CLASS II Device recall · Reported 23 Dec 2015 · FDA Enforcement Report

Unolok Blunt Fill Needle Red, Sterile, Single use recalled

Myco Medical Supplies is recalling Unolok Blunt Fill Needle Red, Sterile, Single use, Non-injectable needle, Single use, distributed nationwide in the US. The recall was initiated on 6 Nov 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesItem #02463, Lot numbers: 19351R, 16561M, 17531D, 22541D, 22551D, 25551D and 25551M.

Quantity recalled2,401,419 units (100ea/bx, 12bx/cs, 1200ea/cs)

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-0444-2016
FDA event ID: 72616
Recalling firm: Myco Medical Supplies, Cary, NC
Classification: Class II
Status: Terminated
Recall initiated: 6 Nov 2015
FDA classified: 17 Dec 2015
Reported: 23 Dec 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Particulate Matter
Device type: Syringes & Needles

Timeline

6 Nov 2015	Recall initiated by company
17 Dec 2015	Classified by FDA	+41 days
23 Dec 2015	Published in enforcement report	+6 days

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

Reason for recall

Particulates: Complaints of rubber coring from the closure of injection vials.

Product as listed by the FDA

Unolok Blunt Fill Needle 18G x 1.5" Red, Sterile, Single use, Non-injectable needle, Single use, non-injection needle

Where it was distributed

Nationwide Distribution including AZ, CA, CO, FL, GA, IL, IN, KY, LA, MA, MI, NJ, NY, NV, OK, PA, TX and UT.

Nationwide Arizona California Colorado Florida Georgia Illinois Indiana Kentucky Louisiana Massachusetts Michigan New Jersey Nevada New York Oklahoma Pennsylvania Texas Utah

Questions about this recall

Why was it recalled?

Particulates: Complaints of rubber coring from the closure of injection vials.

Which lots are affected?

Item #02463, Lot numbers: 19351R, 16561M, 17531D, 22541D, 22551D, 25551D and 25551M.

Where was it sold?

Nationwide Distribution including AZ, CA, CO, FL, GA, IL, IN, KY, LA, MA, MI, NJ, NY, NV, OK, PA, TX and UT.

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 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.

More recalls from Myco Medical Supplies

All 2

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