Richard Wolf Tube Set for TEM Recalled for Potential Tube Mixing
Richard Wolf GmbH is recalling 1,710 units of the Tube Set for TEM (Ref 4170.801) because tube ends may be mixed up.
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: The recall is classified as FDA Class II, and the hazard involves a risk-of-harm product (surgical instrument) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Richard Wolf GmbH is recalling 1,710 units of the Tube Set for TEM, Reference 4170.801. This medical device is used for transanal endoscopic microsurgery. The recall affects lot numbers 32062417 and 32133317, which were distributed worldwide.
The recall was initiated because the tube ends may be mixed up. This potential defect could lead to incorrect usage of the device components during surgical procedures.
Healthcare facilities and users of this product should stop using the affected tube sets immediately. They should contact Richard Wolf GmbH for further instructions on how to return or dispose of the recalled units.
The recalled product
- Product
- RICHARD WOLF TUBE SET FOR TEM, REF 4170.801. Used for the transanal endoscopic microsurgery.
- Manufacturer
- Richard Wolf GmbH
- Affected units
- 1,710
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 (2)
- Lot numbers: 32062417
- 32133317
Distribution
Distribution scope not specified by the agency.
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