CLASS II ONGOING Device recall · Reported 7 Oct 2026 · FDA Enforcement Report
Hopkins Telescope 30¿ recalled by Karl Storz Endoscopy
Karl Storz Endoscopy is recalling Hopkins Telescope 30¿, distributed nationwide in the US. The recall was initiated on 12 Aug 2026 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-3333-2026
- FDA event ID
- 99586
- Recalling firm
- Karl Storz Endoscopy, El Segundo, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 12 Aug 2026
- FDA classified
- 30 Sep 2026
- Reported
- 7 Oct 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Surgical Instruments
Timeline
| 12 Aug 2026 | Recall initiated by company | |
| 30 Sep 2026 | Classified by FDA | +49 days |
| 7 Oct 2026 | Published in enforcement report | +7 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 incorrect inside packaging label for eyepiece.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
HOPKINS Telescope 30¿, 4mm REF 10005BA UDI-DI code: 04048551045121 KARL STORZ HOPKINS¿ and HOPKINS¿ II telescopes are to be used for visualization of the surgical site during diagnostic and therapeutic endoscopic procedures.
Where it was distributed
U.S. Nationwide distribution in the states of AZ, CA and MO.
Questions about this recall
Why was it recalled?
Due to incorrect inside packaging label for eyepiece.
Which lots are affected?
Material Number: 10005BA UDI-DI code: 04048551045121 Serial Numbers: 100011, 100012, 10000Y, and 10000Z
Where was it sold?
U.S. Nationwide distribution in the states of AZ, CA and MO.
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 13 Oct 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 72| 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
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|---|---|---|---|---|---|
| Device | CLASS II | Disposable Tourniquet Cuff, 24" X 4" 1-Line, Yellow recalled | ASP Global | Device Malfunction | Nationwide |
| Device | CLASS II | Mpr Single Use Tourniquet Cuff 15" 1 Line recalled by ASP Global | ASP Global | Device Malfunction | Nationwide |
| Device | CLASS II | Expressaire Disposable Tourniquet Cuff, 12" X 3.5" 1-Line (CS Plum recalled | ASP Global | Device Malfunction | Nationwide |
| Device | CLASS II | Disposable Tourniquet Cuff, 44" X 4" 2-Line, Green recalled | ASP Global | Device Malfunction | Nationwide |
| Device | CLASS II | Expressaire Disposable Tourniquet Cuff, 44" X 4" 2-Line (CS Green recalled | ASP Global | Device Malfunction | Nationwide |