Z-0986-2015Class II

The SurgiCounter Charging Cradle

Name: Z-0986-2015 The SurgiCounter Charging Cradle
Creator: Stryker Instruments Div. of Stryker Corporation
Published: 2013-06-16
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2013-06-16 / Terminated / root cause: design

FDA source

Stryker Instruments Div. of Stryker Corporation began a recall of The SurgiCounter Charging Cradle Product Usage: SurgiCounter Charging Cradles are designed to be used with the SurgiCounter and are part of the SurgiCount... on 2013-06-16. FDA classified it as Class II and gives the reason as "Faulty SurgiCounter Charging Cradle can prevent the scanner from charging or downloading information after a procedure". 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-0986-2015
Classification: Class II
Status: Terminated
Initiated: 2013-06-16
Posted: 2015-01-15
Terminated: 2015-08-20
Recalling firm: Stryker Corp.
Product: The SurgiCounter Charging Cradle Product Usage: SurgiCounter Charging Cradles are designed to be used with the SurgiCounter and are part of the SurgiCount Safety-Sponge System. The SurgiCount Safety-Sponge System is indicated for use in counting and recording the number of Safety-Sponge surgical sponges, laparotomy sponges, and towels used during surgical procedures.
Product code: LWH Counter, Sponge, Surgical
Reason for recall: Faulty SurgiCounter Charging Cradle can prevent the scanner from charging or downloading information after a procedure.
Root cause tag: design
FDA root cause: Device Design
Action: On 6/16/2013, Improvements to the SurgiCounter" charging base notifications were emailed to the affected users with instructions for requesting a replacement product. The notification included a description of the reason for the recall, affected product, and instructions for responding to the notification. For questions, call the Support team any time at (877) 520-2300 option 1, or [email protected].
Quantity in commerce: 3625
Distribution: US Nationwide Distribution in the states of AK, AL, AR, AZ, CA, CT, FL, GA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY.
Product codes and lots: Part number: SC-0014 All lots at time of notice 6/16/2013

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0986-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0986-2015	Class II	Terminated	Voluntary: Firm initiated	2015-01-21	2015-01-15

Product code LWH

K060076Class ISurgicount Safety-Sponge SystemSurgicount Medical / cleared 2006-03-14

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)