Stryker Single Spike Tube Set Recalled for Leaking During Use
Stryker is recalling 11,857 Single Spike Tube Sets due to reports of leaking from the handpiece during use.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a functional defect (leaking) in a medical device where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Stryker Corporation is recalling 11,857 units of the Stryker PKG., Single Spike Tube Set, Catalog Number 0250070530. The recall was initiated because of an increased number of reported complaints consistently describing leaking from the handpiece during use.
The affected products were distributed worldwide, including the United States, Australia, Brazil, Canada, Chile, France, Germany, Indonesia, Italy, Mexico, Netherlands, New Zealand, Philippines, South Korea, Spain, Sweden, Switzerland, Taiwan, and the United Kingdom. The recall includes specific batch numbers and GTIN 07613327061352.
Healthcare providers and consumers should stop using the affected products and contact Stryker Corporation for further instructions or a replacement.
The recalled product
- Product
- STRYKER PKG., SINGLE SPIKE TUBE SET, Catalog Number 0250070530
- Manufacturer
- Stryker Corporation
- Hazard
- Affected units
- 11,857
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)
- GTIN 07613327061352
- Batch Numbers 24260FG2
- 24261FG2
- 24297FG2
- 24298FG2
- 24299FG2
- 24302FG2
- 24340FG2
- 24341FG2
- 25008FG2
- 25009FG2
- 25010FG2
- 25011FG2
- 25024FG2
- 25034FG2
- 25035FG2
- 25052FG2
- 25063FG2
- 25064FG2
- 25084FG2
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 recalled by Stryker Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 5 products in this recall →Related recalls
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