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Browse Device Recalls

2,888 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,888 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 2,888 FDA device recalls in PA.

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DateProductReasonClassFirm
Jun 4, 2025 UROSKOP Omnia. Model Number: 10094910 A resistor in the frequency inverter may strongly overheat potentially igniting the plastic housi... Class II Siemens Medical Solutions USA, Inc
Jun 4, 2025 UROSKOP Omnia Max. Model Number: 10762473 A resistor in the frequency inverter may strongly overheat potentially igniting the plastic housi... Class II Siemens Medical Solutions USA, Inc
May 28, 2025 Philips S7-3t Transducer. Ultrasound transducer devices were refurbished beyond their useful life. Class II Philips Ultrasound, Inc
May 28, 2025 Philips L9-3 Transducer. Ultrasound transducer devices were refurbished beyond their useful life. Class II Philips Ultrasound, Inc
May 28, 2025 Philips L8-4 Transducer. Ultrasound transducer devices were refurbished beyond their useful life. Class II Philips Ultrasound, Inc
May 28, 2025 Philips VL13-5 Transducer. Ultrasound transducer devices were refurbished beyond their useful life. Class II Philips Ultrasound, Inc
May 28, 2025 Philips L12-4 Transducer. Ultrasound transducer devices were refurbished beyond their useful life. Class II Philips Ultrasound, Inc
May 28, 2025 Philips C5-1 Transducer. Ultrasound transducer devices were refurbished beyond their useful life. Class II Philips Ultrasound, Inc
May 28, 2025 Philips XL14-3 Transducer. Ultrasound transducer devices were refurbished beyond their useful life. Class II Philips Ultrasound, Inc
May 28, 2025 Philips S8-3t Transducer. Ultrasound transducer devices were refurbished beyond their useful life. Class II Philips Ultrasound, Inc
May 28, 2025 Philips X5-1 Transducer. Ultrasound transducer devices were refurbished beyond their useful life. Class II Philips Ultrasound, Inc
May 28, 2025 Philips X7-2t Transducer. Ultrasound transducer devices were refurbished beyond their useful life. Class II Philips Ultrasound, Inc
May 28, 2025 Philips 3D9-3v Transducer. Ultrasound transducer devices were refurbished beyond their useful life. Class II Philips Ultrasound, Inc
May 28, 2025 Philips S7-2 Transducer. Ultrasound transducer devices were refurbished beyond their useful life. Class II Philips Ultrasound, Inc
May 28, 2025 Philips S5-1 Transducer. Ultrasound transducer devices were refurbished beyond their useful life. Class II Philips Ultrasound, Inc
May 28, 2025 Philips V6-2 Transducer. Ultrasound transducer devices were refurbished beyond their useful life. Class II Philips Ultrasound, Inc
May 28, 2025 Philips X8-2t Transducer. Ultrasound transducer devices were refurbished beyond their useful life. Class II Philips Ultrasound, Inc
May 28, 2025 Philips X6-1 Transducer. Ultrasound transducer devices were refurbished beyond their useful life. Class II Philips Ultrasound, Inc
May 28, 2025 Philips L12-3 Transducer. Ultrasound transducer devices were refurbished beyond their useful life. Class II Philips Ultrasound, Inc
May 28, 2025 Philips C5-2 Transducer. Ultrasound transducer devices were refurbished beyond their useful life. Class II Philips Ultrasound, Inc
May 28, 2025 Philips eL18-4 Transducer. Ultrasound transducer devices were refurbished beyond their useful life. Class II Philips Ultrasound, Inc
May 28, 2025 Philips C9-5EC Transducer. Ultrasound transducer devices were refurbished beyond their useful life. Class II Philips Ultrasound, Inc
May 28, 2025 Philips eL18-4 EMT Transducer. Ultrasound transducer devices were refurbished beyond their useful life. Class II Philips Ultrasound, Inc
May 15, 2025 ARTIS is a family of dedicated angiography systems developed for single and ... In very rare situations, communication between the sensor measuring dose applied to the area and ... Class II Siemens Medical Solutions USA, Inc
May 15, 2025 interventional fluoroscopic x-ray system In very rare situations, communication between the sensor measuring dose applied to the area and ... Class II Siemens Medical Solutions USA, Inc
May 15, 2025 interventional fluoroscopic x-ray system In very rare situations, communication between the sensor measuring dose applied to the area and ... Class II Siemens Medical Solutions USA, Inc
May 15, 2025 interventional fluoroscopic x-ray system In very rare situations, communication between the sensor measuring dose applied to the area and ... Class II Siemens Medical Solutions USA, Inc
May 9, 2025 BiPAP A30 Ventilators. Intended to provide noninvasive ventilation support in... This device does not indicate for use in patients with respiratory failure. Class I Philips Respironics, Inc.
May 9, 2025 BiPAP A40 Ventilator. Used to provide noninvasive ventilation support for the... This device does not indicate for use in patients with respiratory failure. Class I Philips Respironics, Inc.
May 9, 2025 BiPAP V30 Auto Ventilator. Intended to provide non-invasive ventilatory suppo... This device does not indicate for use in patients with respiratory failure. Class I Philips Respironics, Inc.
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 11, 2025 MedicaLyte Liquid Bicarbonate Concentrate. Model Numbers: BC+201 (45X), BC+10... Potential for the presence of visible foreign matter. Class I Nipro Renal Soultions USA, Corporation
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
Apr 3, 2025 MAGEC 2 Rod, 5.0mm 90mm Standard; Version/Model: MC2-5090S; Devices for the affected lot were not assembled according to product specifications. The distrac... Class II Globus Medical, Inc.
Mar 12, 2025 Brand Name: ID Circuit Product Name: ID Circuit Flex 220 Model/Catalog Numb... The potential for cracks forming in the breathing circuit hose. Class I Draeger, Inc.
Mar 12, 2025 Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex... The potential for cracks forming in the breathing circuit hose. Class I Draeger, Inc.
Mar 12, 2025 Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex... The potential for cracks forming in the breathing circuit hose. Class I Draeger, Inc.
Mar 12, 2025 Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex... The potential for cracks forming in the breathing circuit hose. Class I Draeger, Inc.
Mar 12, 2025 Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex... The potential for cracks forming in the breathing circuit hose. Class I Draeger, Inc.
Mar 12, 2025 Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex... The potential for cracks forming in the breathing circuit hose. Class I Draeger, Inc.
Mar 12, 2025 Brand Name: VentStar Product Name: VentStar Flex 220 Model/Catalog Number: ... The potential for cracks forming in the breathing circuit hose. Class I Draeger, Inc.
Feb 27, 2025 Premier Solo Diamond - Large Invented Cone; SKU: 807016C. The hardness not meeting the material specification and may cause the diamond bur to bend. Class II Premier Dental Products Co
Feb 20, 2025 IVX Station Reconstitution Transfer Set. Model Number: 298921215. Packaging: ... IVX Station Reconstitution Transfer Sets were shipped in advance of the IVX Station upgrade and n... Class II Omnicell, Inc.
Feb 17, 2025 Introcan Safety 3 Closed IV Catheter 22 Ga. x 1 in., PUR, Winged. Passive saf... Increased risk for valve housing detachment causing leakage. Class II B Braun Medical Inc
Jan 31, 2025 Numerous models of nonsterile hemostatic forceps: (1) REF BH198R, Fuchsig ... The forceps have been used in ways not covered by the design resulting in breakage of the clamps. Class II Aesculap Inc
Jan 31, 2025 Numerous models of nonsterile hemostatic forceps: (1) REF FB458R, Glover A... The forceps have been used in ways not covered by the design resulting in breakage of the clamps. Class II Aesculap Inc

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.