CLASS II ONGOING Device recall · Reported 22 Jan 2025 · FDA Enforcement Report
Karl Storz - Endoskope recalled
Karl Storz Endoscopy is recalling Karl Storz - Endoskope, distributed in 32 states. The recall was initiated on 19 Dec 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0837-2025
- FDA event ID
- 95954
- Recalling firm
- Karl Storz Endoscopy, El Segundo, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 19 Dec 2024
- FDA classified
- 10 Jan 2025
- Reported
- 22 Jan 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Surgical Instruments
Timeline
| 19 Dec 2024 | Recall initiated by company | |
| 10 Jan 2025 | Classified by FDA | +22 days |
| 22 Jan 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Due to failure of manual cleaning validation, biopsy and grasping forceps like sterility assurance.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Karl Storz - Endoskope - REF 723400 - Optical Biopsy and Grasping Forceps, CE
Where it was distributed
US: AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NY, OH, OR, PA, SC, TX, VA OUS: None
ArkansasArizonaCaliforniaColoradoConnecticutFloridaGeorgiaHawaiiIowaIdahoIllinoisIndianaKentuckyLouisianaMassachusettsMarylandMichiganMinnesotaMissouriMississippi
Questions about this recall
Why was it recalled?
Due to failure of manual cleaning validation, biopsy and grasping forceps like sterility assurance.
Which lots are affected?
Lot Numbers: All lots of the affected material number/Primary DI Number: 04048551194416
Where was it sold?
US: AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NY, OH, OR, PA, SC, TX, VA OUS: None
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Karl Storz Endoscopy
All 71| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Flexible Hystero-Fiberscope Kits recalled by Karl Storz Endoscopy | Karl Storz Endoscopy | Sterility | Nationwide |
| Device | CLASS II | Karl Storz - Endoskope recalled | Karl Storz Endoscopy | Other | Nationwide |
| Device | CLASS II | Karl Storz - Endoskope recalled | Karl Storz Endoscopy | Other | Nationwide |
| Device | CLASS II | Karl Storz - Endoskope recalled | Karl Storz Endoscopy | Other | Nationwide |
| Device | CLASS II | Karl Storz - Endoskope recalled | Karl Storz Endoscopy | Other | Nationwide |
Other Surgical Instruments recalls
All 3,816| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | REF:2B5LT Ethicon Endo-Surgery recalled by Stryker Sustainability | Stryker Sustainability Solutions | Device Malfunction | Nationwide |
| Device | CLASS II | REF:B11LT Ethicon Endo-Surgery, Inc. Xcel Bladeless Trocar recalled | Stryker Sustainability Solutions | Device Malfunction | Nationwide |
| Device | CLASS II | REF:B12LT Ethicon Endo-Surgery, Inc. Xcel Bladeless Trocar recalled | Stryker Sustainability Solutions | Device Malfunction | Nationwide |
| Device | CLASS II | Hemospray Endoscopic Hemostat recalled by Wilson-Cook Medical | Wilson-Cook Medical | Device Malfunction | Nationwide |
| Device | CLASS II | REF:B5LT Ethicon Endo-Surgery recalled by Stryker Sustainability | Stryker Sustainability Solutions | Device Malfunction | Nationwide |