FDA recall, , Moderate risk
BD Medline 111 Gravity Set
The gravity set was shipped as an engineering sample labeled not for human use.
Summary by Recall Canary from the FDA notice
What happened
BD SWITZERLAND SARL, located in Eysins, Switzerland, began a recall of MEDLINE 111 GRAVITY SET W/3 Needle Free Y-Sites REF DYNDTN0555 on June 4, 2026, because an engineering sample labeled "Not for Human Use" was inadvertently shipped to the U.S. market. The FDA added the recall to its Enforcement Report and classified it on July 2, 2026, with the weekly enforcement report published July 8, 2026.
The product was distributed in Illinois, and the recall involves 50 devices.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is your set affected?
Affected if its lot code matches.
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
- Lot code
- 25X445
Recall details
- Company began the recall
- Sold in
U.S.: Illinois O.U.S: N/A
- Company
- BD SWITZERLAND SARLEysins, Switzerland
- Hazard
- Unapproved product
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99085
- Recall number
- Z-2654-2026
- Quantity recalled
- 50 devices
All recalls from BD SWITZERLAND SARL
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
