CLASS II ONGOING Device recall · Reported 4 Sep 2019 · FDA Enforcement Report

Medline Syringe, Piston,Irr Tray,W/.9 recalled by Medline Industries

Medline Industries is recalling Medline Syringe, Piston,Irr Tray,W/.9, distributed nationwide in the US. The recall was initiated on 9 Aug 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Number 19CAB954

Quantity recalled11962 trays

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-2358-2019
FDA event ID: 83551
Recalling firm: Medline Industries, Northfield, IL
Classification: Class II
Status: Ongoing
Recall initiated: 9 Aug 2019
FDA classified: 23 Aug 2019
Reported: 4 Sep 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Syringes & Needles

Timeline

9 Aug 2019	Recall initiated by company
23 Aug 2019	Classified by FDA	+14 days
4 Sep 2019	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

Samples in the identified lot were found to have incomplete or open packaging seals.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Medline SYRINGE, PISTON,IRR TRAY,W/.9, REF DYNC2303. Sterile Piston Irrigation Syringe Tray with Saline

Where it was distributed

US nationwide distribution

Nationwide

Questions about this recall

Is Medline Syringe, Piston,Irr Tray,W/.9 recalled?

Yes. Medline Industries recalled Medline Syringe, Piston,Irr Tray,W/.9 on 9 Aug 2019. The recall is Class II and its status is Ongoing. Recall number Z-2358-2019.

Why was it recalled?

Samples in the identified lot were found to have incomplete or open packaging seals.

Which lots are affected?

Lot Number 19CAB954

Where was it sold?

US nationwide distribution

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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