CLASS II ONGOING Device recall · Reported 24 Jun 2026 · FDA Enforcement Report
Medline Medical Procedure Kits labeled as: Crani, Medline Kit Number recalled
Medline Industries is recalling Medline Medical Procedure Kits labeled as: Crani, Medline Kit Number, distributed nationwide in the US. The recall was initiated on 4 May 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2508-2026
- FDA event ID
- 98994
- Recalling firm
- Medline Industries, Northfield, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 4 May 2026
- FDA classified
- 17 Jun 2026
- Reported
- 24 Jun 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Other Reasons
- Device type
- Hip & Knee Implants
Timeline
| 4 May 2026 | Recall initiated by company | |
| 17 Jun 2026 | Classified by FDA | +44 days |
| 24 Jun 2026 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
Worldwide distribution - US Nationwide and the countries of AE, BB, BM, BS, CA, CY, GU, NL, PA, QA, SA, VI.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
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.
Where was it sold?
Worldwide distribution - US Nationwide and the countries of AE, BB, BM, BS, CA, CY, GU, NL, PA, QA, SA, VI.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
24 other products · FDA event 98994This product is part of a recall event; the main page for the event is Medline Medical Procedure Kits labeled as: Basic Heart Pack recalled.
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