Hazard

Endotoxin recalls

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

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all endotoxin 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.

101–125 of 130

HighFDA (Devices)·Z-1902-2024·2024-06-05
Trevo XP ProVue neurovascular retriever devices recalled for inadequate endotoxin testing
Stryker Neurovascular's Trevo XP ProVue Retriever devices did not undergo adequate endotoxin testing and may exceed safe limits, potentially causing fever, shock, and aseptic meningitis.
Product
Trevo XP ProVue Retriever 4 x 20, Catalog: 90182 Trevo XP ProVue Retriever 3 x 20, Catalog: 90183 Trevo XP ProVue Retriever 4 x 30, Catalog: 90185 Trevo XP ProVue Retriever 6 x 25, Catalog: 90186 Kits: TREVO XP 3X20+PRO14 2-PACK, Catalog: 80051 TREVO XP 4X20+PRO18 2-PACK
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1903-2024·2024-06-05
Stryker neurovascular devices recalled for inadequate endotoxin testing
Stryker Neurovascular is recalling Trevo ProVue devices due to manufacturing testing deficiency that may result in unsafe endotoxin levels and risk of fever, shock, or aseptic meningitis.
Product
Trevo ProVue, Catalog: 90184
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1904-2024·2024-06-05
Trevo Pro Microcatheters Recalled for Potential Endotoxin Contamination
Stryker Neurovascular is recalling Trevo Pro 14 and 18 Microchethers worldwide due to non-compliance with endotoxin testing standards. High endotoxin levels could cause fever, shock, and meningitis.
Product
Trevo Pro 14 Microcatheter, Catalog: 90231; Trevo Pro 18 Microcatheter, Catalog: 90238
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1905-2024·2024-06-05
Trevo NXT neurovascular devices recalled for inadequate endotoxin testing
Stryker Neurovascular is recalling Trevo NXT neurovascular intervention devices because they did not receive adequate endotoxin testing during manufacturing. High endotoxin levels may cause fever, shock, or aseptic meningitis.
Product
Trevo NXT ProVue 3 x 32, US, Catalog: 90312 Kits: TREVO NXT 3X32+TRAK21 2-PACK - CE, Catalog: 91412 TREVO NXT 4X28+TRAK21 2-PACK - CE, Catalog: 91413 TREVO NXT 4X41+TRAK21 2-PACK - CE, Catalog: 91414 TREVO NXT 6X37+TRAK21 2-PACK - CE, Catalog: 91415 TREVO NXT 3X32+PRO14 2
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1740-2024·2024-05-08
Stryker Distal Access Catheter recalled for out-of-specification endotoxin contamination
Stryker Neurovascular is recalling 43 units of Distal Access Catheter Lot 0000486382 due to out-of-specification endotoxin results. The affected lot was distributed across 12 states.
Product
The Distal Access Catheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque marker on the distal end and a luer hub on the proximal end. The catheter shaft has a hydrophilic coating to reduce friction during use. Device dimensions and configuration ar
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1377-2024·2024-04-03
Baxter Peri-Guard Repair Patch contraindicated for neurosurgical use
Peri-Guard Repair Patch is now contraindicated for neurosurgery because its endotoxin level may exceed the limit allowable for cerebrospinal fluid-contacting devices. Product instructions have been updated.
Product
Baxter Peri-Guard Repair Patch (legacy product codes): a) PC0404NBIO, b) PC0608NBIO, c) PC0814NBIO, d) PC1016NBIO
Category
Medical Device
Distribution
5 states
HighFDA (Devices)·Z-1378-2024·2024-04-03
Baxter Supple Peri-Guard Repair Patch Recall Due to Endotoxin Contraindication
Baxter is recalling Supple Peri-Guard Repair Patch units due to elevated endotoxin levels that may exceed allowable limits for cerebrospinal fluid-contacting devices. The product should not be used in neurosurgery.
Product
Baxter Supple Peri-Guard Repair Patch (legacy product codes): a) PC0404SNBIO, b) PC0608NSBIO, c) PC0814SNBIO, d) PC1016SNBIO
Category
Medical Device
Distribution
5 states
HighFDA (Devices)·Z-1379-2024·2024-04-03
Baxter Peri-Guard Repair Patch Contraindication Added for Neurosurgery
Baxter Healthcare has added a contraindication to Peri-Guard Repair Patch instructions, restricting use in neurosurgery because endotoxin levels may exceed allowable limits for cerebrospinal fluid-contacting devices.
Product
Baxter Peri-Guard Repair Patch (new product codes): a) PG0404, b) PG0608, c) PG0814, d) PG1016, e) PG1225
Category
Medical Device
Distribution
5 states
HighFDA (Devices)·Z-1380-2024·2024-04-03
Baxter Supple Peri-Guard Repair Patch contraindicated for neurosurgery due to endotoxin
Baxter is recalling specific lot codes of Supple Peri-Guard Repair Patch because endotoxin levels may exceed limits for cerebrospinal fluid-contacting devices. The product should not be used in neurosurgery.
Product
Baxter Supple Peri-Guard Repair Patch (new product codes): a) SPG0404, b) SPG0406, c) SPG0608, d) SPG0814, e) SPG1016
Category
Medical Device
Distribution
5 states
HighFDA (Devices)·Z-2207-2023·2023-07-26
Medtronic Durepair Dura Matrix Recalled Due to Endotoxin Contamination
Medtronic is recalling Durepair Dura Regeneration Matrix surgical implants worldwide due to potential endotoxin contamination that may cause inflammation similar to infection.
Product
Durepair Dura Regeneration Matrix: DUREPAIR DURA SUBSTITUTE 2 X 2, 61100; DUREPAIR DURA SUBSTITUTE 3 X 3, 61105; DUREPAIR DURA SUBSTITUTE 1 X 3, 61106; DUREPAIR DURA SUBSTITUTE 4 X 5, 61110; DUREPAIR DURA SUBSTITUTE 1 X 1, 61111; DURA 62100 SUBSTITUTE DUREPAIR 2X2IN NCE, 6
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2081-2023·2023-07-12
PriMatrix Ag Fenestrated dermal repair scaffolds recalled for endotoxin testing issues
TEI Biosciences recalled 7,264 units of PriMatrix Ag Fenestrated dermal repair scaffolds nationwide due to possible out-of-specification endotoxin test results caused by testing methodology defects.
Product
PriMatrix Ag Fenestrated; Dermal Repair Scaffold; Rx Only; Sizes 10x25 cm, 20x25 cm, 4x4 cm, 6x6 cm, 8x12 cm, 8x8 cm.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2082-2023·2023-07-12
Dermal repair scaffold recalled due to endotoxin testing failures
TEI Biosciences is recalling 10,159 units of PriMatrix Ag Meshed dermal repair scaffolds due to testing failures that cannot verify endotoxin levels. Procedures for testing bacterial toxin levels during manufacturing quality control were found to be flawed.
Product
PriMatrix Ag Meshed; Dermal Repair Scaffold; Rx Only; Sizes 10x12 cm (2:1), 10x25 cm (2:1), 20x25 cm (1:1), 4x4 cm (2:1), 6x6 cm (2:1), 8x12 cm (2:1), 8x8 cm (2:1).
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2073-2023·2023-07-12
SurgiMend MP Collagen Matrix Recalled for Endotoxin Testing Issues
TEI Biosciences recalled approximately 3,992 units of SurgiMend MP surgical implants nationwide due to issues with endotoxin testing procedures that may have resulted in unreliable test results.
Product
SurgiMend MP; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x15 cm, 20x20 cm, 13x25 cm, 16x20 cm, 20x25 cm, 20x30 cm, and 25x40 cm.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2080-2023·2023-07-12
PriMatrix Ag Dermal Repair Scaffold Recalled for Endotoxin Testing Issues
TEI Biosciences is recalling 1,689 units of PriMatrix Ag dermal repair scaffolds distributed nationwide due to potential endotoxin testing deficiencies. Testing procedures may not have been conducted reliably.
Product
PriMatrix Ag; Dermal Repair Scaffold; Rx Only; Sizes 10x12 cm, 10x25 cm, 20x25 cm, 4x4 cm, 6x6 cm, 8x12 cm, 8x8 cm.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2076-2023·2023-07-12
Collagen surgical matrix recalled for potential endotoxin testing issues
TEI Biosciences is recalling 9,215 units of SurgiMend PRS Meshed, a surgical collagen matrix, due to possible out-of-specification endotoxin test results.
Product
SurgiMend PRS Meshed; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Size 10cm x 20cm
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2072-2023·2023-07-12
SurgiMend 2.0 Collagen Matrix Recalled for Endotoxin Testing Issues
TEI Biosciences is recalling SurgiMend 2.0 collagen matrices nationwide due to possible out-of-specification endotoxin test results from issues with in-process and finished goods testing procedures.
Product
SurgiMend 2.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 5x6 cm, 6x12 cm, 10x15 cm, 16x20 cm, 13x25 cm, 25x40 cm, 20x30 cm, 20x20 cm, 20x25cm, 10x15cm Semi-Oval,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2085-2023·2023-07-12
Soft tissue repair matrix recalled due to possible endotoxin contamination
TEI Biosciences is recalling 4,832 units of TissueMend Advanced Soft Tissue Repair Matrix due to possible out-of-specification endotoxin test results. No illnesses or injuries have been reported.
Product
TissueMend; Advanced Soft Tissue Repair Matrix; Rx Only; Sizes 5x6 cm, 6x10 cm, and 3x3 cm.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2070-2023·2023-07-12
Surgical collagen matrix recall due to endotoxin testing failures
TEI Biosciences is recalling 22,163 units of SurgiMend PRS collagen matrices due to endotoxin testing deficiencies that may have resulted in contaminated products being distributed. No injuries have been reported.
Product
SurgiMend PRS; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x15 cm Semi-Oval, 7x17 cm Fenestrated, 10x20 cm Fenestrated, 8x16 cm Semi-Oval, 15x15 cm Semi-Oval, 8x20 cm Fenestrated, 10x15 cm Slant Fenestrated, 7x17 cm Semi-Oval, 8x16 cm Thin Semi-Oval, 10x20 cm
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2083-2023·2023-07-12
Revize Collagen Matrix Recalled for Potential Endotoxin Testing Issues
TEI Biosciences recalls 199 units of Revize Collagen Matrix due to possible out-of-specification endotoxin test results from faulty testing procedures. The product is distributed nationwide.
Product
Revize; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x10 cm, 4x12 cm, 4x16 cm.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2075-2023·2023-07-12
SurgiMend 4.0 Collagen Implants Recalled for Endotoxin Testing Failures
TEI Biosciences is recalling 5,664 units of SurgiMend 4.0 soft tissue reconstruction implants nationwide due to issues with endotoxin testing that may have resulted in out-of-specification test results.
Product
SurgiMend 4.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 5x6 cm, 6x12 cm, 10x15 cm, 13x25 cm, 25x40 cm, 20x30 cm, 10x25 cm, 20x0.5 cm, and 10x25 cm Fenestrated.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2077-2023·2023-07-12
PriMatrix Dermal Repair Scaffold recalled due to endotoxin testing issues
TEI Biosciences is recalling 4,159 units of PriMatrix Dermal Repair Scaffold nationwide due to possible out-of-specification endotoxin test results. Quality control issues during testing led to this recall.
Product
PriMatrix; Dermal Repair Scaffold; Rx Only; Sizes 0.2x26.5 cm (3 pack), 10x12cm, 10x25 cm, 20x25 cm, 4x4 cm, 6x6 cm, 8x12 cm, and 8x8 cm.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2079-2023·2023-07-12
Dermal Repair Scaffold Recalled Due to Endotoxin Testing Issues
TEI Biosciences is recalling PriMatrix Meshed dermal repair scaffolds due to endotoxin testing failures. The recall affects 33,277 units distributed nationwide.
Product
PriMatrix Meshed; Dermal Repair Scaffold; Rx Only; Sizes 20x25 cm (1:1), 3x3 cm (2:1), 4x4 cm (2:1), 5x5 cm (2:1), 6x6 cm (2:1), 8x12 cm (2:1), and 8x8 cm (2:1).
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2078-2023·2023-07-12
PriMatrix Dermal Scaffold Recalled Due to Endotoxin Testing Issues
TEI Biosciences is recalling 30,528 units of PriMatrix Fenestrated dermal repair scaffolds due to possible out-of-specification endotoxin test results. The FDA Class II recall affects wound healing products distributed nationwide.
Product
PriMatrix Fenestrated; Dermal Repair Scaffold; Rx Only; Sizes 4x4 cm, 6x6 cm, 8x8 cm, 14mm Disc, 18mm Disc, 2x2 cm, and 10x25 cm (Meshed 2:1).
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2071-2023·2023-07-12
SurgiMend collagen matrices recalled for endotoxin test result quality issues
TEI Biosciences recalls SurgiMend 1.0 collagen matrices due to problems with endotoxin testing procedures that may have produced inaccurate test results. 52 units were distributed nationwide.
Product
SurgiMend 1.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 18x12 cm Thin and 10x15 cm Thin.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2084-2023·2023-07-12
Collagen matrix recalled for endotoxin testing methodology issues
TEI Biosciences recalled 665 units of Revize-X collagen matrix nationwide due to possible out-of-specification endotoxin test results caused by issues with the company's testing procedures. No illnesses have been reported.
Product
Revize-X; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 12x6 cm and 10x9 cm.
Category
Medical Device
Distribution
Distributed nationwide