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 |
|---|---|---|---|---|
| Aug 8, 2018 | Bronchofiberscope BF-P60 | 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-1T60 | 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 | Airway Mobilescope MAF-TM | 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-XT40 | 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-160 | 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-XP60 | 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-XP40 | 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-Q180-AC | 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-Q180 | 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 | Bronchofibercope BF-6C240 | 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-XT160 | 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-P240 | 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 F-1TQ180 | 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 F-1T160 | 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-UC160F-OL8 | 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-240 | 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 | Rhino Laryngo scope ENF-VT2 | 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-XP160F | The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have ... | Class II | Olympus Corporation of the Americas |
| Aug 6, 2018 | AXIOM Multix MT (model number 8395415 or 8395399 or 8395381), a patient table... | In rare cases of high clinical workload, the steel cables inside the lifting column of the overhe... | Class II | Siemens Medical Solutions USA, Inc |
| Aug 6, 2018 | Ysio (model number 10281013 or 10281163) with Tube stand 3D V (model number 7... | In rare cases of high clinical workload, the steel cables inside the lifting column of the overhe... | Class II | Siemens Medical Solutions USA, Inc |
| Aug 6, 2018 | Ysio MAX (model number 10762470) with Tube stand 3D V (model number 7042018 o... | In rare cases of high clinical workload, the steel cables inside the lifting column of the overhe... | Class II | Siemens Medical Solutions USA, Inc |
| Aug 3, 2018 | Multix Fusion system is a radiographic system: Models: Multix Fusion Analog... | Steel cables inside the lifting column of the overhead tube, may rapture without triggering the ... | Class II | Siemens Medical Solutions USA, Inc |
| Jul 30, 2018 | ARROW¿ Bipolar Electrode Catheter with shrouded pins , 6 Fr, 110 cm Product ... | Products are labeled with an incorrect expiration date | Class II | Arrow International Inc |
| Jul 29, 2018 | Artis Q Interventional Fluoroscopic X-Ray System, Model Numbers 10848280, 108... | Temperature of the detector may fall out of its designed working range (cool down) due to incorre... | Class II | Siemens Medical Solutions USA, Inc |
| Jul 29, 2018 | ARTIS Pheno Interventional Fluoroscopic X-Ray System, Model Number 10849000 | Temperature of the detector may fall out of its designed working range (cool down) due to incorre... | Class II | Siemens Medical Solutions USA, Inc |
| Jul 20, 2018 | CE17TB19C CONT EPIDURAL TRAY, Material Number 332242 Connection device us... | The catheter connectors may not stay closed during in and in some cases, leakage or disconnection... | Class II | B. Braun Medical, Inc. |
| Jul 20, 2018 | CE17TKFMHDT 17 GA X 4 FULL EPID KIT, Material Number 332096 Connection de... | The catheter connectors may not stay closed during in and in some cases, leakage or disconnection... | Class II | B. Braun Medical, Inc. |
| Jul 20, 2018 | GOVCE18TK ACCU-BLOC PERIFIX KIT, Material Number 332600 Connection device... | The catheter connectors may not stay closed during in and in some cases, leakage or disconnection... | Class II | B. Braun Medical, Inc. |
| Jul 20, 2018 | CE17TKFPS PERIFIX FX CONT. EPID TRAY-LF, Material Number 332087 Connectio... | The catheter connectors may not stay closed during in and in some cases, leakage or disconnection... | Class II | B. Braun Medical, Inc. |
| Jul 20, 2018 | CE17TOD CONT EPIDURAL TRAY LF, Material Number 332235 Connection device u... | The catheter connectors may not stay closed during in and in some cases, leakage or disconnection... | Class II | B. Braun Medical, Inc. |
| Jul 20, 2018 | CLAMP STYLE CATH. CONNECTOR 18-19 GA- LF, Material Number 332285 Connecti... | The catheter connectors may not stay closed during in and in some cases, leakage or disconnection... | Class II | B. Braun Medical, Inc. |
| Jul 20, 2018 | CE18TOD CONT EPIDURAL TRAY LF, Material Number 332236 Connection device u... | The catheter connectors may not stay closed during in and in some cases, leakage or disconnection... | Class II | B. Braun Medical, Inc. |
| Jul 20, 2018 | CE17TKFSA FULL TRAY W/17G TUOHY 19G SPRW, Material Number 332080 Connecti... | The catheter connectors may not stay closed during in and in some cases, leakage or disconnection... | Class II | B. Braun Medical, Inc. |
| Jul 20, 2018 | CNB400TU3KUE 18GX4 CONTI THY ULTRA 360, Material Number 332170 Connection... | The catheter connectors may not stay closed during in and in some cases, leakage or disconnection... | Class II | B. Braun Medical, Inc. |
| Jul 20, 2018 | CE17TK CONT EPIDURALTUOHY, Material Number 332221 Connection device used ... | The catheter connectors may not stay closed during in and in some cases, leakage or disconnection... | Class II | B. Braun Medical, Inc. |
| Jul 20, 2018 | CE18TKO PERIFIX ONE EPIDURAL FULL TRAY, Material Number 332282 Connection... | The catheter connectors may not stay closed during in and in some cases, leakage or disconnection... | Class II | B. Braun Medical, Inc. |
| Jul 20, 2018 | ES1827KDS SPINAL/EPIDURAL FULL KIT, Material Number 333194 Connection dev... | The catheter connectors may not stay closed during in and in some cases, leakage or disconnection... | Class II | B. Braun Medical, Inc. |
| Jul 20, 2018 | ES1827K SPINAL/EPIDURAL TRAY (LF), Material Number 333192 Connection devi... | The catheter connectors may not stay closed during in and in some cases, leakage or disconnection... | Class II | B. Braun Medical, Inc. |
| Jul 20, 2018 | CE18HKST CONT EPID 20G SOFTIP, Material Number 332084 Connection device u... | The catheter connectors may not stay closed during in and in some cases, leakage or disconnection... | Class II | B. Braun Medical, Inc. |
| Jul 20, 2018 | CNB200T CONTIPLEX TUOHY SET 2 IN, Material Number 331691 Connection devic... | The catheter connectors may not stay closed during in and in some cases, leakage or disconnection... | Class II | B. Braun Medical, Inc. |
| Jul 20, 2018 | CONT STIM BASIC KIT W/4 IN INSUL TUOHY, Material Number 331758 Connection... | The catheter connectors may not stay closed during in and in some cases, leakage or disconnection... | Class II | B. Braun Medical, Inc. |
| Jul 20, 2018 | CONTIPLEX TUOHY SET, 18GX11/2X 1,3X40MM, Material Number 331695 Connectio... | The catheter connectors may not stay closed during in and in some cases, leakage or disconnection... | Class II | B. Braun Medical, Inc. |
| Jul 20, 2018 | CNB400TK CONTIPLEX CONT NERVE BLOCK, Material Number 331706 Connection de... | The catheter connectors may not stay closed during in and in some cases, leakage or disconnection... | Class II | B. Braun Medical, Inc. |
| Jul 20, 2018 | CE17TKFC EPIDURAL TRAY W/ 17GA TUOHY, Material Number 332079 Connection d... | The catheter connectors may not stay closed during in and in some cases, leakage or disconnection... | Class II | B. Braun Medical, Inc. |
| Jul 20, 2018 | CE17TKFS EPIDURAL TRAY, Material Number 332098 Connection device used by ... | The catheter connectors may not stay closed during in and in some cases, leakage or disconnection... | Class II | B. Braun Medical, Inc. |
| Jul 20, 2018 | CNBFX350C CONTIPLEX CONT NERVE BLOCK, Material Number 331672 Connection d... | The catheter connectors may not stay closed during in and in some cases, leakage or disconnection... | Class II | B. Braun Medical, Inc. |
| Jul 20, 2018 | CE18HK ACCU-BLOC PERIFIX KIT, Material Number 332230 Connection device us... | The catheter connectors may not stay closed during in and in some cases, leakage or disconnection... | Class II | B. Braun Medical, Inc. |
| Jul 20, 2018 | GOVES1827K SPINAL/EPIDURAL TRAY (LF), Material Number 332614 Connection d... | The catheter connectors may not stay closed during in and in some cases, leakage or disconnection... | Class II | B. Braun Medical, Inc. |
| Jul 20, 2018 | CE18TIN CONT EPIDURAL SET LF, Material Number 332201 Connection device us... | The catheter connectors may not stay closed during in and in some cases, leakage or disconnection... | Class II | B. Braun Medical, Inc. |
| Jul 20, 2018 | CNB200S CONTIPLEX INSULATED TUOHY NDL, Material Number 331697 Connection ... | The catheter connectors may not stay closed during in and in some cases, leakage or disconnection... | Class II | B. Braun Medical, 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.