Class II Recall

MEDLINE Medical Procedure Kits labeled as: 1) CRANI, Medline Kit Number/SKU DYNJ908097; 2) CRANI, Medline Kit Numbe

Summary

The FDA issued a Class II for MEDLINE Medical Procedure Kits labeled as: 1) CRANI, Medline Kit Number/SKU D by Medline Industries, LP. Reason: During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irr.

Details

Source

Device Recall

External ID

Z-2508-2026

Action Date

2026-06-24

Status

Ongoing

Product Description

MEDLINE Medical Procedure Kits labeled as: 1) CRANI, Medline Kit Number/SKU DYNJ908097; 2) CRANI, Medline Kit Number/SKU DYNJ908097A; 3) CRANI, Medline Kit Number/SKU DYNJ908097B; 4) CRANI, Medline Kit Number/SKU DYNJ908097C; 5) CRANI, Medline Kit Number/SKU DYNJ908097D; 6) DR TUCKER ANT TOTAL HIP, Medline Kit Number/SKU DYNJ912029; 7) JEWISH CRANI PACK, Medline Kit Number/SKU DYNJ55637B; 8) L SCOPE PACK, Medline Kit Number/SKU DYNJ43930A; 9) LAMI PACK, Medline Kit Number/SKU DYNJ67767; 10) LAVH NEW BRAUNFELS, Medline Kit Number/SKU DYNJ61136F; 11) SOI KNEE ARTHROSCOPY, Medline Kit Number/SKU DYNJV0172Q; 12) T AND A PACK, Medline Kit Number/SKU DYNJ86229.

Lot/Code Info: Medline Kit Number, SKU DYNJ908097: UDI/DI 10193489973846 (each), 40193489973847 (case), Lot Number 23FBQ975; Medline Kit Number, SKU DYNJ908097: UDI/DI 10193489973846 (each), 40193489973847 (case), Lot Number 23FBF166; Medline Kit Number, SKU DYNJ908097: UDI/DI 10193489973846 (each), 40193489973847 (case), Lot Number 23DBM780; Medline Kit Number, SKU DYNJ908097: UDI/DI 10193489973846 (each), 40193489973847 (case), Lot Number 22KBM832; Medline Kit Number, SKU DYNJ908097: UDI/DI 10193489973846 (each), 40193489973847 (case), Lot Number 22JBY524; Medline Kit Number, SKU DYNJ908097: UDI/DI 10193489973846 (each), 40193489973847 (case), Lot Number 22GBR089; Medline Kit Number, SKU DYNJ908097: UDI/DI 10193489973846 (each), 40193489973847 (case), Lot Number 22FBR153; Medline Kit Number, SKU DYNJ908097: UDI/DI 10193489973846 (each), 40193489973847 (case), Lot Number 22FBC633; Medline Kit Number, SKU DYNJ908097: UDI/DI 10193489973846 (each), 40193489973847 (case), Lot Number 22EBB478; Medline Kit Number, SKU DYNJ908097: UDI/DI 10193489973846 (each), 40193489973847 (case), Lot Number 22BBX706; Medline Kit Number, SKU DYNJ908097: UDI/DI 10193489973846 (each), 40193489973847 (case), Lot Number 22BBU902; Medline Kit Number, SKU DYNJ908097: UDI/DI 10193489973846 (each), 40193489973847 (case), Lot Number 22ABN864; Medline Kit Number, SKU DYNJ908097: UDI/DI 10193489973846 (each), 40193489973847 (case), Lot Number 21IBO640; Medline Kit Number, SKU DYNJ908097A: UDI/DI 10195327507077 (each), 40195327507078 (case), Lot Number 24EBC216; Medline Kit Number, SKU DYNJ908097A: UDI/DI 10195327507077 (each), 40195327507078 (case), Lot Number 24CBU878; Medline Kit Number, SKU DYNJ908097A: UDI/DI 10195327507077 (each), 40195327507078 (case), Lot Number 23LBV779; Medline Kit Number, SKU DYNJ908097A: UDI/DI 10195327507077 (each), 40195327507078 (case), Lot Number 23JBV724; Medline Kit Number, SKU DYNJ908097A: UDI/DI 10195327507077 (each), 40195327507078 (case), Lot Number 23JBQ243; Medline Kit Number, SKU DYNJ908097A: UDI/DI 10195327507077 (each), 40195327507078 (case), Lot Number 23JBQ188; Medline Kit Number, SKU DYNJ908097A: UDI/DI 10195327507077 (each), 40195327507078 (case), Lot Number 23IBS778; Medline Kit Number, SKU DYNJ908097B: UDI/DI 10198459043499 (each), 40198459043490 (case), Lot Number 24IBU230; Medline Kit Number, SKU DYNJ908097B: UDI/DI 10198459043499 (each), 40198459043490 (case), Lot Number 24HBF200; Medline Kit Number, SKU DYNJ908097B: UDI/DI 10198459043499 (each), 40198459043490 (case), Lot Number 24GBJ113; Medline Kit Number, SKU DYNJ908097B: UDI/DI 10198459043499 (each), 40198459043490 (case), Lot Number 24GBB611; Medline Kit Number, SKU DYNJ908097C: UDI/DI 10198459129773 (each), 40198459129774 (case), Lot Number 24LBI207; Medline Kit Number, SKU DYNJ908097D: UDI/DI 10198459237782 (each), 40198459237783 (case), Lot Number 26BBN470; Medline Kit Number, SKU DYNJ908097D: UDI/DI 10198459237782 (each), 40198459237783 (case), Lot Number 25LBO007; Medline Kit Number, SKU DYNJ908097D: UDI/DI 10198459237782 (each), 40198459237783 (case), Lot Number 25KBT991; Medline Kit Number, SKU DYNJ908097D: UDI/DI 10198459237782 (each), 40198459237783 (case), Lot Number 25EBW026; Medline Kit Number, SKU DYNJ908097D: UDI/DI 10198459237782 (each), 40198459237783 (case), Lot Number 25EBA043; Medline Kit Number, SKU DYNJ908097D: UDI/DI 10198459237782 (each), 40198459237783 (case), Lot Number 25EBA044; Medline Kit Number, SKU DYNJ908097D: UDI/DI 10198459237782 (each), 40198459237783 (case), Lot Number 25CBG395; Medline Kit Number, SKU DYNJ908097D: UDI/DI 10198459237782 (each), 40198459237783 (case), Lot Number 25CBC209; Medline Kit Number, SKU DYNJ908097D: UDI/DI 10198459237782 (each), 40198459237783 (case), Lot Number 25BBH141; Medline Kit Number, SKU DYNJ912029: UDI/DI 10198459600197 (each), 40198459600198 (case), Lot Number 26ABG299; Medline Kit Number, SKU DYNJ55637B: UDI/DI 10889942886418 (each), 40889942886419 (case), Lot Number 21HMB506; Medline Kit Number, SKU DYNJ55637B: UDI/DI 10889942886418 (each), 40889942886419 (case), Lot Number 21CMB156; Medline Kit Number, SKU DYNJ55637B: UDI/DI 10889942886418 (each), 40889942886419 (case), Lot Number 21BMA535; Medline Kit Number, SKU DYNJ43930A: UDI/DI 10889942624065 (each), 40889942624066 (case), Lot Number 26BBQ722; Medline Kit Number, SKU DYNJ43930A: UDI/DI 10889942624065 (each), 40889942624066 (case), Lot Number 25LBT225; Medline Kit Number, SKU DYNJ43930A: UDI/DI 10889942624065 (each), 40889942624066 (case), Lot Number 25JBV630; Medline Kit Number, SKU DYNJ43930A: UDI/DI 10889942624065 (each), 40889942624066 (case), Lot Number 25JBA301; Medline Kit Number, SKU DYNJ43930A: UDI/DI 10889942624065 (each), 40889942624066 (case), Lot Number 25GBG702; Medline Kit Number, SKU DYNJ43930A: UDI/DI 10889942624065 (each), 40889942624066 (case), Lot Number 25FBI032; Medline Kit Number, SKU DYNJ43930A: UDI/DI 10889942624065 (each), 40889942624066 (case), Lot Number 25EBV203; Medline Kit Number, SKU DYNJ43930A: UDI/DI 10889942624065 (each), 40889942624066 (case), Lot Number 25BBU777; Medline Kit Number, SKU DYNJ43930A: UDI/DI 10889942624065 (each), 40889942624066 (case), Lot Number 24LBN665; Medline Kit Number, SKU DYNJ43930A: UDI/DI 10889942624065 (each), 40889942624066 (case), Lot Number 24JBH892; Medline Kit Number, SKU DYNJ43930A: UDI/DI 10889942624065 (each), 40889942624066 (case), Lot Number 24FBR472; Medline Kit Number, SKU DYNJ43930A: UDI/DI 10889942624065 (each), 40889942624066 (case), Lot Number 24DBU491; Medline Kit Number, SKU DYNJ43930A: UDI/DI 10889942624065 (each), 40889942624066 (case), Lot Number 24ABU986; Medline Kit Number, SKU DYNJ43930A: UDI/DI 10889942624065 (each), 40889942624066 (case), Lot Number 23JBH124; Medline Kit Number, SKU DYNJ43930A: UDI/DI 10889942624065 (each), 40889942624066 (case), Lot Number 23HBQ073; Medline Kit Number, SKU DYNJ43930A: UDI/DI 10889942624065 (each), 40889942624066 (case), Lot Number 23GBR436; Medline Kit Number, SKU DYNJ43930A: UDI/DI 10889942624065 (each), 40889942624066 (case), Lot Number 23FBS680; Medline Kit Number, SKU DYNJ43930A: UDI/DI 10889942624065 (each), 40889942624066 (case), Lot Number 23EBU086; Medline Kit Number, SKU DYNJ43930A: UDI/DI 10889942624065 (each), 40889942624066 (case), Lot Number 23BBK246; Medline Kit Number, SKU DYNJ43930A: UDI/DI 10889942624065 (each), 40889942624066 (case), Lot Number 22LBE875; Medline Kit Number, SKU DYNJ43930A: UDI/DI 10889942624065 (each), 40889942624066 (case), Lot Number 22JBD615; Medline Kit Number, SKU DYNJ43930A: UDI/DI 10889942624065 (each), 40889942624066 (case), Lot Number 22HBT661; Medline Kit Number, SKU DYNJ43930A: UDI/DI 10889942624065 (each), 40889942624066 (case), Lot Number 22GMH469; Medline Kit Number, SKU DYNJ43930A: UDI/DI 10889942624065 (each), 40889942624066 (case), Lot Number 22EMH976; Medline Kit Number, SKU DYNJ43930A: UDI/DI 10889942624065 (each), 40889942624066 (case), Lot Number 22AME279; Medline Kit Number, SKU DYNJ43930A: UDI/DI 10889942624065 (each), 40889942624066 (case), Lot Number 21LMD434; Medline Kit Number, SKU DYNJ43930A: UDI/DI 10889942624065 (each), 40889942624066 (case), Lot Number 21JMC555; Medline Kit Number, SKU DYNJ43930A: UDI/DI 10889942624065 (each), 40889942624066 (case), Lot Number 21JMB332; Medline Kit Number, SKU DYNJ43930A: UDI/DI 10889942624065 (each), 40889942624066 (case), Lot Number 21HMG155; Medline Kit Number, SKU DYNJ43930A: UDI/DI 10889942624065 (each), 40889942624066 (case), Lot Number 21GMC422; Medline Kit Number, SKU DYNJ43930A: UDI/DI 10889942624065 (each), 40889942624066 (case), Lot Number 21FMF742; Medline Kit Number, SKU DYNJ43930A: UDI/DI 10889942624065 (each), 40889942624066 (case), Lot Number 21EMF262; Medline Kit Number, SKU DYNJ43930A: UDI/DI 10889942624065 (each), 40889942624066 (case), Lot Number 21DMD509; Medline Kit Number, SKU DYNJ43930A: UDI/DI 10889942624065 (each), 40889942624066 (case), Lot Number 21AMC934; Medline Kit Number, SKU DYNJ67767: UDI/DI 10193489430615 (each), 40193489430616 (case), Lot Number 21ABW707; Medline Kit Number, SKU DYNJ67767: UDI/DI 10193489430615 (each), 40193489430616 (case), Lot Number 21ABM797; Medline Kit Number, SKU DYNJ61136F: UDI/DI 10195327606169 (each), 40195327606160 (case), Lot Number 26ABL734; Medline Kit Number, SKU DYNJ61136F: UDI/DI 10195327606169 (each), 40195327606160 (case), Lot Number 25ABO431; Medline Kit Number, SKU DYNJ61136F: UDI/DI 10195327606169 (each), 40195327606160 (case), Lot Number 24LBH715; Medline Kit Number, SKU DYNJ61136F: UDI/DI 10195327606169 (each), 40195327606160 (case), Lot Number 24KBB752; Medline Kit Number, SKU DYNJ61136F: UDI/DI 10195327606169 (each), 40195327606160 (case), Lot Number 24JBJ191; Medline Kit Number, SKU DYNJ61136F: UDI/DI 10195327606169 (each), 40195327606160 (case), Lot Number 24DBP178; Medline Kit Number, SKU DYNJ61136F: UDI/DI 10195327606169 (each), 40195327606160 (case), Lot Number 24BBF170; Medline Kit Number, SKU DYNJV0172Q: UDI/DI 10193489336238 (each), 40193489336239 (case), Lot Number 21KBS950; Medline Kit Number, SKU DYNJ86229: UDI/DI 10195327604967 (each), 40195327604968 (case), Lot Number 24GMJ630; Medline Kit Number, SKU DYNJ86229: UDI/DI 10195327604967 (each), 40195327604968 (case), Lot Number 24CMG797.

Quantity Affected: 3521 units

Reason for Recall

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.

Distribution

Worldwide distribution - US Nationwide and the countries of AE, BB, BM, BS, CA, CY, GU, NL, PA, QA, SA, VI.

Type: Voluntary: Firm initiated

Recall Initiated: 2026-05-04

Company

Medline Industries, LP

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-2508-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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