Z-1266-2016Class II

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

Name: Z-1266-2016 The S.C.O.R.E.S. Unit (self contained operating room equipment sterilization unit)
Creator: Pmbs, Llc
Published: 2016-01-13
License: https://open.fda.gov/license/

SterCUBE Surgical Systems, LLC / initiated 2016-01-13 / Terminated / root cause: design

FDA source

PMBS, LLC began a recall of The S.C.O.R.E.S. Unit (self contained operating room equipment sterilization unit) on 2016-01-13. FDA classified it as Class II and gives the reason as "Water retention issues. Units with filters that remain wet after the sterilization may compromised sterility". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1266-2016
Classification: Class II
Status: Terminated
Initiated: 2016-01-13
Posted: 2016-03-25
Terminated: 2017-09-27
Recalling firm: SterCUBE Surgical Systems, LLC
Product: The S.C.O.R.E.S. Unit (self contained operating room equipment sterilization unit)
Product code: KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Reason for recall: Water retention issues. Units with filters that remain wet after the sterilization may compromised sterility.
Root cause tag: design
FDA root cause: Device Design
Action: On January 13, 2016 PMBS, LLC sent letters to their customers informing them of the correction. Per product's instructions for use, the SCORES cabinet is to be run for a minimun of a 4 minute sterilization cycle, followed by a 30 munites dry time followed by a 30 minutes door crack time. not all facilities generate completely dry SCORES filters following these instructions. It is imperative that the filters be checked in the Operation Room prior to useing the surgical instruments sterilised within the cabinet. If the filters are wet, do not use the contents. In the letter is a IFU addendum including instructions for running the equiptment with extended cycles. For more information please contact Ms. Michele Mauzerall, CEO at 908-300-7093.
Quantity in commerce: 58 units
Distribution: FL, GA, MN, NY, OH, OR SC, and TN
Product codes and lots: ALL distributed S.C.O.R.E.S. units are affected.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1266-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1266-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-06	2016-03-25

Product code KCT

K110898Class IIS.c.o.r.e.s. UnitAmmed Surgical Equipment, LLC / cleared 2012-07-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)