Medline Industries, LP recalls Medline convenience kits: ACL PACK DYNJ64161C ARTHROSCOPY PACK DYNJ47103D DYNJ…
Reason for recall
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Affected products & lots
- Medline convenience kits: ACL PACK DYNJ64161C ARTHROSCOPY PACK DYNJ47103D DYNJ67197G DYNJ85197A DYNJT4007 BASIC ACCESS PACK-LF DYNJ36698B BASIC BACK TRAY DYNJ89037 BASIC PEDI PACK-LF DYNJ0171446I DYNJ0171446J BASIC SPINE DYNJ910915A BREAST PACK DYNJ87587A BREAST PLASTIC PACK DYNJ84482C C SECTION DYNJ49172I CAROTID ENDARTERECTOMY PACK DYNJ48013L CENTRAL LINE PACK-LF DYNJ0220136S CERVICAL FUSION DYNJ908135B CERVICAL SPINE PACK DYNJ53044G C-SECTION DYNJ909099F DAVINCI PROSTATE PACK DYNJ61711C DEPAUL FOOT & ANKLE-LF DYNJ20010L DIEP PACK DYNJ64964J DYNJ43210K DYNJ61787F DYNJ87065 EAR CUSTOM PACK DYNJ82564A ENT FREE FLAP PACK SAFETY DYNJ54720D EP PACEMAKER SAFETY #1 DYNJ54722F EPCH EXTREMITY PACK DYNJ83095B EXTREMITY PACK DYNJ32934F EXTREMITY PACK-LF DYNJ68935B FISTULA PACK DYNJ66502B GENDER AFFIRMING SURGERY DYNJ66252F GYN LAPAROSCOPY PACK AHSC DYNJT8381 HAND PACK WATCHMAKER-LF DYNJ34580D HEAD & NECK PACK-LF DYNJ0282388T DYNJ88308 HIP SCOPE DYNJ907120D KNEE ARTHRO PACK DYNJ58404F KNEE ARTHROSCOPY PACK DYNJ84740A LAMI OVERHEAD PACK DYNJ46531Q LAMINECTOMY NEURO MPH DYNJT5271 LAMINECTOMY PACK DYNJ68785D LAP APPY PACK DYNJT6005 LAP CHOLE PACK DYNJ82087A LEVY PACK DYNJ83939C MAJOR LAP VCH DYNJ39217P MAJOR NEURO PACK-LF DYNJ0578916AA MAJOR PACK DYNJ58528J MINOR GEN PACK DYNJ61661B MINOR LAPAROTOMY PACK-LF DYNJ0753436P MINOR PACK DYNJ54968B NEURO PACK DYNJ67628D NEURO SHUNT PACK-LF DYNJ0578815W OMFS PACK DYNJ54400C OPEN HEART PACK DYNJT5008 OPEN HEART-LF DYNJ48260F OPEN LAPAROTOMY PACK DYNJ39247I DYNJ39247J PACEMAKER PACK DYNJ31461I DYNJ61411C PACK,ORTHO FLIP DYNJ65471B PED OPEN HEART PACK DYNJ45373G PLASTIC PACK DYNJ82495D PLASTICS PK - NO SYR DYNJ62433F PODIATRY PACK OP7809M PPE BUNDLE KIT DT13351A PROSTATE ROBOTIC PACK DYNJ84120C RADIAL ART LINE INSERTION ARTNC234 ROBOTIC GENERAL WHH DYNJT5376 ROBOTIC PACK DYNJ47978G RR-SPINE PACK DYNJ62643B SHOULDER ARTH PACK DYNJ58410D SHOULDER ARTHROSCOPY PACK DYNJ54477C DYNJT8391 SHOULDER PACK DYNJ61052B DYNJT3266 SHOULDER PACK-LF DYNJ0122428K PHS656414I SPINE PACK DYNJ64949C DYNJ83649B SPINE SHOULDER PACK DYNJ47104D STERILE ACCESS KIT DYNDA2664 TOTAL KNEE PACK DYNJ84741B TUBAL PACK DYNJ68253F UNIVERSAL PACK DYNJ83246B VA TAMPA GENERAL ROBOTIC PACK DYNJT6993 W.C. MINOR LAPAROTOMY PK-LF DYNJ0509186J ZALE OTOLOGY CDSCDS983181GUDI-DI 10198459146961275 affected lots25KBH332DYNJ47103D1019845962500825LMF684DYNJ67197G1019845948199425JBA258DYNJ85197A
+267 more
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
What the firm is doing
Firm began notifying consignees on 4/27/2026. Customers were instructed to request stickers to over-label affected convenience kits with a warning label. Warning label indicates for user to remove the affected component and replace it with product from supply. No kits are to be returned.
DistributionShow detailsHide
US Nationwide distribution. OUS distribution pending.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-2441-2026
- FDA 510(k) clearance · K213481The device's official FDA premarket clearance record
- FDA device classification · LROOfficial FDA classification for this device type
- CFR regulation · 21 CFR 878.4370The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Medline Industries, LPSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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