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.

26–50 of 328

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-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-1992-2026·2026-05-06
Depuy Synthes ATTUNE Revision Hinge Femoral implants recalled for sterility risk
DePuy Synthes is recalling ATTUNE Revision Hinge Femoral knee implants because external sterile packaging was found adhered to internal packaging, potentially compromising sterility.
Product
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 7 CEM. Part Number: 150450207.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1990-2026·2026-05-06
DePuy Synthes ATTUNE Revision Hinge Femoral Component Sterility Recall
DePuy Synthes is recalling 3 units of the ATTUNE REVISION HINGE FEMORAL RT SZ 4 CEM due to external sterile packaging found adhered to internal packaging, potentially compromising sterility.
Product
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 4 CEM. Part Number: 150450204.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1987-2026·2026-05-06
DePuy Synthes ATTUNE Revision Hinge Femoral Component Sterility Recall
DePuy Synthes is recalling one lot of ATTUNE Revision Hinge Femoral components (left size 7, part number 150450107) due to external sterile packaging adhered to internal packaging, potentially compromising product sterility.
Product
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 7 CEM. Part Number: 150450107.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1989-2026·2026-05-06
DePuy Synthes ATTUNE Revision Hinge Femoral Component Recall
DePuy Synthes is recalling 3 units of ATTUNE Revision Hinge Femoral RT Size 3 Cement components due to external sterile packaging that was adhered to internal sterile packaging, potentially compromising sterility.
Product
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 3 CEM. Part Number: 150450203.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1993-2026·2026-05-06
DePuy Synthes ATTUNE Revision Hinge Femoral implant sterility concern
DePuy Synthes is recalling 3 units of ATTUNE Revision Hinge Femoral RT SZ 8 CEM implants due to external sterile packaging adhered to internal sterile packaging, potentially compromising sterility.
Product
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 8 CEM. Part Number: 150450208.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1986-2026·2026-05-06
Depuy Synthes ATTUNE Revision Hinge Femoral Component Sterility Compromise
Depuy Synthes is recalling ATTUNE Revision Hinge Femoral components because external sterile packaging was found adhered to internal sterile packaging, potentially compromising sterility.
Product
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 5 CEM. Part Number: 150450105.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1988-2026·2026-05-06
DePuy Synthes ATTUNE Revision Hinge Femoral Component Sterility Recall
DePuy Synthes is recalling 3 units of ATTUNE REVISION HINGE FEMORAL LT SZ 8 CEM due to external sterile packaging adhered to internal packaging, potentially compromising sterility.
Product
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 8 CEM. Part Number: 150450108.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1985-2026·2026-05-06
DePuy Synthes ATTUNE Revision Hinge Femoral Component Recall
DePuy Synthes is recalling 3 units of ATTUNE Revision Hinge Femoral Left Size 4 Cement prosthetic components because external sterile packaging was found adhered to internal packaging, potentially compromising sterility.
Product
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 4 CEM. Part Number: 150450104.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1420-2026·2026-02-25
Medline surgical and ophthalmology kits recalled for sterilization equipment calibration issues
Medline is recalling 4,853 surgical and ophthalmology convenience kits due to calibration issues with sterilization equipment that could compromise sterility assurance. No illnesses have been reported.
Product
Medline Convenience Kits: 1) KIT OPHTHALMIC RUPTURE GLOBE, Model Number: DYKMBNDL104; 2) KIT OPHTHALMIC RUPTURE GLOBE, Model Number: DYKMBNDL104A; 3) KIT OPHTHALMOLOGY CORNEAL TRAN, Model Number: DYKMBNDL159; 4) KIT OPHTHALMOLOGY CATARACT, Model Number: DYKMBNDL180; 5) K
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1391-2026·2026-02-25
Medline PICC and Central Line Procedure Kits Recalled for Sterilization Equipment Calibration Issues
Medline Industries is recalling 5,346 sterile surgical procedure kits due to calibration issues in sterilization equipment that may compromise sterility assurance. The kits were distributed nationwide.
Product
Medline Convenience Kits: 1) PICC LINE TRAY, Model Number: 00-401993O; 2) CODE CART ADULT 4 CENTRAL LINE, Model Number: ACC010268B; 3) CODE CART ADULT 4 CENTRAL LINE, Model Number: ACC010268C; 4) TRAY 6 CENTRAL LINE A, Model Number: ACC010487; 5) PEDS PICC INSERTION TRAY
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1386-2026·2026-02-25
Medline convenience kits recalled for sterilization equipment calibration issues
Medline is recalling 779 units of five convenience kit models due to calibration issues in sterilization equipment. These issues may compromise the sterility assurance of affected devices.
Product
Medline Convenience Kits: 1) SCC RF PAIN MGMT, Model Number: DYNJ56436A; 2) SCC RF PAIN MGMT, Model Number: DYNJ56436B; 3) CPNB SETUP TRAY, Model Number: DYNJRA1979; 4) CPNB SETUP TRAY, Model Number: DYNJRA1979A; 5) CPNB SETUP TRAY, Model Number: SAMPA0108
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1413-2026·2026-02-25
Medline Neurosurgery Convenience Kits Recalled for Sterilization Calibration Issues
Medline is recalling 7,494 neurosurgery convenience kits due to sterilization equipment calibration problems that could impact sterility assurance. No illnesses or injuries have been reported.
Product
Medline Convenience Kits: 1) NEURO SHUNT- CODMAN, Model Number: CDS860018G; 2) NEURO SHUNT- CODMAN, Model Number: CDS860018I; 3) KIT NEUR FUS LUM POST CRANDALL, Model Number: DYKMBNDL138; 4) KIT NEURO FUS LUM POST SANSUR, Model Number: DYKMBNDL142; 5) KIT NEURO FUS LUM P
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1397-2026·2026-02-25
Medline surgical kits recalled for potential sterility compromise due to calibration issues
Medline is recalling 4,757 surgical kits and packs due to calibration issues with sterilization equipment that could affect sterility assurance. No illnesses or injuries have been reported.
Product
Medline Convenience Kits: 1) PLASTIC BIN W/MISC KITS, Model Number: ACC010499; 2) KIT UROLOGY URETHROPLASTY, Model Number: DYKMBNDL117C; 3) KIT PLASTIC INSERT TISSUE EXPA, Model Number: DYKMBNDL158; 4) KIT PLASTIC ABDOMINOPLASTY, Model Number: DYKMBNDL170; 5) KIT PLASTIC
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1425-2026·2026-02-25
Medline Surgical Packs Recalled for Sterilization Equipment Calibration Issues
Medline Industries recalls over 193,000 surgical packs due to sterilization equipment calibration issues that could compromise sterility assurance. No injuries have been reported.
Product
Medline Surgical Packs: 1) PACK,UNIVERSAL,ULTRAGARD,5/CS, Model Number: DYNJP1050UG; 2) PACK,SHOULDER,DRAPE,POUCH,10/CSModel Number: DYNJP8401
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1423-2026·2026-02-25
Medline Surgical Drapes Recalled Due to Sterilization Equipment Calibration Issues
Medline Industries is recalling over 14 million surgical drapes due to sterilization equipment calibration issues that could compromise product sterility. No illnesses or injuries have been reported.
Product
Medline Surgical Drapes: 1) SHEET,DRAPE,40X58,STERILE, Model Number: DYNJP2410; 2) DRAPE,SHEET,ECONOMY,40X58",ST,20/CS, Model Number: DYNJP2411; 3) SHEET,DRAPE, 40X70,STERILE, Model Number: DYNJP2412; 4) DRAPE,MEDIUM,TAPE,40X70",ST,50/CS, Model Number: DYNJP2412T; 5) SHE
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1419-2026·2026-02-25
Medical Device Surgical Kits Recalled for Sterilization Equipment Calibration Issues
Medline is recalling 31 models of surgical instrument kits due to calibration issues with sterilization equipment that could affect sterility assurance. The recall affects approximately 7,725 units distributed nationwide.
Product
Medline Convenience Kits: 1) BAP NORTH ROBOTIC SURGERY CDS, Model Number: CDS982407N; 2) TOT/ GYN LITHOTOMY CDS, Model Number: CDS985431K; 3) TOT/ GYN LITHOTOMY CDS, Model Number: CDS985431O; 4) KIT ROBOTICS GYN, Model Number: DYKMBNDL109A; 5) KIT ROBOTICS UROLOGY PROSTA
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1399-2026·2026-02-25
Medline Convenience Kits Recalled Due to Sterilization Calibration Issues
Medline Industries recalls 154,427 sterilized medical convenience kits due to calibration issues with sterilization and packaging equipment that may impact sterility assurance. No illnesses have been reported.
Product
Medline Convenience Kits: 1) DRAWER 6-IV FLUIDS GLOVES, Model Number: ACC010326; 2) DRAWER 6-IV FLUIDS GLOVES, Model Number: ACC010326A; 3) DRAWER #5, Model Number: ACC010475; 4) DRAWER 1 NEURO CART, Model Number: ACC010542; 5) DRAWER 2 NEURO CART, Model Number: ACC01054
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1403-2026·2026-02-25
Medline Convenience Kits Recalled Due to Potential Sterility Compromise
Medline Industries is recalling convenience kits due to calibration problems with sterilization equipment that could affect whether devices remain sterile.
Product
Medline Convenience Kits: 1) WMC I D PACK-LF, Model Number: DYNJ50806L
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1334-2026·2026-02-18
Medline Medical Kits With BD ChloraPrep Swabsticks Recalled for Open Packaging Seals
Medline Industries is recalling 8,445 medical convenience kits nationwide due to open seals on BD ChloraPrep Triple Swabstick applicator packaging. The defect may compromise product sterility.
Product
Medline medical convenience kits packaged as: ) LVAD DRESSING CHANGE TRAY, Kit SKU DM320C; 2) PORT AND IO ACCESS DRESSING KI, Kit SKU DT15780A; 3) PORT-A-CATH DRESSING CHANGE TR, Kit SKU DT16615; 4) LARGE BORE CENTRAL LINE DRSG C, Kit SKU DT19660; 5) CENTRAL LINE DRESS
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1338-2026·2026-02-18
Halyard Transport Bag Kit Recalled for Potential Sterility Compromise
AVID Medical is recalling Halyard Transport Bag Kits (Kit Code LIFE0080-01) due to a Tyvek bag seal defect that may compromise the sterility of the kit. No illnesses or injuries have been reported.
Product
Halyard TRANSPORT BAG KIT. Kit Code: LIFE0080-01.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0899-2026·2025-12-17
Medline Curad Quick Strip Bandages Recalled for Open Packaging Seals
Medline is recalling Curad Quick Strip Fabric Bandages (18,000 units) due to open seals that may compromise sterility. Distribution affected: US, Guam, Canada, and United Arab Emirates.
Product
Curad Quick Strip Fabric Bandages Containing 30 Bandages of 3/4" x 3", Medline Item Number CUR1930P
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0904-2026·2025-12-17
Medline Quick Strip Fabric Bandages recalled for potentially compromised sterility
Medline is recalling all lots of Quick Strip Fabric Sterile Adhesive Bandages because open packaging seals may compromise product sterility. The recall affects 11,291,800 units.
Product
Quick Strip Fabric Sterile Adhesive Bandages, 1" x 3", Medline Item Number NON25660QS
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0900-2026·2025-12-17
Medline Quick Strip Plastic Bandages Recalled for Potentially Compromised Sterility
Medline is recalling approximately 1.7 million Quick Strip Plastic Sterile Adhesive Bandages due to open packaging seals that may compromise product sterility. Affected products were distributed in the US, Guam, Canada, and UAE.
Product
Quick Strip Plastic Sterile Adhesive Bandages, 0.75" x 3", Medline Item Number NON25500QS
Category
Medical Device
Distribution
0 states