Injection needles and cannulas recalled for cleaning process efficacy issues
Karl Storz Endoscopy is recalling injection needles and cannulas because the manual cleaning process may not effectively remove contaminants, potentially exposing patients to infection risk.
What this means for you
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: FDA Class II recall without reported illnesses or hospitalization. Classified as High severity for a risk-of-harm medical device (potential infection) where injury has not yet been reported.
Plain-English summary
Karl Storz Endoscopy is recalling Injection Needle (3 Fr., REF: 27030N) and Injection Cannula (6 Fr., REF: 27182A) devices across all lot numbers. Approximately 990 units were affected.
The manual cleaning process for these injection needles and cannulas cannot be assured to be effective. Inadequate cleaning may leave contaminants on the devices.
These devices are intended for use in general and visceral surgery. If used without proper cleaning, they may expose patients to a higher risk of infection.
Healthcare facilities that have received these devices should stop using them until proper cleaning procedures can be verified. Facilities should contact Karl Storz Endoscopy for additional information and instructions for device replacement or return.
The recalled product
- Product
- Injection Needle, 3 Fr., REF: 27030N; Injection Cannula, 6 Fr., REF: 27182A
- Manufacturer
- Karl Storz Endoscopy
- Hazard
- contamination
- infection-risk
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 (2)
- REF/UDI-DI: 27030N/4048551257180
- 27182A/4048551081457 All lot numbers.
Distribution
Distributed in 38 states:
- AK
- AR
- CA
- CO
- DC
- FL
- GA
- HI
- IA
- ID
- IL
- IN
- KS
- KY
- LA
- MA
- MD
- MI
- MN
- MO
- MS
- NC
- NH
- NJ
- NM
- NV
- NY
- OH
- OK
- OR
- PA
- SC
- TX
- VA
- VT
- WA
- WI
- WV
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