OLYMPUS ShockPulse-SE Lithotripsy System recall
OLYMPUS ShockPulse-SE Lithotripsy System, Model SPL-T Transducer
Why was OLYMPUS ShockPulse-SE Lithotripsy System recalled?
A component of the Olympus ShockPulse Transducer was manufactured with non-conforming material that could allow water ingress during autoclaving sterilization.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Serial numbers: 1910PW30607705, 1910PW30607712, 1910PW30607601, 1910PW30607708, 1910PW30607709, 1910PW30607701, 1910PW30607814, 1910PW30607906, 1910PW30607603, 1910PW30607706, 1910PW30607802, 1910PW30607808, 1910PW30607809, 1910PW30607804, 1910PW30607713, 1910PW30607803 Lot Numbers: CG2003, CG2010, CG2011, CG2026, CG2027, CG2033, CG2035, CG2000, CG2025, CG2001, CG2019, CG2022, CG2029, CG2021, CG2008, CG2036, CG2037, CG2006, CG2004, CG2007, CG2012, CG2013, CG2015
- Product
- OLYMPUS ShockPulse-SE Lithotripsy System, Model SPL-T Transducer
- Recalling firm
- Olympus Corporation of the Americas
- Quantity
- 18
- Distribution
- Distribution US nationwide to states of: Texas, Ohio, New Mexico, California, Oklahoma, Michigan, Connecticut, North Carolina, Nebraska, and Pennsylvania; and Canada.
- Recall date
- June 10, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)