Gyrus Acmi, Llc
264 devices · 3,519 adverse event reports · 16 deaths reported · 94 devices named in recalls
Counts reflect reports that name each device's exact identifier. Larger companies sell more devices, so totals should not be read as a safety ranking.
- SOLTIVE TFL-PLSPowered laser surgical instrument6 recalls450 reports
- ViziShot 2 FLEX NA-U403SX-4019Bronchoscope accessory1 recall349 reports
- SOLTIVE TFL-SLSPowered laser surgical instrument6 recalls33 reports
- SOLTIVE TFL-FBX200BSPowered Laser Surgical Instrument4 recalls84 reports
- Olympus PS-0537CJDAElectrosurgical, cutting & coagulation & accessories2 recalls184 reports
- ShockPulse SPL-TLithotriptor, ultrasonic279 reports
- ShockPulse SPL-SLithotriptor, ultrasonic2 recalls159 reports
- SOLTIVE TFL-FBX200SPowered Laser Surgical Instrument3 recalls93 reports
- Olympus PS-0523CJDAElectrosurgical, cutting & coagulation & accessories3 recalls90 reports
- Gyrus ACMI 744000ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES237 reports
- SOLTIVE TFL-FBX550SPowered laser surgical instrument3 recalls63 reports
- SHOCKPULSE SPL-SRLithotriptor, Ultrasonic2 recalls97 reports
- SOLTIVE TFL-FBX150BSPowered Laser Surgical Instrument3 recalls18 reports
- Olympus PK-CF0533ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES2 recalls67 reports
- Spiration Valve System SVS-V9-00Valve, Pulmonary1 recall5 deaths100 reports
- SOLTIVE TFL-FBX150SPowered Laser Surgical Instrument2 recalls21 reports
- OLYMPUS 3006ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES2 recalls16 reports
- BiCOAG CD-B622LAUnit, electrosurgical, endoscopic (with or without accessories)2 recalls16 reports
- SOLTIVE TFL-FBX365SPowered Laser Surgical Instrument2 recalls11 reports
- Olympus BD-400P-2080Dilator, esophageal1 recall60 reports
- ShockPulse SPL-GLithotriptor, ultrasonic2 recalls10 reports
- Olympus PS-0544CJDAElectrosurgical, cutting & coagulation & accessories2 recalls10 reports
- OLYMPUS 3005ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES2 recalls6 reports
- Olympus BD-400P-1580Dilator, esophageal2 recalls4 reports
- Gyrus ACMI 777000ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES103 reports
- Soltive TFL-CPLUPowered laser surgical instrument2 recalls2 reports
- SOLTIVE TFL-FBX940SPowered Laser Surgical Instrument2 recalls1 report
- Gyrus ACMI 190AEVACUATOR, GASTRO-UROLOGY2 recalls0 reports
- EZDilate BD-410X-1055Dilator, esophageal2 recalls0 reports
- SOLTIVE TFL-CSLUPowered laser surgical instrument2 recalls0 reports
- Spiration Valve System SVS-V7-00Valve, Pulmonary3 deaths84 reports
- SOLTIVE TFL-AFSWLPowered laser surgical instrument83 reports
- Gyrus ACMI HACF0533ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 recall21 reports
- EZDilate BD-410X-2055Dilator, esophageal1 recall18 reports
- M3 Gold M3-30AELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL1 recall11 reports
- UroPass 61238BXACCESSORIES, CATHETER, G-U1 recall10 reports
- PK TECHNOLOGY 920005PKELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 recall9 reports
- USA Elite MLE-24-012ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL1 recall9 reports
- BERKELEY VC-10Curette, Suction, Endometrial (And Accessories)1 recall8 reports
- EZDilate BD-410X-1855Dilator, esophageal1 recall8 reports
- BiCOAG CD-B610LAUnit, electrosurgical, endoscopic (with or without accessories)1 recall7 reports
- BiCOAG CD-B620LAUnit, electrosurgical, endoscopic (with or without accessories)1 recall7 reports
- BiCOAG CD-B612LAUnit, electrosurgical, endoscopic (with or without accessories)1 recall6 reports
- Olympus BD-410X-1355Dilator, esophageal1 recall5 reports
- UroPass 61024BXACCESSORIES, CATHETER, G-U1 recall5 reports
- UroPass 61138BXACCESSORIES, CATHETER, G-U1 recall5 reports
- SOLTIVE TFL-AFSWPowered laser surgical instrument1 recall5 reports
- Classic Series C650-129AHysteroscope (And Accessories)1 recall4 reports
- UroPass 61046BXACCESSORIES, CATHETER, G-U1 recall4 reports
- UroPass 61054BXACCESSORIES, CATHETER, G-U1 recall4 reports
- UroPass 61146BXACCESSORIES, CATHETER, G-U1 recall4 reports
- UroPass 61224BXACCESSORIES, CATHETER, G-U1 recall4 reports
- UroPass 61254BXACCESSORIES, CATHETER, G-U1 recall4 reports
- PeriView FLEX NA-403D-2021Bronchoscope accessory54 reports
- Olympus BD-400P-1080Dilator, esophageal1 recall3 reports
- Olympus BD-400P-1380Dilator, esophageal1 recall3 reports
- EZDilate BD-410X-1555Dilator, esophageal1 recall3 reports
- UroPass 61324BXACCESSORIES, CATHETER, G-U1 recall3 reports
- Olympus BD-400P-0880Dilator, esophageal1 recall2 reports
- UroPass 61338BXACCESSORIES, CATHETER, G-U1 recall2 reports
- PK TECHNOLOGY 3005PKELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 recall2 reports
- Diego Elite MBUR6060FRCVBUR, EAR, NOSE AND THROAT1 recall2 reports
- Blue Silicone CS-B612Hysteroscope (And Accessories)1 recall2 reports
- InstaClear LCS1500UNOLNASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)1 recall2 reports
- EZDilate BPCN0815KCATHETER, NEPHROSTOMY1 recall1 report
- UroPass 61154BXACCESSORIES, CATHETER, G-U1 recall1 report
- UroPass 61246BXACCESSORIES, CATHETER, G-U1 recall1 report
- UroPass 61346BXACCESSORIES, CATHETER, G-U1 recall1 report
- USA Elite RBELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL1 recall1 report
- InstaClear LCS1800UNSTNASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)1 recall1 report
- InstaClear LCS1870BTSTNASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)1 recall1 report
- Toomey 188EVACUATOR, GASTRO-UROLOGY1 recall0 reports
- Toomey 188AEVACUATOR, GASTRO-UROLOGY1 recall0 reports
- Gyrus ACMI 194Hysteroscope (And Accessories)1 recall0 reports
- Gyrus ACMI 194-2EVACUATOR, GASTRO-UROLOGY1 recall0 reports
- Gyrus ACMI 190-4EVACUATOR, GASTRO-UROLOGY1 recall0 reports
- USA Elite 190-NRSHysteroscope (And Accessories)1 recall0 reports
- USA Elite 191-NRSEVACUATOR, GASTRO-UROLOGY1 recall0 reports
- M3 Gold M3-70AELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL1 recall0 reports
- Gyrus ACMI 240044TUBE, TYMPANOSTOMY1 recall0 reports
- Olympus BD-410X-0855Dilator, esophageal1 recall0 reports
- GYRUS ACMI, INC 61038BXACCESSORIES, CATHETER, G-U1 recall0 reports
- UroPass 61124BXACCESSORIES, CATHETER, G-U1 recall0 reports
- UroPass 61354BXACCESSORIES, CATHETER, G-U1 recall0 reports
- DIEGO ELITE MBUR5060FRCVBUR, EAR, NOSE AND THROAT1 recall0 reports
- Diego Elite MBUR7060FRCVBUR, EAR, NOSE AND THROAT1 recall0 reports
- GYRUS ACMI, INC 920000PKELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 recall0 reports
- Gyrus ACMI CS-G7Hysteroscope (And Accessories)1 recall0 reports
- InstaClear LCS1830TPSTNASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)1 recall0 reports
- InstaClear LCS1830BTSTNASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)1 recall0 reports
- InstaClear LCS1845TPSTNASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)1 recall0 reports
- InstaClear LCS1845BTSTNASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)1 recall0 reports
- InstaClear LCS1870TPSTNASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)1 recall0 reports
- InstaClear LCS1530TPOLNASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)1 recall0 reports
- InstaClear LCS1530BTOLNASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)1 recall0 reports
- InstaClear LCS1545TPOLNASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)1 recall0 reports
- InstaClear LCS1545BTOLNASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)1 recall0 reports
- InstaClear LCS1570TPOLNASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)1 recall0 reports
- InstaClear LCS1570BTOLNASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)1 recall0 reports
- SOLTIVE TFL-FBX940RPowered Laser Surgical Instrument1 recall0 reports