CLASS II ONGOING Device recall · Reported 2 Sep 2026 · FDA Enforcement Report
Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled
Medline Industries is recalling Medline convenience kits labeled as: Femoral Pack, Medline Kit, distributed nationwide in the US. The recall was initiated on 10 Jul 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-3019-2026
- FDA event ID
- 99507
- Recalling firm
- Medline Industries, Northfield, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 10 Jul 2026
- FDA classified
- 26 Aug 2026
- Reported
- 2 Sep 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
| 10 Jul 2026 | Recall initiated by company | |
| 26 Aug 2026 | Classified by FDA | +47 days |
| 2 Sep 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
Kits contain a potentially contaminated component which were recalled by the manufacturer
Product as listed by the FDA
Medline convenience kits labeled as: 1) FEMORAL PACK, Medline Kit SKU DYNJ909393A; 2) FEVAR, Medline Kit SKU DYNJ910295D.
Where it was distributed
US Nationwide distribution in the states of AL, CA, FL, IL, KS, LA, MA, MD, MO, MS, MT, NV, NY, OH, OK, SC, TX, WI.
Nationwide AlabamaCaliforniaFloridaIllinoisKansasLouisianaMassachusettsMarylandMissouriMississippiMontanaNevadaNew YorkOhioOklahomaSouth CarolinaTexasWisconsin
Questions about this recall
Why was it recalled?
Kits contain a potentially contaminated component which were recalled by the manufacturer
Which lots are affected?
1) Medline Kit SKU DYNJ909393A, UDI/DI 10195327613945 (each) 40195327613946 (case) Lot Number 25ILA297; 2) Medline Kit SKU DYNJ910295D, UDI/DI 10198459586477 (each) 40198459586478 (case), Lot Number 26CBT178.
Where was it sold?
US Nationwide distribution in the states of AL, CA, FL, IL, KS, LA, MA, MD, MO, MS, MT, NV, NY, OH, OK, SC, TX, WI.
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
10 other products · FDA event 99507This product is part of a recall event; the main page for the event is Medline convenience kits labeled as: Lami Fusion, Medline Kit recalled.
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