The Recall Desk

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.

1251–1275 of 1441

  • 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…
    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…
    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
  • 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…
    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…
    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…
    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
  • ModerateFDA (Devices)·Z-0454-2016·2015-12-30

    DePuy Spine Recalls Aegis Torque Handles Due to Assembly Defect

    DePuy Spine is recalling 16 Aegis Torque Handles because a manufacturing error may prevent them from fully assembling with the tightener shaft.

    Product
    Aegis Torque Handle CATALOG NO. : 2871-10-800. A spinal surgical instrument used on the AEGIS Anterior Lumbar Plate System.
    Category
    Medical Device
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-0397-2016·2015-12-16

    In2Bones Recalls Osteosynthesis Screws with Incorrect Torx Imprint

    In2Bones is recalling 20 units of Model S25 ST014 osteosynthesis screws distributed in Tennessee because they were manufactured with the incorrect Torx imprint on the screw head.

    Product
    IBS - Osteosynthesis screws for bone fixation Model S25 ST014.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0201-2016·2015-11-11

    Exactech Recalls Eight Hip Implant Stems Lacking Coating

    Exactech is recalling eight Novation Element femoral hip implant stems that did not receive the specified Hydroxyapatite coating.

    Product
    Novation Element Press-Fit, Cementless, HA Coated, Collared, Standard Offset, Size 9, Femoral Hip Implant Stems, Intended for press-fit fixation
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0206-2016·2015-11-11

    Bausch + Lomb Recalls Biotrue ONEday Lenses Due to Surface Defects

    Bausch + Lomb is recalling Biotrue ONEday contact lenses because a manufacturing defect on the lens surface may cause visual disturbances like halos or poor vision.

    Product
    BAUSCH + LOMB Biotrue ONEday lenses (nesofilcon A), Product Order Number Biotrue SVS - 7201, STERILE, Rx Only; The lenses are available in 5 pack, 30 pack and 90 pack sizes; Biotrue ONEday Foil - Part Number 8098001, Biotrue ONEday 5 pack Carton International - Part Number…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0134-2016·2015-10-28

    Synthes Recalls Spinal Pedicle Fixation Rods Due to Finishing Process Error

    Synthes (USA) Products LLC is recalling 492 spinal pedicle fixation rods because they were produced using a bead blast 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; Orthosis, Spinal, Pedicle fixation Intended to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0026-2016·2015-10-14

    Ortho Solutions Recalls UltOS 3.5mm Locking Screws Due to Manufacturing Defect

    Ortho Solutions Inc is recalling 875 units of UltOS 3.5mm locking screws because the locking thread feature was not manufactured to specification, creating a risk that the screw may not lock onto the plate.

    Product
    Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile Orthopaedic Bone Screw
    Category
    Medical Device
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-0110-2016·2015-10-14

    Beckman Coulter Recalls Access Free T3 Reagent Kits Due to Filling Errors

    Beckman Coulter is recalling Access Free T3 Reagent Kits because they were filled incorrectly and contain insufficient reagents.

    Product
    Access Free T3 Reagent Kit, P/N A13422 The Access Free T3 assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of free triiodothyronine levels in human serum and plasma using the Access Immunoassay Systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2718-2015·2015-09-09

    Volcano Pioneer Plus Re-Entry Catheter Recalled for Manufacturing Defect

    Volcano Corporation is recalling 5,042 Pioneer Plus Re-Entry Catheters due to a manufacturing defect that may allow a small wire to extend through the catheter shaft.

    Product
    Volcano Pioneer Plus Re-Entry Catheter; Product Code PPLUS20, Catheter for Crossing Total Occlusions. Cardiovascular: The Volcano Pioneer Plus Intravascular Ultrasound Re-Entry Catheter (Pioneer Plus) is intended to facilitate the placement and positioning of catheters…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2539-2015·2015-09-09

    Limacorporate Recalls SMR Shoulder Trial Humeral Heads Due to Assembly Issues

    Limacorporate is recalling specific SMR Shoulder Trial Humeral Heads because their dimensions are out of specification, making them difficult to assemble.

    Product
    SMR Shoulder/Spalla Trial Humeral Head diameter .42 mm, REF 9013.22.425; SMR Shoulder/Spalla Trial Humeral Head diameter .44 mm, REF 9013.22.445; SMR Shoulder/Spalla Trial Humeral Head diameter .46 mm, REF 9013.22.465; for use in shoulder implant surgery.
    Category
    Medical Device
    Distribution
    16 states
  • ModerateFDA (Devices)·Z-2540-2015·2015-09-09

    Limacorporate Recalls SMR Shoulder Trial Heads Due to Assembly Issues

    Limacorporate S.p.A is recalling 93 units of SMR Shoulder Trial Heads because dimensions are out of specification, making assembly difficult.

    Product
    SMR Shoulder/Spalla Trial Heads ECC .4 mm Adaptor, REF 9013.30.021; SMR Shoulder/Spalla Trial Heads ECC .8 mm Adaptor, REF 9013.30.031; for use in shoulder implant surgery.
    Category
    Medical Device
    Distribution
    16 states
  • ModerateFDA (Devices)·Z-2483-2015·2015-09-09

    Biomet Vision RingLoc Hip Prosthesis Recalled for Missing Screw Hole Plugs

    Biomet, Inc. is recalling five units of the Vision RingLoc Shell 50 mm hip prosthesis because they were assembled without screw hole plugs.

    Product
    Vision RingLoc Shell 50 mm Size 23. Hip joint replacement prosthesis.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-2434-2015·2015-08-26

    BD Vacutainer SST Plus Blood Collection Tubes Recalled for Stopper Defects

    Becton Dickinson & Company is recalling specific lots of BD Vacutainer SST Plus Blood Collection Tubes because some stoppers were manufactured with a reduced cycle cure time.

    Product
    BD Vacutainer SST Plus Blood Collection Tubes, 5.0 mL, 13 x 100 mm, Sterile. Provides a means of collecting, transporting, separating, and processing blood in a closed tube.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-1794-2015·2015-06-24

    Medtronic Passive Planar Blunt Probe Recalled Due to Sharp Tip Defect

    Medtronic is recalling 18 Passive Planar Blunt Probes because they were manufactured with sharp tips instead of blunt tips. The devices are used in navigated surgery.

    Product
    Medtronic Passive Planar Blunt Probe Part Number 960-556, also included in Part Number Kits: 9732540, 9732622, 9733174, 9733935. As part of kits, the product is either packaged with other instruments or into a holding tray. The Passive Planar Blunt Probe is an optically…
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1730-2015·2015-06-17

    Smiths Medical Recalls Low Volume Extension Sets Due to Tubing Defect

    Smiths Medical is recalling 6,000 units of Low Volume Extension Sets because under-sized tubing was used in production. The affected product was distributed to five states.

    Product
    Low Volume Extension Set, 72' w/Clamp FLL/MLL APV=1.3ml, STERILE, AND FLUID PATH NONPYROGENIC UNLESS PACKAGE IS DAMAGED OR OPENED. LATEX FREE, SINGLE USE Tyvek pouches, 10 per box, Smiths Medical ASD, Inc. Used to administer fluid and drugs intravenously.
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1658-2015·2015-06-03

    Siemens Immulite 2000 Water Bottle Recall for Quality Defects

    Siemens Medical Solutions Diagnostics is recalling 186 Immulite 2000 water bottles because the openings may be undersized or deformed, preventing caps from closing securely.

    Product
    Water bottles, Catalog#10380062, #10291586. The Immulite 2000 and 2000 XPi systems are continuous random-access instruments that perform chemiluminescent immunoassays. These instruments use serum, plasma, or urine samples for in vitro diagnostic testing.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-1630-2015·2015-05-27

    CooperSurgical Recalls Carter-Thomason II Port Closure System Due to Printing Defect

    CooperSurgical is recalling 430 units of the Carter-Thomason II Port Closure System because pad printing on the suture guide may flake off.

    Product
    Carter-Thomason II Port Closure System; Model Number(s) CTI-1015P, for use in endoscopic and laparoscopic surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide