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.

976–1000 of 1434

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 60M
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-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 713
Category
Medical Device
Distribution
0 states
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 co
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 venou
Category
Medical Device
Distribution
Distributed nationwide
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
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
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-1876-2020·2020-05-13
Maquet Hemashield Platinum Vascular Grafts Recalled for Seam Line Bleeding Risk
Maquet Cardiovascular is recalling specific Hemashield Platinum vascular grafts due to potential small holes at seam lines that may cause intra-operative bleeding.
Product
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-3 Branch, Product Code: M00202175912P0 - 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-1859-2020·2020-05-13
Maquet Hemashield Vascular Grafts Recalled for Potential Seam Line Holes
Maquet Cardiovascular is recalling specific Hemashield Gold vascular grafts due to potential small holes at seam lines that could cause intra-operative bleeding.
Product
Hemashield Gold Knitted Microvel Double Velour Vascular Graft-Axillo-bifemoral, Product Code: M002020955010 - 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
HighFDA (Devices)·Z-1869-2020·2020-05-13
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 may cause intra-operative bleeding.
Product
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch, Product Code: M00202175822P0 - 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-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-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-1882-2020·2020-05-13
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 may cause intra-operative bleeding.
Product
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Branch, Product Code: M00202175930P0 - 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-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-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-1903-2020·2020-05-13
Ortho Development Recalls Tibial Tray Due to Manufacturing Defect
Ortho Development Corporation is recalling 27 units of Tibial Tray Nonporous A Size 2 due to a manufacturing defect in the locking mechanism that may cause assembly resistance.
Product
Tibial Tray Nonporous A Size 2; Model # PN 162-1200-A; Material: Ti6Al4V.
Category
Medical Device
Distribution
6 states
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-1873-2020·2020-05-13
Maquet Hemashield Platinum Vascular Grafts Recalled for Seam Line Defects
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- 1 Branch, Product Code: M00202175830P0 - 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-1878-2020·2020-05-13
Maquet Hemashield Platinum Vascular Grafts Recalled for Potential Seam Holes
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: M00202175922P0 - 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-1862-2020·2020-05-13
Maquet Hemashield Platinum Vascular Grafts Recalled for Potential Seam Holes
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-Thoracoabdominal, Product Code: M00202175426T0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.
Category
Medical Device
Distribution
Distributed nationwide