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.

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.

976–1000 of 1441

  • ModerateFDA (Devices)·Z-0076-2021·2020-10-14

    Biomet 3i Recalls BellaTek Abutments Due to Manufacturing Misalignment

    Biomet 3i is recalling 4 units of BellaTek abutments because the hex was misaligned by 30 degrees, preventing correct placement in patients.

    Product
    CERTAIN BELLATEK TIN ABUTMENT 5.0MM Reference Number: IEDAN5
    Category
    Medical Device
    Distribution
    11 states
  • ModerateFDA (Devices)·Z-0075-2021·2020-10-14

    Biomet 3i Recalls Misaligned BellaTek Dental Abutments

    Biomet 3i is recalling 9 units of BellaTek Encode Definitive Abutments because the hex was misaligned by 30 degrees during manufacturing, preventing correct placement.

    Product
    CERTAIN BELLATEK TIN ABUTMENT 4.1MM Reference Number: IEDAN4
    Category
    Medical Device
    Distribution
    11 states
  • ModerateFDA (Devices)·Z-0078-2021·2020-10-14

    Biomet 3i Recalls BellaTek Titanium Abutments Due to Manufacturing Misalignment

    Biomet 3i is recalling 10 units of BellaTek Titanium Abutments because the hex was misaligned by 30 degrees during manufacturing, preventing correct placement.

    Product
    CERTAIN BELLATEK TITANIUM ABUTMENT 5.0MM Reference Number: IEDAT5
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-2964-2020·2020-09-23

    Cook Zenith Alpha Abdominal Endovascular Graft Recalled for Excess Glue

    Cook Inc. is recalling Zenith Alpha Abdominal Endovascular Grafts due to excess glue in the delivery system handle, which may prevent full deployment.

    Product
    Zenith Alpha Abdominal Endovascular Graft - Distributed OUS only. Indicated for the endovascular treatment of patients with abdominal aortic or aorto-iliac aneurysms Reference Part Number (RPN): ZIMB-22-108 ZIMB-22-118 ZIMB-22-128 ZIMB-22-70 ZIMB-22-84 ZIMB-22-98…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2706-2020·2020-08-05

    Richard Wolf Recalls Tube Set for Transanal Endoscopic Microsurgery

    Richard Wolf GmbH is recalling 338 Tube Sets for TEM because smaller diameter tube material was used. The affected units were distributed internationally.

    Product
    Tube Set for TEM - Product Usage: Transanal Endoscopic Microsurgery (TEM) combination system and the instrument set for the TEM procedure are designed to provide access to the rectal cavity and accessible part of the lower sigmoid colon using a stereo and/or monocular endoscope…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2685-2020·2020-07-29

    Smith & Nephew Recalls TRIGEN Intramedullary Nail Sleeves Due to Sterilization Error

    Smith & Nephew is recalling 12 TRIGEN intramedullary nail sleeves because a manufacturing error led to improper re-sterilization of the polyethylene material.

    Product
    TRIGEN, Intramedullary nail - Product Usage: is intended to provide resistance for screw back-out. It provides additional friction to help hold the screws in place.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2428-2020·2020-07-01

    Providence Medical Technologies Recalls Ally Bone Screws Due to Dimensional Error

    Providence Medical Technologies is recalling 208 units of Ally Bone Screws due to a potential dimensional manufacturing error that poses a safety risk to patients.

    Product
    Ally Bone Screw - Product Usage:Bone Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation appropriate for the size of the device. Screws are intended for single use only. L Providence Medical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2336-2020·2020-06-17

    Smith & Nephew Recalls R3 Acetabular Shells Due to Manufacturing Error

    Smith & Nephew is recalling 58 R3 Acetabular Shells because a manufacturing error resulted in out-of-specification devices.

    Product
    smith&nephew R3 MULTI HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 48MM 71338733 50MM 71338734 52MM 71338735 54MM 71338736 56MM 71338737 58MM 71338738 62MM 71338740 64MM 71338741 Orthopedic implant…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2335-2020·2020-06-17

    Smith & Nephew Recalls R3 Multi Hole Hemispherical Shells Due to Manufacturing Error

    Smith & Nephew is recalling 1,766 R3 Multi Hole Hemispherical Stiktite Coated Shells because a manufacturing error resulted in out-of-specification devices.

    Product
    smith&nephew R3 MULTI HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Sizes REF/product number 48MM 71338663 50MM 71338664 52MM 71338665 54MM 71338666 56MM 71338667 58MM 71338668 Orthopedic implant component.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2333-2020·2020-06-17

    Smith & Nephew Recalls R3 Acetabular Shells Due to Manufacturing Error

    Smith & Nephew is recalling R3 Acetabular Shells because a manufacturing error resulted in out-of-specification devices.

    Product
    smith&nephew R3 THREE HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 40MM 71335540 42MM 71335542 44MM 71335544 46MM 71335546 48MM 71335548 50MM 71335550 52MM 71335552 54MM 71335554 56MM 71335556 58MM 71335558…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2334-2020·2020-06-17

    Smith & Nephew Recalls R3 Acetabular Shells Due to Manufacturing Error

    Smith & Nephew is recalling 4,172 R3 Acetabular Shells distributed worldwide because a manufacturing error resulted in out-of-specification devices.

    Product
    smith&nephew R3 THREE HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 42MM 71331942 46MM 71331946 48MM 71331948 50MM 71331950 52MM 71331952 54MM 71331954 56MM 71331956 58MM 71331958 60MM 71331960 62MM…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1928-2020·2020-05-20

    Edwards HemoSphere Oximetry Cable Recalled for Inconsistent Connector Crimping

    Edwards Lifesciences is recalling 35 HemoSphere oximetry cables due to intermittent communication caused by inconsistent crimping of connectors.

    Product
    Oxymetry Cable, Rxonly. REF/UDI: HEMOXSC100/(01)00690103196986 - Product Usage: The HemoSphere oximetry cable is a multi-use device that connects with a compatible Edwards monitor on one end and any approved Edwards oximetry catheter on the other end to continuously measure…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1920-2020·2020-05-13

    ICU Medical Recalls 10 Drop Primary IV Sets Due to Cannula Error

    ICU Medical is recalling 50 units of 10 Drop Primary IV Sets because they may contain 15 drops/mL cannulas, risking under-delivery of critical medications.

    Product
    REF: Z3806, 131" (333 cm) 10 Drop Primary Set w/2 MicroClave, Remv 4 Gang 4-way Stopcocks (1 Remv), Check Valve, Rotating Luer, 1 Ext, Sterile R, UDI: (01)00887709059108
    Category
    Medical Device
    Distribution
    44 states
  • SevereFDA (Devices)·Z-1911-2020·2020-05-13

    ICU Medical Recalls Veterinary IV Administration Sets with Incorrect Drop Cannula

    ICU Medical is recalling veterinary IV administration sets that may contain a 15 drops/mL cannula instead of 10 drops/mL, risking under-delivery of medication.

    Product
    REF: AH7117 111" 10 Drop Admin Set w/2 Inj Sites, Rotating Luer, Sterile R, For Veterinary Use Only, (01) 1 0887709 051475
    Category
    Medical Device
    Distribution
    44 states
  • SevereFDA (Devices)·Z-1913-2020·2020-05-13

    ICU Medical Recalls IV Administration Sets with Incorrect Drop Cannula

    ICU Medical is recalling 14,000 IV administration sets that may contain a 15 drops/mL cannula instead of 10 drops/mL, risking under-delivery of critical medication.

    Product
    REF: B90240-50, 96" (244 cm) Appx 11.2 ml, 10 Drop Admin Set w/Coiled Tubing, Pre-Slit Port, Clave, Rotating Luer, Sterile R, UDI: (01)00887709077058
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-1880-2020·2020-05-13

    Maquet Hemashield Vascular Grafts Recalled for Potential Seam Holes

    Maquet Cardiovascular is recalling Hemashield Platinum vascular grafts due to potential small holes at seam lines that could cause intra-operative bleeding.

    Product
    HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Branch, Product Code: M00202175926P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1874-2020·2020-05-13

    Maquet Hemashield Vascular Grafts Recalled for Potential Seam Holes

    Maquet Cardiovascular is recalling Hemashield Platinum vascular grafts due to potential small holes at seam lines that could cause intra-operative bleeding.

    Product
    HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-1 Branch, Product Code: M00202175832P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1916-2020·2020-05-13

    ICU Medical Recalls IV Administration Sets with Incorrect Drop Cannula

    ICU Medical is recalling 650 units of IV administration sets that may contain a 15 drops/mL cannula instead of 10 drops/mL, risking under-delivery of critical medication.

    Product
    REF: Z2560, 100" 10 Drop Admin Set w/Hand Pump, 2 Clave", Rotating Luer, 1 Pressure Infusion (400psig) Ext, Purple Clamp, UDI: (01)(01)00887709026889
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-1866-2020·2020-05-13

    Maquet Hemashield Platinum Vascular Grafts Recalled for Seam Line Bleeding Risk

    Maquet Cardiovascular is recalling Hemashield Platinum Woven Double Velour Vascular Grafts due to potential small holes at seam lines that may cause intra-operative bleeding.

    Product
    HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Branch, Product Code: M00202175732P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1881-2020·2020-05-13

    Maquet Hemashield Platinum Vascular Grafts Recalled for Seam Defects

    Maquet is recalling Hemashield Platinum vascular grafts due to potential small holes at seam lines that could cause intra-operative bleeding.

    Product
    HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 4 Branch, Product Code: M00202175928P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1877-2020·2020-05-13

    Maquet Hemashield Vascular Grafts Recalled for Potential Seam Holes

    Maquet Cardiovascular is recalling Hemashield Platinum vascular grafts due to potential small holes at the seam lines that could cause intra-operative bleeding.

    Product
    HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-3 Branch, Product Code: M00202175914P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1871-2020·2020-05-13

    Maquet Hemashield Vascular Grafts Recalled for Potential Seam Holes

    Maquet Cardiovascular is recalling Hemashield Platinum vascular grafts due to potential small holes at seam lines that could cause intra-operative bleeding.

    Product
    HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-1 Branch, Product Code: M00202175826P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1868-2020·2020-05-13

    Maquet Hemashield Vascular Grafts Recalled for Potential Seam Holes

    Maquet Cardiovascular is recalling Hemashield Platinum vascular grafts due to potential small holes at seam lines that could cause intra-operative bleeding.

    Product
    HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch, Product Code: M00202175820P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1860-2020·2020-05-13

    Maquet Hemashield Vascular Grafts Recalled for Potential Seam Holes

    Maquet Cardiovascular is recalling Hemashield Gold Knitted Microvel Double Velour Vascular Grafts due to potential small holes at the seam lines that may cause intra-operative bleeding.

    Product
    Hemashield Gold Knitted Microvel Double Velour Vascular Graft-Axillo-bifemoral, Product Code: M002020955880 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1861-2020·2020-05-13

    Maquet Hemashield Vascular Grafts Recalled for Potential Seam Holes

    Maquet Cardiovascular is recalling specific Hemashield Gold vascular grafts due to potential small holes at the seam lines that may cause intra-operative bleeding.

    Product
    Hemashield Gold Knitted Microvel Double Velour Vascular Graft Axillo-bifemoral, Product Code: M002020955890 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.
    Category
    Medical Device
    Distribution
    Distributed nationwide