Hazard

Sterilization Failure recalls

249 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 sterilization failure 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 249

ModerateFDA (Devices)·Z-2117-2026·2026-05-13
Medline Convenience Kits recalled due to sterilization calibration issues
Medline Industries is recalling two models of gastrointestinal convenience kits (BAPTIST FLOYD ENDO GI KIT and GI LAB OTHER ENDO KIT) due to calibration issues in sterilization equipment that may have impacted the sterility assurance level of the products.
Product
Medline Convenience Kits: 1) BAPTIST FLOYD ENDO GI KIT, Model Number: DYKE1455B; 2) GI LAB OTHER ENDO KIT, Model Number: DYKE1721
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2129-2026·2026-05-13
Medline Surgical Gowns Sterilization Calibration Issues
Medline Industries has recalled multiple lots of surgical gowns due to calibration issues with sterilization and packaging equipment that may affect the sterility assurance level of the products.
Product
See complete list in RES, exceeds character limit. Medline Surgical Gowns
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2111-2026·2026-05-13
Medline Convenience Kits recalled due to sterilization calibration issues
Medline Industries has recalled 6,676 units of multiple Medline Convenience Kits used in gynecological and other surgical procedures due to calibration issues with sterilization equipment that may affect sterility assurance.
Product
Medline Convenience Kits: 1) HYSTEROSCOPY, Model Number: CDS984086I; 2) KIT GYN ONCOLOGY LAP, Model Number: DYKMBNDL91A; 3) VAGINAL HYSTERECTOMY PACK-LF, Model Number: DYNJ0373807J; 4) VAGINAL HYSTERECTOMY PACK-LF, Model Number: DYNJ0373807K; 5) D&C/HYSTEROSCOPY PACK, Mo
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2112-2026·2026-05-13
Medline Surgical Convenience Kits Recalled Due to Sterilization Calibration Issues
Medline Industries has recalled multiple surgical convenience kits after discovering calibration issues with sterilization equipment that may impact the sterility assurance level of the devices. The kits include robotic surgery, gynecology, urology, and general surgical packs distributed nationwide.
Product
Medline Convenience Kits: 1) BAP NORTH ROBOTIC SURGERY CDS, Model Number: CDS982407N; 2) BAP NORTH ROBOTIC SURGERY CDS, Model Number: CDS982407N; 3) TOT/ GYN LITHOTOMY CDS, Model Number: CDS985431J; 4) TOT/ GYN LITHOTOMY CDS, Model Number: CDS985431K; 5) TOT/ GYN LITHOTO
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1924-2026·2026-04-29
Flamingo Funnel Small surgical device recalled for sterilization defect
SurgiSmoke Solutions is recalling certain lots of the Flamingo Funnel Small (Model SQ20012-01) due to a manufacturing issue involving use of a non-gamma sterilization compatible drape.
Product
Flamingo Funnel Small, Model Number SQ20012-01
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1612-2026·2026-04-01
Olympus Endoscope Reprocessor OER-Elite Loses Compatibility with MAJ-1443 and MAJ-1444 Models
Olympus Endoscope Reprocessor OER-Elite is no longer compatible with MAJ-1443 and MAJ-1444 endoscope models. Affected endoscopes may not be properly sterilized when processed in this reprocessor, creating infection risk.
Product
Olympus Endoscope Reprocessor OER-Elite. Model Number: N5789340.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1418-2026·2026-02-25
Medline Surgical Convenience Kits Recalled for Sterilization Calibration Issues
Medline is recalling surgical and gynecological convenience kits due to calibration issues with sterilization and packaging equipment that could compromise sterility assurance. No illnesses have been reported to date.
Product
Medline Convenience Kits: 1) HYSTEROSCOPY, Model Number: CDS984086I; 2) KIT GYN ONCOLOGY LAP, Model Number: DYKMBNDL91A; 3) VAGINAL HYSTERECTOMY PACK-LF, Model Number: DYNJ0373807J; 4) VAGINAL HYSTERECTOMY PACK-LF, Model Number: DYNJ0373807K; 5) MINOR VAGINAL #76-RF, Mod
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1409-2026·2026-02-25
Medline Convenience Kits Recalled Due to Sterilization Equipment Calibration Issues
Medline is recalling two medical device convenience kits due to calibration issues with sterilization equipment that could impact product sterility.
Product
Medline Convenience Kits: 1) DRAPE PACK, Model Number: DYNJ35363A; 2) SICK KIDS-GENERAL CUSTOM SPLIT, Model Number: SPTPCD10005
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
HighFDA (Devices)·Z-1393-2026·2026-02-25
Medline Dental Pack Kits Recalled for Sterilization Equipment Calibration Issues
Medline is recalling Dental Pack convenience kits (Model DYNDA3003) due to calibration issues in sterilization equipment that may compromise sterility assurance. Healthcare providers should stop use and contact Medline for replacement.
Product
Medline Convenience Kits: 1) DENTAL PACK, Model Number: DYNDA3003
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1390-2026·2026-02-25
Medline Surgical Device Kits Recalled for Sterilization Calibration Issues
Medline is recalling approximately 39,315 surgical device kits due to calibration issues in sterilization equipment that could compromise device sterility. The affected kits are used in cardiac, vascular, and general surgical procedures.
Product
Medline Convenience Kits: 1) OPEN HEART CDS, Model Number: CDS840015AQ; 2) OPEN HEART CDS, Model Number: CDS840023T; 3) OFF PUMP CABG CDS, Model Number: CDS840087AI; 4) OFF PUMP CABG CDS, Model Number: CDS840087AK; 5) OFF PUMP CABG CDS, Model Number: CDS840087AL; 6) OP
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1417-2026·2026-02-25
Medline C-Section Surgical Kits Recalled for Sterilization Equipment Calibration Issues
Medline Industries is recalling 4,525 C-section surgical kits due to calibration problems with sterilization equipment that could affect sterility assurance. No injuries have been reported.
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-1416-2026·2026-02-25
Medline Urology Convenience Kits Recalled for Sterilization Calibration Issues
Medline is recalling five types of urology convenience kits due to calibration issues with sterilization equipment that may have compromised the sterility assurance of the devices. Approximately 59 units distributed nationwide are affected.
Product
Medline Convenience Kits: 1) KIT UROLOGY SLING, Model Number: DYKMBNDL106; 2) KIT UROLOGY SLING, Model Number: DYKMBNDL106A; 3) KIT UROLOGY PENILE REPAIR, Model Number: DYKMBNDL188; 4) KIT UROLOGY PERIPHERAL STIMULA, Model Number: DYKMBNDL189; 5) KIT UROLOGY PERIPHERAL S
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1422-2026·2026-02-25
Medline Arthroscopy Surgical Kits Recalled Over Sterilization Calibration Issue
Medline Industries recalled five arthroscopy surgical kit models due to calibration issues with sterilization and packaging equipment that could compromise sterility assurance. The recall affects 175 units distributed nationwide.
Product
Medline Convenience Kits: 1) ARTHROSCOPY CDS, Model Number: CDS984609B; 2) ARTHROSCOPY TRAYS, Model Number: DYNJ22501G; 3) ARTHROSCOPY PACK, Model Number: DYNJ32715F; 4) CHS ARTHROSCOPY PACK, Model Number: DYNJ50834C; 5) ARTHROSCOPY TRAY-LF, Model Number: DYNJ51069
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1408-2026·2026-02-25
Medline PPE Convenience Kit Sterilization Calibration Issue Recall
Medline is recalling approximately 7,575 PPE Convenience Kits (Model DYK1011945P) due to sterilization equipment calibration issues that may compromise device sterility. Affected products were distributed nationwide.
Product
Medline Convenience Kits: 1) PPE KIT, Model Number: DYK1011945P
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1404-2026·2026-02-25
Medline Burn Care Kits Recalled Due to Sterilization Equipment Calibration Issues
Medline is recalling 291 units of three burn care convenience kit models due to calibration issues with sterilization equipment that may impact product sterility. No illnesses or injuries have been reported.
Product
Medline Convenience Kits: 1) BURN PACK, Model Number: DYNJ15668R; 2) BURN PACK-LF, Model Number: DYNJ42829B; 3) BURN CARE PACK-LF, Model Number: DYNJT3437
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1402-2026·2026-02-25
Medline Surgical Convenience Kits Recalled for Sterilization Failure Risk
Medline is recalling 684 surgical convenience kits due to equipment calibration issues that may have compromised sterility assurance levels. Affected devices may not meet required sterilization standards.
Product
Medline Convenience Kits: 1) LVAD DRIVELINE TRAY, Model Number: DM1035; 2) KIT SURG ONC INSERT CENT.VENOU, Model Number: DYKMBNDL43
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1405-2026·2026-02-25
Medline Convenience Kits Recalled Due to Sterilization Equipment Calibration Issues
Medline is recalling 108 Convenience Kits nationwide due to sterilization equipment calibration defects that could compromise sterility assurance on medical closure devices.
Product
Medline Convenience Kits: 1) KIT GENERAL CLOSURE, Model Number: DYKMBNDL200A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1392-2026·2026-02-25
Medline Surgical and Biopsy Kits Recalled Due to Sterilization Equipment Calibration Issues
Medline is recalling 2,740 surgical and biopsy convenience kits due to calibration issues with sterilization equipment that may have compromised product sterility. No injuries have been reported.
Product
Medline Convenience Kits: 1) KIT SURG ONC EXCISION BREAST, Model Number: DYKMBNDL84A; 2) KIT SURG ONC EXPLORATORY LAP, Model Number: DYKMBNDL87A; 3) CT BIOPSY TRAY, Model Number: DYNDH1143C; 4) BIOPSY SPECIALS PACK, Model Number: DYNDH1873; 5) BIOPSY SPECIALS PACK, Model
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1414-2026·2026-02-25
Medline Surgical Kits Recalled for Potential Sterilization Compromise
Medline is recalling labor and delivery surgical kits due to calibration issues in sterilization equipment that could compromise product sterility. The recall affects 27,320 units distributed nationwide and worldwide.
Product
Medline Convenience Kits: 1) OB KIT, Model Number: DYKM2326; 2) KIT LABOR DELIVERY TUBAL LIGAT, Model Number: DYKMBNDL165; 3) KIT LABOR & DELIVERY D&C/D&E, Model Number: DYKMBNDL31; 4) KIT LABOR & DELIVERY CERCLAGE, Model Number: DYKMBNDL38; 5) L & D PACK-LF, Model Numbe
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1394-2026·2026-02-25
Medline Surgical Device Kits Recalled for Sterilization Equipment Calibration Issues
Medline Industries, LP is recalling 9,051 surgical device kits due to sterilization equipment calibration issues that could compromise sterility assurance levels. The recalled kits may not be adequately sterile despite undergoing validated sterilization processes.
Product
Medline Convenience Kits: 1) CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS983069G; 2) CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS983069I; 3) HEAD & NECK CDS-LF, Model Number: CDS983782C; 4) BAPTIST FLOYD BRONCHOSCOPY, Model Number: DYKE1456D; 5) BRONCHOSCOPY SETUP KI
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1396-2026·2026-02-25
Medline Endoscopy Kits Recalled Due to Sterilization Equipment Calibration Issues
Medline is recalling over 23,000 endoscopy procedure kits due to calibration issues with sterilization equipment that may affect the sterility assurance level of the devices.
Product
Medline Convenience Kits: 1) BAPTIST FLOYD ENDO GI KIT, Model Number: DYKE1455B; 2) GI LAB OTHER ENDO KIT, Model Number: DYKE1721
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-1410-2026·2026-02-25
Medline Admission Kits Recalled Due to Sterilization Equipment Calibration Issues
Medline is recalling Admission Kits (Model DYKA1343A) due to calibration problems in sterilization equipment that could compromise the sterility of the devices. The recall affects 1,070 units distributed nationwide.
Product
Medline Convenience Kits: 1) ADMIT KIT, Model Number: DYKA1343A
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