Hazard

Sepsis recalls

45 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total: 45
Critical: 0
Severe: 15
Most recent: 2024-03-27

Of the 45 sepsis recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 15 (33%) 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 sepsis 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.

26–45 of 45

HighFDA (Devices)·Z-1655-2023·2023-06-07
QUADROX-i Pediatric Oxygenators Recalled for Packaging Sterility Defects
QUADROX-i Pediatric Oxygenators used in cardiopulmonary bypass surgery are recalled for packaging defects that may compromise sterility, potentially causing inflammation, infection, sepsis, or ischemia.
Product
QUADROX-i Pediatric, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 30000-USA 701070384 HMO 31000-USA 701070388
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1637-2023·2023-06-07
QUADROX-i Small Adult Oxygenator Recall Due to Sterile Packaging Defects
Maquet is recalling QUADROX-i Small Adult Oxygenators due to packaging defects that may compromise the sterile barrier. Exposure to non-sterile product could cause infection, sepsis, and ischemia.
Product
QUADROX-i Small Adult, Oxygenator used during cardiopulmonary bypass Model Item no. HMO 50000-USA 701067891 HMO 51000-USA 701067895
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1642-2023·2023-06-07
Venous Hardshell Cardiotomy Reservoirs recalled for sterile packaging defects
Maquet Medical Systems USA is recalling Venous Hardshell Cardiotomy Reservoirs for cardiopulmonary bypass due to sterile packaging defects. Exposure to non-sterile product could result in infection, sepsis, or ischemia.
Product
Venous Hardshell Cardiotomy Reservoir, used during cardiopulmonary bypass Model Item No. VKMO 10000-USA 701070441 VKMO 11000-USA 701070445
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1661-2023·2023-06-07
Venous Hardshell Cardiotomy Reservoir packaging pinholes may compromise sterility
Maquet Medical Systems is recalling Venous Hardshell Cardiotomy Reservoirs because packaging pinholes may compromise the sterile barrier, potentially exposing patients to non-sterile devices that could cause infection or sepsis.
Product
Venous Hardshell Cardiotomy Reservoir, used during cardiopulmonary bypass Model Item No. VKMO 10000-USA 701070441 VKMO 11000-USA 701070445
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1662-2023·2023-06-07
QUADROX-iR Heart-Lung Oxygenator Recalled for Sterile Barrier Packaging Defect
Maquet Medical is recalling QUADROX-iR oxygenators used in heart-lung bypass procedures due to potential pinholes in packaging that may compromise the sterile barrier, creating risk of serious infection.
Product
QUADROX-iR, used during cardiopulmonary bypass Model Item No. Description BEQ-HMO 51100-USA 701067936 Small Adult with filter, with BIOLINE coating BEQ-HMO 71100-USA 701067880 Adult with filter, with
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1188-2023·2023-03-08
Maquet CARDIOHELP System extracorporeal support device components recalled for sterility
Maquet is recalling CARDIOHELP System components due to insufficient evidence of packaging sterility. Non-sterile medical devices could expose patients to infection, sepsis, or ischemia.
Product
BEQ-HLS 5050 USA; HLS Set Advanced 5.0, Product Code 70106.9077, BEQ-HLS 7050 USA; HLS Set Advanced 7.0, Product Code 70106.9078. Part of the CARDIOHELP System, a pre-connected set used for extracorporeal respiratory and/or cardiovascular support.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1683-2021·2021-06-02
Radiometer Recalls PICO70 Arterial Blood Samplers Due to Sterile Barrier Breach
Radiometer is recalling PICO70 Arterial Blood Samplers because a sterile barrier breach was found during testing, posing a risk of bacterial infection.
Product
PIC070 Arterial Blood Sampler PICO70 - Product Usage: Preheparinized, electrolyte-balanced, arterial blood sampler product line for collection of arterial samples for pH, blood gas, oximetry, electrolyte and metabolite analysis. Model Number/Product Description: 956-518 PICO7
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1831-2019·2019-06-26
FDA Recalls 3.1 Million Covidien Surgical Staplers Due to Missing Pins
The FDA is recalling 3,113,280 units of EGIA45 CT AR MD THK REL surgical staplers because missing pin components may cause incomplete staple formation, leading to serious surgical complications.
Product
EGIA45 CT AR MD THK REL, EGIA45CTAMT
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1830-2019·2019-06-26
Covidien EGIA 60 Curved Tip Surgical Stapler Recall for Missing Pins
FDA is recalling 3,113,280 units of the EGIA 60 Curved Tip Art Med Thick Sulu surgical stapler because missing pin components may cause incomplete staple formation and serious medical complications.
Product
EGIA 60 CURVED TIP ART MED THICK SULU, EGIA60CTAMT
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1835-2019·2019-06-26
Recall of Signia Tri-Staple Surgical Devices Due to Missing Pin Components
Covidien LLC is recalling Signia Tri-Staple 2.0 devices because missing pin components may cause incomplete staple formation, potentially leading to serious surgical complications.
Product
SIGNIA TRI-STAPLE 2.0 CURVED TIP 45MM MEDIUM/ THIC , SIG45CTAMT
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1833-2019·2019-06-26
Recall of Signia Tri-Staple 2.0 Reloads Due to Missing Pin Components
Covidien LLC is recalling Signia Tri-Staple 2.0 reloads because missing pin components may cause incomplete staple formation, leading to serious surgical complications.
Product
SIGNIA TRI-STAPLE 2.0 BLACK 45MM EXTRA THICK RELOA, SIG45AXT
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1827-2019·2019-06-26
FDA Recalls 3.1 Million Covidien EGIA 45 Articulating Xtra Thick Sulu Devices
The FDA is recalling 3,113,280 units of the EGIA 45 Articulating Xtra Thick Sulu device due to a missing pin component that may cause incomplete staple formation and serious medical complications.
Product
EGIA 45 ARTICULATING XTRA THICK SULU, Item Code EGIA45AXT
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1829-2019·2019-06-26
Covidien EGIA 60 Articulating Medical Stapler Recall for Missing Pins
FDA is recalling 3,113,280 units of the EGIA 60 Articulating Medical Stapler due to missing pin components that may cause incomplete staple formation and serious surgical complications.
Product
EGIA 60 ARTICULATING MED THICK SULU , EGIA60AMT
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1832-2019·2019-06-26
Recall of Signia Tri-Staple 2.0 Surgical Reloads Due to Missing Pins
Covidien LLC is recalling Signia Tri-Staple 2.0 reloads because missing pin components may cause incomplete staple formation, potentially leading to serious surgical complications.
Product
SIGNIA TRI-STAPLE 2.0 30MM MEDIUM/ THICK RELOAD , SIG30AMT
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1826-2019·2019-06-26
Covidien EGIA 45 Articulating Medical Stapler Recall for Missing Pins
FDA is recalling 3.1 million EGIA 45 staplers due to missing pins that may cause incomplete stapling and serious surgical complications.
Product
EGIA 45 ARTICULATING MED THICK SULU, Item Code EGIA45AMT
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1828-2019·2019-06-26
FDA Recalls Covidien EGIA 60 Articulating Extra Thick Sulu Devices
The FDA is recalling 3,113,280 units of the EGIA 60 Articulating Extra Thick Sulu device due to a missing pin component that may cause incomplete staple formation and serious surgical complications.
Product
EGIA 60 ARTICULATING EXTRA THICK SULU, Item code EGIA60AXT
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1825-2019·2019-06-26
FDA Recalls Covidien EGIA 30 Articulating Medical Devices
The FDA is recalling 3,113,280 units of the EGIA 30 Articulating Medical device due to missing pin components that may cause incomplete staple formation and serious surgical complications.
Product
EGIA 30 ARTICULATING MED THICK SULU, Item Code EGIA30AMT
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1834-2019·2019-06-26
FDA Recalls Signia Tri-Staple 2.0 Devices Due to Missing Pin Components
The FDA is recalling Signia Tri-Staple 2.0 devices because missing pin components may cause incomplete staple formation, leading to serious surgical complications.
Product
SIGNIA TRI-STAPLE 2.0 BLACK 60MM EXTRA THICK RELOA, SIG60AXT
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1836-2019·2019-06-26
Signia Tri-Staple Surgical Device Recalled Due to Missing Pin Components
The FDA is recalling Signia Tri-Staple 2.0 devices because missing pin components may cause incomplete staple formation, leading to serious surgical complications.
Product
SIGNIA TRI-STAPLE 2.0 CURVED TIP 60MM MEDIUM/ THIC , SIG60CTAMT
Category
Medical Device
Distribution
Distributed nationwide
SevereCPSC·13112·2013-01-31
SCS Direct Recalls Magnet Balls Due to Ingestion and Injury Risk
SCS Direct is recalling Magnet Balls sets sold on Amazon.com because swallowed magnets can cause serious intestinal injuries.
Product
Magnet Balls® Manipulative Magnet Sets
Category
Consumer Product
Distribution
Distributed nationwide