Karl Storz Endoscopy Recalls Insufflation Tubing Due to Ethylene Oxide Residues
Karl Storz Endoscopy is recalling sterile insufflation tubing because it may contain higher ethylene oxide residues than the acceptable level.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class III, which indicates the product is not likely to cause adverse health consequences. The hazard involves chemical residues (ethylene oxide) without reported illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Karl Storz Endoscopy is recalling specific lots of sterile single-use insufflation tubing. The recall is due to the possibility that the tubing may contain higher ethylene oxide (EO) residues than the acceptable level.
The affected products are insufflation tubing used with various insufflator units, specifically reference numbers 031200-10, 031322-10, 031532-10, and 031622-10. A total of 543 boxes were distributed to 57 consignees in the United States, covering states including 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.
Healthcare facilities and consumers should stop using the affected tubing and contact Karl Storz Endoscopy for further instructions or a return. The specific lot numbers involved are W-027781, W-029058, W-028738, W-027197, W-028171, W-027939, W-028207, W-026437, W-027332, W-026871, and W-029555.
The recalled product
- Product
- Insufflation tubing to be used with varies insufflator units. REF 031200-10; REF 031322-10; REF 031532-10; REF 031622-10
- Manufacturer
- Karl Storz Endoscopy
- Category
- Medical Device — Surgical Tubing
- Hazard
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 (11)
- 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
Distribution
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