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.
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: 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
- Affected units
- 990
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
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.
See all 5 products in this recall →Related recalls
Same manufacturer · Karl Storz Endoscopy
See all →- LowKarl Storz Recalls HOPKINS Telescope Eyepieces Due to Labeling Error
FDA (Devices) · 2026-10-07
- HighFlexible Hystero-Fiberscope Kits Recalled Due to Expired Sterile Seals
FDA (Devices) · 2026-07-29
- HighKarl Storz Uretero-Renoscope Recalled for Unapproved Reprocessing Instructions
FDA (Devices) · 2025-02-05
- HighKarl Storz Pediatric Uretero-Renoscope Recalled for Unapproved Reprocessing Instructions
FDA (Devices) · 2025-02-05
- HighKarl Storz Uretero-Renoscope Recalled for Unapproved Reprocessing Instructions
FDA (Devices) · 2025-02-05
Same hazard · contamination
See all →- SevereEthicon Recalls Silk Surgical Sutures Packaged with Alcohol-Based Fluid
FDA (Devices) · 2026-10-21
- ModerateBioFire FilmArray Pneumonia Panel Plus Recalled for Potential Contamination
FDA (Devices) · 2026-10-21
- ModerateBioFire Joint Infection Panel Recalled for Potential Contamination
FDA (Devices) · 2026-10-21
- ModerateBioFire FilmArray Pneumonia Panel Recalled for Potential Contamination
FDA (Devices) · 2026-10-21
- ModerateAVID Medical Recalls Urology Kits for Potential Lubricant Contamination
FDA (Devices) · 2026-10-14
Similar recalls
- HighKarl Storz Cysto-Urethroscope Recalled for Unapproved Reprocessing Instructions
FDA (Devices) · 2025-02-05
- HighKarl Storz Flexible Intubation Video Endoscope Recall for Sterilization Instructions
FDA (Devices) · 2020-09-02
- HighKarl Storz Ureteroscope Recall Due to Unapproved Reprocessing Instructions
FDA (Devices) · 2025-02-05
- HighMedical endoscope recalled for unapproved sterilization instructions
FDA (Devices) · 2024-10-02
- HighKarl Storz Uretero-Renoscope Recalled for Unapproved Reprocessing Instructions
FDA (Devices) · 2025-02-05
- HighKarl Storz Laser Surgical Instruments Recalled Due to Sterilization Concerns
FDA (Devices) · 2024-05-22