Hazard

Endotoxin Contamination recalls

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

What the numbers show

Total: 71
Critical: 0
Severe: 4
Most recent: 2026-09-02

Of the 71 endotoxin contamination recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 4 (6%) 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 endotoxin contamination 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.

51–71 of 71

HighFDA (Devices)·Z-2153-2020·2020-06-03
Biomet Vanguard Knee System Recalled for Elevated Endotoxin Levels
Biomet is recalling 93 Vanguard Knee System tibial bearings due to potential endotoxin levels exceeding specifications. The recall covers units distributed worldwide.
Product
Knee Products: 183742 Vanguard Knee System, PS+ Tibial Bearing, 12 MM, 71/75 MM EP-183608 Vanguard Knee System, PS Tibial Bearing, E1 Infused, 18 MM X 59 MM EP-183608 Vanguard Knee System, PS Tibial Bearing, E1 Infused, 18 MM X 59 MM 183744 Vanguard Knee…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2145-2020·2020-06-03
Biomet Recalls RingLoc Hip System Components Due to Endotoxin Levels
Biomet, Inc. is recalling specific RingLoc Hip System components due to potential elevated endotoxin levels that exceed specification limits.
Product
Hip Products Item Number: 1) 110010462 RingLoc Hip System, Acetabular Bi-Polar Cup, 28 MM X 51 MM 2) 11-165218 RingLoc Bi-Polar Hip System, Acetabular Cup, 28 MM X 47 MM 3) XL-105916 588500 RingLoc Hip System, Acetabular Liner, 36 MM, Size 26 Product Usage: Hemi hip…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2148-2020·2020-06-03
Biomet Oxford Partial Knee Systems Recalled for Elevated Endotoxin Levels
Biomet, Inc. is recalling 76 units of Oxford Partial Knee Systems due to potential endotoxin levels exceeding specification limits.
Product
Knee Products: 154335 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Left, Cemented, D3 154336 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Left, Cemented, D4 154339 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Left, Cemented, D7…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2147-2020·2020-06-03
Biomet Recalls Knee Prosthesis Components Due to Endotoxin Concerns
Biomet, Inc. is recalling 12 units of the Orthopedic Salvage System Tibial Bearing because of potential elevated endotoxin levels.
Product
Knee Products: 150414 Orthopedic Salvage System (OSS) Tibial Bearing, 20 MM Standard - Product Usage: Knee prosthesis
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2149-2020·2020-06-03
Biomet Recalls AGC Knee System Tibial Components Due to Endotoxin Levels
Biomet, Inc. is recalling 54 units of AGC Knee System PS Molded Tibial Components because they may contain elevated endotoxin levels that exceed specification limits.
Product
Knee Products: 155308 Knees AGC Knee System PS Molded Tibial Component, 10 MM X 65 MM 155326 Knees AGC Knee System PS Molded Tibial Component, 10 MM X 70 MM 155330 Knees AGC Knee System PS Molded Tibial Component, 14 MM X 70 MM 155344 Knees AGC Knee System PS Molded Tibial…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2151-2020·2020-06-03
Biomet Vanguard Knee System Recalled for Elevated Endotoxin Levels
Biomet, Inc. is recalling 11 units of Vanguard Knee System tibial bearings due to potential endotoxin levels exceeding specification limits.
Product
Knee Products: 189260 Vanguard Knee System, CR-L Mono Lock Tibial Bearing, 10 MM X 71 MM 189720 Vanguard Knee System, CR Mono Lock Tibial Bearing, 10 MM X 83 MM 189320 Vanguard Knee System, CR-L Mono Lock Tibial Bearing, 10 MM X 83 MM 189700 Vanguard Knee System, CR Mono…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1841-2019·2019-06-26
Ethicon Recalls Polyester Sutures Due to Potential High Endotoxin Levels
Ethicon, Inc. is recalling specific lots of ETHIBOND EXCEL polyester sutures because raw materials may contain high endotoxin levels.
Product
ETHIBOND EXCEL¿ Polyester Suture-ETHIBOND Green 75cm USP1 Single Armed CT-1 Product Code: X425H Product Usage: ETHIBOND EXCEL Suture is intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0102-2019·2018-10-24
OriGen Biomedical Recalls Reinforced Dual Lumen Cannulas Due to Endotoxin Failure
OriGen Biomedical is recalling 106 units of Reinforced Dual Lumen Cannulas because they failed endotoxin testing. The devices were distributed in 25 US states and four foreign countries.
Product
Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO; and ECMO Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1861-2017·2017-04-26
Zimmer Biomet Recalls Polyethylene Knee Implants Due to Endotoxin Levels
Zimmer Biomet is recalling 28,253 polyethylene knee implants because endotoxin levels exceeded process maximum limits. The affected products were distributed worldwide.
Product
various polyethylene implants Knees Revision Tibial Tray Systems Oxford Partial Knee Orthopedic Salvage System Vanguard Complete Knee System Vanguard SSK Revision System Biomet Patella Maxim Complete Knee System Biomet Series A Patella Vanguard 360 Revision System…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1858-2017·2017-04-26
Zimmer Biomet Recalls Polyethylene Implants Due to High Endotoxin Levels
Zimmer Biomet is recalling BIO PLUG 10MM polyethylene implants because endotoxin levels exceeded process maximum limits.
Product
various polyethylene implants BIO PLUG 10MM Product Usage: Non-weight bearing accessory. Sterile, optional speciality components that are non-bioabsorbable, implantable devices designed to be inserted into the medullary canal of a bone during orhtopedic surgery to…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1859-2017·2017-04-26
Zimmer Biomet Recalls Polyethylene Implants Due to High Endotoxin Levels
Zimmer Biomet is recalling 28,253 polyethylene implants for shoulder and elbow replacements because endotoxin levels exceeded process maximum limits.
Product
various polyethylene implants Extremities, Shoulders and Elbows BioModular Shoulder System; Comprehensive Shoulder System; Comprehensive Reverse Shoulder System Product Usage: Shoulder Replacement Elbow Replacement
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1860-2017·2017-04-26
Zimmer Biomet Recalls Polyethylene Hip Implants Due to Endotoxin Levels
Zimmer Biomet is recalling 28,253 polyethylene hip implant components worldwide because endotoxin levels exceeded process maximum limits.
Product
various polyethylene implants Hips Active Articulation ArComXL Bearings Active Articulation E1 Bearings Arcos Taper Cap BIOLOX delta Option Head E1 RingLoc Bi-Polar Freedom Constrained Liner +5mm Hi-Wall ArcomXL All Poly Rimloc E1 10 Degree Liner RingLoc +3mm Hi-Wall…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1862-2017·2017-04-26
Zimmer Biomet Recalls Polyethylene Implants Due to High Endotoxin Levels
Zimmer Biomet is recalling 28,253 custom polyethylene implants because endotoxin levels exceeded process maximum limits. The affected parts were distributed worldwide.
Product
various polyethylene implants Custom parts Product Usage: Custom
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1863-2017·2017-04-26
Zimmer Biomet Recalls Polyethylene Implants Due to High Endotoxin Levels
Zimmer Biomet is recalling Repicci II Tibial Components for partial knee replacement because endotoxin levels exceeded process maximum limits.
Product
various polyethylene implants Sports Med Repicci II Tibial Components Product Usage: Partial knee replacement
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2002-2016·2016-06-22
Datascope Small Patient ECC Pack Recalled for Excess Endotoxin
Datascope Corporation is recalling 17 units of Small Patient ECC Packs due to endotoxin levels exceeding regulatory limits. The affected units were distributed in Georgia.
Product
Small Patient ECC Pack, REF BEQ-TOP 24100, Product Usage: The HLM Tubing Sets with Bioline Coating are for single use only. They may be sold sterile, non-sterile and bulk packed. Custom tubing sets that are sold sterile are not to be re-sterilized by the user. In open heart…
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1922-2016·2016-06-15
Baxter Recalls Actifuse Bone Void Fillers Due to Endotoxin Concerns
Baxter Healthcare is voluntarily recalling Actifuse ABX and MIS System bone void fillers because they may contain endotoxin levels above specification criteria.
Product
Actifuse ABX/Actifuse MIS System A bone void filler intended only for orthopedic applications as a filler for gaps and voids that are not intrinsic to the stability of the bony structure.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1230-2016·2016-03-30
Qiagen QFT TB Antigen Tubes Recalled for Potential Endotoxin Contamination
Qiagen is recalling QFT TB Antigen Tubes due to potential endotoxin presence that could cause false positive results in tuberculosis tests.
Product
QFT TB Antigen Tube. QIAGEN Sciences, LLC. The QuantiFERON TB-Gold is an indirect test for M. tuberculosis infection (including disease)
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-0947-2014·2014-02-19
Ecolab Recalls Microtek Medical Bur Hole Latex Probe Covers
Ecolab Inc is recalling specific lots of Microtek Medical Bur Hole Latex Probe Covers because they did not undergo proper endotoxin testing.
Product
MICROTEK(TM) MEDICAL BUR HOLE LATEX PROBE COVER WITH GEL, featuring IsoSilk(R), 13cm x 249 cm, REF 3688UK, STERILE EO, QTY 20, Microtek Medical, Inc., Columbus, MS 39702
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0943-2014·2014-02-19
Ecolab Recalls Microtek Medical Bur Hole Probe Covers for Testing Defects
Ecolab is recalling specific lots of Microtek Medical Bur Hole Probe Covers because they did not undergo proper endotoxin testing.
Product
MICROTEK(TM) MEDICAL BUR HOLE LATEX FREE PROBE COVER, featuring IsoSilk(R), 13cm x 244 cm, 5" x 96", REF PC3688N, QTY 100, Microtek Medical, Inc., Columbus, MS 39702.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1590-2013·2013-07-03
Medtronic Recalls INFUSE Bone Graft Kits Due to Endotoxin Levels
Medtronic is recalling INFUSE Bone Graft kits because they contain a collagen sponge with possible elevated endotoxin levels.
Product
INFUSE(R) Bone Graft, MEDIUM KIT, REF 7510400, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-040-2013·2012-11-14
Merit Medical Systems Recalls Cytosol Ophthalmics Balanced Salt Solution Kits
Merit Medical Systems is recalling Cytosol Ophthalmics Balanced Salt Solution kits due to a lack of assurance of sterility and potential endotoxin contamination.
Product
Merit Convenience Kits containing Cytosol Ophthalmics Balanced Salt Solution, 18 mL Single Dose Bottle, NDC 23731-8100-8, Sterile.
Category
Medical Device
Distribution
4 states