Browse Device Recalls
415 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 415 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Medical Device Recalls
Browse 415 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| May 6, 2025 | Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Premium ... | Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or u... | Class II | Olympus Corporation of the Americas |
| May 6, 2025 | Brand Name: Powered Laser Surgical Instrument Product Name: Soltive SuperPul... | Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or u... | Class II | Olympus Corporation of the Americas |
| May 5, 2025 | Olympus EVIS EXERA III Duodenovideoscope. Model Number: TJF-Q190V | Recent post-market surveillance data suggests a possible association of higher microbial contamin... | Class II | Olympus Corporation of the Americas |
| Apr 4, 2025 | Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Pro Supe... | Preset treatment parameters are not consistently being used in accordance with the IFU. | Class II | Olympus Corporation of the Americas |
| Jan 15, 2025 | Olympus Single Use Guide Sheath Kits with the following product descriptions ... | Potential for the radiopaque tip of the guide sheath component to disassociate and fall off into ... | Class I | Olympus Corporation of the Americas |
| Dec 18, 2024 | Olympus MAJ-891 Forceps/Irrigation Plug (Isolated Type). Model/Catalog Number... | Potential for inadvertent retention of biomaterial when the reprocessing procedure is not perform... | Class I | Olympus Corporation of the Americas |
| Dec 16, 2024 | LithoCrushV Single Use Mechanical Lithotriptor V. Model Number: BML-V442QR-30... | Potential for distal tip tearing of the Mechanical Lithotriptor V. | Class II | Olympus Corporation of the Americas |
| Nov 25, 2024 | Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument P... | The probe tips of the hand instruments are being damaged or breaking including pad damage and det... | Class II | Olympus Corporation of the Americas |
| Nov 25, 2024 | Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument P... | The probe tips of the hand instruments are being damaged or breaking including pad damage and det... | Class II | Olympus Corporation of the Americas |
| Nov 25, 2024 | Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument P... | The probe tips of the hand instruments are being damaged or breaking including pad damage and det... | Class II | Olympus Corporation of the Americas |
| Nov 25, 2024 | Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument P... | The probe tips of the hand instruments are being damaged or breaking including pad damage and det... | Class II | Olympus Corporation of the Americas |
| Nov 25, 2024 | Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument P... | The probe tips of the hand instruments are being damaged or breaking including pad damage and det... | Class II | Olympus Corporation of the Americas |
| Nov 25, 2024 | Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument P... | The probe tips of the hand instruments are being damaged or breaking including pad damage and det... | Class II | Olympus Corporation of the Americas |
| Nov 25, 2024 | Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument P... | The probe tips of the hand instruments are being damaged or breaking including pad damage and det... | Class II | Olympus Corporation of the Americas |
| Nov 25, 2024 | Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument P... | The probe tips of the hand instruments are being damaged or breaking including pad damage and det... | Class II | Olympus Corporation of the Americas |
| Nov 25, 2024 | Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument P... | The probe tips of the hand instruments are being damaged or breaking including pad damage and det... | Class II | Olympus Corporation of the Americas |
| Nov 25, 2024 | Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument P... | The probe tips of the hand instruments are being damaged or breaking including pad damage and det... | Class II | Olympus Corporation of the Americas |
| Nov 25, 2024 | Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument P... | The probe tips of the hand instruments are being damaged or breaking including pad damage and det... | Class II | Olympus Corporation of the Americas |
| Nov 19, 2024 | Duravent Silicone Ventilation Tube. Model Number: 240075. | Potential that Duravent Silicone Ventilation Tubes may contain incorrect product, specifically, 1... | Class II | Olympus Corporation of the Americas |
| Oct 31, 2024 | EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190. Model Number: GIF-1TH190 | High-level disinfection ("HLD") with Acecide-C disinfectant in the Olympus OER-Pro Automated Endo... | Class II | Olympus Corporation of the Americas |
| Sep 24, 2024 | Quest Spectrum 3 Fluorescent Imaging System Model/Catalog Number: ART-SYS-00... | Does not meet the requirements for electromagnetic compatibility (EMC) of the standard IEC 60601-... | Class II | Olympus Corporation of the Americas |
| Sep 18, 2024 | Brand Name: EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190 Product Na... | To better define the drying procedures described in the IFU to improve the instructions for easie... | Class II | Olympus Corporation of the Americas |
| Sep 13, 2024 | Olympus Cystoscope Outer Sheath; Model/Catalog number: WA22810A; | Product being removed due to incompatibility when used in conjunction with a GreenLight Laser for... | Class II | Olympus Corporation of the Americas |
| Sep 13, 2024 | EZDilate Wire Guided Balloon- Indicated for use in adult and adolescent (> 12... | Mislabeled Glo Cath Label (attached to the device) states: 11 mm, 12 mm, 13 mm however the balloo... | Class II | Olympus Corporation of the Americas |
| Sep 13, 2024 | Brand Name: Olympus Product Name: Cystoscope Outer Sheath Model/Catalog Num... | Olympus is removing the statement of compatibility with a GreenLight Laser for BPH therapy from t... | Class II | Olympus Corporation of the Americas |
| Sep 11, 2024 | Brand Name: UroPass Ureteral Access Sheaths Product Name: Ureteral Access Sh... | Exposure of the UroPass product to Ultraviolet ( UV ) Radiation can cause brittleness of the devi... | Class II | Olympus Corporation of the Americas |
| Sep 4, 2024 | Olympus Electrosurgical Generator, Model Number ESG-410 (SEP) Version WA91327U | There was an increase in complaints indicating an occurrence of system error E1226 "Could not wri... | Class II | Olympus Corporation of the Americas |
| Aug 23, 2024 | Olympus Endoscopic Flushing Pump, Model/Catalog Number: OFP-2 (K10001141) | During product testing, Olympus identified an intermittent loss of function of the OFP-2 Flushing... | Class II | Olympus Corporation of the Americas |
| Aug 21, 2024 | Olympus Gastrointestinal Videoscope, Model/Catalog Number: GIF-1100 | It was discovered during device performance testing that the CCD imaging sensors were programmed ... | Class II | Olympus Corporation of the Americas |
| Aug 13, 2024 | Soltive Pro SuperPulsed Laser Systems-Intended for incision, excision, resect... | The term Bladder Stone was incorrectly translated in both Spanish and Portuguese to Kidney Stone(... | Class II | Olympus Corporation of the Americas |
| Aug 13, 2024 | Soltive Premium SuperPulsed Laser - Intended for incision, excision, resectio... | The term Bladder Stone was incorrectly translated in both Spanish and Portuguese to Kidney Stone(... | Class II | Olympus Corporation of the Americas |
| Jul 1, 2024 | The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm ... | Fractures and breakages in packaging trays and Tyvek covers, which may result in a sterility breach | Class II | Olympus Corporation of the Americas |
| Jul 1, 2024 | The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm ... | Fractures and breakages in packaging trays and Tyvek covers, which may result in a sterility breach | Class II | Olympus Corporation of the Americas |
| Jul 1, 2024 | The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm ... | Fractures and breakages in packaging trays and Tyvek covers, which may result in a sterility breach | Class II | Olympus Corporation of the Americas |
| Jun 21, 2024 | ESG-410 Electrosurgical Generator- In conjunction with electrosurgical access... | Electrosurgical Generators ESG-410 does not power on upon use, may result in delays in initiating... | Class II | Olympus Corporation of the Americas |
| May 31, 2024 | Soltive Pro SuperPulsed Laser System, Model TFL-SLS | Difficulties in pairing the wireless footswitch with the Soltive Laser, potentially delaying the ... | Class II | Olympus Corporation of the Americas |
| May 31, 2024 | Soltive SuperPulsed Laser System Wireless Footswitch, Model TFL-AFSWL | Difficulties in pairing the wireless footswitch with the Soltive Laser, potentially delaying the ... | Class II | Olympus Corporation of the Americas |
| May 31, 2024 | Soltive Premium SuperPulsed Laser System, Model TFL-PLS | Difficulties in pairing the wireless footswitch with the Soltive Laser, potentially delaying the ... | Class II | Olympus Corporation of the Americas |
| Apr 24, 2024 | EasySuite 4K Integrated Operating Room System Model/Catalog Number: EasySuit... | A subset of the ES4K systems do not have complete records for earth leakage testing. The earth le... | Class II | Olympus Corporation of the Americas |
| Apr 18, 2024 | OES 4000 Hysteroscope, Model/Catalog Number: A4674A | The required leakage test was not performed following of a re-work for a non-conformity. This cou... | Class II | Olympus Corporation of the Americas |
| Apr 3, 2024 | InstaClear Lens Sheath. The InstaClear lens cleaner system and versatile shea... | Potential for distal end of the sheath to break off during a procedure. | Class II | Olympus Corporation of the Americas |
| Mar 7, 2024 | POWERSEAL 5 mm, 37 cm, Curved Jaw Sealer and Divider, Double Action is indica... | Upon initial activation of the seal function, the POWERSEAL non-conformance results in an immedia... | Class II | Olympus Corporation of the Americas |
| Mar 7, 2024 | POWERSEAL 5 mm, 23 cm, Curved Jaw Sealer and Divider, Double Action is indica... | Upon initial activation of the seal function, the POWERSEAL non-conformance results in an immedia... | Class II | Olympus Corporation of the Americas |
| Mar 7, 2024 | POWERSEAL 5 mm, 44 cm, Curved Jaw Sealer and Divider, Double Action is indica... | Upon initial activation of the seal function, the POWERSEAL non-conformance results in an immedia... | Class II | Olympus Corporation of the Americas |
| Mar 1, 2024 | Olympus Triangle Tip Electrosurgical Knives- to be used with Olympus endoscop... | Due to increase in complaints for the KD-640L and KD-645L Triangle Tip Electrosurgical Knives br... | Class II | Olympus Corporation of the Americas |
| Mar 1, 2024 | Olympus Triangle Tip Electrosurgical Knives- to be used with Olympus endoscop... | Due to increase in complaints for the KD-640L and KD-645L Triangle Tip Electrosurgical Knives br... | Class II | Olympus Corporation of the Americas |
| Feb 17, 2024 | Brand Name: Single Use Electrosurgical Knife KD-645 Product Name: Olympus Si... | A deterioration of the cutting knife, including overheating and burning, can contribute to tip br... | Class II | Olympus Corporation of the Americas |
| Feb 17, 2024 | Brand Name: Single Use Electrosurgical Knife Product Name: Olympus Single Us... | A deterioration of the cutting knife, including overheating and burning, can contribute to tip br... | Class II | Olympus Corporation of the Americas |
| Jan 29, 2024 | SOLTIVE Premium SuperPulsed Laser (TFL-PLS ) | A non-compliant power cord may have been supplied in regions that do not utilize the Type B or Ty... | Class II | Olympus Corporation of the Americas |
| Jan 29, 2024 | SOLTIVE Pro SuperPulsed Laser (TFL-SLS ) | A non-compliant power cord may have been supplied in regions that do not utilize the Type B or Ty... | Class II | Olympus Corporation of the Americas |
Frequently Asked Questions
When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.
All types, from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.
Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.