Browse Device Recalls

2,968 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,968 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 2,968 FDA device recalls in PA.

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DateProductReasonClassFirm
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 9, 2024 DISP.HASSON TROCAR 12/110MM, Product Code EK240SU. For use in laparoscopic pr... The sterile blister packaging may be damaged, and sterility may be compromised. Class II Aesculap Inc
Jan 9, 2024 DISP.TROCAR W. DILATING PIN 10/110MM, Product Code EK224SU. For use in laparo... The sterile blister packaging may be damaged, and sterility may be compromised. Class II Aesculap Inc
Jan 9, 2024 DISP.TROCAR W.DILATING PIN 12/110MM, Product Code EK236SU. For use in laparos... The sterile blister packaging may be damaged, and sterility may be compromised. Class II Aesculap Inc
Jan 9, 2024 DISP.TROCAR W.DILATING PIN 12/110MM, Product Code EK234SU. For use in laparos... The sterile blister packaging may be damaged, and sterility may be compromised. Class II Aesculap Inc
Jan 9, 2024 DISP.HASSON TROCAR 10/110MM, Product Code EK230SU. For use in laparoscopic pr... The sterile blister packaging may be damaged, and sterility may be compromised. Class II Aesculap Inc
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 29, 2023 MB362R - JACOBSON DUROGRIP TC Micro Needle Holder, straight, 8 3/4", (220 mm)... Needle Holder MB215R was inadvertently distributed as MB362R. Similarly, MB362R was distributed a... Class II Aesculap Inc
Dec 29, 2023 MB215R - MILLS DUROGRIP TC Micro Needle Holder, straight, 8:, (203 mm), "TC M... Needle Holder MB215R was inadvertently distributed as MB362R. Similarly, MB362R was distributed a... Class II Aesculap Inc
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 15, 2023 ExcelsiusGPS Cannula A, 9mm x 250mm, Cannula used with ball tip probes, Model... Devices may not be rendered sterile due to an internal gap that may be present on some devices ca... Class II Globus Medical, Inc.
Dec 11, 2023 Globus Medical Cranial Drill with Stop, 3.20mm - instruments for access, pre... Sterile-packed Cranial Drills may not be sterile due to a breach in the packaging and/or may have... Class II Globus Medical, Inc.
Dec 11, 2023 Globus Medical Cranial Drill with Stop, 2.40mm - Instruments for access, prep... Sterile-packed Cranial Drills may not be sterile due to a breach in the packaging and/or may have... Class II Globus Medical, Inc.
Dec 11, 2023 Globus Medical Cranial Drill, 6.00mm - instruments for access, preparation, a... Sterile-packed Cranial Drills may not be sterile due to a breach in the packaging and/or may have... Class II Globus Medical, Inc.
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 7, 2023 ExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit, Part number 6203.2100 A calibration error associated with the Flat Panel Fluoroscopy Fixture when used with ExcelsiusGP... Class I Globus Medical, Inc.
Dec 5, 2023 Ultrasound EA (Ergonomic Advantage) table versions; G2 (GENERAL 2) -An Ultras... Backrest platform stress fracture - the table is not operational in an inclined position Class II Oakworks Inc
Dec 5, 2023 Ultrasound EA (Ergonomic Advantage) table version; V2 (Vascular 2 Section) Ec... Backrest platform stress fracture - the table is not operational in an inclined position Class II Oakworks Inc
Dec 5, 2023 Ultrasound EA (Ergonomic Advantage) table versions; G3 (General 3 Section) Ec... Backrest platform stress fracture - the table is not operational in an inclined position Class II Oakworks Inc
Dec 5, 2023 Ultrasound EA (Ergonomic Advantage) table versions; G3 Multi-Specialty Echoca... Backrest platform stress fracture - the table is not operational in an inclined position Class II Oakworks Inc
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 29, 2023 Sensis Vibe Hemo The possibility of the Sensis documentation functionality application to crash. Class II Siemens Medical Solutions USA, Inc
Nov 27, 2023 Trilogy Evo and Trilogy Evo O2 Material Numbers BL2110X15B BR2110X18B CA21... The following was missing from the Contraindications Statement: The AVAPS-AE therapy mode is cont... Class II Philips Respironics, Inc.
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 13, 2023 CORI REAL INTELLIGENCE Robotic Drill, Product No. ROB10013 and ROB10013S Possibility that the user is unable to resolve drill disconnection error messages. Class II Blue Belt Technologies, Inc
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
Nov 10, 2023 EZDilate Fixed Wire Balloon 8.5-9.5-10.5. Indicated for endoscopic dilation o... 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 11-12-13. 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 8.5-9.5-10.5. indicated for endoscopic dilation... 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 18-19-20. 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 13.5-14.5-15.5. Indicated for endoscopic dilation... 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 6-7-8. Indicated for endoscopic dilation of stric... 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 16-17-18. 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 6-7-8. indicated for endoscopic dilation of str... Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting a... Class II Olympus Corporation of the Americas
Nov 6, 2023 Olympus ENDOEYE HD II Rigid Videoscope Catalog Numbers: WA50040A, WA50042A ... Reports of a pink or green coloration of the image. If the issue is encountered during a procedur... 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.