CLASS III Device recall · Reported 20 May 2020 · FDA Enforcement Report
Insufflation tubing to be used with varies insufflator units recalled
Karl Storz Endoscopy is recalling Insufflation tubing to be used with varies insufflator units, distributed in 27 states. The recall was initiated on 9 Jan 2019 and the FDA has classified it as Class III.
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-1942-2020
- FDA event ID
- 85388
- Recalling firm
- Karl Storz Endoscopy, El Segundo, CA
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 9 Jan 2019
- FDA classified
- 8 May 2020
- Reported
- 20 May 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 9 Jan 2019 | Recall initiated by company | |
| 8 May 2020 | Classified by FDA | +485 days |
| 20 May 2020 | 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
The sterile single-use tubing may contain higher ethylene oxide (EO) residues than the acceptable level.
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
Insufflation tubing to be used with varies insufflator units. REF 031200-10; REF 031322-10; REF 031532-10; REF 031622-10
Where it was distributed
57 consignees in the US. AL,AZ,CA,CT,DE,FL,GA,IL,LA,MA,MD,ME,MI,MN,NE,NH,NJ,NY,OH,OK,PA,SC,TX,VA,VT,WA and WI
AlabamaArizonaCaliforniaConnecticutDelawareFloridaGeorgiaIllinoisLouisianaMassachusettsMarylandMaineMichiganMinnesotaNebraskaNew HampshireNew JerseyNew YorkOhioOklahoma
Questions about this recall
Why was it recalled?
The sterile single-use tubing may contain higher ethylene oxide (EO) residues than the acceptable level.
Which lots are affected?
Model/Lot Number: 031200-10/Lot W-027781, W-029058, W-028738; 031322-10/ Lot W-027197, W-028171, W-027939, W-028207; 031532-10/ Lot W-026437, W-027332, W-026871; 031622-10/Lot W-029555
Where was it sold?
57 consignees in the US. AL,AZ,CA,CT,DE,FL,GA,IL,LA,MA,MD,ME,MI,MN,NE,NH,NJ,NY,OH,OK,PA,SC,TX,VA,VT,WA and WI
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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.
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| Device | CLASS II | Karl Storz - Endoskope recalled | Karl Storz Endoscopy | Other | Nationwide |
| Device | CLASS II | Karl Storz - Endoskope recalled | Karl Storz Endoscopy | Other | Nationwide |
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