Olympus Corporation of the Americas
Complete recall history across all FDA and CPSC categories — 389 total recalls
Olympus Corporation of the Americas 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 (389)
FDA medical device enforcement actions by Olympus Corporation of the Americas. Showing most recent 50.
| Date | Product | Reason | Class |
|---|---|---|---|
| Feb 25, 2026 | Brand Name: Olympus HALO PKS Cutting Forceps, 5mm 33cm Product Name: HALO PK... | Olympus identified that the Cutting Forceps contain components for which the ... | Class II |
| Feb 25, 2026 | Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting ... | Olympus identified that the Cutting Forceps contain components for which the ... | Class II |
| Feb 25, 2026 | Brand Name: Olympus Everest Bipolar Cutting Forceps w/Cord, 5mm 33 cm Produc... | Olympus identified that the Cutting Forceps contain components for which the ... | Class II |
| Feb 25, 2026 | Brand Name: Olympus Everest Bipolar Cutting Forceps, 5 mm 33 cm Product Name... | Olympus identified that the Cutting Forceps contain components for which the ... | Class II |
| Feb 25, 2026 | Brand Name: Olympus PK Cutting Forceps, 5mm 33cm Product Name: PK Cutting Fo... | Olympus identified that the Cutting Forceps contain components for which the ... | Class II |
| Feb 25, 2026 | Brand Name: Olympus PKS Cutting Forceps w/Cord, 5mm 24cm Product Name: PKS C... | Olympus identified that the Cutting Forceps contain components for which the ... | Class II |
| Feb 25, 2026 | Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting ... | Olympus identified that the Cutting Forceps contain components for which the ... | Class II |
| Feb 12, 2026 | Olympus Endoscope Air/Water Valve - MAJ-1444. Model Number: MAJ-1444. | The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-... | Class II |
| Feb 12, 2026 | Olympus Endoscope Reprocessor OER-Elite. Model Number: N5789340. | The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-... | Class II |
| Feb 12, 2026 | Olympus Endoscope Reprocessor OER-Pro. Model Number: N3058140. | The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-... | Class II |
| Feb 12, 2026 | Olympus Endoscope Suction Valve - MAJ-1443. Model Number: MAJ-1443. | The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-... | Class II |
| Jan 29, 2026 | Olympus Single Use Biopsy Valve. Model/Catalog Number: MAJ-1218. 20 units per... | Potential for rubber fragment detachment during use. | Class II |
| Jan 29, 2026 | Olympus Single use Biopsy Valve. Model/Catalog Number: MAJ-210. 20 units per ... | Potential for rubber fragment detachment during use. | Class II |
| Jan 16, 2026 | Olympus High Flow Insufflation Unit. Model Number: UHI. Used for insuffla... | Issue with software algorithm which may lead to overpressure events. | Class I |
| Jan 16, 2026 | Olympus High Flow Insufflation Unit. Model/ Number: UHI-2. Used for insuf... | Issue with software algorithm which may lead to overpressure events. | Class I |
| Jan 16, 2026 | Olympus High Flow Insufflation Unit. Model Number: UHI-3. Used for insuff... | Issue with software algorithm which may lead to overpressure events. | Class I |
| Jan 8, 2026 | Brand Name: Olympus ShockPulse-SE Lithotripsy System with Generator Product ... | Mis-wired component-the improperly wired component can result in additional n... | Class II |
| Jan 7, 2026 | Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model... | Devices which did not undergo thermoforming could deform and lose performance. | Class II |
| Jan 7, 2026 | Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-... | Devices which did not undergo thermoforming could deform and lose performance. | Class II |
| Jan 7, 2026 | Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: K... | Devices which did not undergo thermoforming could deform and lose performance. | Class II |
| Jan 7, 2026 | Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V... | Devices which did not undergo thermoforming could deform and lose performance. | Class II |
| Jan 7, 2026 | Product Name: Single Use Sphincterotome V (Distal Wire guided) Model/Catalog... | Devices which did not undergo thermoforming could deform and lose performance. | Class II |
| Jan 7, 2026 | Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model... | Devices which did not undergo thermoforming could deform and lose performance. | Class II |
| Jan 7, 2026 | Brand Name: Disposable Triple Lumen Sphincterotome Product Name: Disposable ... | Devices which did not undergo thermoforming could deform and lose performance. | Class II |
| Jan 7, 2026 | Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model... | Devices which did not undergo thermoforming could deform and lose performance. | Class II |
| Jan 7, 2026 | Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-... | Devices which did not undergo thermoforming could deform and lose performance. | Class II |
| Jan 7, 2026 | Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V... | Devices which did not undergo thermoforming could deform and lose performance. | Class II |
| Jan 7, 2026 | Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V... | Devices which did not undergo thermoforming could deform and lose performance. | Class II |
| Jan 7, 2026 | Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model... | Devices which did not undergo thermoforming could deform and lose performance. | Class II |
| Jan 7, 2026 | Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model... | Devices which did not undergo thermoforming could deform and lose performance. | Class II |
| Jan 7, 2026 | Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-... | Devices which did not undergo thermoforming could deform and lose performance. | Class II |
| Jan 7, 2026 | Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model... | Devices which did not undergo thermoforming could deform and lose performance. | Class II |
| Jan 7, 2026 | Brand Name: CleverCut Product Name: Single Use 3-Lumen Sphincterotome V Mod... | Devices which did not undergo thermoforming could deform and lose performance. | Class II |
| Jan 7, 2026 | Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: K... | Devices which did not undergo thermoforming could deform and lose performance. | Class II |
| Jan 7, 2026 | Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model... | Devices which did not undergo thermoforming could deform and lose performance. | Class II |
| Jan 7, 2026 | Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-... | Devices which did not undergo thermoforming could deform and lose performance. | Class II |
| Jan 7, 2026 | Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model... | Devices which did not undergo thermoforming could deform and lose performance. | Class II |
| Jan 7, 2026 | Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: K... | Devices which did not undergo thermoforming could deform and lose performance. | Class II |
| Jan 7, 2026 | Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model... | Devices which did not undergo thermoforming could deform and lose performance. | Class II |
| Jan 7, 2026 | Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: K... | Devices which did not undergo thermoforming could deform and lose performance. | Class II |
| Jan 7, 2026 | Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: K... | Devices which did not undergo thermoforming could deform and lose performance. | Class II |
| Jan 7, 2026 | Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V... | Devices which did not undergo thermoforming could deform and lose performance. | Class II |
| Jan 7, 2026 | Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: K... | Devices which did not undergo thermoforming could deform and lose performance. | Class II |
| Jan 7, 2026 | Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-... | Devices which did not undergo thermoforming could deform and lose performance. | Class II |
| Jan 7, 2026 | Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-... | Devices which did not undergo thermoforming could deform and lose performance. | Class II |
| Jan 7, 2026 | Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: K... | Devices which did not undergo thermoforming could deform and lose performance. | Class II |
| Jan 7, 2026 | Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V... | Devices which did not undergo thermoforming could deform and lose performance. | Class II |
| Nov 14, 2025 | Brand Name: ShockPulse-SE Lithotripsy System SPL-S Product Name: ShockPulse-... | Ongoing investigations identified additional instances of the device Generato... | Class II |
| Nov 14, 2025 | Brand Name: ShockPulse-SE Lithotripsy System SPL-SR Product Name: ShockPulse... | Ongoing investigations identified additional instances of the device Generato... | Class II |
| Nov 14, 2025 | Brand Name: ShockPulse-SE Lithotripsy System Product Name: ShockPulse-SE Lit... | Ongoing investigations identified additional instances of the device Generato... | 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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