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 0 critical, 50 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 Mar 4, 2026 to Apr 29, 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 Apr 29, 2026

Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 45cm. Model Number: TB2-0545FC.

FDA Devices Moderate Apr 29, 2026

OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2115.

FDA Devices Moderate Apr 29, 2026

Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 20cm. Model Number: TB2-0520FC.

FDA Devices Moderate Apr 29, 2026

OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2113.

FDA Devices Moderate Apr 29, 2026

OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2119.

FDA Devices Moderate Apr 29, 2026

OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2114.

FDA Devices Moderate Apr 29, 2026

OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2138.

FDA Devices Moderate Apr 29, 2026

OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2118.

FDA Devices Moderate Apr 29, 2026

Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 35cm. Model Number: TB2-0535FC.

FDA Devices Moderate Apr 29, 2026

OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2112

FDA Devices Moderate Apr 29, 2026

OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2117.

FDA Devices Moderate Apr 29, 2026

OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2110. May be included with the Olympus OER-ELITE.

FDA Devices Moderate Apr 29, 2026

Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 25cm. Model Number: TB2-0525FC.

FDA Devices Moderate Apr 29, 2026

OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2111

FDA Devices Moderate Apr 29, 2026

OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2116.

FDA Devices Moderate Apr 29, 2026

OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2330.

FDA Devices Moderate Apr 8, 2026

Brand Name: Olympus SOLTIVE Premium SuperPulsed Laser System Product Name: SOLTIVE Premium Laser System TFL-PLS Model/Catalog Number: TFL-PLS conta…

FDA Devices Moderate Apr 8, 2026

Brand Name: Olympus SOLTIVE Pro SuperPulsed Laser System Product Name: SOLTIVE Pro Laser System TFL-SLS Model/Catalog Number: TFL-SLS containing TF…

FDA Devices Moderate Apr 1, 2026

Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting Forceps Model/Catalog Number: 3005PK Product Description: The PKS Cutt…

FDA Devices Moderate Apr 1, 2026

Olympus Endoscope Suction Valve - MAJ-1443. Model Number: MAJ-1443.

FDA Devices Moderate Apr 1, 2026

Brand Name: Olympus PKS Cutting Forceps w/Cord, 5mm 24cm Product Name: PKS Cutting Forceps Model/Catalog Number: 920000PK Product Description: The…

FDA Devices Moderate Apr 1, 2026

Olympus Endoscope Reprocessor OER-Pro. Model Number: N3058140.

FDA Devices Moderate Apr 1, 2026

Brand Name: Olympus PK Cutting Forceps, 5mm 33cm Product Name: PK Cutting Forceps Model/Catalog Number: PK-CF0533 Product Description: An assembly…

FDA Devices Moderate Apr 1, 2026

Olympus Endoscope Reprocessor OER-Elite. Model Number: N5789340.

FDA Devices Moderate Apr 1, 2026

Olympus Endoscope Air/Water Valve - MAJ-1444. Model Number: MAJ-1444.

FDA Devices Moderate Apr 1, 2026

Brand Name: Olympus Everest Bipolar Cutting Forceps, 5 mm 33 cm Product Name: Everest Bipolar Cutting Forceps Model/Catalog Number: 3005 Product D…

FDA Devices Moderate Apr 1, 2026

Brand Name: Olympus Everest Bipolar Cutting Forceps w/Cord, 5mm 33 cm Product Name: Everest Bipolar Cutting Forceps Model/Catalog Number: 3006 Pro…

FDA Devices Moderate Apr 1, 2026

Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting Forceps Model/Catalog Number: 920005PK Product Description: The PKS Cu…

FDA Devices Moderate Apr 1, 2026

Brand Name: Olympus HALO PKS Cutting Forceps, 5mm 33cm Product Name: HALO PKS Cutting Forceps Model/Catalog Number: HACF0533 Product Description: …

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 11, 2026

Brand Name: ShockPulse-SE Lithotripsy System SPL-SR Product Name: ShockPulse-SE Lithotripsy System - Reusable Probes Model/Catalog Number: SPL-SR …

FDA Devices Moderate Mar 11, 2026

Brand Name: Olympus ShockPulse-SE Lithotripsy System with Generator Product Name: ShockPulse-SE Lithotripsy System - Reuseable Probes Model/Catalog…

FDA Devices Moderate Mar 11, 2026

Brand Name: ShockPulse-SE Lithotripsy System SPL-S Product Name: ShockPulse-SE Lithotripsy System - Single Use Probes Model/Catalog Number: SPL-S …

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.

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.