PlainRecalls

Olympus Corporation of the Americas

Compiled from official public sources by the editorial team.

407 recalls on record · Latest: Apr 29, 2026

Olympus Corporation of the Americas Recall Insight

Olympus Corporation of the Americas appears on 407 federal recall records indexed by PlainRecalls, out of 101,704 total recalls tracked across the FDA, CPSC, and NHTSA. That represents approximately 0.400% of the federal archive, a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated Apr 29, 2026, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 50 entries, severity tagging shows 3 critical, 47 moderate, and 0 lower-severity recalls. Affected-unit counts are disclosed on 50 of 50 entries, unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 1 distinct product categories, with issuing agencies dominated by FDA Devices (50). The date window on this page runs from Feb 11, 2026 to Mar 4, 2026.

Manufacturer-level browsing is useful when monitoring a single firm for patterns, whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current, deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement, always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.

FDA Devices Moderate Mar 4, 2026

Olympus Resection Sheath, 24 Fr; Model No. A22041A. Resection sheath for urologic applications.

FDA Devices Moderate Mar 4, 2026

Olympus Resection Sheath, 26 Fr.; Model No. A22042A. Resection sheath for urologic applications.

FDA Devices Moderate Mar 4, 2026

Olympus Cystoscope Outer Sheath; Model/Catalog number: WA22810A;

FDA Devices Moderate Mar 4, 2026

Olympus Resection Sheath. Model No. A22014A and A22014T. for endoscopic diagnosis and treatment in urological applications.

FDA Devices Moderate Mar 4, 2026

Olympus Inner Sheath. Model No. A2642. for endoscopic diagnosis and treatment in urological applications.

FDA Devices Moderate Mar 4, 2026

Olympus Inner Sheath, Long; Model No. WA22017T. Inner sheath for urological and gynecological applications.

FDA Devices Moderate Feb 25, 2026

Olympus Thunderbeat 5 mm, 45 cm, Front-Actuated Grip Type S

FDA Devices Moderate Feb 25, 2026

Olympus Thunderbeat, 5mm, 35 cm, Pistol Grip

FDA Devices Moderate Feb 25, 2026

Olympus Thunderbeat 5 mm, 20 cm, Front-Actuated Grip Type S

FDA Devices Critical Feb 25, 2026

Olympus High Flow Insufflation Unit. Model Number: UHI-3. Used for insufflation of the abdominal cavity, and automatic suction and smoke evacuati…

FDA Devices Moderate Feb 25, 2026

Olympus Thunderbeat, 5 mm, 20 cm, Inline Grip

FDA Devices Critical Feb 25, 2026

Olympus High Flow Insufflation Unit. Model/ Number: UHI-2. Used for insufflation of the abdominal cavity, and automatic suction and smoke evacuat…

FDA Devices Moderate Feb 25, 2026

Olympus Thunderbeat 5 mm, 35 cm, Front-Actuated Grip

FDA Devices Moderate Feb 25, 2026

Olympus Thunderbeat, 5 mm, 45 cm, Pistol Grip

FDA Devices Moderate Feb 25, 2026

Olympus Thunderbeat 5 mm, 10 cm, Inline Grip

FDA Devices Critical Feb 25, 2026

Olympus High Flow Insufflation Unit. Model Number: UHI. Used for insufflation of the abdominal cavity, and automatic suction and smoke evacuation…

FDA Devices Moderate Feb 25, 2026

Olympus Thunderbeat, 5 mm, 35 cm, Front-Actuated Grip Type S

FDA Devices Moderate Feb 25, 2026

Olympus Thunderbeat, 5 mm, 45 cm Front-Actuated Grip

FDA Devices Moderate Feb 25, 2026

Olympus Thunderbeat, 5 mm, 35 cm, Inline Grip

FDA Devices Moderate Feb 25, 2026

Olympus Thunderbeat, 5 mm, 45 cm Inline Grip

FDA Devices Moderate Feb 25, 2026

Olympus Thunderbeat 5 mm, 20 cm, Front-Actuated Grip

FDA Devices Moderate Feb 11, 2026

Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These instruments have been designed to …

FDA Devices Moderate Feb 11, 2026

Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These instruments have been designed t…

FDA Devices Moderate Feb 11, 2026

Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0330; Software Version: N/A Product Description: These instrumen…

FDA Devices Moderate Feb 11, 2026

Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0725; Software Version: N/A Product Description: These instrumen…

FDA Devices Moderate Feb 11, 2026

Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0730 Product Description: These instruments have been designed t…

FDA Devices Moderate Feb 11, 2026

Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3025 Product Description: These instruments have been designed to …

FDA Devices Moderate Feb 11, 2026

Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-431Q-0720 Product Description: These instruments have been designed t…

FDA Devices Moderate Feb 11, 2026

Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0720 Product Description: These instruments have been designed t…

FDA Devices Moderate Feb 11, 2026

Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0725; Software Version: N/A Product Descrip…

FDA Devices Moderate Feb 11, 2026

Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-411Q-0730 Product Description: These instruments have been designed t…

FDA Devices Moderate Feb 11, 2026

Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0720; Software Version: N/A Product Descrip…

FDA Devices Moderate Feb 11, 2026

Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V431M-0720; Software Version: N/A Product Description: These instrumen…

FDA Devices Moderate Feb 11, 2026

Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC431Q-0730; Software Version: N/A Product Descri…

FDA Devices Moderate Feb 11, 2026

Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-411Q-0720 Product Description: These instruments have been designed t…

FDA Devices Moderate Feb 11, 2026

Brand Name: CleverCut Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0320; Software Version: N/A Product Descri…

FDA Devices Moderate Feb 11, 2026

Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number:KD-VC433Q-0730; Software Version: N/A Product Descript…

FDA Devices Moderate Feb 11, 2026

Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0730; Software Version: N/A Product Description: These instrumen…

FDA Devices Moderate Feb 11, 2026

Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0320; Software Version: N/A Product Descrip…

FDA Devices Moderate Feb 11, 2026

Brand Name: Single Use Electrosurgical Knife Product Name: Olympus Single Use Electrosurgical Knife KD-640L Model/Catalog Number: KD640-L Product …

FDA Devices Moderate Feb 11, 2026

Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0730; Software Version: N/A Product Descrip…

FDA Devices Moderate Feb 11, 2026

Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3030 Product Description: These instruments have been designed to …

FDA Devices Moderate Feb 11, 2026

Brand Name: Single Use Electrosurgical Knife KD-645 Product Name: Olympus Single Use Electrosurgical Knife KD-645 Model/Catalog Number: KD-645L Pr…

FDA Devices Moderate Feb 11, 2026

Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3020 Product Description: These instruments have been designed to …

FDA Devices Moderate Feb 11, 2026

Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V431M-0730; Software Version: N/A Product Description: These instrumen…

FDA Devices Moderate Feb 11, 2026

Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0330; Software Version: N/A Product Descrip…

FDA Devices Moderate Feb 11, 2026

Brand Name: Disposable Triple Lumen Sphincterotome Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0320 Product…

FDA Devices Moderate Feb 11, 2026

Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC412Q-0215; Software Version: N/A Product Descrip…

FDA Devices Moderate Feb 11, 2026

Product Name: Single Use Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC431Q-0720 Product Description: These instruments have bee…

FDA Devices Moderate Feb 11, 2026

Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1530 Product Description: These instruments have been designed to …

Nearby Manufacturers

Other firms with recall activity tracked in the PlainRecalls index.

Compare Olympus Corporation of the Americas with Zimmer Biomet, Inc. →

Data Sources

  • Source: FDA + CPSC + NHTSA - federal recall filings naming this firm. Verify with FDA, CPSC, or NHTSA directly.
  • Source: PlainRecalls Manufacturer Index - firm-level aggregation across all three federal recall feeds

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Recalls are aggregated across FDA, CPSC and NHTSA filings that name this firm; the total reflects the federal record, not an independent investigation. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.