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.

1226–1250 of 1434

ModerateFDA (Devices)·Z-2095-2016·2016-07-06
Smith & Nephew Legion HK Femoral Assembly Recalled for Surface Defect
Smith & Nephew is recalling 97 units of the Legion HK Femoral Assembly because the internal surface is below specification, potentially affecting cement adhesion.
Product
LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 5 RIGHT, A/P 62 MM, M/L 70 MM, REF 71421365 The LEGION Hinge Knee System is indicated for: 1. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight and activity lev
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2099-2016·2016-07-06
Dako HER2 CISH pharmDx Kit Recalled for Incorrect Probe Concentration
Dako North America Inc. is recalling 31 kits of the HER2 CISH pharmDx Kit because the HER2 probe concentration was too low.
Product
Dako HER2 CISH pharmDx Kit, product code: SK 109 Product Usage: For in vitro diagnostic use. HER2 CISH pharmDx Kit is intended for dualcolor chromogenic visualization of signals achieved with directly labeled in situ hybridization probes targeting the HER2 gene and centromer
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2091-2016·2016-07-06
Smith & Nephew Recalls Legion Hinge Knee Femoral Assemblies
Smith & Nephew is recalling Legion Hinge Knee femoral assemblies because the cement application surface is below specification.
Product
LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 3 RIGHT, A/P 54.5 MM, M/L 62 MM, REF 71421363 The LEGION Hinge Knee System is indicated for: 1. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight and activity l
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2094-2016·2016-07-06
Smith & Nephew Legion HK Femoral Assembly Recalled for Surface Defect
Smith & Nephew is recalling 10 units of Legion HK Femoral Assemblies because the internal cement surface is below specification.
Product
LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 5 LEFT, A/P 62 MM, M/L 70 MM, REF 71421375 The LEGION Hinge Knee System is indicated for: 1. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight and activity leve
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1980-2016·2016-06-22
Navilyst Medical Recalls Xcela Hybrid PICC Catheters Due to Hemolysis Risk
Navilyst Medical is recalling 357 Xcela Hybrid PICC catheters manufactured before July 15, 2014, because they lack a specification change that reduces hemolysis during blood sampling.
Product
Xcela Hybrid PICC with PASV Valve Technology, Intermediate MST-45 Kit, 6F-55cm, UPN H965952440 & UPN H965952450, Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1937-2016·2016-06-15
Becton Dickinson Recalls 10 mL Syringes Due to Manufacturing Non-Conformities
Becton Dickinson is recalling 811,200 units of 10 mL syringes due to possible adulteration and non-conforming manufacturing practices.
Product
Henry Schein Single Use Syringe Luer-Lock, 10 mL, Intended for use by health care professionals for general purpose fluid aspiration/injection
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1936-2016·2016-06-15
Becton Dickinson Recalls 10 mL Syringes Due to Manufacturing Issues
Becton Dickinson is recalling 176,000 units of 10 mL syringes due to possible adulteration and non-conforming manufacturing practices.
Product
Henry Schein Single Use Syringe Luer-Lock, 10 mL, Intended for use by health care professionals for general purpose fluid aspiration/injection
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1846-2016·2016-06-08
Sterilmed Recalls Reprocessed Microline Scissor Tips Due to Manufacturing Defect
Sterilmed is recalling 11,326 reprocessed Microline Scissor Tips due to a potential manufacturing defect that could result in patient injury.
Product
Reprocessed Microline Scissor Tips intended to be used with a reusable hand piece and designed for minimally invasive and open surgical procedures to facilitate cutting, preparation, mobilization, and coagulation of tissue. Model #'s MIC3112, MIC3122, MIC3132, MIC3142, MIC3152, M
Category
Medical Device
Distribution
28 states
ModerateFDA (Devices)·Z-1667-2016·2016-05-25
Anspach Otologic Diamond Ball Burrs Recalled for Missing Coating
The Anspach Effort, Inc. is recalling specific lots of Otologic Curved Micro Diamond Ball Burrs because they may lack the diamond coating or be the incorrect size.
Product
ANSPACH, Rx only, Otologic Curved Micro (OCCM) Diamond Ball Burr, 1.5 MM, Part # OCM7-15SD Product Usage: The Otologic Curved Micro (OCCM) Attachment and burrs are intended for cutting and shaping bone primarily in otology procedures such as cochleostomies.
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-1623-2016·2016-05-18
Stanmore Distal Femoral Replacement Recalled for Incorrect Component
Stanmore Implants Worldwide Ltd. is recalling one custom-made distal femoral replacement implant due to the use of an incorrect component during manufacturing.
Product
Distal Femoral Replacement (patient specific, custom made orthopedic implant device). PIN 19960
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1547-2016·2016-04-27
Smith & Nephew Recalls TC-PLUS Tibial Knee Prosthesis Components
Smith & Nephew is recalling 33 units of TC-PLUS tibial knee prosthesis components due to a dimensional deviation that may prevent proper seating of the polyethylene insert during surgery.
Product
TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 4 RIGHT, STERILE R, REF 12 000 024, S&N 7500279, Smith & Nephew Orthopaedics AG Product Usage: Tibial knee prosthesis
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1288-2016·2016-04-06
Ossur Recalls Multiple Medical Devices Including Miami J Collars
Ossur Americas is recalling various medical devices, including Miami J collars and knee shields, due to a manufacturing defect.
Product
Miami J Collar Product Usage: Miami J collars are applied to patients afflicted with cervical injuries to ensure immobilization.
Category
Medical Device
Distribution
48 states
HighFDA (Devices)·Z-1195-2016·2016-03-30
Arthrex Recalls IBalance TKA Tibial Trays Due to Surface Texture Defect
Arthrex, Inc. is recalling 2,378 IBalance TKA Tibial Trays because the outer metal surface is smooth instead of textured. The devices were distributed nationwide.
Product
Arthrex IBalance TKA Tibial Tray Size 2 - Catalog # AR-503-TTTC, Size 3 - Catalog # AR-503-TTTD, Size 4 -Catalog # AR-503-TTTE, Size 5 - Catalog # AR-503-TTTF, Size 6 - Catalog # AR-503-TTTG , Size 7 -Catalog # AR-503-TTTH, and Size 8 - Catalog # AR-503-TTTJ. Intended for imp
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1152-2016·2016-03-23
Zimmer NexGen Taper Plug Recalled for Insufficient Sealer Calibration Data
Zimmer Manufacturing B.V. is recalling 1,767 NexGen Taper Plugs used in total knee arthroplasty due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.
Product
Product 54 consists of all product under product code: JWH and same usage: Item no: 596009900 NEXGEN TAPER PLUG for use in total knee arthroplasty
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1126-2016·2016-03-23
Zimmer Manufacturing Recalls Sterile Femoral Hip Implant Components
Zimmer Manufacturing B.V. is recalling specific sterile femoral hip implant components due to insufficient sealer calibration data.
Product
Product 28 consists of all product under product code: JDI and same usage: Item no: 32902605000 FEMORAL HD 28MM MEDIUM 32902604000 FEMORAL HD 28MM SHORT 32902604035 FEMORAL HD 28MM SHT+ 3.5M For use in total or hemi hip arthroplasty
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1131-2016·2016-03-23
Zimmer HGP II Acetabular Cup Recall Due to Sealer Calibration
Zimmer Manufacturing B.V. is recalling 2,236 HGP II Acetabular Cup components due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.
Product
Product 33 consists of all product under product code: JDI and same usage: Item no: 662406515 HGP II ACETABULAR CUP BON 662406520 HGP II ACETABULAR CUP BON 662406525 HGP II ACETABULAR CUP BON 662406530 HGP II ACETABULAR CUP BON 662406535 HGP II ACETABULAR CUP BON 6624065
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1120-2016·2016-03-23
Zimmer Manufacturing Recalls Hip Arthroplasty Components Due to Sealer Calibration Issues
Zimmer Manufacturing B.V. is recalling specific hip arthroplasty components due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.
Product
Product 22 consists of all product under product code: JDI and same usage: Item no: 811400218 CPT 12/14 COCR REVISION S 811400318 CPT 12/14 COCR REVISION S 811400420 CPT 12/14 COCR REVISION S 811400423 CPT 12/14 COCR REVISION S 811400426 CPT 12/14 COCR REVISION S 811400
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1155-2016·2016-03-23
Zimmer Manufacturing Recalls Pressfit Femoral Stems Due to Sealer Calibration
Zimmer Manufacturing B.V. is recalling sterile pressfit femoral stems used in hip arthroplasty due to insufficient sealer calibration data.
Product
Product 57 consists of all product code: JDI and same usage: Item no: 763401000 PRESSFIT FEM ST FX 10 X 115 763401100 PRESSFIT FEM ST FX 11 X 1 763401200 PRESSFIT FEM ST FX 12 X 1 763401300 PRESSFIT FEM ST FX 13 X 1 763401400 PRESSFIT FEM ST FX 14 X 1 763401500 PRESSFIT F
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1165-2016·2016-03-23
Zimmer Versys Advocate Cemented Hip Implants Recalled for Calibration Data Issues
Zimmer Manufacturing B.V. is recalling 5,013 units of Versys Advocate Cemented hip implants due to insufficient sealer calibration data. The affected sterile products were distributed nationwide.
Product
Product 67 consists of all product under product code: JDI and same usage: Item no: 785001100 VERSYS ADVOCATE CEMENTED 785001200 VERSYS ADVOCATE CEMENTED 785001220 VERSYS ADVOCATE CEMENTED 785001300 VERSYS ADVOCATE CEMENTED 785001320 VERSYS ADVOCATE CEMENTED 785001400 VER
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1167-2016·2016-03-23
Zimmer Versys Cemented Femoral Stem Recall for Calibration Issues
Zimmer Manufacturing B.V. is recalling 13 Versys Cemented Femoral Stems due to insufficient sealer calibration data. The affected sterile products were distributed nationwide in the US.
Product
Product 69 consists of all product under product code: JDI and same usage: Item no: 785301701 VERSYS CEMENTED FEM STEM 785301521 VERSYS CEMENTED FEM STEM 15X140MM X-OFF 785301601 VERSYS CEMENTED FEM STEM 16X145MM For use in total or hemi hip arthroplasty
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1151-2016·2016-03-23
Zimmer NexGen Knee Implant Recall Due to Sealer Calibration Issues
Zimmer Manufacturing B.V. is recalling NexGen knee implant components due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.
Product
Product 53 consists of all product under: product code: JWH and same usage: Item no: 597002501 NEXGEN PRECOAT PEG TIB PL 597002502 NEXGEN PRECOAT PEG TIB PL 597003501 NEXGEN PRECOAT PEG TIB PL 597003502 NEXGEN PRECOAT PEG TIB PL 597004501 NEXGEN PRECOAT PEG TIB PL 5970
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0815-2016·2016-02-24
Lab Vision Recalls CEA/CD66e Antibody Lots Due to Dilution Error
Lab Vision Corporation is recalling specific lots of CEA/CD66e Ab-2 antibody because they were produced with an incorrect dilution factor.
Product
CEA / CD66e Ab-2, Product code RB-368-R7, RB-368-R1; 7 ml each. Description Carcinoembryonic antigen (CEA), is synthesized during development in the fetal gut, and is re-expressed in increased amounts in intestinal carcinomas and several other tumors. Antibody to CEA is re
Category
Medical Device
Distribution
9 states
HighFDA (Devices)·Z-0622-2016·2016-01-20
OrthoPediatrics Recalls Response Spine Pedicle Screws Due to Manufacturing Defect
OrthoPediatrics Corp is recalling 102 Response Spine UniAxial Pedicle Screws because they may have been manufactured incorrectly, preventing the driver from fully engaging the screw.
Product
UniAxial Pedicle Screw & UniAxial Reduction Pedicle Screw The Response 5.5/6.0 Spine System is intended for immobilization and stabilization of the posterior, non-cervical spine in skeletally mature patients as an adjunct to fusion for the following indications: degenerative d
Category
Medical Device
Distribution
20 states
LowFDA (Devices)·Z-0583-2016·2016-01-13
Ultradent Recalls InterGuard Dental Refills Due to Manufacturing Defect
Ultradent is recalling InterGuard 5.5mm Econo Refills because the floss tether hole was not completely punched through.
Product
InterGuard 5.5mm Econo Refill, sizes, 4.0mm for short anatomical crowns and 5.5mm, part # 4012 Product Usage: InterGuard is a preventive aid for operative dentistry. It is used to protect adjacent teeth from iatrogenic preparation damage. This includes cavity and tunnel pre
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0566-2016·2016-01-06
Aesculap Valve XS Atrium Retractor Blades Recalled Due to Corrosion
Aesculap is recalling 41 Valve XS Atrium Retractor blades distributed in New York because corrosion was found on a ball joint caused by incorrect manufacturing materials.
Product
Valve XS Atrium Retractor FC429R 52154756 The Valve XS Atrium Lift Retractor is used in heart surgery. The retractor is used for the temporary dilation of the left atrium in mitral valve surgery and for assistance in tricuspid valve surgery.
Category
Medical Device
Distribution
1 state