MEDLINE 111 GRAVITY SET W/3 Needle Free Y-Sites REF DYNDTN0555 Catalog Number: SAM2461 UDI code: N/A Engineering S
Summary
The FDA issued a Class II for MEDLINE 111 GRAVITY SET W/3 Needle Free Y-Sites REF DYNDTN0555 Catalog Number: by BD SWITZERLAND SARL. Reason: Due to engineering sample labeled "Not for Human Use" being inadvertently shipped it the U.S. market..
Details
Source
Device Recall
External ID
Z-2654-2026
Action Date
2026-07-08
Status
Ongoing
Category
device
Product Description
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 Info: Catalog Number: SAM2461 REF: DYNDTN0555 UDI code: N/A Lot Number: 25X445
Quantity Affected: 50 devices
Reason for Recall
Due to engineering sample labeled "Not for Human Use" being inadvertently shipped it the U.S. market.
Distribution
U.S.: IL O.U.S: N/A
Type: Voluntary: Firm initiated
Recall Initiated: 2026-06-04
Company
Eysins, N/A
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 186 device recalls issued in the same week, part of 534 device-related FDA actions this month.
BD SWITZERLAND SARL has 10 FDA actions in our database, including 10 recalls.
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 (BD SWITZERLAND SARL) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does BD SWITZERLAND SARL have FDA actions?
BD SWITZERLAND SARL has 10 FDA actions in our database, including 10 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2654-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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