Key facts
| Recalling firm | BD SWITZERLAND SARL |
|---|---|
| Manufacturer | Not disclosed in the FDA record. |
| Brand name | Not disclosed in the FDA record. |
| 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 |
| Classification | Class II |
| Recall number | Z-2654-2026 |
| Report date | Not disclosed in the FDA record. |
| Status | Ongoing |
| Reason for recall | Due to engineering sample labeled "Not for Human Use" being inadvertently shipped it the U.S. market. |
What consumers should do
Facilities, clinicians, and consumers holding an affected unit or lot of 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 should stop using it for the purpose described in the recall notice and hold remaining stock pending instructions from BD SWITZERLAND SARL. FDA recall records typically direct the recalling firm to notify known accounts directly with a recall letter describing the specific corrective action -- replacement, field correction, refund, or return. Anyone who received the product through a distributor rather than directly from BD SWITZERLAND SARL should confirm with their supplier whether their specific lot or unit is on the affected list, since recall notices are lot- or unit-specific and not every unit of a product line is necessarily included. Questions about a specific unit's status should go to BD SWITZERLAND SARL directly or to the distributor that supplied it; Argus HQ is a public-record aggregator, not the recalling firm, and cannot confirm individual unit status.
What this classification means
A Class II recall is FDA’s middle classification. FDA assigns Class II when use of, or exposure to, the recalled product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. FDA still requires the recalling firm to notify affected accounts and submit status reports on the correction, though the monitoring intensity is lower than for a Class I recall. FDA's Center for Devices and Radiological Health (for devices) or Center for Drug Evaluation and Research (for drugs) reviews the classification and can require additional corrective action if the initial response is judged insufficient. Because this record is filed as Class II, professionals and consumers handling an affected lot should treat FDA's own classification -- not this page's summary of it -- as the authoritative risk signal. A Class I recall is FDA’s most serious classification. FDA assigns Class I when there is a reasonable probability that use of, or exposure to, the recalled product will cause serious adverse health consequences or death. This classification does not mean harm has already occurred in every case -- it reflects FDA’s assessment of the realistic worst-case risk profile of the defect described in the recall, based on the reason for recall reported by the firm. Class I recalls receive the closest FDA monitoring of the three classes: the recalling firm typically must submit a recall strategy, periodic status reports, and effectiveness checks confirming that the affected lots have actually been removed from distribution or corrected in the field.
BD SWITZERLAND SARL’s FDA history
Argus HQ has recorded 3 total FDA actions tied to BD SWITZERLAND SARL: 0 warning letters, 3 recalls, 0 approval records, and 0 Form 483 inspection citations.
Frequently asked questions
- What is the current status of this recall?
- Status as recorded by FDA: Ongoing.
- Where can I verify this recall directly with FDA?
- The verbatim FDA record is the source of truth for every recall Argus HQ tracks — always confirm against fda.gov before acting.
- Is MEDLINE 111 GRAVITY SET W/3 Needle Free Y-Sites REF DYNDTN0 recalled?
- Yes. FDA lists a Class II recall by BD SWITZERLAND SARL for 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, reported 20260708, with status "Ongoing." FDA recall number: Z-2654-2026.
- What is the recall class for BD SWITZERLAND SARL's recall?
- FDA classified this recall as Class II. A Class II recall is FDA’s middle classification. FDA assigns Class II when use of, or exposure to, the recalled product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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Related enforcement actions
Full FDA history for BD SWITZERLAND SARLCompiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder
Cite this record
Reusing this data in reporting or research? Here’s a ready-made citation.
Argus HQ Research (2026). Recall Record: Class II Recall: MEDLINE 111 GRAVITY SET W/3 Needle Free Y-Sites… by BD SWITZERLAND SARL. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/recall/bd-switzerland-sarl-z-2654-2026-2026-07-08
"Recall Record: Class II Recall: MEDLINE 111 GRAVITY SET W/3 Needle Free Y-Sites… by BD SWITZERLAND SARL." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/recall/bd-switzerland-sarl-z-2654-2026-2026-07-08.
Argus HQ Research. "Recall Record: Class II Recall: MEDLINE 111 GRAVITY SET W/3 Needle Free Y-Sites… by BD SWITZERLAND SARL." Digital Empire Holdings LLC. Accessed August 27, 2026. https://argushq.ai/recall/bd-switzerland-sarl-z-2654-2026-2026-07-08.
@misc{argushq_argushq_ai_recall_bd_switzerland_sarl_z_2654_2026_2026_07_08_2026,
title = {Recall Record: Class II Recall: MEDLINE 111 GRAVITY SET W/3 Needle Free Y-Sites… by BD SWITZERLAND SARL},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire Holdings LLC},
url = {https://argushq.ai/recall/bd-switzerland-sarl-z-2654-2026-2026-07-08},
note = {Accessed: August 27, 2026}
}Source: FDA.gov — Recalls ↗