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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Feb 14, 2019 | SOMATOM Edge Plus, Model Number 10267000 Product Usage: Computed tomograp... | Potential risk of scans being aborted when using the optional Dual Spiral Dual Engery mode due to... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 14, 2019 | SOMATOM Definition Edge, Model Number 10590000 Product Usage: Computed to... | Potential risk of scans being aborted when using the optional Dual Spiral Dual Engery mode due to... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 14, 2019 | SOMATOM Confidence, Model Number 10590100 Product Usage: Computed tomogra... | Potential risk of scans being aborted when using the optional Dual Spiral Dual Engery mode due to... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 14, 2019 | SOMATOM Definition AS with Option syngo DE Scan for Single Source (Dual Spira... | Potential risk of scans being aborted when using the optional Dual Spiral Dual Engery mode due to... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 8, 2019 | Uroskop Omnia -fluoroscopic X-ray system Model # 10094910 The Uroskop Omn... | The swivel arm holding the monitors may become dislodged from the carrying arm. | Class II | Siemens Medical Solutions USA, Inc |
| Feb 8, 2019 | Uroskop Omnia Max -fluoroscopic X-ray system Model # 10762473 Uroskop Om... | The swivel arm holding the monitors may become dislodged from the carrying arm. | Class II | Siemens Medical Solutions USA, Inc |
| Jan 10, 2019 | Arrow¿ Two-Lumen Central Venous Catheterization Kit with Blue FlexTip¿ Cathe... | The product lidstock contains a labelling error. The lidstock states the incorrect priming volume... | Class II | Arrow International Inc |
| Jan 10, 2019 | Arrow¿ Two-Lumen Central Venous Catheterization Set with Blue FlexTip¿ Cathe... | The product lidstock contains a labelling error. The lidstock states the incorrect priming volume... | Class II | Arrow International Inc |
| Dec 21, 2018 | VentStar Anesthesia WT(P) 180, Catalog Number MP00374 Breathing Circuits/... | Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit ... | Class I | Draeger Medical, Inc. |
| Dec 21, 2018 | ID Circuit Basic 250, Catalog Number MP01348 Breathing Circuits/Anesthesi... | Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit ... | Class I | Draeger Medical, Inc. |
| Dec 21, 2018 | VentStar Basic (P) 180, Catalog Number MP00351 Breathing Circuits/Anesthe... | Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit ... | Class I | Draeger Medical, Inc. |
| Dec 21, 2018 | VentStar Basic 180, Catalog Number MP00349 Breathing Circuits/Anesthesia ... | Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit ... | Class I | Draeger Medical, Inc. |
| Dec 21, 2018 | VentStar Basic (P) 250, Catalog Number MP00352 Breathing Circuits/Anesthe... | Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit ... | Class I | Draeger Medical, Inc. |
| Dec 21, 2018 | ID Circuit Watertrap (P) 180, Catalog Number MP01341 Breathing Circuits/... | Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit ... | Class I | Draeger Medical, Inc. |
| Dec 21, 2018 | VentStar Basic 250, Catalog Number MP00350 Breathing Circuits/Anesthesia S... | Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit ... | Class I | Draeger Medical, Inc. |
| Dec 21, 2018 | VentStar Watertrap (P) 180, Catalog Number MP00361 Breathing Circuits/Ane... | Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit ... | Class I | Draeger Medical, Inc. |
| Dec 21, 2018 | ID Circuit Basic 180, Catalog Number MP01350 Breathing Circuits/Anesthesi... | Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit ... | Class I | Draeger Medical, Inc. |
| Dec 17, 2018 | Olympus GF-UCT180 Ultrasound Gastrovideoscope - Product Usage: These endoscop... | The adhesive used in the repair of the endoscope was incorrectly prepared. It is unknown what af... | Class II | Olympus Corporation of the Americas |
| Dec 17, 2018 | Olympus GIF-H180J Gastrointestinal Videoscope - Product Usage: These endoscop... | The adhesive used in the repair of the endoscope was incorrectly prepared. It is unknown what af... | Class II | Olympus Corporation of the Americas |
| Dec 17, 2018 | Olympus TJF-Q180V Duodenoscope - Product Usage: These endoscopes are intended... | The adhesive used in the repair of the endoscope was incorrectly prepared. It is unknown what af... | Class II | Olympus Corporation of the Americas |
| Dec 17, 2018 | Olympus PCF-Q180AC Video Colonoscope - Product Usage: These endoscopes are in... | The adhesive used in the repair of the endoscope was incorrectly prepared. It is unknown what af... | Class II | Olympus Corporation of the Americas |
| Dec 14, 2018 | MAVIG Portegra or Portegra2 Overhead Counterpoise System (OCS) used in conjun... | If the head mount knob is not properly tightened and the operator directly uses the injector head... | Class II | Bayer Medical Care, Inc. |
| Dec 13, 2018 | Arrow PICC powered by Arrow VPS Precision Stylet Product Code:CDC-45052-VPS2... | Kits labeled as containing a 40 cm PICC may contain a 50 cm PICC, and kits labeled as containing ... | Class II | Arrow International Inc |
| Dec 13, 2018 | Arrow PICC powered by Arrow VPS Precision Stylet Product Code:CDC-44052-VPS2... | Kits labeled as containing a 40 cm PICC may contain a 50 cm PICC, and kits labeled as containing ... | Class II | Arrow International Inc |
| Dec 6, 2018 | Vyon DUALSTOP White Cap used for intravascular lines Product Code: 9888.002-... | DualStop Caps defect causing leaks in affected product | Class II | Vygon U.S.A. |
| Dec 6, 2018 | Vygon DUALSTOP Red Cap used for intravascular lines Product Code: 9888.00 - ... | DualStop Caps defect causing leaks in affected product | Class II | Vygon U.S.A. |
| Nov 29, 2018 | Sensis Vibe System, Model Number 11007642, with software version VD10B. | A software error may result in a system crash. The system must be restarted before the clinical ... | Class II | Siemens Medical Solutions USA, Inc |
| Nov 14, 2018 | Arrow CVC 2 Lumen, Pediatric Two-Lumen Central Venous Cauterization Set with ... | The lidstock states the incorrect priming volume and flow rates. | Class II | Arrow International Inc |
| Oct 26, 2018 | Artis Zee and Zeego, model no. 10272462 AXIOM Artis zee/Zeego is a family ... | This recall has been initiated due to a possible leakage of a hose in the cooling unit of the X-r... | Class II | Siemens Medical Solutions USA, Inc |
| Oct 19, 2018 | ARTIS zee biplane systems with Material 10094141- a Angiographic x-ray system... | Vibrations of the C-arm of the plane B may result in reduced image quality caused by the screw co... | Class II | Siemens Medical Solutions USA, Inc |
| Oct 19, 2018 | ARTIS Q.zen biplane with Material 10848355 - a Angiographic x-ray system ... | Vibrations of the C-arm of the plane B may result in reduced image quality caused by the screw co... | Class II | Siemens Medical Solutions USA, Inc |
| Oct 19, 2018 | ARTIS Q biplane with Material 10848282- - a Angiographic x-ray system Pro... | Vibrations of the C-arm of the plane B may result in reduced image quality caused by the screw co... | Class II | Siemens Medical Solutions USA, Inc |
| Oct 2, 2018 | AF 550 x 5ML/HR CPNB, Product code MC0050XL CPNB, Arrow AutoFuser Disposable ... | Possible cracks on the body of the fill port connector, which may result in a leak. If the leak i... | Class II | Arrow International Inc |
| Oct 2, 2018 | AF 550 x 5ML/H FH DL 30hole SAT C,4"IN, Product code MC0050XLYK2 CP, Arrow Au... | Possible cracks on the body of the fill port connector, which may result in a leak. If the leak i... | Class II | Arrow International Inc |
| Oct 2, 2018 | AF w/AS 550x 0.5 7 ml/hr, 5ml 30 LO CPNB, Product code MVAX30XL CPNB, Arrow A... | Possible cracks on the body of the fill port connector, which may result in a leak. If the leak i... | Class II | Arrow International Inc |
| Oct 2, 2018 | AF550x5ML/H 2ML 60LO 6" CATH, 4.5" IN, Product code MT5060XLSK5 CP, Arrow Aut... | Possible cracks on the body of the fill port connector, which may result in a leak. If the leak i... | Class II | Arrow International Inc |
| Oct 2, 2018 | AF 550 x 8ML/HR 2ML 15LO CPNBMT8015XL CP, Product code MT8015XL CPNB, Arrow A... | Possible cracks on the body of the fill port connector, which may result in a leak. If the leak i... | Class II | Arrow International Inc |
| Oct 2, 2018 | 0F 550 x 8ML/HR 2ML 60LO CPNB, Product code MT8060XL CPNB, Arrow AutoFuser Di... | Possible cracks on the body of the fill port connector, which may result in a leak. If the leak i... | Class II | Arrow International Inc |
| Oct 2, 2018 | AF 550x8ML/H 2ML 15LO 8.7" DUAL CATHS, 4, Product code MT8015XLYK10 CP, Arrow... | Possible cracks on the body of the fill port connector, which may result in a leak. If the leak i... | Class II | Arrow International Inc |
| Oct 2, 2018 | AF w/AS 550 x 0.5-7 ml,w/Y site,DL CPNB, Product code MVAXL2Y CPNB, Arrow Aut... | Possible cracks on the body of the fill port connector, which may result in a leak. If the leak i... | Class II | Arrow International Inc |
| Oct 2, 2018 | AF 550 x 5ML/HR 2ML 60LO CPNB, Product code MT5060XL CPNB, Arrow AutoFuser Di... | Possible cracks on the body of the fill port connector, which may result in a leak. If the leak i... | Class II | Arrow International Inc |
| Oct 2, 2018 | AF550x5ML/H 2ML 60LO 6" DUAL CATHS, 4.5", Product MT5060XLYK5 CP, Arrow AutoF... | Possible cracks on the body of the fill port connector, which may result in a leak. If the leak i... | Class II | Arrow International Inc |
| Oct 2, 2018 | AF w/AS 550 x 1-14ML/HR 5ML-60LO CPNB, Product code MVBX60XL CPNB, Arrow Auto... | Possible cracks on the body of the fill port connector, which may result in a leak. If the leak i... | Class II | Arrow International Inc |
| Oct 2, 2018 | AF w/AS 550 x 1-14ML/HR 2ML-15LO CPNB, Product code MVBT15XL-CPNB, Arrow Auto... | Possible cracks on the body of the fill port connector, which may result in a leak. If the leak i... | Class II | Arrow International Inc |
| Oct 2, 2018 | AF w/AS 550 x 1-14ML/HR 2ML-30LO CPNB, Product code MVBT30XL CPNB, Arrow Auto... | Possible cracks on the body of the fill port connector, which may result in a leak. If the leak i... | Class II | Arrow International Inc |
| Oct 2, 2018 | AF 550 x 5ML/H 6" DUAL CATHS, 4.5", Product code MC0050XLYK5 CP, Arrow AutoFu... | Possible cracks on the body of the fill port connector, which may result in a leak. If the leak i... | Class II | Arrow International Inc |
| Oct 2, 2018 | AF 550 x 5ML/H 6" CATH, 4.5" IN, Product code MC0050XLSK5 CP, Arrow AutoFuser... | Possible cracks on the body of the fill port connector, which may result in a leak. If the leak i... | Class II | Arrow International Inc |
| Oct 2, 2018 | AF w/AS 550 x 1-14 ml/hr, 5ml30 LOCPNB, Product code MVBX30XLCPNB, Arrow Auto... | Possible cracks on the body of the fill port connector, which may result in a leak. If the leak i... | Class II | Arrow International Inc |
| Oct 2, 2018 | AF w/AS 550 x 1-14ML/HR CPNB, Product code MVBXL- CPNB, Arrow AutoFuser Dispo... | Possible cracks on the body of the fill port connector, which may result in a leak. If the leak i... | Class II | Arrow International Inc |
| Oct 1, 2018 | C3 Wave App, v. 2.0.5 | When the iPad is updated with Apple iOS software version 12, the C3 application malfunctions. Up... | Class II | Medical Components, Inc dba MedComp |
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.