0770-2013·2013-02-13
Zimmer Recalls Trilogy Acetabular Shells for Porosity Defects
Zimmer, Inc. is recalling Trilogy F/M Acetabular Shells because some units have porosity levels below the specified range. The recall includes units manufactured since March 2009 and was expanded in October 2012.
Product
Trilogy F/M Acetabular Shell without holes SOLID HA. Several ODs: 38MM, 40MM, 42MM, 44MM, 46MM, 48MM, 50MM, 52MM, 54MM, 56MM, 58MM, 60MM, 62MM, 64MM, 66MM, 68MM, 70MM. The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0776-2013·2013-02-13
Zimmer Recalls Trilogy Acetabular Shells Due to Porosity Defect
Zimmer, Inc. is recalling Trilogy Acetabular AB Shells with Holes because some units may have porosity below the specified range.
Product
Trilogy Acetabular AB Shells with Holes. The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing surgery for rehabilitating hip damage.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0773-2013·2013-02-13
Zimmer Recalls Trilogy Acetabular Shells Due to Porosity Defect
Zimmer, Inc. is recalling Trilogy Acetabular Shells because some units may have porosity below the specified range, potentially affecting the device's performance.
Product
Trilogy Acetabular Shell with Cluster Holes. The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing surgery for rehabilitating hip damage.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0775-2013·2013-02-13
Zimmer Recalls Trilogy Acetabular Shells with Porosity Defects
Zimmer, Inc. is recalling Trilogy Acetabular Shells with holes because some units have porosity below the specified range, which may affect bone ingrowth.
Product
Trilogy Acetabular Shells with Holes. The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing surgery for rehabilitating hip damage.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0774-2013·2013-02-13
Zimmer Recalls Trilogy Acetabular Shells Due to Porosity Defects
Zimmer, Inc. is recalling Trilogy Acetabular AB Shells because some units have porosity levels below the required specification.
Product
Trilogy Acetabular AB Shells with Cluster Holes. The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing surgery for rehabilitating hip damage.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0771-2013·2013-02-13
Zimmer Recalls Trilogy Acetabular Shells Due to Porosity Defects
Zimmer, Inc. is recalling Trilogy F/M Acetabular Shells with Uni-Hole because some units have porosity below the specified range.
Product
Trilogy F/M Acetabular Shell with Uni-Hole. The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing surgery for rehabilitating hip damage.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0789-2013·2013-02-13
ConMed Linvatec Recalls PopLok Bone Punch Due to Incorrect Shaft Diameter
ConMed Linvatec recalled one lot of PopLok bone punches because the metal shaft diameter is 4.5mm instead of the specified 3.5mm.
Product
ConMed Linvatec Biomaterials, PopLok bone Punch PKL-35M, 3.5mm Orthopedic manual surgical instrument - Bone Punch
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-0753-2013·2013-02-06
Biomet TUNNELOC Round Head Interference Screw Recalled for Undersized Tip Hole
Biomet is recalling 44 TUNNELOC Round Head Interference Screws because the hole at the tip is undersized. The defect may affect the device's performance during orthopedic procedures.
Product
TUNNELOC ROUND HEAD INTERFERENCE SCREW 8MMX25MM Biomet Sports Medicine manufactures a variety of internal fixation devices intended to aid in arthroscopic and orthopedic reconstructive procedures requiring soft tissue fixation, due to injury or degenerative disease. Implants…
Category
Medical Device
Distribution
7 states
HighFDA (Devices)·Z-0464-2013·2012-12-12
Merit Medical Systems Recalls Custom Procedural Trays Due to Missing Tape
Merit Medical Systems is recalling 83 custom procedural trays because clear protective tape was not applied during manufacturing.
Product
Custom Procedural Trays: Merit's Custom Total Hip Pack, K12T-05537, Merit's Total Knee Pack, K12T05538 A custom procedural tray is a combination of legally marketed medical devices placed into one container for the convenience of the user and used within the limits of the…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0297-2013·2012-11-28
Biomet 3i Recalls OSSEOTITE Dental Implants Due to Shallow Hex Depth
Biomet 3i is recalling 191 OSSEOTITE dental implants because a manufacturing defect makes the internal hex too shallow, which may prevent the driver or abutment from fully engaging.
Product
Product is Full OSSEOTITE 2 Tapered Certain Implant, Model Number XIFNT413, and size 4 x 13 mm. The product is sterile. Product provides a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0434-2013·2012-11-28
SenTec V-Sign Membrane Changer Insert Recalled for Manufacturing Defect
Sentec AG is recalling SenTec V-Sign Membrane Changer Inserts due to a manufacturing defect that prevents electrolyte presence, potentially degrading PCO2 sensor performance.
Product
SenTec V-Sign Membrane Changer Insert (VS-MCI), 5 pieces. The SenTec V-Sign Membrane Changer Insert is indicated for use with the V-Sign Membrane Changer only. The V-sign Sensor is indicated for use with the SenTec Digital Monitor when continuous non-invasive monitoring of…
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-0433-2013·2012-11-28
SenTec V-Sign Membrane Changer Recalled for Manufacturing Defect
Sentec AG is recalling 195 boxes of SenTec V-Sign Membrane Changers due to a manufacturing defect that prevents electrolyte presence, potentially degrading PCO2 performance.
Product
SenTec V-Sign Membrane Changer (VS-MC), 9 pieces. The SenTec V-Sign Membrane Changer is indicated for use with the V-Sign Sensor only. The V-sign Sensor is indicated for use with the SenTec Digital Monitor when continuous non-invasive monitoring of carbon dioxide tension…
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-0406-2013·2012-11-28
INTRABEAM Balloon Applicator Set Recalled for Manufacturing Defect
Carl Zeiss Meditec is recalling INTRABEAM Balloon Applicator Sets due to a manufacturing defect that could cause a small tube to become dislodged.
Product
INTRABEAM Balloon Applicator Set; 4.0 cm, Carl Zeiss Meditec AG, Oberkochen, Germany INTRABEAM System is intended for radiation therapy treatments.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0410-2013·2012-11-28
Zimmer Recalls Multipolar Bipolar Cup Liners Due to Assembly Error
Zimmer, Inc. is removing 195 Multipolar Bipolar Cup Liners because the split poly ring was incorrectly assembled. The recall covers units distributed in the US and several international countries.
Product
Multipolar¿ Bipolar Cup Liner 22 mm LD.; Item 00-5001-040-22 Product Usage: The liner snaps into the Multipolar¿ Bipolar Cup and serves as the articulation surface for the femoral head. The split poly locking ring helps contain the head within the liner and also provides a…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0432-2013·2012-11-28
OrthoPediatrics Recalls 4.5mm PLEO Osteotomy Guide Instruments
OrthoPediatrics Corp is recalling 24 units of the 4.5mm PLEO Osteotomy Guide because the device was not manufactured to design specifications and will not function as intended.
Product
4.5mm PLEO Osteotomy Guide. OrthoPediatrics Corp. markets a pediatric, extension osteotomy bone plate system. This system is marketed under the brand name OrthoPediatrics PediLock Extension Osteotomy Plate ( PLEO ). The product included in this recall is a Class I, 4.5mm PLEO…
Category
Medical Device
Distribution
Distributed nationwide