Browse Device Recalls
2,969 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,969 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 2,969 FDA device recalls in PA.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| Sep 21, 2018 | Arrow AGB+ Multi-Lumen CVC Kit, 7 Fr., 3 Lumen, 20cm catheter length, .025 in... | The products labeling contains inconsistencies. In certain instances, the lidstock, banner card ... | Class II | Arrow International Inc |
| Sep 12, 2018 | 3.0mm Headless Compression Screw, Long Thread 18mm, Part Number 04.226.118 ... | The product inside the package does not match the label. The product was labeled as long thread ... | Class II | Synthes (USA) Products LLC |
| Sep 7, 2018 | Codan Filter (Codan catalog number BC 693) used with Medrad Patient Administr... | Bayer has received reports of loose particulate in the filter when the dust cap is removed. Bayer... | Class II | Bayer Medical Care, Inc. |
| Aug 30, 2018 | Arrow AGB + Multi-Lumen CVC Kit, Cat. No. CDC-42703-B1A. Product Usage - The ... | The product was shipped after its expiry date due to a system error. The product lidstock identi... | Class II | Arrow International Inc |
| Aug 28, 2018 | CyPass System 241, Intraocular Pressure Lowering Implant, CYPASS MICRO-STENT,... | Analysis of the completed dataset from the COMPASS-XT long-term study showed that the CyPass Micr... | Class I | Alcon Research, LTD. |
| Aug 28, 2018 | CyPass ULTRA SYSTEM, CYPASS MICRO-STENT, CYPASS APPLIER, REF CATALOG #: 8065... | Analysis of the completed dataset from the COMPASS-XT long-term study showed that the CyPass Micr... | Class I | Alcon Research, LTD. |
| Aug 28, 2018 | CyPass System 241, Intraocular Pressure Lowering Implant, CYPASS MICRO-STENT,... | Analysis of the completed dataset from the COMPASS-XT long-term study showed that the CyPass Micr... | Class I | Alcon Research, LTD. |
| Aug 28, 2018 | CyPass System 241-S, CYPASS MICRO-STENT, CYPASS LOADED, CYPASS APPLIER, REF C... | Analysis of the completed dataset from the COMPASS-XT long-term study showed that the CyPass Micr... | Class I | Alcon Research, LTD. |
| Aug 8, 2018 | Bronchovideoscope BF-3C160 | The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have ... | Class II | Olympus Corporation of the Americas |
| Aug 8, 2018 | Bronchovideoscope BF-P160 | The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have ... | Class II | Olympus Corporation of the Americas |
| Aug 8, 2018 | Bronchovidescope BF-1T240 | The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have ... | Class II | Olympus Corporation of the Americas |
| Aug 8, 2018 | Bronchovideoscope BF-1T40 | The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have ... | Class II | Olympus Corporation of the Americas |
| Aug 8, 2018 | Bronchofiberscope BF-40 | The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have ... | Class II | Olympus Corporation of the Americas |
| Aug 8, 2018 | Bronchovideoscope BF-1T180 | The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have ... | Class II | Olympus Corporation of the Americas |
| Aug 8, 2018 | Bronchovideoscope BF-MP60 | The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have ... | Class II | Olympus Corporation of the Americas |
| Aug 8, 2018 | Ultrasonic Bronchoscope BF-UC180F | The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have ... | Class II | Olympus Corporation of the Americas |
| Aug 8, 2018 | Bronchofiberscope BF-P40 | The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have ... | Class II | Olympus Corporation of the Americas |
| Aug 8, 2018 | Bronchovideoscope BF-P180 | The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have ... | Class II | Olympus Corporation of the Americas |
| Aug 8, 2018 | Bronchovideoscope BF-MP160F | The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have ... | Class II | Olympus Corporation of the Americas |
| Aug 8, 2018 | Bronchovideoscope BF-3C40 | The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have ... | 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.