Manufacturer

Medline Industries, LP

534 recalls in our database name Medline Industries, LP as the manufacturing or recalling firm.

What the numbers show

Total: 534
Critical: 38
Severe: 92
Most recent: 2026-09-09

Of the 534 recalls from Medline Industries, LP we have scored against our rubric, 38 (7%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 92 (17%) are Severe.

Which agencies issued them

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

376–400 of 534

HighFDA (Devices)·Z-1423-2026·2026-02-25
Surgical drapes recalled over sterilization equipment calibration issues
Medline is recalling 14,927,765 units of surgical drapes because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.
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-1410-2026·2026-02-25
Admit kits recalled over sterilization equipment calibration issues
Medline is recalling 1,070 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.
Product
Medline Convenience Kits: 1) ADMIT KIT, Model Number: DYKA1343A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1411-2026·2026-02-25
LVAD driveline trays recalled over sterilization equipment calibration issues
Medline is recalling 9,720 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.
Product
Medline Convenience Kits: 1) LVAD DRIVELINE TRAY, Model Number: DM1035A; 2) LVAD DRIVELINE TRAY, Model Number: DM1035; 3) CENTRAL LINE DRESSING CHANGE TRAY, Model Number: DT8670A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1424-2026·2026-02-25
Surgical gowns recalled over sterilization equipment calibration issues
Medline is recalling 70,376,042 units of surgical gowns because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.
Product
Medline Surgical Gowns: 1) GOWN,NONRNF,L,30/CS, Model Number: DYNJP2001; 2) GOWN,SIRUS,NONRNF,SETINSLV,L,20/CS, Model Number: DYNJP2001S; 3) GOWN,ECLIPSE,NONRNF,XL,ST,30/CS, Model Number: DYNJP2002; 4) GOWN,SIRUS,NONRNF,SETINSLV,XL,20/CS, Model Number: DYNJP2002S; 5) GOW
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1408-2026·2026-02-25
PPE kits recalled over sterilization equipment calibration issues
Medline is recalling 7,575 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.
Product
Medline Convenience Kits: 1) PPE KIT, Model Number: DYK1011945P
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1398-2026·2026-02-25
Lithotomy packs recalled over sterilization equipment calibration issues
Medline is recalling 808 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.
Product
Medline Convenience Kits: 1) LITHOTOMY PACK, Model Number: DYNJ83185; 2) LITHOTOMY PACK, Model Number: DYNJ83185A;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1401-2026·2026-02-25
Line insertion kits recalled over sterilization equipment calibration issues
Medline is recalling 553 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.
Product
Medline Convenience Kits: 1) KIT ACES INSERT PEG, Model Number: DYKMBNDL130; 2) KIT ACES INSERT PEG, Model Number: DYKMBNDL130A; 3) KIT ACES INSERT PERCUTANEOUS T, Model Number: DYKMBNDL4; 4) NICU LINE CHANGE TRAY, Model Number: LC295; 5) OSC SHERMAN KNEE ARTHRO BASIC, M
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1406-2026·2026-02-25
Choice drape packs recalled over sterilization equipment calibration issues
Medline is recalling 72 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.
Product
Medline Convenience Kits: 1) DRAPE PACK-CHOICE, Model Number: DYNJ63118A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1407-2026·2026-02-25
Triple lumen insertion kits recalled over sterilization calibration issues
Medline is recalling 15 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.
Product
Medline Convenience Kits: 1) KIT TRIPLE LUMEN INSERTION, Model Number: DYNDM1031A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1389-2026·2026-02-25
Arteriogram and catheter kits recalled over sterilization calibration issues
Medline is recalling 30,958 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.
Product
Medline Convenience Kits: 1) OR ARTERIOGRAM, Model Number: CDS985094F; 2) KIT SURG ONC LAP DIAG/CV CATH, Model Number: DYKMBNDL153; 3) KIT ACES INSERT PERCUTANEOUS T, Model Number: DYKMBNDL4A; 4) KIT ACES INSERT PERCUTANEOUS T, Model Number: DYKMBNDL4B; 5) VEIN PROCEDURE
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1421-2026·2026-02-25
Spinal and hip kits recalled over sterilization equipment calibration issues
Medline is recalling 117,907 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.
Product
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-LF, Model Number: CDS980832R; 5) TOTAL HIP CDS-LF, Model Number: CDS980832S; 6) TOTAL KNEE CDS-
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1417-2026·2026-02-25
Medline C-Section Surgical Kits Recalled Over Sterilization Calibration
Medline is recalling 4,525 C-section convenience kits worldwide due to calibration issues with sterilization and packaging equipment that could affect sterility 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-1384-2026·2026-02-25
Medline Convenience Kits Recalled Due to Potential Sterility Assurance Issues
Medline Industries, LP is recalling certain Medline Convenience Kits because equipment calibration issues may have impacted the sterility assurance level of the products.
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-1390-2026·2026-02-25
Medline Cardiac Surgical Convenience Kits Recalled Due to Sterility Calibration Issues
Medline Industries is recalling cardiac surgical convenience kits due to sterilization equipment calibration issues that could affect device sterility assurance levels.
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-1386-2026·2026-02-25
Medline Convenience Kits and CPNB Setup Trays Recalled Due to Sterilization Calibration Issues
Medline Industries is recalling 779 units of convenience kits and setup trays due to potential sterility assurance issues from equipment calibration problems during manufacturing.
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-1420-2026·2026-02-25
Medline Medical Device Kits Recalled Due to Sterilization Calibration Issues
Medline Industries is recalling 4,853 medical device kits due to potential sterility issues from equipment calibration problems during manufacturing.
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-1394-2026·2026-02-25
Cochlear and head kits recalled over sterilization equipment calibration issues
Medline is recalling 9,051 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.
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-1392-2026·2026-02-25
Oncology and biopsy kits recalled over sterilization calibration issues
Medline is recalling 2,740 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.
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-1396-2026·2026-02-25
GI endoscopy kits recalled over sterilization equipment calibration issues
Medline is recalling 23,238 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.
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-1412-2026·2026-02-25
Medline Convenience Kits Recalled Due to Potential Sterility Assurance Issues
Medline Industries, LP is recalling specific Medline Convenience Kits (CHEST/BREAST-LF) because equipment calibration issues may have impacted the sterility assurance level of the products.
Product
Medline Convenience Kits: 1) CHEST/BREAST-LF, Model Number: DYNJ83950
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1418-2026·2026-02-25
Medline Convenience Kits Recalled Due to Potential Sterility Assurance Issues
Medline Industries, LP is recalling various Medline Convenience Kits because equipment calibration issues may have impacted the sterility assurance level of the products.
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-1366-2026·2026-02-25
Medline Industries IV Administration and Extension Sets Recalled Due to Potential Leaks
Medline Industries, LP is recalling various IV administration and extension sets because male luer connectors may leak, crack, or break during use.
Product
Medline Industries IV Administration and Extension Sets: 1) DBD-IV ADMIN SET,60DRP,1NEEDLE-FREE VALV, Model Number: DYNDTB0529; 2) IV ADMIN SET, 10DRP, 1NF, 92, Model Number: DYNDTB1029; 3) DBD-IVEXTSET2.4ML2 NEEDLE-FREEVLVE,35, Model Number: DYNDTB1516; 4) DBD-IV ADMIN SE
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1400-2026·2026-02-25
Medline Convenience Kits Recalled Due to Potential Sterility Assurance Issues
Medline Industries, LP is recalling various Medline Convenience Kits because equipment calibration issues may have impacted the sterility assurance level of the products.
Product
Medline Convenience Kits: 1) TOTE ABRAMS KNEE ARTHROSCOPY, Model Number: DYKM1801B; 2) TOTE SEN OSC HAND REPAIR, Model Number: DYKM1776; 3) TOTE MOMENI SB CAPSULOTOMY REC, Model Number: DYKM1765A; 4) TOTE YAO OSC HAND REPAIR, Model Number: DYKM1796A; 5) TOTE SB NGUYEN CA
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1416-2026·2026-02-25
Urology kits recalled over sterilization equipment calibration issues
Medline is recalling 59 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.
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-1419-2026·2026-02-25
Robotic surgery kits recalled over sterilization equipment calibration issues
Medline is recalling 7,725 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.
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