Hazard

Sterility Compromise recalls

328 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 sterility compromise 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 328

SevereFDA (Devices)·Z-2192-2026·2026-05-20
Reprocessed Electrophysiology Catheter with Incomplete Sterile Seals Recalled
Stryker Sustainability Solutions is recalling 107 units of Daig Livewire Steerable reprocessed electrophysiology catheters due to incomplete seals on the sterile product packaging. The incomplete seals may compromise sterility assurance.
Product
Daig Livewire Steerable, Product Number 401905; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2186-2026·2026-05-20
Reprocessed Electrophysiology Catheters Recalled for Incomplete Seals
Stryker Sustainability Solutions is recalling Daig Livewire Steerable reprocessed electrophysiology catheters due to incomplete seals on sterile product packaging, which could compromise sterility and patient safety.
Product
Daig Livewire Steerable, Product Number 401575; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2187-2026·2026-05-20
Reprocessed Electrophysiology Catheter Recall Due to Incomplete Sterile Seals
Stryker Sustainability Solutions is recalling 108 units of Daig Livewire Steerable reprocessed electrophysiology catheters due to incomplete seals on the sterile product packaging. The defect may compromise sterility assurance.
Product
Daig Livewire Steerable, Product Number 401581; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2176-2026·2026-05-20
Reprocessed Electrophysiology Catheter with Incomplete Sterile Seals
Stryker Sustainability Solutions is recalling BARD Dynamic Tip Steerable reprocessed electrophysiology catheters (Product Number 200344) due to incomplete seals on sterile product packaging that could compromise sterility.
Product
BARD Dynamic Tip Steerable, Product Number 200344; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2194-2026·2026-05-20
Daig Livewire Steerable Reprocessed Electrophysiology Catheters Recalled
Stryker Sustainability Solutions is recalling Daig Livewire Steerable reprocessed electrophysiology catheters due to incomplete seals on sterile product packaging. The defect may compromise sterility.
Product
Daig Livewire Steerable, Product Number 401914; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2198-2026·2026-05-20
Daig Livewire Steerable BDB Electrophysiology Catheter Recall
Stryker Sustainability Solutions is recalling Daig Livewire Steerable BDB reprocessed electrophysiology catheters due to incomplete seals on the sterile product.
Product
Daig Livewire Steerable BDB, Product Number 401918, REPROCESSED ELECTROPHYSIOLOGY CATHETER
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2182-2026·2026-05-20
BARD EP XT Steerable Reprocessed Electrophysiology Catheter Recall
Stryker Sustainability Solutions is recalling BARD EP XT Steerable reprocessed electrophysiology catheters due to incomplete seals on sterile product, which may compromise sterility. Affected units were distributed in the US, Israel, and Canada.
Product
BARD EP XT Steerable, Product Number 200794; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2180-2026·2026-05-20
Reprocessed Electrophysiology Catheter Recalled for Incomplete Seals
Stryker Sustainability Solutions is recalling BARD Dynamic XT Steerable reprocessed electrophysiology catheters due to incomplete seals on the sterile product, which could compromise sterility.
Product
BARD Dynamic XT Steerable, Product Number 201104; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2177-2026·2026-05-20
BARD Dynamic Tip Steerable Medical Device Recall Due to Incomplete Seals
Stryker Sustainability Solutions is recalling BARD Dynamic Tip Steerable devices due to incomplete seals on the sterile product. The recall affects 427 units distributed nationwide and in Israel and Canada.
Product
BARD Dynamic Tip Steerable, Product Number 6DYNTP001;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2189-2026·2026-05-20
Daig Livewire Steerable Electrophysiology Catheters Recalled for Incomplete Seals
Stryker Sustainability Solutions is recalling Daig Livewire Steerable electrophysiology catheters with incomplete seals on sterile packaging. The defect may allow contamination of the sterile product.
Product
Daig Livewire Steerable, Product Number 401603, REPROCESSED ELECTROPHYSIOLOGY CATHETER
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2181-2026·2026-05-20
Reprocessed Electrophysiology Catheter Recalled for Incomplete Sterile Seals
Stryker Sustainability Solutions is recalling 217 units of BARD EP XT Decapolar Steerable reprocessed electrophysiology catheters due to incomplete seals on the sterile product packaging.
Product
BARD EP XT Decapolar Steerable, Product Number 201007; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2174-2026·2026-05-20
Reprocessed Electrophysiology Catheter Recalled for Incomplete Seals
Stryker Sustainability Solutions is recalling BARD Dynamic Deca Steerable reprocessed electrophysiology catheters (Product Number 201101) distributed nationwide and in Israel and Canada due to incomplete seals on the sterile product packaging. The incomplete seals may compromise sterility.
Product
BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2179-2026·2026-05-20
Reprocessed Electrophysiology Catheter Recalled for Incomplete Seals
Stryker Sustainability Solutions is recalling BARD Dynamic XT Steerable reprocessed electrophysiology catheters (Product Number 201103) due to incomplete seals on the sterile product packaging.
Product
BARD Dynamic XT Steerable, Product Number 201103, REPROCESSED ELECTROPHYSIOLOGY CATHETER
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2183-2026·2026-05-20
Reprocessed Electrophysiology Catheter Recalled for Incomplete Sterile Seals
Stryker Sustainability Solutions is recalling 154 units of BW Webster Duo-Decapolar reprocessed electrophysiology catheters due to incomplete seals on the sterile product packaging, which may compromise sterility.
Product
BW Webster Duo-Decapolar, Product Number D728260RT; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2185-2026·2026-05-20
Reprocessed Electrophysiology Catheter Recall Due to Incomplete Seals
Stryker Sustainability Solutions is recalling 816 units of CS Uni-Directional w Auto ID reprocessed electrophysiology catheters due to incomplete seals on the sterile product packaging.
Product
CS Uni-Directional w Auto ID, Product Number D135304; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2190-2026·2026-05-20
Reprocessed Electrophysiology Catheter with Incomplete Sterile Seals
Stryker Sustainability Solutions is recalling reprocessed electrophysiology catheters due to incomplete seals on the sterile product packaging, which may compromise sterility.
Product
Daig Livewire Steerable, Product Number 401652; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2195-2026·2026-05-20
Daig Livewire Steerable Electrophysiology Catheter Incomplete Seals Recall
Stryker Sustainability Solutions is recalling 206 units of Daig Livewire Steerable reprocessed electrophysiology catheters due to incomplete seals on sterile product. The catheters were distributed nationwide and in Israel and Canada.
Product
Daig Livewire Steerable, Product Number 401915; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2109-2026·2026-05-13
Medline Surgical Device Kits Recalled Due to Sterilization Equipment Calibration Issues
Medline Industries is recalling approximately 15,806 surgical device kits used in gynecology, urology, and thoracic procedures. Calibration issues with sterilization and packaging equipment may have compromised the sterility assurance level of the devices.
Product
See full list in RES, exceeds character limit 1) GYN LAPAROSCOPY CDS, Model Number: CDS981504G; 2) BAP NORTH ROBOTIC SURGERY CDS, Model Number: CDS982407P; 3) ROBOTIC GYN CDS-1, Model Number: CDS982893I; 4) GYN LAPAROSCOPY CDS, Model Number: CDS983300J; 5) NHP ROBOTIC GY
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2089-2026·2026-05-13
Medline Convenience Kits recalled due to sterilization calibration issue
Medline is recalling two models of Convenience Kits because calibration issues with sterilization and packaging equipment may have compromised the sterility assurance level of the devices.
Product
Medline Convenience Kits: 1) ANCILLARY PACK-LF, Model Number:DYNJ0185290G; 2) OPEN HEART ANESTHESIA ICC-A, Model Number:DYNJ905567A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2121-2026·2026-05-13
Medline Convenience Kits General Closure sterilization calibration issue
Medline Industries is recalling Convenience Kits (Model DYKMBNDL200A) due to calibration issues in sterilization equipment that may have compromised sterility assurance. The kits were distributed nationwide.
Product
Medline Convenience Kits: 1) KIT GENERAL CLOSURE, Model Number: DYKMBNDL200A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2103-2026·2026-05-13
Medline Convenience Kits Recalled Over Sterilization Calibration Issues
Medline is recalling three models of medical convenience kits (central line, LVAD driveline, and surgical oncology) distributed nationwide due to calibration issues in sterilization equipment that may have reduced sterility assurance.
Product
Medline Convenience Kits: 1) CENTRAL LINE UNIVERSAL INSERTI, Model Number: CVI3780; 2) LVAD DRIVELINE TRAY, Model Number: DM1035; 3) KIT SURG ONC INSERT CENT.VENOU, Model Number: DYKMBNDL43
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2116-2026·2026-05-13
Medline Basic Nerve Block Tray sterilization calibration issue
Medline is recalling Basic Nerve Block Trays due to calibration issues with sterilization equipment that may have compromised the sterility assurance level of the devices.
Product
Medline Convenience Kits: 1) BASIC NERVE BLOCK TRAY W/LINEN, Model Number:PAIN0150C
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2090-2026·2026-05-13
Medline Convenience Kits recalled for potential sterilization compromise
Medline Industries is recalling eight models of Convenience Kits due to calibration issues with sterilization equipment that may have affected the sterility assurance level of the devices.
Product
Medline Convenience Kits: 1) SCC RF PAIN MGMT, Model Number:DYNJ56436A; 2) SCC RF PAIN MGMT, Model Number:DYNJ56436B; 3) SCC RF PAIN MGMT, Model Number:DYNJ56436C; 4) CPNB SETUP TRAY, Model Number:DYNJRA1979; 5) CPNB SETUP TRAY, Model Number:DYNJRA1979A; 6) CPNB SETUP
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2110-2026·2026-05-13
Medline Convenience Kits for C-Section and Obstetric Procedures
Medline Industries is recalling 12,529 units of sterile surgical convenience kits used in cesarean section and obstetric procedures worldwide due to equipment calibration issues that may compromise sterilization assurance.
Product
Medline Convenience Kits: 1) C-SECTION PACK, Model Number: CDS820080N; 2) C-SECTION CDS, Model Number: CDS983523G; 3) C-SECTION, Model Number: CDSCCR611O; 4) C-SECTION, Model Number: CDSCCR611P; 5) LUD C-SECTION-LF, Model Number: DYNJ0101616I; 6) C-SECTION TRAY, Model
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2119-2026·2026-05-13
Medline Convenience Kits medical devices recalled due to sterilization calibration issues
Medline is recalling Convenience Kits (Model DYNJ50806L) because equipment calibration issues may have affected the sterility assurance level of the devices. The products were exposed to sterilization and packaging cycles but the calibration problems could impact their sterility.
Product
Medline Convenience Kits: 1) WMC I D PACK-LF, Model Number: DYNJ50806L
Category
Medical Device
Distribution
Distributed nationwide