Injection Needle Recall Due to Cleaning Process Concerns
Karl Storz Endoscopy is recalling injection needles used in general and visceral surgery because the manual cleaning process cannot be assured effective, which may expose patients to a higher risk of infection.
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 a Class II medical device recall involving surgical instruments with theoretical infection risk from cleaning process failure. Per the rubric, risk-of-harm products where injury has not yet been reported receive a High (3) severity score.
Plain-English summary
Karl Storz Endoscopy is recalling injection needles (REF: 25207) intended for use in general surgery and visceral surgery. The recall is due to concerns that the efficacy of the manual cleaning process for these needles cannot be assured.
The affected injection needles have been distributed to healthcare facilities across the United States (Michigan, New Hampshire, South Carolina, Pennsylvania, Florida, New York, North Carolina, Mississippi, Missouri, California, New Jersey, Illinois, Nevada, Oklahoma, Colorado, Ohio, Washington, Wisconsin, Virginia, Indiana, Iowa, Arkansas, Texas, West Virginia, Maryland, Minnesota, Georgia, Massachusetts, New Mexico, Vermont, Alaska, Oregon, Idaho, Louisiana, Kansas, Washington D.C., Kentucky, and Hawaii), as well as Mexico, Canada, and Germany. All lot numbers of product REF: 25207 are affected, identified by UDI-DI: 04048551085776.
If used without assured cleaning efficacy, these injection needles may expose patients to a higher risk of infection during surgical procedures. Healthcare facilities in possession of this product should consult with Karl Storz Endoscopy and the FDA regarding the recall.
The recalled product
- Product
- Injection Needle, REF: 25207
- Manufacturer
- Karl Storz Endoscopy
- Affected units
- 1
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 (1)
- UDI-DI: 04048551085776. 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 · infection risk
See all →- SevereSteris VERIFY Biological/Integrator Challenge Pack Recall for Sterilization Monitoring Failure
FDA (Devices) · 2026-10-14
- HighRecall of Medical Convenience Kits with Contaminated Pericare Wipes
FDA (Devices) · 2026-10-07
- HighFDA Recalls Medical Kits with Contaminated Pericare Wipes
FDA (Devices) · 2026-10-07
- SevereFDA Recalls Medical Kits with Contaminated Pericare Wipes
FDA (Devices) · 2026-10-07
- SevereAvKare Carboxymethylcellulose Sodium Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
Similar recalls
- HighKarl Storz Flexible Intubation Video Endoscope Recall for Sterilization Instructions
FDA (Devices) · 2020-09-02
- ModerateKarl Storz Nephroscope Recall Due to Unapproved Reprocessing Instructions
FDA (Devices) · 2024-10-02
- ModerateKarl Storz Hopkins Telescope 6 endoscope recalled for unapproved reprocessing instructions
FDA (Devices) · 2024-10-02
- HighKarl Storz Uretero-Renoscope Recalled for Unapproved Reprocessing Instructions
FDA (Devices) · 2025-02-05
- HighKarl Storz Ureteroscope Recall Due to Unapproved Reprocessing Instructions
FDA (Devices) · 2025-02-05
- HighKarl Storz Flexible DCI Intubation Fiberscope Recall for Sterilization Instructions
FDA (Devices) · 2020-09-02