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Olympus Corporation of the Americas

317 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Olympus High Flow Insufflation Unit - UHI-4. Model Number: UHI-4 recall (Z-2776-2026)Olympus Corporation of the Americas2026-07-22
Olympus 4K UHD LCD Monitor. Model Number: OEV321UH. An electrically powered visual display recall (Z-2761-2026)Olympus Corporation of the Americas2026-07-20
Olympus Toomey Evacuator 30cc with Adaptor. Model Number: 188. recall (Z-2718-2026)Olympus Corporation of the Americas2026-07-10
Olympus Toomey Evacuator 50cc with Adaptor. Model Number: 188A. recall (Z-2719-2026)Olympus Corporation of the Americas2026-07-10
Olympus Ellik Evacuator Includes Glass Body, Male Connecting Tubing & Latex Bulb. Model Nu recall (Z-2720-2026)Olympus Corporation of the Americas2026-07-10
Olympus Glass Body for 194 Ellik Evacuator. Model Number: 190A. recall (Z-2721-2026)Olympus Corporation of the Americas2026-07-10
Olympus Single Use Distal Cover, Catalog Number MAJ-2315, Used with: EVIS EXERA III Duoden recall (Z-2676-2026)Olympus Corporation of the Americas2026-07-07
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2110. May be i recall (Z-1898-2026)Olympus Corporation of the Americas2026-04-22
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2111 recall (Z-1899-2026)Olympus Corporation of the Americas2026-04-22
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2112 recall (Z-1900-2026)Olympus Corporation of the Americas2026-04-22
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2113. recall (Z-1901-2026)Olympus Corporation of the Americas2026-04-22
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2114. recall (Z-1902-2026)Olympus Corporation of the Americas2026-04-22
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2115. recall (Z-1903-2026)Olympus Corporation of the Americas2026-04-22
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2116. recall (Z-1904-2026)Olympus Corporation of the Americas2026-04-22
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2117. recall (Z-1905-2026)Olympus Corporation of the Americas2026-04-22
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2118. recall (Z-1906-2026)Olympus Corporation of the Americas2026-04-22
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2119. recall (Z-1907-2026)Olympus Corporation of the Americas2026-04-22
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2138. recall (Z-1908-2026)Olympus Corporation of the Americas2026-04-22
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2330. recall (Z-1909-2026)Olympus Corporation of the Americas2026-04-22
Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 20cm. Model Number: TB2-0520FC. recall (Z-1851-2026)Olympus Corporation of the Americas2026-04-17
Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 25cm. Model Number: TB2-0525FC. recall (Z-1852-2026)Olympus Corporation of the Americas2026-04-17
Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 35cm. Model Number: TB2-0535FC. recall (Z-1853-2026)Olympus Corporation of the Americas2026-04-17
Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 45cm. Model Number: TB2-0545FC. recall (Z-1854-2026)Olympus Corporation of the Americas2026-04-17
Brand Name: Olympus SOLTIVE Premium SuperPulsed Laser System Product Name: SOLTIVE Premium recall (Z-1694-2026)Olympus Corporation of the Americas2026-03-30
Brand Name: Olympus SOLTIVE Pro SuperPulsed Laser System Product Name: SOLTIVE Pro Laser S recall (Z-1695-2026)Olympus Corporation of the Americas2026-03-30
Brand Name: Olympus Everest Bipolar Cutting Forceps, 5 mm 33 cm Product Name: Everest Bipo recall (Z-1638-2026)Olympus Corporation of the Americas2026-03-25
Brand Name: Olympus Everest Bipolar Cutting Forceps w/Cord, 5mm 33 cm Product Name: Everes recall (Z-1639-2026)Olympus Corporation of the Americas2026-03-25
Brand Name: Olympus PK Cutting Forceps, 5mm 33cm Product Name: PK Cutting Forceps Model/Ca recall (Z-1640-2026)Olympus Corporation of the Americas2026-03-25
Brand Name: Olympus HALO PKS Cutting Forceps, 5mm 33cm Product Name: HALO PKS Cutting Forc recall (Z-1641-2026)Olympus Corporation of the Americas2026-03-25
Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting Forceps Model/ recall (Z-1642-2026)Olympus Corporation of the Americas2026-03-25
Brand Name: Olympus PKS Cutting Forceps w/Cord, 5mm 24cm Product Name: PKS Cutting Forceps recall (Z-1643-2026)Olympus Corporation of the Americas2026-03-25
Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting Forceps Model/ recall (Z-1644-2026)Olympus Corporation of the Americas2026-03-25
Olympus Endoscope Suction Valve - MAJ-1443. Model Number: MAJ-1443. recall (Z-1610-2026)Olympus Corporation of the Americas2026-03-20
Olympus Endoscope Air/Water Valve - MAJ-1444. Model Number: MAJ-1444. recall (Z-1611-2026)Olympus Corporation of the Americas2026-03-20
Olympus Endoscope Reprocessor OER-Elite. Model Number: N5789340. recall (Z-1612-2026)Olympus Corporation of the Americas2026-03-20
Olympus Endoscope Reprocessor OER-Pro. Model Number: N3058140. recall (Z-1613-2026)Olympus Corporation of the Americas2026-03-20
Brand Name: Olympus ShockPulse-SE Lithotripsy System with Generator Product Name: ShockPul recall (Z-1494-2026)Olympus Corporation of the Americas2026-03-05
Olympus Single use Biopsy Valve. Model/Catalog Number: MAJ-210. 20 units per box. The MAJ- recall (Z-1488-2026)Olympus Corporation of the Americas2026-03-03
Olympus Single Use Biopsy Valve. Model/Catalog Number: MAJ-1218. 20 units per box. The MAJ recall (Z-1489-2026)Olympus Corporation of the Americas2026-03-03
Brand Name: ShockPulse-SE Lithotripsy System SPL-SR Product Name: ShockPulse-SE Lithotrips recall (Z-1477-2026)Olympus Corporation of the Americas2026-02-27
Brand Name: ShockPulse-SE Lithotripsy System SPL-S Product Name: ShockPulse-SE Lithotripsy recall (Z-1478-2026)Olympus Corporation of the Americas2026-02-27
Brand Name: ShockPulse-SE Lithotripsy System Product Name: ShockPulse-SE Lithotripsy Syste recall (Z-1479-2026)Olympus Corporation of the Americas2026-02-27
Olympus Cystoscope Outer Sheath; Model/Catalog number: WA22810A; recall (Z-1437-2026)Olympus Corporation of the Americas2026-02-20
Olympus Resection Sheath. Model No. A22014A and A22014T. for endoscopic diagnosis and trea recall (Z-1438-2026)Olympus Corporation of the Americas2026-02-20
Olympus Resection Inner Sheath, for 26 Fr. Outer Sheath. Model No. A22040A. Resection shea recall (Z-1439-2026)Olympus Corporation of the Americas2026-02-20
Olympus Resection Inner Sheath for 26 Fr. Outer Sheath. Model No. A22040T. Resection sheat recall (Z-1440-2026)Olympus Corporation of the Americas2026-02-20
Olympus Resection Sheath, 24 Fr; Model No. A22041A. Resection sheath for urologic applicat recall (Z-1441-2026)Olympus Corporation of the Americas2026-02-20
Olympus Resection Sheath, 24 Fr., with Deflecting Obturator; Model No. A22041T. Resection recall (Z-1442-2026)Olympus Corporation of the Americas2026-02-20
Olympus Resection Sheath, 26 Fr.; Model No. A22042A. Resection sheath for urologic applica recall (Z-1443-2026)Olympus Corporation of the Americas2026-02-20
Olympus Resection Sheath, 26 Fr. with Deflecting Obturator; Model No. A22042T. Resection s recall (Z-1444-2026)Olympus Corporation of the Americas2026-02-20
Olympus Resection Sheath, 28 Fr.; Model No. A22043A. Resection sheath for urologic applica recall (Z-1445-2026)Olympus Corporation of the Americas2026-02-20
Olympus Resection Sheath, 28 Fr. with Deflecting Obturator. Model No. A22043T. Resection s recall (Z-1446-2026)Olympus Corporation of the Americas2026-02-20
Olympus Inner Sheath; Model No. A2660. for endoscopic diagnosis and treatment in urologica recall (Z-1447-2026)Olympus Corporation of the Americas2026-02-20
Olympus Resection Sheath, 8 mm. Model No. A42011A. Resection sheath for gynecological appl recall (Z-1448-2026)Olympus Corporation of the Americas2026-02-20
Olympus Inner Sheath. Model No. A4741. for endoscopic diagnosis and treatment in gynecolog recall (Z-1449-2026)Olympus Corporation of the Americas2026-02-20
Olympus Inner Sheath, Long; Model No. WA22017A. Inner sheath for urological and gynecologi recall (Z-1450-2026)Olympus Corporation of the Americas2026-02-20
Olympus Inner Sheath, Long; Model No. WA22017T. Inner sheath for urological and gynecologi recall (Z-1451-2026)Olympus Corporation of the Americas2026-02-20
Olympus Resection Sheath; Model No. A2666. Resection sheath for urologic applications. recall (Z-1452-2026)Olympus Corporation of the Americas2026-02-20
Olympus Inner Sheath 21 Fr. Model No. A2660T. for endoscopic diagnosis and treatment in ur recall (Z-1453-2026)Olympus Corporation of the Americas2026-02-20
Olympus Sheath, 10 Fr. Model No. A37004A. for endoscopic diagnosis and treatment in urolog recall (Z-1454-2026)Olympus Corporation of the Americas2026-02-20
Olympus Inner Sheath. Model No. A2641. for endoscopic diagnosis and treatment in urologica recall (Z-1455-2026)Olympus Corporation of the Americas2026-02-20
Olympus Inner Sheath. Model No. A2642. for endoscopic diagnosis and treatment in urologica recall (Z-1456-2026)Olympus Corporation of the Americas2026-02-20
Olympus Resection Sheath. Model No. A2666T. for endoscopic diagnosis and treatment in urol recall (Z-1457-2026)Olympus Corporation of the Americas2026-02-20
Olympus High Flow Insufflation Unit. Model Number: UHI. Used for insufflation of the abdom recall (Z-1352-2026)Olympus Corporation of the Americas2026-02-18
Olympus High Flow Insufflation Unit. Model/ Number: UHI-2. Used for insufflation of the ab recall (Z-1353-2026)Olympus Corporation of the Americas2026-02-18
Olympus High Flow Insufflation Unit. Model Number: UHI-3. Used for insufflation of the abd recall (Z-1354-2026)Olympus Corporation of the Americas2026-02-18
Olympus Thunderbeat 5 mm, 45 cm, Front-Actuated Grip Type S recall (Z-1371-2026)Olympus Corporation of the Americas2026-02-17
Olympus Thunderbeat, 5 mm, 35 cm, Front-Actuated Grip Type S recall (Z-1372-2026)Olympus Corporation of the Americas2026-02-17
Olympus Thunderbeat 5 mm, 20 cm, Front-Actuated Grip Type S recall (Z-1373-2026)Olympus Corporation of the Americas2026-02-17
Olympus Thunderbeat, 5 mm, 45 cm Front-Actuated Grip recall (Z-1374-2026)Olympus Corporation of the Americas2026-02-17
Olympus Thunderbeat 5 mm, 35 cm, Front-Actuated Grip recall (Z-1375-2026)Olympus Corporation of the Americas2026-02-17
Olympus Thunderbeat 5 mm, 20 cm, Front-Actuated Grip recall (Z-1376-2026)Olympus Corporation of the Americas2026-02-17
Olympus Thunderbeat, 5 mm, 45 cm, Pistol Grip recall (Z-1377-2026)Olympus Corporation of the Americas2026-02-17
Olympus Thunderbeat, 5mm, 35 cm, Pistol Grip recall (Z-1378-2026)Olympus Corporation of the Americas2026-02-17
Olympus Thunderbeat, 5 mm, 45 cm Inline Grip recall (Z-1379-2026)Olympus Corporation of the Americas2026-02-17
Olympus Thunderbeat, 5 mm, 35 cm, Inline Grip recall (Z-1380-2026)Olympus Corporation of the Americas2026-02-17
Olympus Thunderbeat, 5 mm, 20 cm, Inline Grip recall (Z-1381-2026)Olympus Corporation of the Americas2026-02-17
Olympus Thunderbeat 5 mm, 10 cm, Inline Grip recall (Z-1382-2026)Olympus Corporation of the Americas2026-02-17
Brand Name: CleverCut Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Numb recall (Z-1268-2026)Olympus Corporation of the Americas2026-02-05
Product Name: Single Use Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC recall (Z-1269-2026)Olympus Corporation of the Americas2026-02-05
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-431Q-0720 Pr recall (Z-1270-2026)Olympus Corporation of the Americas2026-02-05
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0330; Sof recall (Z-1271-2026)Olympus Corporation of the Americas2026-02-05
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0720; Sof recall (Z-1272-2026)Olympus Corporation of the Americas2026-02-05
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0725; Sof recall (Z-1273-2026)Olympus Corporation of the Americas2026-02-05
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0730; Sof recall (Z-1274-2026)Olympus Corporation of the Americas2026-02-05
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V431M-0720; Sof recall (Z-1275-2026)Olympus Corporation of the Americas2026-02-05
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V431M-0730; Sof recall (Z-1276-2026)Olympus Corporation of the Americas2026-02-05
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Numbe recall (Z-1277-2026)Olympus Corporation of the Americas2026-02-05
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Numbe recall (Z-1278-2026)Olympus Corporation of the Americas2026-02-05
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Numbe recall (Z-1279-2026)Olympus Corporation of the Americas2026-02-05
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Numbe recall (Z-1280-2026)Olympus Corporation of the Americas2026-02-05
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Numbe recall (Z-1281-2026)Olympus Corporation of the Americas2026-02-05
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Numbe recall (Z-1282-2026)Olympus Corporation of the Americas2026-02-05
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Numbe recall (Z-1283-2026)Olympus Corporation of the Americas2026-02-05
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Numbe recall (Z-1284-2026)Olympus Corporation of the Americas2026-02-05
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-411Q-0720 Pr recall (Z-1285-2026)Olympus Corporation of the Americas2026-02-05
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-411Q-0730 Pr recall (Z-1286-2026)Olympus Corporation of the Americas2026-02-05
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Pr recall (Z-1287-2026)Olympus Corporation of the Americas2026-02-05
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0720 Pr recall (Z-1288-2026)Olympus Corporation of the Americas2026-02-05
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0730 Pr recall (Z-1289-2026)Olympus Corporation of the Americas2026-02-05
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