Stryker Universal Battery Charger Recalled for Software Data Transmission Issue
Stryker is recalling 223 Universal Battery Chargers because they are not transmitting usage data to the Stryker Cloud as designed. A software correction is being initiated.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The issue is a software data transmission error with no reported injuries or illnesses.
Plain-English summary
Stryker Instruments Div. of Stryker Corporation is recalling 223 units of the Stryker Universal Battery Charger. The product is a four-station, modular battery charger intended to charge Stryker handpiece battery packs and has the optional functionality to track device usage data.
The recall is being initiated because the chargers are not transmitting usage data to the Stryker Cloud as designed. The firm is initiating a software correction to address the issue.
The affected units were distributed nationwide in the United States in the states of AL, AR, AZ, CA, CO, FL, GA, IA, IL, IN, KS, KY, MD, MI, MO, MS, MT, NC, NH, NV, NY, OH, OK, PA, SC, TN, TX, UT, VA, VT, WA, and WI, as well as in Canada. Affected units are identified by Part No. 7110-120-000 and specific serial numbers listed in the recall documentation.
The recalled product
- Product
- Universal Charger Product Usage: The Stryker Universal Battery Charger is designed to be used in conjunction with and provide power to non-sterile and sterile batteries. The Stryker Universal Battery Charger is a four station, modular battery charger intended to charge…
- Manufacturer
- Stryker Instruments Div. of Stryker Corporation
- Hazard
- Affected units
- 223
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 (20)
- Part No. 7110-120-000
- Affected serial numbers as follows: 1234701323
- 1402902743
- 1402902893
- 1221503173
- 326305393
- 1217705113
- 1315004963
- 1222700863
- 1326305403
- 1217705123
- 1315005013
- 1222701093
- 1217705283
- 1324801023
- 1217705083
- 1322600723
- 1217900123
- 1324801083
- 1217705093
Distribution
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