Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

1,565 results found for sterilization Page 2 of 63
Medline Industries, LP
Class II Ongoing
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: DYNJP...
Reason: Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packag...
Z-2128-2026 May 13, 2026 Northfield, IL
Medline Industries, LP
Class II Ongoing
Medline Convenience Kits: 1) DYNDA3003, Model Number: DENTAL PACK; 2) DYNJ87157, Model Number: GULLO SURGICAL PACK
Reason: Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packag...
Z-2096-2026 May 13, 2026 Northfield, IL
Medline Industries, LP
Class II Ongoing
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
Reason: Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packag...
Z-2103-2026 May 13, 2026 Northfield, IL
Medline Industries, LP
Class II Ongoing
See complete list in RES, exceeds character limit. Medline Surgical Gowns
Reason: Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packag...
Z-2129-2026 May 13, 2026 Northfield, IL
Medline Industries, LP
Class II Ongoing
See RES for complete list. Medline Convenience Kits: 1) DRAWER 6-IV FLUIDS GLOVES, Model Number: ACC010326; 2) DRAWER 6-IV FLUIDS GLOVES, Model Number: ACC010326A; 3) DRAWER 6-IV FLUIDS GLOVES, Model ...
Reason: Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packag...
Z-2101-2026 May 13, 2026 Northfield, IL
Medline Industries, LP
Class II Ongoing
See RES for full list. 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 Numbe...
Reason: Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packag...
Z-2097-2026 May 13, 2026 Northfield, IL
Medline Industries, LP
Class II Ongoing
See RES for complete list. Medline Convenience Kits: 1) SPINAL CDS, Model Number: CDS940087AG; 2) SPINAL CDS, Model Number: CDS940087AI; 3) TOTAL HIP CDS-LF, Model Number: CDS980832Q; 4) TOTAL HIP CDS...
Reason: Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packag...
Z-2114-2026 May 13, 2026 Northfield, IL
Medline Industries, LP
Class II Ongoing
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) BI...
Reason: Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packag...
Z-2095-2026 May 13, 2026 Northfield, IL
Medline Industries, LP
Class II Ongoing
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 LABO...
Reason: Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packag...
Z-2108-2026 May 13, 2026 Northfield, IL
Medline Industries, LP
Class II Ongoing
Medline Convenience Kits: 1) ANGIO PROCEDURE PACK, Model Number:00-401824AB; 2) OR ARTERIOGRAM, Model Number:CDS985094F; 3) INTRAVASOR CATH KIT, Model Number:DYK1060193I; 4) KIT SURG ONC LAP DI...
Reason: Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packag...
Z-2092-2026 May 13, 2026 Northfield, IL
Medline Industries, LP
Class II Ongoing
Medline Convenience Kits: 1) CHEST TUBE INSERTION TRAY, Model Number: DYNDA2941A; 2) CHEST/BREAST-LF, Model Number: DYNJ83950; 3) HERNIA REPAIR TOTE, Model Number: DYNJ908337A; 4) HERNIA REPAIR...
Reason: Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packag...
Z-2106-2026 May 13, 2026 Northfield, IL
Medline Industries, LP
Class II Ongoing
Medline Convenience Kits: 1) CVC PACK, Model Number: CVI4500A; 2) TOTE KAMAL OSC HAND REPAIR, Model Number: DYKM1730A; 3) TOTE CHANGE OSC HAND REPAIR, Model Number: DYKM1751A; 4) TOTE SB NGUYEN...
Reason: Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packag...
Z-2102-2026 May 13, 2026 Northfield, IL
Medline Industries, LP
Class II Ongoing
Medline Surgical Packs: 1) PACK,UNIVERSAL,ULTRAGARD,5/CS, Model Number: DYNJP1050UG; 2) PACK,SHOULDER,DRAPE,POUCH,10/CS, Model Number: DYNJP8401
Reason: Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packag...
Z-2130-2026 May 13, 2026 Northfield, IL
Medline Industries, LP
Class II Ongoing
Medline Convenience Kits: 1) LVAD DRIVELINE TRAY, Model Number: DM1035; 2) LVAD DRIVELINE TRAY, Model Number: DM1035A; 3) CENTRAL LINE DRESSING CHANGE TRAY, Model Number: DT8670A
Reason: Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packag...
Z-2125-2026 May 13, 2026 Northfield, IL
Medline Industries, LP
Class II Ongoing
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: CDS98543...
Reason: Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packag...
Z-2112-2026 May 13, 2026 Northfield, IL
Medline Industries, LP
Class II Ongoing
Medline Convenience Kits: 1) DRAPE PACK-CHOICE, Model Number: DYNJ63118A
Reason: Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packag...
Z-2122-2026 May 13, 2026 Northfield, IL
Medline Industries, LP
Class II Ongoing
Medline Convenience Kits: 1) KIT GENERAL CLOSURE, Model Number: DYKMBNDL200A
Reason: Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packag...
Z-2121-2026 May 13, 2026 Northfield, IL
Medline Industries, LP
Class II Ongoing
Medline medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: 1. BLOOD CULTURE KIT, Medline Kit SKU DYNDH1520; 2. BLOOD DRAW KIT, Medline Kit SKU EBSI1317.
Reason: Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal Health has deemed Web...
Z-2040-2026 May 6, 2026 Northfield, IL
Medline Industries, LP
Class II Ongoing
Medline and Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: 1. LVAD DRIVELINE KIT (Centurion), Medline Kit SKU DT17360 (Centurion); 2. LONG TERM/INPATI...
Reason: Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal Health has deemed Web...
Z-2045-2026 May 6, 2026 Northfield, IL
Medline Industries, LP
Class II Ongoing
Medline and Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: 1. FOLEY CARE KIT, Medline Kit SKU UROT1044; 2. IV START KIT WITH EXTENSION TUBING, Medline ...
Reason: Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal Health has deemed Web...
Z-2041-2026 May 6, 2026 Northfield, IL
Medline Industries, LP
Class II Ongoing
Medline or Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: 1. NEONATAL IV START KIT (Centurion), Medline Kit SKU IV8310E; 2. IV SECUREMENT KIT (Centurio...
Reason: Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal Health has deemed Web...
Z-2043-2026 May 6, 2026 Northfield, IL
Medline Industries, LP
Class II Ongoing
Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: Universal Central/Art Line Insertion Kit, Medline Kit SKU ART155A
Reason: Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal Health has deemed Web...
Z-2039-2026 May 6, 2026 Northfield, IL
Medline Industries, LP
Class II Ongoing
Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: DERMATOLOGY SHAVE KIT, Medline Kit SKU SK395
Reason: Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal Health has deemed Web...
Z-2044-2026 May 6, 2026 Northfield, IL
Medline Industries, LP
Class II Ongoing
Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: LATEX FREE GENERAL PURPOSE TRAY, Medline Kit SKU 75670
Reason: Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal Health has deemed Web...
Z-2042-2026 May 6, 2026 Northfield, IL
SurgiSmoke Solutions
Class II Ongoing
Flamingo Funnel Small, Model Number SQ20012-01
Reason: Certain lots of product were associated with a manufacturing nonconformance involving use of a non-gamma sterilization compatible drape.
Z-1924-2026 April 29, 2026 Saint Paul, MN