The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0986-2015·Announced 2015-01-21

Stryker Recalls SurgiCounter Charging Cradles Due to Charging Defects

Stryker is recalling 3,625 SurgiCounter Charging Cradles because they may fail to charge the scanner or download data after surgical procedures.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a functional defect (failure to charge/download data) rather than a direct physical injury or high-risk pathogen, fitting the criteria for a moderate severity recall.

Plain-English summary

Stryker Instruments Div. of Stryker Corporation is recalling 3,625 units of the SurgiCounter Charging Cradle. The product is part of the SurgiCount Safety-Sponge System, which is indicated for use in counting and recording the number of Safety-Sponge surgical sponges, laparotomy sponges, and towels used during surgical procedures.

The recall was initiated because faulty charging cradles can prevent the scanner from charging or downloading information after a procedure. The affected units are identified by part number SC-0014 and include all lots at the time of the notice on June 16, 2013.

The recalled products were distributed nationwide in the United States, specifically 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. Healthcare facilities should stop using the affected charging cradles and contact Stryker for further instructions.

The recalled product

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…
Manufacturer
Stryker Instruments Div. of Stryker Corporation
Category
Medical Device — Surgical Counting System
Hazard
Affected units
3,625

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Part number: SC-0014 All lots at time of notice 6/16/2013

Distribution

Distributed nationwide across the United States.

The notice also names 38 states specifically:

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