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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| Jan 31, 2025 | Numerous models of nonsterile hemostatic forceps: (1) REF BH100R, Carrel Art... | 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 BJ500R, Phaneuf ... | 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 BH951R, Negus To... | The forceps have been used in ways not covered by the design resulting in breakage of the clamps. | Class II | Aesculap Inc |
| Jan 27, 2025 | Osstem Implant System - Abutment: ET Multi AbutmentSize: 4.8D 5.0GH - Abutme... | Patient chart stickers provided inside the packaging may incorrectly identify ET Rigid Abutments ... | Class II | Hiossen Inc. |
| Jan 27, 2025 | ET Rigid Abutment (Mini) Size: 4.5D 2.0G/H 4.0H- Intended for use with a dent... | Patient chart stickers provided inside the packaging may incorrectly identify ET Rigid Abutments ... | Class II | Hiossen Inc. |
| Jan 27, 2025 | ET Rigid Abutment (Mini) SIze: 4.5D 3.0G/H 7.0H - Intended for use with a den... | Patient chart stickers provided inside the packaging may incorrectly identify ET Rigid Abutments ... | Class II | Hiossen Inc. |
| Jan 27, 2025 | ET Rigid Abutment (Mini) Size 4.5D 1.0G/H 5.0H - Intended for use with a den... | Patient chart stickers provided inside the packaging may incorrectly identify ET Rigid Abutments ... | Class II | Hiossen Inc. |
| Jan 27, 2025 | Osstem Implant System - Abutment ET Multi Abutment Size: 4.8D 3.0G/H- Abutme... | Patient chart stickers provided inside the packaging may incorrectly identify ET Rigid Abutments ... | Class II | Hiossen Inc. |
| Jan 27, 2025 | ET Rigid Abutment (Mini) SIze: 4.5D 4.0G/H 4.0H - Intended for use with a den... | Patient chart stickers provided inside the packaging may incorrectly identify ET Rigid Abutments ... | Class II | Hiossen Inc. |
| Jan 21, 2025 | A.L.P.S. mvX-P: ANATOMIC LAT FIB PLATE 12H LT- Anatomic Lateral Fibula Plate,... | Complaints of the locking screw passing through the locking hole intra-operatively during use of ... | Class II | Tyber Medical |
| Jan 21, 2025 | A.L.P.S. mvX -ANATOMIC LAT FIB PLATE 6H LT- Anatomic Lateral Fibula Plate, 6-... | Complaints of the locking screw passing through the locking hole intra-operatively during use of ... | Class II | Tyber Medical |
| Jan 21, 2025 | A.L.P.S. mvX- MEDIAL TIBIA PLATE 16H LT-Medial Tibia Plate, 16-Hole, Left In... | Complaints of the locking screw passing through the locking hole intra-operatively during use of ... | Class II | Tyber Medical |
| Jan 21, 2025 | A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 10H RT- Anatomic Lateral Fibula Plate, 1... | Complaints of the locking screw passing through the locking hole intra-operatively during use of ... | Class II | Tyber Medical |
| Jan 21, 2025 | A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 8H RT: Anatomic Lateral Fibula Plate, 8-... | Complaints of the locking screw passing through the locking hole intra-operatively during use of ... | Class II | Tyber Medical |
| Jan 21, 2025 | A.L.P.S. mvX- MEDIAL TIBIA PLATE 6H RT-Medial Tibia Plate, 6-Hole, Right Mod... | Complaints of the locking screw passing through the locking hole intra-operatively during use of ... | Class II | Tyber Medical |
| Jan 21, 2025 | A.L.P.S. mvX -ANATOMIC LAT FIB PLATE 4H RT: Anatomic Lateral Fibula Plate, 4-... | Complaints of the locking screw passing through the locking hole intra-operatively during use of ... | Class II | Tyber Medical |
| Jan 21, 2025 | A.L.P.S. mvX- MEDIAL TIBIA PLATE 16H RT -Medial Tibia Plate, 16-Hole, Right ... | Complaints of the locking screw passing through the locking hole intra-operatively during use of ... | Class II | Tyber Medical |
| Jan 21, 2025 | A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 12H RT- Anatomic Lateral Fibula Plate, 1... | Complaints of the locking screw passing through the locking hole intra-operatively during use of ... | Class II | Tyber Medical |
| Jan 21, 2025 | A.L.P.S. mvX - ANATOMIC LAT FIB PLATE 4H LT: Anatomic Lateral Fibula Plate, 4... | Complaints of the locking screw passing through the locking hole intra-operatively during use of ... | Class II | Tyber Medical |
| Jan 21, 2025 | A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 8H LT: Anatomic Lateral Fibula Plate, 8-... | Complaints of the locking screw passing through the locking hole intra-operatively during use of ... | Class II | Tyber Medical |
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.