CLASS II ONGOING Device recall · Reported 8 Jul 2026 · FDA Enforcement Report
Medline 111 Gravity Set W/3 Needle Free Y-Sites recalled
Bd Switzerland Sarl is recalling Medline 111 Gravity Set W/3 Needle Free Y-Sites, distributed in Illinois. The recall was initiated on 4 Jun 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-2654-2026
- FDA event ID
- 99085
- Recalling firm
- Bd Switzerland Sarl, Eysins, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 4 Jun 2026
- FDA classified
- 2 Jul 2026
- Reported
- 8 Jul 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- N/A
- Reason category
- Other Reasons
- Device type
- Syringes & Needles
Timeline
| 4 Jun 2026 | Recall initiated by company | |
| 2 Jul 2026 | Classified by FDA | +28 days |
| 8 Jul 2026 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Due to engineering sample labeled "Not for Human Use" being inadvertently shipped it the U.S. market.
Product as listed by the FDA
MEDLINE 111 GRAVITY SET W/3 Needle Free Y-Sites REF DYNDTN0555 Catalog Number: SAM2461 UDI code: N/A Engineering Sample/Not for Human Use
Where it was distributed
U.S.: IL O.U.S: N/A
Questions about this recall
Is Medline 111 Gravity Set W/3 Needle Free Y-Sites recalled?
Yes. Bd Switzerland Sarl recalled Medline 111 Gravity Set W/3 Needle Free Y-Sites on 4 Jun 2026. The recall is Class II and its status is Ongoing. Recall number Z-2654-2026.
Why was it recalled?
Due to engineering sample labeled "Not for Human Use" being inadvertently shipped it the U.S. market.
Which lots are affected?
Catalog Number: SAM2461 REF: DYNDTN0555 UDI code: N/A Lot Number: 25X445
Where was it sold?
U.S.: IL O.U.S: N/A
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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