The Recall Desk

Hazard

Bacterial Endotoxin recalls

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

What the numbers show

Total
76
Critical
3
Severe
31
Most recent
2026-09-16

Of the 76 bacterial endotoxin recalls we have scored against our rubric, 3 (4%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 31 (41%) 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 bacterial 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.

1–25 of 76

  • HighFDA (Devices)·Z-3112-2026·2026-09-16

    Atrium Medical Recalls Getinge PVC Thoracic Catheters Due to Endotoxin Testing

    Atrium Medical is recalling specific lots of Getinge PVC Thoracic Catheters because one lot failed bacterial endotoxin testing.

    Product
    Getinge PVC Thoracic Catheter, Soft PVC Right Angle, 10 per Case; Size(Model Number): 1. 24FR(8124), 2. 28FR(8128), 3. 32FR(8132), 4. 36FR(8136);
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3113-2026·2026-09-16

    Atrium Medical Recalls Getinge PVC Thoracic Catheters Due to Endotoxin Testing

    Atrium Medical Corporation is recalling specific lots of Getinge PVC Thoracic Catheters because bacterial endotoxin testing results were out of specification.

    Product
    Getinge PVC Thoracic Catheter, Firm PVC Straight, 10 per Case; Size(Model Number): 1. 28FR(15028), 2. 36FR(15036);
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3111-2026·2026-09-16

    Atrium Medical Recalls Getinge PVC Thoracic Catheters Due to Endotoxin Testing

    Atrium Medical Corporation is recalling specific lots of Getinge PVC Thoracic Catheters because an out-of-specification result was found in bacterial endotoxin testing.

    Product
    Getinge PVC Thoracic Catheter, Soft PVC Straight, 10 per Case; Size(Model Number): 1. 16FR(8016), 2. 24FR(8024), 3. 28FR(8028), 4. 32FR(8032), 5. 36FR(8036);
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0851-2026·2026-09-09

    Optimal Balance Pharmacy Recalls Contaminated Glutathione Injection Vials

    Optimal Balance Pharmacy is recalling 53 vials of Glutathione 200 mg/mL due to bacterial endotoxin contamination.

    Product
    Glutathione 200 mg/mL, 30 mL sterile multidose vial, Each vial contains: Glutathione, Ascorbic Acid, Benzyl Alcohol & sterile water for injection, For IM or IV Injection Use Only, RX only, Optimal Balance Pharmacy, 2204 Cypress Creek Pkwy Suite F, Houston, TX 77090
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0772-2026·2026-08-19

    Victory Medical Center Pharmacy Recalls Glutathione Vials Due to Contamination

    Victory Medical Center Pharmacy is recalling 91 vials of Glutathione (MDV) 200 mg/mL due to bacterial endotoxin contamination.

    Product
    Glutathione (MDV), 200 mg/mL, 30 mL vial, each mL contains Glutathione 200 mg, Ascorbic Acid 20 mg, Benzyl Alcohol 1.5%, Na Hydroxide (Ph Adjust) in sterile water for injection, VMC.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1460-2025·2025-04-02

    Medline ReNewal Electrophysiology Catheters Recalled for Elevated Bacterial Endotoxin Levels

    Medline is recalling ReNewal Reprocessed Livewire Steerable Electrophysiology Catheters used in cardiac procedures because the devices may contain higher than expected levels of bacterial endotoxin.

    Product
    Medline ReNewal Reprocessed Livewire Steerable Electrophysiology Catheters, Medline Item Numbers: 401582R, 401904R, 401904R, 401905R, 401933R, and 401991R
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3155-2024·2024-09-25

    Shoulder implant recalled due to excessive bacterial endotoxin

    Tornier, Inc. is recalling one lot of the Stryker TORNIER PERFORM HUMERAL SYSTEM - STEMLESS shoulder implant due to bacterial endotoxin exceeding safety specifications. The 5 affected units were distributed in Illinois, Wisconsin, Arizona, Nevada, and South Dakota.

    Product
    stryker TORNIER PERFORM HUMERAL SYSTEM - STEMLESS US Anatomic Nucleus, REF DWM003A; anatomic total arthroplasty of the shoulder
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1832-2024·2024-05-22

    EchoTip Ultra HD Endoscopic Ultrasound Access Needle recalled for elevated bacterial endotoxin

    Cook Medical has recalled EchoTip Ultra HD Endoscopic Ultrasound Access Needles (lots C2145003, C2144407) due to elevated levels of bacterial endotoxin. The devices were distributed internationally in Germany, Netherlands, Switzerland, and the United Kingdom.

    Product
    EchoTip¿ Ultra HD Endoscopic Ultrasound Access Needle, ECHO-HD-19-A, G52012
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1833-2024·2024-05-22

    Cook Medical EchoTip Ultra needle recalled due to elevated bacterial endotoxin levels

    Cook Medical is recalling EchoTip Ultra endoscopic ultrasound access needles that may contain elevated bacterial endotoxin levels. The affected units were distributed internationally.

    Product
    EchoTip¿ Ultra Endoscopic Ultrasound Access Needle, ECHO-19, G31520
    Category
    Medical Device
    Distribution
    0 states
  • 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…
    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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (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-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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (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…
    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…
    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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0521-2020·2019-12-04

    Zimmer Biomet Recalls Acromium Flange Sets Due to Cleaning Issues

    Zimmer Biomet is recalling Acromium Flange Sets because elevated levels of bacterial endotoxin and residual debris remain on the devices due to a cleaning issue.

    Product
    ACROMIUM FLANGE SET (Custom product) Item No. PM555148 - Product Usage: Arcomium replacement.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0519-2020·2019-12-04

    Zimmer Biomet Recalls Compress Mini Compress Devices Due to Cleaning Issues

    Zimmer Biomet is recalling Compress Mini Compress devices because elevated bacterial endotoxin and residual debris remain on the devices due to a cleaning issue.

    Product
    Compress, Mini Compress; Item Nos. 178350 178351 178352 178353 178354 178355 178356 178357 178358 178359 178360 178361 178362 178363 178364 178365 178366 178367 178368 178369 178370 178371 178372 178373 178464 178472 178480 178488 178496 178504…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0526-2020·2019-12-04

    Zimmer Biomet Recalls Custom Medical Devices Due to Cleaning Issues

    Zimmer Biomet is recalling various custom medical devices because elevated levels of bacterial endotoxin and residual debris remain on the products due to a cleaning issue.

    Product
    Various Custom Products, Item Nos. CP102940 CP102941 CP102942 CP102943 CP102944 CP102945 CP102946 CP102947 CP102948 CP112662 CP112663 CP112664 CP112674 CP112675 CP113771 CP113777 CP113778 CP113782 CP113783 CP114083 CP114090 CP114112 CP114118 CP114148…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0520-2020·2019-12-04

    Zimmer Biomet Recalls Shoulder Baseplates Due to Cleaning Issues

    Zimmer Biomet is recalling COMP RVRS Shoulder Baseplates because elevated levels of bacterial endotoxin and residual debris remain on the devices due to a cleaning issue.

    Product
    COMP RVRS Shoulder Baseplates, including Custom Products, Item numbers 115331S 115331 115330S 115330 110040610 110040620 010000589 CP561861 PM0001456 PM551047 PM551063 PM555137 PM555160 PM555209 PM555322 PM555406 PM555415 UDI…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0533-2020·2019-12-04

    Zimmer Biomet Recalls Custom Shoulder Implants Due to Cleaning Issues

    Zimmer Biomet is recalling specific custom shoulder replacement implants because elevated levels of bacterial endotoxin and residual debris remain on the devices due to a cleaning issue.

    Product
    BIOMOD PORCOAT HA GLENTRAY; Custom Shoulder Products Item Nos. PM0000097 PM555140 PM555147 PM555319 PM555418 113867 113865 113863 Product Usage: Total Shoulder Replacement
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0528-2020·2019-12-04

    Zimmer Biomet Recalls HA Pins and Hoffman/Colles Pins Due to Cleaning Issues

    Zimmer Biomet is recalling HA Pins and Hoffman/Colles Pins because elevated bacterial endotoxin and residual debris remain on the devices due to a cleaning issue.

    Product
    HA Pins (DFS HA Cort Screw), Hoffman/Colles Pins (Colles CSER Sterile w/ Pin Kit) Item Nos: HAA60-09030 HAA60-09040 HAA60-10030 HAA60-10040 HAA60-11030 HAA60-11040 HAA60-11050 HAA60-12040 HAA60-12060 HAA60-13030 HAA60-13040 HAA60-13050 HAA60-13060 HAA60-13070…
    Category
    Medical Device
    Distribution
    Distributed nationwide