Surgical Injection Needles Recalled for Uncertain Manual Cleaning Efficacy
Karl Storz Endoscopy injection needles used in surgery may not be reliably cleaned by hand, exposing patients to higher infection risk. The recall affects 4,878 units.
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: This is an FDA Class II recall with no reported illnesses or injuries. The hazard involves potential infection risk from uncertain cleaning efficacy, representing a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Karl Storz Endoscopy is recalling three models of surgical injection needles: curved 23 cm (REF 8598A), straight 23 cm (REF 8598B), and distal 45-degree 23 cm (REF 8598D). A total of 4,878 units have been distributed across the United States, Mexico, Canada, and Germany.
The needles, intended for general surgery and visceral surgery, cannot be reliably cleaned using manual processes. The manufacturer has determined that the efficacy of the manual cleaning process cannot be assured, which may expose patients to a higher risk of infection if the needles are used.
The recalled product
- Product
- Injection Needle, curved 23 cm, REF: 8598A; Injection Needle, straight, 23 cm, REF: 8598B; Injection Needle, distal 45-degrees, 23 cm, REF: 8598D
- Manufacturer
- Karl Storz Endoscopy
- Affected units
- 4,878
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 (3)
- REF/UDI-DI: 8598A/04048551213278
- 8598B/04048551001462
- 8598D/04048551213285 All lot numbers.
Distribution
Part of a larger recall action
This product is one of 5 recalled by Karl Storz Endoscopy 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.
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