PlainRecalls

Olympus Corporation of the Americas

259 recalls on record · Latest: Mar 11, 2026

Olympus Corporation of the Americas Recall Insight

Olympus Corporation of the Americas appears on 259 federal recall records indexed by PlainRecalls, out of 83,949 total recalls tracked across the FDA, CPSC, NHTSA, and USDA FSIS. That represents approximately 0.309% 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 Mar 11, 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 11, 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 11, 2026

Olympus Single use Biopsy Valve. Model/Catalog Number: MAJ-210. 20 units per box. The MAJ-210 has been designed to be attached to the instrument c…

FDA Devices Moderate Mar 11, 2026

Olympus Single Use Biopsy Valve. Model/Catalog Number: MAJ-1218. 20 units per box. The MAJ-1218 has been designed to be attached to the instrument…

FDA Devices Moderate Mar 11, 2026

Brand Name: ShockPulse-SE Lithotripsy System Product Name: ShockPulse-SE Lithotripsy System - Generator Model/Catalog Number: SPL-G Product Descri…

FDA Devices Moderate Mar 4, 2026

Olympus Sheath, 10 Fr. Model No. A37004A. for endoscopic diagnosis and treatment in urological applications.

FDA Devices Moderate Mar 4, 2026

Olympus Resection Sheath, 24 Fr., with Deflecting Obturator; Model No. A22041T. Resection sheath for urologic applications.

FDA Devices Moderate Mar 4, 2026

Olympus Inner Sheath, Long; Model No. WA22017A. Inner sheath for urological and gynecological applications.

FDA Devices Moderate Mar 4, 2026

Olympus Resection Sheath, 28 Fr.; Model No. A22043A. Resection sheath for urologic applications.

FDA Devices Moderate Mar 4, 2026

Olympus Inner Sheath. Model No. A2641. for endoscopic diagnosis and treatment in urological applications.

FDA Devices Moderate Mar 4, 2026

Olympus Resection Sheath, 28 Fr. with Deflecting Obturator. Model No. A22043T. Resection sheath for urologic applications.

FDA Devices Moderate Mar 4, 2026

Olympus Inner Sheath; Model No. A2660. for endoscopic diagnosis and treatment in urological applications.

FDA Devices Moderate Mar 4, 2026

Olympus Resection Inner Sheath, for 26 Fr. Outer Sheath. Model No. A22040A. Resection sheath for urologic applications.

FDA Devices Moderate Mar 4, 2026

Olympus Resection Sheath, 26 Fr. with Deflecting Obturator; Model No. A22042T. Resection sheath for urologic applications.

FDA Devices Moderate Mar 4, 2026

Olympus Resection Sheath, 8 mm. Model No. A42011A. Resection sheath for gynecological applications.

FDA Devices Moderate Mar 4, 2026

Olympus Resection Sheath; Model No. A2666. Resection sheath for urologic applications.

FDA Devices Moderate Mar 4, 2026

Olympus Inner Sheath. Model No. A4741. for endoscopic diagnosis and treatment in gynecological applications.

FDA Devices Moderate Mar 4, 2026

Olympus Resection Inner Sheath for 26 Fr. Outer Sheath. Model No. A22040T. Resection sheath for urologic applications.

FDA Devices Moderate Mar 4, 2026

Olympus Resection Sheath. Model No. A2666T. for endoscopic diagnosis and treatment in urological applications.

FDA Devices Moderate Mar 4, 2026

Olympus Inner Sheath 21 Fr. Model No. A2660T. for endoscopic diagnosis and treatment in urological applications.

FDA Devices Moderate Mar 4, 2026

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

Nearby Manufacturers

Other firms with recall activity tracked in the PlainRecalls index.

Compare Olympus Corporation of the Americas with FORD →

Data Sources

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