CLASS II Device recall · Reported 6 Apr 2016 · FDA Enforcement Report

The S.C.O.R.E.S recalled by PMBS

PMBS is recalling The S.C.O.R.E.S, distributed in 7 states. The recall was initiated on 13 Jan 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesALL distributed S.C.O.R.E.S. units are affected.

Quantity recalled58 units

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-1266-2016
FDA event ID: 73157
Recalling firm: PMBS, Stockton, NJ
Classification: Class II
Status: Terminated
Recall initiated: 13 Jan 2016
FDA classified: 25 Mar 2016
Reported: 6 Apr 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Other Medical Devices

Timeline

13 Jan 2016	Recall initiated by company
25 Mar 2016	Classified by FDA	+72 days
6 Apr 2016	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

Water retention issues. Units with filters that remain wet after the sterilization may compromised sterility.

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

The S.C.O.R.E.S. Unit (self contained operating room equipment sterilization unit)

Where it was distributed

FL, GA, MN, NY, OH, OR SC, and TN

Florida Georgia Minnesota New York Ohio South Carolina Tennessee

Questions about this recall

Is The S.C.O.R.E.S recalled?

Yes. PMBS recalled The S.C.O.R.E.S on 13 Jan 2016. The recall is Class II and its status is Terminated. Recall number Z-1266-2016.

Why was it recalled?

Water retention issues. Units with filters that remain wet after the sterilization may compromised sterility.

Which lots are affected?

ALL distributed S.C.O.R.E.S. units are affected.

Where was it sold?

FL, GA, MN, NY, OH, OR SC, and TN

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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