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 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 |
| Jan 16, 2024 | InstaClear Lens Cleaner-indicated for use during routine diagnostic procedure... | Japanese IFU version had slightly different language and illustrations from the English IFU, whic... | Class II | Olympus Corporation of the Americas |
| Jan 16, 2024 | Water Filter MAJ-2318. This MAJ-2318 water filter has been designed to be use... | Water filter may have been assembled incorrectly, resulting in unfiltered tap water being used fo... | Class II | Olympus Corporation of the Americas |
| Jan 11, 2024 | Colonoscope, Model Number PCF-H190L. | Specific repaired colonovideoscopes were assembled without an adhesive which protects them from c... | Class II | Olympus Corporation of the Americas |
| Jan 11, 2024 | Colonoscope, Model Number PCF-H190TL. | Specific repaired colonovideoscopes were assembled without an adhesive which protects them from c... | Class II | Olympus Corporation of the Americas |
| Jan 11, 2024 | Colonoscope, Model Number PCF-HQ190L. | Specific repaired colonovideoscopes were assembled without an adhesive which protects them from c... | Class II | Olympus Corporation of the Americas |
| Jan 11, 2024 | Colonoscope, Model Number CF-HQ190I. | Specific repaired colonovideoscopes were assembled without an adhesive which protects them from c... | Class II | Olympus Corporation of the Americas |
| Jan 11, 2024 | Colonoscope, Model Number PCF-Q180AL. | Specific repaired colonovideoscopes were assembled without an adhesive which protects them from c... | Class II | Olympus Corporation of the Americas |
| Jan 11, 2024 | Colonoscope, Model Number CF-HQ190L. | Specific repaired colonovideoscopes were assembled without an adhesive which protects them from c... | Class II | Olympus Corporation of the Americas |
| Jan 11, 2024 | Colonoscope, Model Number PCF-H180AL. | Specific repaired colonovideoscopes were assembled without an adhesive which protects them from c... | Class II | Olympus Corporation of the Americas |
| Jan 11, 2024 | Colonoscope, Model Number CF-H180AL. | Specific repaired colonovideoscopes were assembled without an adhesive which protects them from c... | Class II | Olympus Corporation of the Americas |
| Jan 11, 2024 | Colonoscope, Model Number CF-Q180AL. | Specific repaired colonovideoscopes were assembled without an adhesive which protects them from c... | Class II | Olympus Corporation of the Americas |
| Jan 11, 2024 | Colonoscope, Model Number PCF-H190DL. | Specific repaired colonovideoscopes were assembled without an adhesive which protects them from c... | Class II | Olympus Corporation of the Americas |
| Jan 5, 2024 | Hemostasis Probe, Model: CD-B622LA | The BICOAG Hemostasis Probe with a coaxial plug was mispackaged into the package and labeled as a... | Class II | Olympus Corporation of the Americas |
| Dec 15, 2023 | ESG PK CUTTING FORCEPS, 5MM, 33CM | The jaw may fracture prior to the procedure during the inspection instructed per the IFU, or duri... | Class II | Olympus Corporation of the Americas |
| Dec 11, 2023 | Olympus/Gyrus Paparrela-Type Vent Tube 1.02MM, Silicone, Sterile- to ventilat... | The expiration date is missing from the primary (inner) packaging. The secondary (outer) box labe... | Class II | Olympus Corporation of the Americas |
| Dec 8, 2023 | Single Use Distal Cover MAJ-2315 Used with: EVIS EXERA III Duodenovideoscope ... | Single Use Distal Cover MAJ-2315 may unexpectedly detach from the duodenoscope during use result ... | Class II | Olympus Corporation of the Americas |
| Dec 4, 2023 | Soltive SuperPulsed Laser System TFL FIBER CLEAVER, Model Number TFL-AFC | The strippers and cleavers are provided non-sterile and labelled as reusable/autoclavable. Olympu... | Class II | Olympus Corporation of the Americas |
| Dec 4, 2023 | SOLTIVE SuperPulsed Laser Fibers, Model No. TFL-FBX200BS | Affected products may potentially have a breached sterile pouch seal. A breached sterile pouch se... | Class II | Olympus Corporation of the Americas |
| Dec 4, 2023 | Soltive SuperPulsed Laser System TFL Fiber Stripper, Model Numbers TFL-AFS150... | The strippers and cleavers are provided non-sterile and labelled as reusable/autoclavable. Olympu... | Class II | Olympus Corporation of the Americas |
| Dec 1, 2023 | SOLTIVE SuperPulsed Laser Fibers Model Numbers TFL-FBX150S, TFL-FBX200S, TFL... | Olympus identified inconsistencies in the Instructions for Use regarding cleaning the fiber tip a... | Class II | Olympus Corporation of the Americas |
| Nov 20, 2023 | OLYMPUS ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE (10 mm diameter) Model: LTF-S1... | Instructions for Use-User Deviations related to the reprocessing of the videoscope detailed in t... | Class II | Olympus Corporation of the Americas |
| Nov 20, 2023 | OLYMPUS ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE (5.4 mm diameter) Model: LTF-S1... | Instructions for Use-User Deviations related to the reprocessing of the videoscope detailed in t... | Class II | Olympus Corporation of the Americas |
| Nov 10, 2023 | EZDilate Fixed Wire Balloon 16-17-18. Indicated for endoscopic dilation of st... | Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting a... | Class II | Olympus Corporation of the Americas |
| Nov 10, 2023 | EZDilate Fixed Wire Balloon 11-12-13. Indicated for endoscopic dilation of st... | Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting a... | Class II | Olympus Corporation of the Americas |
| Nov 10, 2023 | EZDilate Wire Guided Balloon 18-19-20. Indicated for endoscopic dilation of... | Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting a... | Class II | Olympus Corporation of the Americas |
| Nov 10, 2023 | EZDilate Wire Guided Balloon 13.5-14.5-15.5. Indicated for endoscopic dilati... | Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting a... | 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.