Browse Device Recalls
389 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 389 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 389 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Sep 11, 2025 | EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-H190 | Additional IFU updates to provide further clarification on safe and effective use of bronchoscope... | Class I | Olympus Corporation of the Americas |
| Sep 11, 2025 | BRONCHOFIBERSCOPE OLYMPUS BF TYPE PE2 | Additional IFU updates to provide further clarification on safe and effective use of bronchoscope... | Class I | Olympus Corporation of the Americas |
| Sep 11, 2025 | BRONCHOVIDEOSCOPE OLYMPUS BF-1TQ170 | Additional IFU updates to provide further clarification on safe and effective use of bronchoscope... | Class I | Olympus Corporation of the Americas |
| Sep 11, 2025 | EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Q180-AC | Additional IFU updates to provide further clarification on safe and effective use of bronchoscope... | Class I | Olympus Corporation of the Americas |
| Sep 11, 2025 | BRONCHOVIDEOSCOPE OLYMPUS BF-1TH1100 | Additional IFU updates to provide further clarification on safe and effective use of bronchoscope... | Class I | Olympus Corporation of the Americas |
| Sep 11, 2025 | EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1T180 | Additional IFU updates to provide further clarification on safe and effective use of bronchoscope... | Class I | Olympus Corporation of the Americas |
| Sep 11, 2025 | BRONCHOVIDEOSCOPE OLYMPUS BF TYPE P150 | Additional IFU updates to provide further clarification on safe and effective use of bronchoscope... | Class I | Olympus Corporation of the Americas |
| Sep 11, 2025 | OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE 1T60 | Additional IFU updates to provide further clarification on safe and effective use of bronchoscope... | Class I | Olympus Corporation of the Americas |
| Sep 11, 2025 | BRONCHOFIBERSCOPE OLYMPUS BF TYPE TE2 | Additional IFU updates to provide further clarification on safe and effective use of bronchoscope... | Class I | Olympus Corporation of the Americas |
| Sep 11, 2025 | OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE XT40 | Additional IFU updates to provide further clarification on safe and effective use of bronchoscope... | Class I | Olympus Corporation of the Americas |
| Sep 11, 2025 | EVIS EXERA BRONCHOVIDEOSCOPE OLYMPUS BF TYPE XT160 | Additional IFU updates to provide further clarification on safe and effective use of bronchoscope... | Class I | Olympus Corporation of the Americas |
| Aug 6, 2025 | ViziShot 2FLEX. Single Use Aspiration Needle. Model Number: NA-U403SX-4019. ... | Potential for undetected, deformed a-traumatic tips. | Class I | Olympus Corporation of the Americas |
| Jul 25, 2025 | Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Gen... | Potential for the ESG-410 Electrosurgical Generator to display an error message: "E0662 System Er... | Class II | Olympus Corporation of the Americas |
| Jul 25, 2025 | Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Gen... | Potential for the ESG-410 Electrosurgical Generator to display an error message: "E0662 System Er... | Class II | Olympus Corporation of the Americas |
| Jun 18, 2025 | Blue Silicone, Reusable Silicone Seal 6 - 12 FR. Model Number: CS-B612. ... | Discrepancies between sterilization instructions in the Japanese language product package inserts... | Class II | Olympus Corporation of the Americas |
| Jun 18, 2025 | Green Silicone Seal for Accessories, Reusable Silicone Seal 0 - 7 FR. Model N... | Discrepancies between sterilization instructions in the Japanese language product package inserts... | Class II | Olympus Corporation of the Americas |
| Jun 18, 2025 | Ellik Evacuator Adapter, Locking. Model Number: 190-NRS. The Ellik Evacua... | Discrepancies between sterilization instructions in the Japanese language product package inserts... | Class II | Olympus Corporation of the Americas |
| Jun 18, 2025 | Ellik Latex Bulb, Ellik Evacuator. Model Number: 194-2. The Ellik Evacuat... | Discrepancies between sterilization instructions in the Japanese language product package inserts... | Class II | Olympus Corporation of the Americas |
| Jun 18, 2025 | Glass Body For 194 Ellik Evacuator. Model Number: 190A. The Ellik Evacuat... | Discrepancies between sterilization instructions in the Japanese language product package inserts... | Class II | Olympus Corporation of the Americas |
| Jun 18, 2025 | Cone with Male Tubing, Non-Locking, Ellik Evacuator. Model Number: 191-NRS. ... | Discrepancies between sterilization instructions in the Japanese language product package inserts... | Class II | Olympus Corporation of the Americas |
| Jun 18, 2025 | Tubing for Male Connector 194, Ellik Evacuator. Model Number: 190-4. The E... | Discrepancies between sterilization instructions in the Japanese language product package inserts... | Class II | Olympus Corporation of the Americas |
| Jun 18, 2025 | Ellik Evacuator. Model Number: 194. The Ellik Evacuator and adapter access... | Discrepancies between sterilization instructions in the Japanese language product package inserts... | Class II | Olympus Corporation of the Americas |
| May 6, 2025 | Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Pro Supe... | 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 Reusable... | 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 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 |
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.