Aomori Olympus Co., Ltd.
Complete recall history across all FDA and CPSC categories — 113 total recalls
Aomori Olympus Co., Ltd. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Device Recalls (113)
FDA medical device enforcement actions by Aomori Olympus Co., Ltd.. Showing most recent 50.
| Date | Product | Reason | Class |
|---|---|---|---|
| Jul 27, 2023 | Reusable distal attachments Models: MH-462, MH-463, MH-464, MH-465, MH-466,... | The Distal Attachment contain di-2-ethylhexyl phthalate (DEHP), which exceeds... | Class II |
| Jul 27, 2023 | Olympus Distal Attachment (in Olympus Disposable EMR Kit)- Designed to be att... | The Distal Attachment contain di-2-ethylhexyl phthalate (DEHP), which exceeds... | Class II |
| Jan 4, 2021 | NA-201SX-4021 ASPIRATION NEEDLE VIZISHOT 21G, model no. NA-201SX-4021 - Produ... | Inspection confirmed a small percentage of sterile packages with inadequate p... | Class II |
| Jan 4, 2021 | INJECTOR FORCEMAX LOWER 23G 5MM, model no. NM-400U-0523 - Product Usage: Used... | Inspection confirmed a small percentage of sterile packages with inadequate p... | Class II |
| Jan 4, 2021 | INJECTOR FORCEMAX UP 2.8MMCH 21G 4MM, model no. NM-400L-0421 - Product Usage:... | Inspection confirmed a small percentage of sterile packages with inadequate p... | Class II |
| Jan 4, 2021 | NEEDLEMASTER 4MMx 26G UPPER, model no. NM-610L-0426 - Product Usage: Used wit... | Inspection confirmed a small percentage of sterile packages with inadequate p... | Class II |
| Jan 4, 2021 | SD-210U-10 ELECTROSURGICAL SNARE, model no. SD-210U-10 - Product Usage: Used ... | Inspection confirmed a small percentage of sterile packages with inadequate p... | Class II |
| Jan 4, 2021 | NA-411D-1521 ASPIRATION NEEDLE, model no. NA-411D-1521 - Product Usage: Used ... | Inspection confirmed a small percentage of sterile packages with inadequate p... | Class II |
| Jan 4, 2021 | CRESCENT SNARE, model no. SD-221L-25 - Product Usage: Used with endoscopes to... | Inspection confirmed a small percentage of sterile packages with inadequate p... | Class II |
| Jan 4, 2021 | INJECTOR FORCEMAX UP 2.8MMCH 25G 5MM, model no. NM-400L-0525 - Product Usage:... | Inspection confirmed a small percentage of sterile packages with inadequate p... | Class II |
| Jan 4, 2021 | B-V243Q-A 3-LUMEN EXTRACTION BALLOON V, model no. B-V243Q-A - Product Usage: ... | Inspection confirmed a small percentage of sterile packages with inadequate p... | Class II |
| Jan 4, 2021 | INJECTOR FORCEMAX UP 2MM CH 23G 6MM, model no. NM-401L-0623 - Product Usage: ... | Inspection confirmed a small percentage of sterile packages with inadequate p... | Class II |
| Jan 4, 2021 | NEEDLEMASTER 4MMx 23G LOWER, model no. NM-610U-0423 - Product Usage: Used wit... | Inspection confirmed a small percentage of sterile packages with inadequate p... | Class II |
| Jan 4, 2021 | INJECTOR FORCEMAX UP 2MM CH 25G 4MM, model no. NM-401L-0425 - Product Usage: ... | Inspection confirmed a small percentage of sterile packages with inadequate p... | Class II |
| Jan 4, 2021 | NEEDLEMASTER 6MMx 25G UPPER, model no. NM-610L-0625 - Product Usage: Used wit... | Inspection confirmed a small percentage of sterile packages with inadequate p... | Class II |
| Jan 4, 2021 | INJECTOR FORCEMAX UP 2.8MMCH 23G 5MM, model no. NM-400L-0523 - Product Usage:... | Inspection confirmed a small percentage of sterile packages with inadequate p... | Class II |
| Jan 4, 2021 | NEEDLEMASTER 1.8MMx 26G LOWER, model no. NM-610U-1826 - Product Usage: Used w... | Inspection confirmed a small percentage of sterile packages with inadequate p... | Class II |
| Jan 4, 2021 | NEEDLEMASTER 6MMx 21G UPPER, model no. NM-610L-0621 - Product Usage: Used wit... | Inspection confirmed a small percentage of sterile packages with inadequate p... | Class II |
| Jan 4, 2021 | SD-400U-10 SNAREMASTER PLUS Hot/Cold 10m, model no. SD-400U-10 - Product Usag... | Inspection confirmed a small percentage of sterile packages with inadequate p... | Class II |
| Jan 4, 2021 | INJECTOR FORCEMAX LOWER 23G 5MM, model no. NM-400U-0523 - Product Usage: Used... | Inspection confirmed a small percentage of sterile packages with inadequate p... | Class II |
| Jan 4, 2021 | NEEDLEMASTER 4MMx 26G LOWER, model no. NM-610U-0426 - Product Usage: Used wit... | Inspection confirmed a small percentage of sterile packages with inadequate p... | Class II |
| Jan 4, 2021 | B7-2C BALLOON CATHETER 13mm dia 2.8; model no. B7-2C - Product Usage: Used wi... | Inspection confirmed a small percentage of sterile packages with inadequate p... | Class II |
| Jan 4, 2021 | NEEDLEMASTER 6MMx 25G LOWER, model no. NM-610U-0625 - Product Usage: Used wit... | Inspection confirmed a small percentage of sterile packages with inadequate p... | Class II |
| Jan 4, 2021 | KD-612L ELECTROSURGICAL KNIFE, model no. KD-612L - Product Usage: Used with e... | Inspection confirmed a small percentage of sterile packages with inadequate p... | Class II |
| Jan 4, 2021 | NEEDLEMASTER 6MMx 23G UPPER, model no. NM-610L-0623 - Product Usage: Used wit... | Inspection confirmed a small percentage of sterile packages with inadequate p... | Class II |
| Jan 4, 2021 | KD-612U ELECTROSURGICAL SNARE, model no. KD-612U - Product Usage: Used with e... | Inspection confirmed a small percentage of sterile packages with inadequate p... | Class II |
| Jan 4, 2021 | INJECTOR FORCEMAX UP 2MM CH 25G 6MM, model no. NM-401L-0625 - Product Usage: ... | Inspection confirmed a small percentage of sterile packages with inadequate p... | Class II |
| Jan 4, 2021 | NEEDLEMASTER 4MMx 21G UPPER, model no. NM-610L-0421 - Product Usage: Used wit... | Inspection confirmed a small percentage of sterile packages with inadequate p... | Class II |
| Jan 4, 2021 | NEEDLEMASTER 4MMx 25G UPPER, model no. NM-610L-0425 - Product Usage: Used wit... | Inspection confirmed a small percentage of sterile packages with inadequate p... | Class II |
| Jan 4, 2021 | KD-650U ELECTROSURGICAL SNARE, model no. KD-650U - Product Usage: Used with e... | Inspection confirmed a small percentage of sterile packages with inadequate p... | Class II |
| Jan 4, 2021 | KD-640L ELECTROSURGICAL SNARE, model no. KD-640L - Product Usage: Used with e... | Inspection confirmed a small percentage of sterile packages with inadequate p... | Class II |
| Jan 4, 2021 | INJECTOR FORCEMAX UP 2MM CH 25G 5MM, model no. NM-401L-0525 - Product Usage: ... | Inspection confirmed a small percentage of sterile packages with inadequate p... | Class II |
| Jan 4, 2021 | NEEDLEMASTER 4MMx 25G LOWER, model no. NM-610U-0425 - Product Usage: Used wit... | Inspection confirmed a small percentage of sterile packages with inadequate p... | Class II |
| Jan 4, 2021 | SD-240U-10 ELECTROSURGICAL SNARE, model no. SD-240U-10 - Product Usage: Used ... | Inspection confirmed a small percentage of sterile packages with inadequate p... | Class II |
| Jan 4, 2021 | NEEDLEMASTER 3MMx 23G LOWER, model no. NM-610U-0523 - Product Usage: Used wit... | Inspection confirmed a small percentage of sterile packages with inadequate p... | Class II |
| Jan 4, 2021 | CRESCENT SNARE, model no. SD-221U-25 - Product Usage: Used with endoscopes to... | Inspection confirmed a small percentage of sterile packages with inadequate p... | Class II |
| Jan 4, 2021 | INJECTOR FORCEMAX LOWER 25G 2.5MM, model no. NM-400U-0425 - Product Usage: Us... | Inspection confirmed a small percentage of sterile packages with inadequate p... | Class II |
| Jan 4, 2021 | B-V443Q-A 3-LUMEN EXTRACTION BALLOON V, model no. B-V443Q-A - Product Usage: ... | Inspection confirmed a small percentage of sterile packages with inadequate p... | Class II |
| Jan 4, 2021 | INJECTOR FORCEMAX LOWER 23G 4MM, model no. NM-400U-0423 - Product Usage: Used... | Inspection confirmed a small percentage of sterile packages with inadequate p... | Class II |
| Jan 4, 2021 | NA-601D-1519 ASPIRATION NEEDLE, model no. NA-601D-1519 - Product Usage: Used ... | Inspection confirmed a small percentage of sterile packages with inadequate p... | Class II |
| Jan 4, 2021 | INJECTOR FORCEMAX UP 2.8MMCH 23G 5MM, model no. NM-400L-0523 - Product Usage:... | Inspection confirmed a small percentage of sterile packages with inadequate p... | Class II |
| Jan 4, 2021 | MAJ-244 SINGLE USE 30MM REPLACEMENT BASKET, model no. MAJ-244 - Product Usage... | Inspection confirmed a small percentage of sterile packages with inadequate p... | Class II |
| Jan 4, 2021 | NA-411D-1321 ASPIRATION NEEDLE, model no. NA-411D-1321 - Product Usage: Used ... | Inspection confirmed a small percentage of sterile packages with inadequate p... | Class II |
| Jan 4, 2021 | NEEDLEMASTER 4MMx 23G UPPER, model no. NM-610L-0423 - Product Usage: Used wit... | Inspection confirmed a small percentage of sterile packages with inadequate p... | Class II |
| Jan 4, 2021 | SD-210U-25 ELECTROSURGICAL SNARE, SD-210U-25 - Product Usage: Used with endos... | Inspection confirmed a small percentage of sterile packages with inadequate p... | Class II |
| Jan 4, 2021 | INJECTOR FORCEMAX LOWER 23G 4MM, model no. NM-400U-0423 - Product Usage: Used... | Inspection confirmed a small percentage of sterile packages with inadequate p... | Class II |
| Jan 4, 2021 | SD-400U-15 SNAREMASTER PLUS Hot/Cold 15m, model no. SD-400U-15 - Product Usag... | Inspection confirmed a small percentage of sterile packages with inadequate p... | Class II |
| Jan 4, 2021 | SD-210U-15 ELECTROSURGICAL SNARE, SD-210U-15 - Product Usage: Used with endos... | Inspection confirmed a small percentage of sterile packages with inadequate p... | Class II |
| Jan 4, 2021 | NA-201SX-4022-C ASPIRATION NEEDLE ViziShot 22G w/o stylet, model no. NA-201SX... | Inspection confirmed a small percentage of sterile packages with inadequate p... | Class II |
| Jan 4, 2021 | NA-201SX-4022-ASPIRATION NEEDLE VIZISHOT 22G, model no. NA-201SX-4022-A - Pro... | Inspection confirmed a small percentage of sterile packages with inadequate p... | Class II |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
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