The Recall Desk

Hazard

Inflammatory Response recalls

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

What the numbers show

Total
16
Critical
1
Severe
4
Most recent
2026-04-01

Of the 16 inflammatory response recalls we have scored against our rubric, 1 (6%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 4 (25%) 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 inflammatory response 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.

1–16 of 16

  • HighFDA (Devices)·Z-1650-2026·2026-04-01

    Puracol collagen wound dressings recalled over elevated endotoxin levels

    Medline is recalling Puracol and Puracol Plus collagen wound dressings after elevated endotoxin levels were identified in affected lots.

    Product
    Puracol and Puracol Plus Collagen Wound Dressings: MSC8522 DRESSING,COLLAGEN,PURACOL,STRL,2" X 2" MSC8622EP DRESSING,COLLAGEN,PURACOL PLUS, 2X2.2"
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-1249-2023·2023-03-22

    Plato 17 Microcatheter Recalled Due to Loose Particle Risk

    Scientia Vascular is recalling Plato 17 Microcatheters due to manufacturing defects that may introduce loose particles into the catheter lumen, potentially causing blood vessel blockage or inflammatory reactions.

    Product
    Plato 17 Microcatheter: Straight Tip, PL17-160-000 ; 45 degree Tip, PL17-160-045; 90 degree Tip, PL17-160-090
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0951-2023·2023-01-18

    FDA Recalls BIOSTOP G Cement Restrictor Due to Elevated Endotoxin Levels

    DePuy Ireland is recalling all lots of BIOSTOP G Bioresorbable Cement Restrictor because endotoxin levels exceeded FDA regulatory guidance. Endotoxins can cause inflammatory responses, from mild fever to potential organ damage.

    Product
    BIOSTOP G BIORESORBABLE CEMENT RESTRICTOR Catalog Numbers: 546308000 (Size 8); 546310000 (Size 10); 546312000 (Size 12); 546314000 (Size 14); 546316000 (Size 16); 546318000 (Size 18); 546320000 (Size 20)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1195-2021·2021-03-24

    Medtronic Custom Perfusion Pack Recalled for Bacterial Endotoxin Levels

    Medtronic is recalling 4 units of Custom Perfusion Packs due to potentially elevated bacterial endotoxin levels that may cause acute inflammatory responses.

    Product
    Medtronic Custom Perfusion Pack (CUSTOM PACK HY11B40R1 1/4 RESPIRATO). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is a single-use device designed to collect and store blood during extracorporeal circulation. Cardiotomy blood is collected, filte
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1196-2021·2021-03-24

    Medtronic Affinity Pixie Cardiotomy Reservoir Recalled for Bacterial Endotoxin

    Medtronic is recalling 70 units of Affinity Pixie Cardiotomy/Venous Reservoirs due to potentially elevated bacterial endotoxin levels that may cause acute inflammatory responses.

    Product
    Custom Perfusion System (CUSTOM PACK BB10H89R4 ECLR). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is a single-use device designed to collect and store blood during extracorporeal circulation. Cardiotomy blood is collected, filtered, and defoamed
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1192-2021·2021-03-24

    Medtronic Recalls Custom Perfusion System Due to Endotoxin Risk

    Medtronic Perfusion Systems is recalling three units of its Custom Perfusion System because they may contain elevated levels of bacterial endotoxins. Patients exposed to these devices could develop an acute inflammatory response.

    Product
    Custom Perfusion System (CUSTOM PACK HY10J00R6 ECC SMALL CAR). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is a single-use device designed to collect and store blood during extracorporeal circulation. Cardiotomy blood is collected, filtered, an
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1197-2021·2021-03-24

    Medtronic Affinity Pixie Cardiotomy Reservoir Recalled for Bacterial Endotoxin

    Medtronic is recalling 5 units of Affinity Pixie Cardiotomy Reservoirs due to potentially elevated bacterial endotoxin levels that may cause acute inflammatory responses.

    Product
    Medtronic Custom Pack CP Kinderset 1/4-1/4 MIT Pixie 1/B (PERFUSION M490817B 1/B). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is a single-use device designed to collect and store blood during extracorporeal circulation. Cardiotomy blood is coll
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1199-2021·2021-03-24

    Medtronic Recalls Custom Perfusion System Due to Endotoxin Risk

    Medtronic Perfusion Systems is recalling 7 units of the Custom Perfusion System because they may contain elevated levels of bacterial endotoxins, which can cause acute inflammatory responses in patients.

    Product
    Custom Perfusion System (CUSTOM PACK BB7W03R8 CCSM NEON). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is a single-use device designed to collect and store blood during extracorporeal circulation. Cardiotomy blood is collected, filtered, and defo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1198-2021·2021-03-24

    Medtronic Pediatric Cardiotomy Reservoir Recalled for Bacterial Endotoxin

    Medtronic is recalling 4 units of a pediatric cardiotomy reservoir due to potentially elevated bacterial endotoxin levels that may cause acute inflammatory responses.

    Product
    Medtronic Custom Pack CP 1/4-1/4 Pediatric Set 1/B (PERFUSION M484901D 1/B). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is a single-use device designed to collect and store blood during extracorporeal circulation. Cardiotomy blood is collected,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1191-2021·2021-03-24

    Medtronic Affinity Pixie Oxygenator Recalled for Bacterial Endotoxin

    Medtronic is recalling 57 units of Affinity Pixie oxygenators due to potentially elevated bacterial endotoxin levels that may cause acute inflammatory responses.

    Product
    Medtronic Affinity Pixie BP241 Hollow Fiber Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface (OXYGENATOR BBP241 W/CVR NI BB STERILE). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is a single-use device designed to collect and sto
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1193-2021·2021-03-24

    Medtronic Infant Tubingset Recalled for Elevated Bacterial Endotoxin Levels

    Medtronic is recalling 14 units of infant tubingsets due to potentially elevated bacterial endotoxin levels that may cause acute inflammatory responses.

    Product
    Medtronic Custom Pack Infant Tubingset Pixie Flow 0,8->1,5-1,8 1/B (PERFUSION M483203D 1/B). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is a single-use device designed to collect and store blood during extracorporeal circulation. Cardiotomy bl
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1194-2021·2021-03-24

    Medtronic Affinity Pixie Cardiotomy Reservoir Recalled for Bacterial Endotoxin

    Medtronic is recalling 10 units of the Affinity Pixie Cardiotomy/Venous Reservoir due to potentially elevated bacterial endotoxin levels that may cause acute inflammatory responses.

    Product
    Medtronic Custom Pack EVNP Clinical with AP40 1/B (PERFUSION M448036B 1/B). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is a single-use device designed to collect and store blood during extracorporeal circulation. Cardiotomy blood is collected,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1190-2021·2021-03-24

    Medtronic Affinity Pixie Oxygenator Recalled for Bacterial Endotoxin

    Medtronic is recalling Affinity Pixie Oxygenators due to potentially elevated bacterial endotoxin levels that may cause acute inflammatory responses in patients.

    Product
    Medtronic Affinity Pixie Hollow Fiber Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface (OXYGENATOR BBP241 AFFINITY PIXIE WCVR OU). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is a single-use device designed to collect and store
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0612-2020·2021-02-03

    Enztec Femoral Impactor Recall Due to Arm Fracture Risk

    Enztec Limited is recalling 312 femoral impactors used with the DJO EMPOWR 3D KNEE system because the arm may fracture during use, potentially causing surgical delays or inflammatory responses.

    Product
    REF 800-05-035, ENZTEC FEMORAL IMPACTOR - DJO, (01) 09421028110624 (10) 999999, To be used only with DJO EMPOWR 3D KNEE
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1576-2015·2015-05-13

    B. Braun Medical Recalls Pain Control Trays Due to Sterile Barrier Risk

    B. Braun Medical is recalling specific pain control trays because a potential hole in the outer tray may compromise the sterile barrier, posing a risk of contamination.

    Product
    CONTIPLEX Continuous Peripheral Nerve Block Tray, CONTIPLEX Stirn Continuous Nerve Block Tray, Custom Epidural and Anesthesia Tray, Custom Epidural Anesthesia Tray, Custom Kit, Custom Single Dose Epidural Anesthesia Tray, Custom Spinal Anesthesia Tray, Custom Spinal Epidural A
    Category
    Medical Device
    Distribution
    Distributed nationwide