Hazard

Infection recalls

2,518 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total: 2,518
Critical: 31
Severe: 1,671
Most recent: 2026-08-26

Of the 2,518 infection recalls we have scored against our rubric, 31 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1,671 (66%) 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 infection 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.

26–50 of 2518

HighFDA (Drugs)·D-0376-2024·2024-03-20
TRP Blur Relief Eye Drops Recalled Nationwide for Sterility Assurance Failure
TRP Blur Relief sterile eye drops (Lot #B905) are recalled due to inability to assure product sterility. Approximately 7,248 bottles were distributed nationwide.
Product
TRP Blur Relief, Sterile Eye Drops, Homeopathic 0.5 FL OZ (15mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-002-11.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1153-2024·2024-02-28
EndoVive Replacement Button Kits mislabeled with incorrect sizing
Boston Scientific is recalling EndoVive Replacement Button Kits due to sizing mislabeling that could cause undersizing and serious complications including tissue damage and sepsis.
Product
EndoVive Replacement Button Kit w/ ENFIT 28F 2.8 CM, Outer Box UPN M00509500 or M00509510.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1077-2024·2024-02-21
Medical Device Recall: Heart-Lung Machine Component Sterile Barrier Defect
The BEQ-HLS 7050 USA HLS Set Advanced 7.0 is recalled due to a compromised sterile barrier on its Emergency Priming Line component. This defect may cause inflammation, sepsis, or infection.
Product
BEQ-HLS 7050 USA, HLS Set Advanced 7.0, Product Code/Part Number 70106.9078. Used with the CARDIOHELP heart-lung machine.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0977-2024·2024-02-14
RotaFlow Centrifugal Pump Seal Defect Poses Infection Risk
Maquet Medical Systems is recalling 1,090 RotaFlow centrifugal pumps used in heart surgery due to seal defects that could compromise sterile barriers and expose patients to infection.
Product
BEQ-RF-32-USA RotaFlow Centrifugal Pump with BIOLINE Coating, Product Code 701047554. For use with an extracorporeal cardiovascular or cardiopulmonary bypass circuit.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0709-2024·2024-01-24
Express Chest Drains Recalled for Infection Risk from Recalled Syringes
Maquet Cardiovascular is recalling Express chest drains pre-packaged with recalled sterile water syringes. If not kept upright, patients may be exposed to infectious material, risking infection, abscess, sepsis, and death.
Product
Product REF 4000-100N, DRAIN, EXPRESS SINGLE W/AC, Single Collection
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0710-2024·2024-01-24
FDA Recalls Express Chest Drain Blood Recovery Units Over Infection Risk
Maquet Cardiovascular is recalling Express chest drain units with defective sterile water syringes. If not kept upright, patients risk exposure to infectious material that may cause infection, abscess, sepsis, or death.
Product
Product REF 4050-100N, DRAIN, EXPRESS BRU W/AC, Blood Recovery Unit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0650-2024·2024-01-17
Abiomed Introducer Kit Sterile Barrier Compromise Risks Infection
Abiomed introducer kits may have holes in the outer pouch, compromising sterility and exposing patients to potential microbial contamination. This could lead to serious infections including bacteremia or sepsis.
Product
Abiomed Kit, 14Fr Introducer, 13cm, Long Taper Individual (0052-0038)-Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3052
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0647-2024·2024-01-17
Abiomed Oscor Introducer Kit Recalled Due to Sterile Barrier Compromise
Abiomed is recalling its Oscor Introducer Kit due to holes in the outer pouch that may compromise the sterile barrier. Non-sterile introducers could expose patients to infection, bacteremia, or sepsis.
Product
Oscor Introducer Kit, 14Fr x Short Individual (0052-0001)- Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3014
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0648-2024·2024-01-17
Abiomed Oscor Introducer Kit sterile barrier holes risk infection
Abiomed Oscor Introducer Kits may have holes in the outer pouch that compromise sterility. This could allow bacteria to enter the patient's bloodstream during catheter insertion.
Product
Abiomed Oscor Introducer Kit, 14Fr x Long Individual (0052-0017)- Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3015
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0340-2024·2023-11-29
Mobile Airway Scope Recalled Due to Unvalidated Drying Process
Aizu Olympus has recalled 33 Mobile Airway Scope units due to an unvalidated air drying process. Some repaired units had wet channels, creating a potential risk of contamination and infection.
Product
Mobile airway scope-diagnosis and observation to access airway anatomy, endotracheal/endobronchial intubation and management. Model Numbers: MAF-DM2, MAF-GM, MAF-GM2, MAF-TM, MAF-TM2.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2604-2023·2023-09-27
DJO Surgical Orthopedic Implants Recalled for Sterilization Failure
DJO Surgical orthopedic implants (lot 878B1171) were shipped without sterilization and may cause infection if implanted, potentially requiring treatment, monitoring, or revision surgery. Contact your healthcare provider to verify your lot number.
Product
DJO Surgical: Delta Ceramic Femoral Head, 44 mm + 4.0 mm, REF: 400-03-443
Category
Medical Device
Distribution
26 states
HighFDA (Devices)·Z-2607-2023·2023-09-27
Orthopedic implant components recalled due to sterilization failure
Encore Medical is recalling 15 orthopedic implants (DJO Surgical Altivate Reverse) due to sterilization failure. If implanted, unsterilized components may cause infection requiring treatment, monitoring, or revision surgery.
Product
DJO Surgical: Altivate Reverse, Humeral Stem, Small Shell, Size 6 x 108mm, REF: 533-06-108
Category
Medical Device
Distribution
26 states
HighFDA (Devices)·Z-2605-2023·2023-09-27
Orthopedic hip stem implant recalled due to sterilization failure
Encore Medical has recalled a hip stem orthopedic implant that was not sterilized before shipment. Non-sterile implants may cause infection if implanted, requiring treatment and potentially revision surgery.
Product
DJO Surgical: CLP Hip, Stem, Polished Neck, Lateral Offset Implant, Size#3, REF: 426-11-030
Category
Medical Device
Distribution
26 states
HighFDA (Devices)·Z-2603-2023·2023-09-27
Orthopedic knee implant component lacks final sterilization before shipment
Encore Medical recalls 20 DJO Surgical Empowr Knee tibia baseplate components that were not sterilized before shipment. If implanted, these components may cause infection requiring treatment or revision surgery.
Product
DJO Surgical: Empowr Knee, Universal Tibia Baseplate, 6R, REF: 352-02-106
Category
Medical Device
Distribution
26 states
SevereFDA (Devices)·Z-2467-2023·2023-09-06
EVIS EXERA III Duodenovideoscope Recalled Due to Patient Infection Reports
Olympus Corporation recalls 6,426 units of the EVIS EXERA III Duodenovideoscope (Model TJF-Q190V) due to recent reports of patient infections. The device was distributed nationwide in the United States.
Product
EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2198-2023·2023-07-26
Medline Probe Cover Kits recalled due to inadequate seam barriers
Medline Probe Cover Kits may have inadequate seam barriers that could allow contamination during diagnostic ultrasound procedures. Approximately 575 units have been distributed worldwide since December 2017.
Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ULTRASOUND PACK, Model Number DYNDH1112; b) PARA THORACENTESIS TRAY, Model Number DYNDH1165A; c) ULTRASOUND TRAY, Model Number DYNDH1204;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1636-2023·2023-06-07
FDA Recalls QUADROX-i Small Oxygenator Due to Packaging Integrity Issues
Maquet Medical Systems USA is recalling 1,784 QUADROX-i Small Oxygenators due to packaging defects that may compromise the sterile barrier, risking infection and other serious complications.
Product
BEQ-HMO 50000-USA/ QUADROX-i Small, Oxygenator used during cardiopulmonary bypass Item no. 701067905
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1641-2023·2023-06-07
QUADROX-i Pediatric Oxygenator Packaging Defects Compromise Sterile Barrier
FDA Class II recall of QUADROX-i Pediatric oxygenators due to packaging defects—creases, holes, cracks—that compromise sterile barriers, risking infection and sepsis during cardiopulmonary bypass procedures.
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-1635-2023·2023-06-07
Oxygenator devices recalled due to packaging damage compromising sterile barrier
Maquet Medical Systems USA recalls 15,880 QUADROX-iD oxygenators nationwide due to packaging damage that may compromise sterile barriers, potentially exposing patients to infection.
Product
BEQ-HMOD70000-USA/QUADROX-iD, Oxygenator used during cardiopulmonary bypass Item no. 701067859
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1656-2023·2023-06-07
QUADROX-iD Adult Oxygenator recalled for packaging defect compromising sterile barrier
Maquet Medical Systems USA recalls 24,250 QUADROX-iD Adult Oxygenators due to small pinholes in product packaging that may compromise the sterile barrier, potentially exposing patients to non-sterile devices during cardiopulmonary bypass surgery.
Product
QUADROX-iD Adult, Oxygenator used during cardiopulmonary bypass Model Item No. HMOD 70000-USA 701067840 BEQ-HMOD70000-USA 701067859
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-1640-2023·2023-06-07
QUADROX-i Neonatal oxygenator recalled for compromised sterile packaging
Maquet Medical Systems is recalling QUADROX-i Neonatal oxygenators due to packaging defects that may compromise sterility. Improper accessory placement and packaging damage could expose the device to contamination, risking infection and sepsis.
Product
QUADROX -i Neonatal, Oxygenator used during cardiopulmonary bypass Model Item no. HMO 10000-USA 701070412 HMO 11000-USA 701070416
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1658-2023·2023-06-07
QUADROX-iD Pediatric Oxygenator Recalled Due to Packaging Sterile Barrier Defect
Maquet Medical Systems USA recalls 5,022 QUADROX-iD Pediatric Oxygenators distributed nationwide due to small pinholes in product packaging that may compromise the sterile barrier, potentially exposing patients to non-sterile devices.
Product
QUADROX-iD Pediatric, Oxygenator used during cardiopulmonary bypass Model Item No. BEQ-HMOD30000-USA 701070397 BEQ-HMOD30000-USA 701050330
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1660-2023·2023-06-07
QUADROX-i Neonatal Oxygenator packaging may compromise sterile barrier
QUADROX-i Neonatal Oxygenators may have small pinholes in packaging that compromise the sterile barrier, potentially exposing the device to non-sterile conditions and risk of infection, sepsis, or ischemia.
Product
QUADROX -i Neonatal, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 10000-USA 701070412 HMO 11000-USA 701070416
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