Medline convenience kits: DISCECTOMY PACK DYNJ86476B EAR DYNJ81460C DYNJ900004J DYNJ901779J DYNJ902900F EA
Summary
The FDA issued a Class II for Medline convenience kits: DISCECTOMY PACK DYNJ86476B EAR DYNJ81460C DYN by Medline Industries, LP. Reason: Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable fo.
Details
Source
Device Recall
External ID
Z-2421-2026
Action Date
2026-06-24
Status
Ongoing
Category
device
Product Description
Medline convenience kits: DISCECTOMY PACK DYNJ86476B EAR DYNJ81460C DYNJ900004J DYNJ901779J DYNJ902900F EAR PACK DYNJ81419D ENT PACK DYNJ40498B HEAD & NECK CDS DYNJ901246J JEWISH DR SEVERTSON EAR DYNJ909252C JEWISH HEAD&NECK DYNJ909255C KIT HEAD AND NECK MHS DYNJ905364B MAJOR EAR CDS983347S MAJOR EAR FMOL LADY OF THE LAK DYNJ89581 MAJOR EAR PACK DYNJT4872 MAJOR HEAD AND NECK PACK DYNJ38985G MAJOR HEAD NECK PACK DYNJ45706B MZ EAR CDS DYNJ905642F PARATHYROID PACK DYNJ81389F PK,ENT-EAR DYNJ43700B SM-HEAD AND NECK PACK-LF DYNJ0780036W THYROID CDS CDS983693I TYMPANOPLASTY CDS982720S TYMPANOPLASTY MASTOIDECTOM DYNJ66231B TYMPANOPLASTY PACK-LF DYNJ62820D WH FACIAL HEAD AND NECK PACK DYNJ89028A WMC COCHLEAR IMPLANT ADD ON DYNJ907206G
Lot/Code Info: DYNJ86476B UDI-DI 10198459440366 Lot 25KBL478 DYNJ81460C UDI-DI 10198459434679 Lot 25KBE552 DYNJ900004J UDI-DI 10198459560354 Lot 26AMA112 DYNJ901779J UDI-DI 10193489979749 Lot 25LMI890 DYNJ902900F UDI-DI 10198459496936 Lot 25KBA607 DYNJ81419D UDI-DI 10198459113444 Lot 25KBM670 DYNJ40498B UDI-DI 10193489806779 Lots 25KBC776 25LBO494 DYNJ901246J UDI-DI 10198459447310 Lots 25KBQ989 26ABI798 26DBH373 DYNJ909252C UDI-DI 10198459318726 Lots 25JBS227 25KBC598 25LBR040 DYNJ909255C UDI-DI 10198459210167 Lot 25LBH411 DYNJ905364B UDI-DI 10198459346255 Lots 25LBM363 26BBO336 CDS983347S UDI-DI 10198459397370 Lots 26BBC029 26CBR342 DYNJ89581 UDI-DI 10198459278594 Lot 25LBP819 DYNJT4872 UDI-DI 10198459459672 Lot 25KBA908 DYNJ38985G UDI-DI 10195327385682 Lots 25JBA164 25KBG575 DYNJ45706B UDI-DI 10193489856293 Lot 25KBK200 DYNJ905642F UDI-DI 10195327587277 Lot 26AME607 DYNJ81389F UDI-DI 10198459394775 Lot 26BBC753 DYNJ43700B UDI-DI 10195327523039 Lot 25LBD750 DYNJ0780036W UDI-DI 10198459036972 Lot 25LMJ600 CDS983693I UDI-DI 10193489953848 Lot 25KBQ399 CDS982720S UDI-DI 10198459530258 Lots 25KBU081 25LBT481 26ABC446 DYNJ66231B UDI-DI 10195327341640 Lots 25JBY408 25KBK197 DYNJ62820D UDI-DI 10198459105463 Lot 25LMH554 DYNJ89028A UDI-DI 10198459472565 Lot 25KBI158 DYNJ907206G UDI-DI 10198459368028 Lot 25LBM564
Quantity Affected: 49,654 kits total
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.
Distribution
US Nationwide distribution. OUS distribution pending.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-04-27
Company
Northfield, IL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 254 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Medline Industries, LP has 442 FDA actions in our database, including 415 recalls and 27 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Medline Industries, LP) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Medline Industries, LP have FDA actions?
Medline Industries, LP has 442 FDA actions in our database, including 415 recalls and 27 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2421-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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