Every recall we track for Aomori Olympus Co., Ltd. — 113 in all — plus the complaints and injury reports the public filed about them.
Aomori Olympus recalls reusable distal attachments models MH-462 to MH-598 and MAJ-289 to MAJ-666 due to di-2-ethylhexyl phthalate (DEHP) exceeding permissible exposure levels. Consumers should contact the manufacturer for details.
Olympus recalls disposable EMR kits with distal attachments containing DEHP that exceeds safe exposure levels per ISO 10993-17:2002. Affected kits include specific model numbers and lot ranges.
Olympus recalls certain Vizishot 21G aspiration needles due to potential inadequate packaging seals, which could lead to infections if non-sterile equipment is used. Affected models include NA-201SX-4021 with specific serial numbers.
Olympus recalls INJECTOR FORCEMAX LOWER 23G 5MM (model NM-400U-0523) due to potential infection from non-sterile packaging. Affected units sold in specific batches.
Olympus recalls certain INJECTOR FORCEMAX UP 2.8MMCH 21G 4MM models due to potential inadequate sterile packaging seals, which could lead to infections if non-sterile equipment is used.
Olympus recalls specific NEEDLEMASTER 4MMx 26G UPPER models due to inadequate sterile packaging seals, which could lead to infections if non-sterile equipment is used. Affected units were sold in certain regions and models.
Olympus recalls SD-210U-10 electrosurgical snare models with inadequate sterile package seals, which could lead to patient infections if non-sterile equipment is used. Affected units include specific model numbers and versions.
Olympus recalls NA-411D-1521 aspiration needles due to inadequate sterile packaging seals that could lead to infections if non-sterile equipment is used. Affected units sold in specific model ranges.
Olympus recalls Crescent Snare surgical device model SD-221L-25 due to potential packaging seal failures that could lead to infections if non-sterile equipment is used during procedures.
Olympus recalls certain INJECTOR FORCEMAX UP 2.8MMCH 25G 5MM endoscopic needles due to inadequate sterile packaging seals, which could lead to infections if used improperly.
Olympus recalls B-V243Q-A 3-Lumen extraction balloons due to potential inadequate sterile packaging seals, which could lead to infections if non-sterile equipment is used. Affected units sold in specific versions.
Olympus recalls certain INJECTOR FORCEMAX UP 2MM CH 23G 6MM endoscopic injection devices due to potential inadequate package seals that could lead to infections if non-sterile equipment is used.
Olympus recalls NEEDLEMASTER 4MMx23G Lower (model NM-610U-0423) due to potential inadequate package seals that could cause infections if non-sterile equipment is used. Affected units sold in specific batches.
Olympus recalls certain INJECTOR FORCEMAX UP 2MM CH 25G 4MM models due to potential inadequate package seals that could lead to infections if non-sterile equipment is used. Affected units include specific model numbers and production batches.
Olympus recalls NEEDLEMASTER 6MMx 25G UPPER (model NM-610L-0625) due to potential inadequate sterile packaging seals that could lead to infections if non-sterile equipment is used.
Olympus recalls specific endoscopic injectors due to inadequate sterile packaging seals, potentially causing infections. Affected models include NM-400L-0523 with serial numbers 01K-09ZK. Consumers should contact Olympus for details.
Olympus recalls NEEDLEMASTER 1.8MMx26G Lower (model NM-610U-1826) due to inadequate sterile packaging seals that could cause infections. Affected units sold in specific batches.
Olympus recalls NEEDLEMASTER 6MMx 21G UPPER (model NM-610L-0621) due to potential packaging failures that could lead to infections. Affected units were sold with specific model codes.
Olympus recalls SD-400U-10 SNAREMASTER PLUS Hot/Cold 10m endoscopes due to potential infection from inadequate sterile packaging seals. Affected units may need replacement to prevent patient infections.
Olympus recalls INJECTOR FORCEMAX LOWER 23G 5MM (model NM-400U-0523) due to potential inadequate sterile packaging seals, which could lead to infections if non-sterile equipment is used.
Olympus recalls NEEDLEMASTER 4MMx26G Lower (model NM-610U-0426) due to inadequate package seals that could lead to infections if non-sterile equipment is used. Affected units sold in specific batches.
Olympus recalls B7-2C balloon catheters with inadequate sterile packaging seals that could lead to infections if used improperly. Affected units include specific model numbers and batch codes.
Olympus recalls NEEDLEMASTER 6MMx 25G LOWER (model NM-610U-0625) due to potential inadequate package seals that could lead to infections if non-sterile equipment is used. Affected units were sold in specific regions and models.
Olympus recalls KD-612L electrosurgical knives with inadequate sterile package seals that could lead to patient infections if non-sterile equipment is used. Affected units were sold in specific model series.
Olympus recalls NEEDLEMASTER 6MMx 23G UPPER (model NM-610L-0623) due to potential inadequate package seals that could lead to infections if non-sterile equipment is used. Affected units sold with endoscopes for GI procedures.
Olympus recalls KD-612U electrosurgical snare models with inadequate sterile package seals, which may lead to infections if non-sterile equipment is used during procedures.
Olympus recalls specific endoscopic injectors due to inadequate sterile packaging seals, which could lead to infections if non-sterile equipment is used. Affected models include NM-401L-0625 with certain batch codes.
Olympus recalls NEEDLEMASTER 4MMx 21G UPPER (model NM-610L-0421) due to potential inadequate package seals that could lead to infections if non-sterile equipment is used. Affected units were sold in specific regions and models.
Olympus recalls NEEDLEMASTER 4MMx 25G UPPER (model NM-610L-0425) due to potential inadequate package seals that could lead to infections if non-sterile equipment is used. Affected units were sold with specific model codes.
Olympus recalls KD-650U electrosurgical snare models with inadequate sterile package seals, which may lead to infections if non-sterile equipment is used during procedures.
Olympus recalls KD-640L electrosurgical snare models with inadequate sterile package seals, which may lead to infections if non-sterile equipment is used during procedures.
Olympus recalls certain INJECTOR FORCEMAX UP 2MM CH 25G 5MM endoscopic injectors due to inadequate sterile packaging seals that could lead to infections. Affected models include NM-401L-0525 with serial numbers 01K-09ZK.
Olympus recalls NEEDLEMASTER 4MMx 25G Lower (model NM-610U-0425) due to potential inadequate sterile package seals, which could lead to infections if non-sterile equipment is used. Affected units sold in specific batches.
Olympus recalls SD-240U-10 electrosurgical snare models with potentially inadequate sterile package seals, which could lead to infections if non-sterile equipment is used. Affected units were sold with specific model numbers and voltage codes.
Olympus recalls NEEDLEMASTER 3MMx 23G Lower (model NM-610U-0523) due to inadequate sterile package seals that could cause infections if non-sterile equipment is used. Affected units were sold in specific batches.
Olympus recalls Crescent Snare model SD-221U-25 due to potential inadequate sterile packaging seals, which could lead to patient infections if non-sterile equipment is used. Affected units were sold in specific batches.
Olympus recalls certain INJECTOR FORCEMAX LOWER 25G 2.5MM endoscopic needles due to inadequate sterile packaging seals, which may cause infections if used improperly.
Olympus recalls B-V443Q-A 3-Lumen extraction balloons due to potential inadequate sterile packaging seals, which could lead to infections if non-sterile equipment is used. Affected units sold in specific versions.
Olympus recalls certain INJECTOR FORCEMAX LOWER 23G 4MM endoscopic needles due to inadequate sterile packaging seals, which could lead to patient infections if non-sterile equipment is used.
Olympus recalls NA-601D-1519 aspiration needles due to inadequate sterile packaging seals, which may lead to infections if non-sterile equipment is used. Affected units were sold in specific model ranges.
Olympus recalls specific endoscopic injectors due to inadequate sterile packaging seals, which may lead to infections if used improperly. Affected models include NM-400L-0523 with certain serial numbers.
Olympus recalls MAJ-244 single-use replacement baskets due to potential inadequate packaging seals that could lead to infections if non-sterile equipment is used.
Olympus recalls NA-411D-1321 aspiration needles due to inadequate sterile packaging seals that could lead to infections. Affected units were sold in specific model ranges.
Olympus recalls NEEDLEMASTER 4MMx23G Upper (model NM-610L-0423) due to inadequate sterile package seals that could lead to infections if non-sterile equipment is used. Affected units were sold in specific batches.
Olympus recalls SD-210U-25 electrosurgical snare devices with inadequate sterile packaging seals. Patients may get infections if non-sterile equipment is used. Affected units have specific model codes.
Olympus recalls certain INJECTOR FORCEMAX Lower 23G 4MM endoscopic needles due to inadequate sterile packaging seals, which could lead to infections if used improperly.
Olympus recalls SD-400U-15 SNAREMASTER PLUS Hot/Cold 15m endoscopes due to potential packaging seal failures that could lead to infections if non-sterile equipment is used. Affected units sold in specific regions and models.
Olympus recalls SD-210U-15 electrosurgical snare devices with inadequate sterile packaging seals. Patients may get infections if non-sterile equipment is used. Affected units include specific model numbers and batch codes.
Olympus recalls some ViziShot 22G aspiration needles due to inadequate package seals that could lead to infections if non-sterile equipment is used. Affected models were sold with specific serial numbers.
Olympus recalls certain Vizishot 22G aspiration needles used with ultrasound. A small percentage have inadequate package seals, potentially causing infections if non-sterile equipment is used.
Olympus recalls INJECTOR FORCEMAX UP 2.8MMCH 21G 4MM (model NM-400L-0421) due to inadequate sterile packaging seals. Patients may get infections if non-sterile equipment is used. Contact Olympus for details.
Olympus recalls certain endoscopic injectors due to potential inadequate sterile packaging, which could lead to infections if used improperly. Affected models include NM-400U-0623 with specific serial numbers.
Olympus recalls certain INJECTOR FORCEMAX UP 2MM CH 23G 3MM endoscopic injectors due to potential inadequate package seals that could lead to infections. Affected models include NM-401L-0523 with serial numbers 01K-09ZK.
Olympus recalls NEEDLEMASTER 5MMx 25G Lower (model NM-610U-0525) due to potential inadequate package seals that could cause infections. Affected units sold in specific batches.
Olympus recalls PBD-203-0704 biliary stents with inadequate package seals that may cause infections. Affected units were sold in the U.S. from 2023. Consumers should check product labels and contact Olympus for details.
Olympus recalls KD-650L electrosurgical snare models with inadequate sterile package seals, which could lead to patient infections if non-sterile equipment is used. Affected units were sold in specific batches.
Olympus recalls INJECTOR FORCEMAX UP 2.8MMCH 25G 6MM (model NM-400L-0625) due to potential inadequate sterile package seals, which could lead to patient infections if non-sterile equipment is used.
Olympus recalls B7-2Q balloon catheters with inadequate sterile packaging seals that could lead to infections if used improperly. Affected units were sold in specific model series.
Olympus recalls K-202 Guide Sheath Kit 2.0MM due to potential inadequate sterile packaging seals, which could lead to infections if non-sterile equipment is used. Affected units include specific model numbers and batch codes.
Olympus recalls B5-2Q balloon catheters with inadequate sterile packaging seals that could lead to infections if used improperly. Affected units have model numbers ending in 01K through 9ZK. Consumers should contact Olympus for details.
