Browse Device Recalls

2,939 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,939 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 2,939 FDA device recalls in PA.

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DateProductReasonClassFirm
May 7, 2026 Atlan A350. Model Number: 8211500. anesthesia workstation The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use o... Class I Draeger, Inc.
May 7, 2026 Atlan A350XL. Model Number: 8621600. anesthesia workstation The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use o... Class I Draeger, Inc.
May 6, 2026 Design Options Spinal Tray Spinal Needle Anesthesia procedure kits: Materia... These procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP. The manufactur... Class I B Braun Medical Inc
May 6, 2026 Spinal Needle procedure kits: Material Description (Material Number) 24GA.... These procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP. The manufactur... Class I B Braun Medical Inc
May 6, 2026 Spinocan Spinal Needle procedure kits: Material Description (Material Numbe... These procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP. The manufactur... Class I B Braun Medical Inc
Apr 24, 2026 Avanta Multi-Patient Administration Tube Sets (AVA 500 MPAT (Part 2 of 2)) us... Supplier changes resulted in a fit issue with the Contrast Flow Control Valve (CFCV) interface on... Class II Bayer Medical Care, Inc.
Mar 25, 2026 Rolls of label stock used with the Omnicell i.v.Station. 1. Part Number ... Potential for mislabeled syringe produced by the i.v.STATION device. Class I Omnicell, Inc.
Mar 25, 2026 OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2... Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely. Class II Olympus Corporation of the Americas
Mar 25, 2026 OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2... Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely. Class II Olympus Corporation of the Americas
Mar 25, 2026 OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2111 Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely. Class II Olympus Corporation of the Americas
Mar 25, 2026 OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2... Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely. Class II Olympus Corporation of the Americas
Mar 25, 2026 OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2... Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely. Class II Olympus Corporation of the Americas
Mar 25, 2026 OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2112 Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely. Class II Olympus Corporation of the Americas
Mar 25, 2026 OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2... Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely. Class II Olympus Corporation of the Americas
Mar 25, 2026 OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2... Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely. Class II Olympus Corporation of the Americas
Mar 25, 2026 OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2... Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely. Class II Olympus Corporation of the Americas
Mar 25, 2026 OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2... Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely. Class II Olympus Corporation of the Americas
Mar 25, 2026 OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2... Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely. Class II Olympus Corporation of the Americas
Mar 25, 2026 OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2... XXX Class II Olympus Corporation of the Americas
Mar 23, 2026 Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 25cm. Model Number: TB2... Potential for detachment of a distal tip component of the device during use. Class II Olympus Corporation of the Americas
Mar 23, 2026 Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 35cm. Model Number: TB2... Potential for detachment of a distal tip component of the device during use. Class II Olympus Corporation of the Americas
Mar 23, 2026 Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 20cm. Model Number: TB2... Potential for detachment of a distal tip component of the device during use. Class II Olympus Corporation of the Americas
Mar 23, 2026 Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 45cm. Model Number: TB2... Potential for detachment of a distal tip component of the device during use. Class II Olympus Corporation of the Americas
Mar 20, 2026 Prodisc C SK U.S. IMPLANT EXTRA LARGE 6MM. Model Number: PDSXL6. Total cer... Product labeling mix up. The prodisc C SK U.S. Implant Extra Large 6mm product was labeled as a 5... Class II Centinel Spine, Inc.
Mar 20, 2026 Prodisc C SK U.S. IMPLANT EXTRA LARGE 5MM. Model: PDSXL5 Total cervical di... Product labeling mix up. The prodisc C SK U.S. Implant Extra Large 6mm product was labeled as a 5... Class II Centinel Spine, Inc.
Mar 19, 2026 B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG. Model ... Potential for the accumulation of small air bubbles in the arterial line due to adherence of bloo... Class I B Braun Medical Inc
Mar 19, 2026 B. Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 2.6MM PUMP SEGMENT. Mod... Potential for the accumulation of small air bubbles in the arterial line due to adherence of bloo... Class I B Braun Medical Inc
Mar 19, 2026 B Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 4.8MM PUMP SEGMENT. Mode... Potential for the accumulation of small air bubbles in the arterial line due to adherence of bloo... Class I B Braun Medical Inc
Mar 19, 2026 B. Braun Hemodialysis Bloodlines, STREAMLINE FRESENIUS FOR DAVITA. Model Numb... Potential for the accumulation of small air bubbles in the arterial line due to adherence of bloo... Class I B Braun Medical Inc
Mar 19, 2026 B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG DR. M... Potential for the accumulation of small air bubbles in the arterial line due to adherence of bloo... Class I B Braun Medical Inc
Mar 19, 2026 B. Barun Hemodialysis Bloodlines, StreamLine Bloodline Long Version, FMC. Mod... Potential for the accumulation of small air bubbles in the arterial line due to adherence of bloo... Class I B Braun Medical Inc
Mar 12, 2026 ARTIS Pheno VE30A and VE40A, Model 10849000 During 3D acquisitions, lighter and darker patient images may be captured, which may result in le... Class II Siemens Medical Solutions USA, Inc
Mar 10, 2026 ARTIS pheno and ARTIS Icono biplane, floor and ceiling. Model Numbers 1084900... During patient examinations, the system may sporadically display a major increase of the x-ray do... Class II Siemens Medical Solutions USA, Inc
Mar 9, 2026 ARTIS pheno, Model 10849000. interventional fluoroscopic x-ray system During patient examinations, the system may sporadically display a 0 x-ray dose administered to... Class II Siemens Medical Solutions USA, Inc
Mar 9, 2026 ARTIS Icono biplane, floor and ceiling.: ARTIS icono biplane Model 11327600. ... During patient examinations, the system may sporadically display a 0 x-ray dose administered to... Class II Siemens Medical Solutions USA, Inc
Mar 2, 2026 Philips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home... In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the r... Class I Philips Respironics, Inc.
Mar 2, 2026 Philips Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous ho... In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the r... Class I Philips Respironics, Inc.
Mar 2, 2026 Philips Respironics Trilogy Evo Universal, Software Version 1.05.15.00. Conti... In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the r... Class I Philips Respironics, Inc.
Mar 2, 2026 Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous h... In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the r... Class I Philips Respironics, Inc.
Mar 2, 2026 Philips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home... Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy ... Class I Philips Respironics, Inc.
Mar 2, 2026 Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous h... Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy ... Class I Philips Respironics, Inc.
Mar 2, 2026 Philips Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous ho... Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy ... Class I Philips Respironics, Inc.
Mar 2, 2026 Philips Respironics Trilogy Evo Universal, Software Version 1.05.15.00. Conti... Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy ... Class I Philips Respironics, Inc.
Feb 27, 2026 Brand Name: Olympus SOLTIVE Pro SuperPulsed Laser System Product Name: SOLTI... Following a complaint investigation, Olympus identified a potential defect in the 24V power suppl... Class II Olympus Corporation of the Americas
Feb 27, 2026 Brand Name: Olympus SOLTIVE Premium SuperPulsed Laser System Product Name: S... Following a complaint investigation, Olympus identified a potential defect in the 24V power suppl... Class II Olympus Corporation of the Americas
Feb 25, 2026 2.4 VOLT(TM) TAP CORTEX SCREW TO 90MM. Part Number: 03.424.126-US. A full lot swap between VOLT Locking Screw Tap 03.424.124 lot 68900P9 and Cortical Screw Tap 03.4... Class II Synthes (USA) Products LLC
Feb 25, 2026 2.4 VOLT TAP LOCKING SCREW TAP TO 90MM. Part Number: 03.424.124-US. A full lot swap between VOLT Locking Screw Tap 03.424.124 lot 68900P9 and Cortical Screw Tap 03.4... Class II Synthes (USA) Products LLC
Feb 25, 2026 Brand Name: Olympus HALO PKS Cutting Forceps, 5mm 33cm Product Name: HALO PK... Olympus identified that the Cutting Forceps contain components for which the supplier did not ade... Class II Olympus Corporation of the Americas
Feb 25, 2026 Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting ... Olympus identified that the Cutting Forceps contain components for which the supplier did not ade... Class II Olympus Corporation of the Americas
Feb 25, 2026 Brand Name: Olympus Everest Bipolar Cutting Forceps w/Cord, 5mm 33 cm Produc... Olympus identified that the Cutting Forceps contain components for which the supplier did not ade... 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.