CLASS I ONGOING Device recall · Reported 18 Oct 2023 · FDA Enforcement Report

Syringe Luer Lock W/needle recalled by Fresenius Medical Care

Fresenius Medical Care Holdings is recalling Syringe Luer Lock W/needle, distributed nationwide in the US. The recall was initiated on 8 Aug 2023 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesUDI-DI: 16945060500125; All Lots

Quantity recalled124,773 boxes total

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-0006-2024
FDA event ID: 92906
Recalling firm: Fresenius Medical Care Holdings, Waltham, MA
Classification: Class I
Status: Ongoing
Recall initiated: 8 Aug 2023
FDA classified: 6 Oct 2023
Reported: 18 Oct 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Foreign Material
Device type: Syringes & Needles

Timeline

8 Aug 2023	Recall initiated by company
6 Oct 2023	Classified by FDA	+59 days
18 Oct 2023	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

There is a potential for blood backfill leakage and foreign material.

Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.

Product as listed by the FDA

10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case

Where it was distributed

US Nationwide.

Nationwide

Questions about this recall

Why was it recalled?

There is a potential for blood backfill leakage and foreign material.

Which lots are affected?

UDI-DI: 16945060500125; All Lots

Where was it sold?

US Nationwide.

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 I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

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

2 other products · FDA event 92906

This product is part of a recall event; the main page for the event is Syringe Luer Lock with needle 20GX1 recalled by Fresenius Medical Care.

Reported	Class	Recall	Company	Reason	Where
18 Oct 2023	CLASS I	Syringe Luer Lock with needle 20GX1 recalled by Fresenius Medical Care	Fresenius Medical Care Holdings	Foreign Material	Nationwide
18 Oct 2023	CLASS I	Syringe Luer Lock W/out Needle recalled by Fresenius Medical Care	Fresenius Medical Care Holdings	Foreign Material	Nationwide

More recalls from Fresenius Medical Care Holdings

All 165

Reported	Class	Recall	Company	Reason	Where
15 Jul 2026Device	CLASS II	5008X Blood Tubing Set recalled by Fresenius Medical Care	Fresenius Medical Care Holdings	Other	Nationwide
17 Jun 2026Device	CLASS II	Bicarby" Dialysate recalled by Fresenius Medical Care	Fresenius Medical Care Holdings	Packaging Defects	Nationwide
17 Jun 2026Device	CLASS II	Bicarby Dialysate recalled by Fresenius Medical Care	Fresenius Medical Care Holdings	Other	TX
13 May 2026Drug	CLASS II	Delflex, Dextrose Peritoneal Dialysis Solution recalled	Fresenius Medical Care Holdings	Sterility	Nationwide
13 May 2026Drug	CLASS II	Delflex, Dextrose Peritoneal Dialysis Solution recalled	Fresenius Medical Care Holdings	Sterility	Nationwide

Other Syringes & Needles recalls

All 1,060

Reported	Class	Recall	Company	Reason	Where
26 Aug 2026Device	CLASS I	BD Needle Kit for Powered Driver recalled by Bard Access Systems	Bard Access Systems	Other	32 states
19 Aug 2026Device	CLASS II	Boston Scientific Enhance Transcarotid/Peripheral Access Kit recalled	Galt Medical	Other	Nationwide
15 Jul 2026Device	CLASS II	Geneva Brachytherapy Applicator recalled by Elekta	Elekta	Other	Nationwide
15 Jul 2026Device	CLASS II	Brachytherapy Applicator Advanced Gynecological Applicator recalled	Elekta	Other	Nationwide
8 Jul 2026Device	CLASS II	Medline 111 Gravity Set W/3 Needle Free Y-Sites recalled	BD Switzerland Sarl	Other	IL