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 |
|---|---|---|---|---|
| Aug 18, 2026 | POWERSEAL 5 MM (in diameter) 23 CM (long), Curved Jaw Sealer & Divider, Doubl... | Potential labeling deficiency in which an outer shelf box is incorrectly labeled as a 37-cm device. | Class II | Olympus Corporation of the Americas |
| Jul 9, 2026 | Grandio Universal Nano-Hybrid Restorative Material - Capsules 0.25Gm, Product... | Specific lots were distributed in the US with incorrect packaging and Instructions for Use (IFU) ... | Class II | Henry Schein Inc. |
| Jul 9, 2026 | Structur 2 SC Temporary Resin Cartridge Refill 75Gm, Product Codes: 1) 114... | Specific lots were distributed in the US with incorrect packaging and Instructions for Use (IFU) ... | Class II | Henry Schein Inc. |
| Jul 8, 2026 | TD Navio Maxi Speech Generating Device Model/Catalog Number: 1000799 | Under certain conditions, the battery mounting tabs may become damaged, allowing the battery to m... | Class II | Tobii Dynavox Llc |
| Jul 8, 2026 | TD Navio Midi Speech Generating Device Model/Catalog Number: 1000798 | Under certain conditions, the battery mounting tabs may become damaged, allowing the battery to m... | Class II | Tobii Dynavox Llc |
| Jul 7, 2026 | Olympus 4K UHD LCD Monitor. Model Number: OEV321UH. An electrically powere... | Potential for the HDMI and DisplayPort (DP) connectors can become faulty resulting in image loss ... | Class II | Olympus Corporation of the Americas |
| Jun 25, 2026 | Brand Name: Quantum Rehab Product Name: Quantum 4Front 2HD Model/Catalog Nu... | If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appe... | Class II | Pride Mobility Products Corp. |
| Jun 25, 2026 | Brand Name: Quantum Rehab Product Name: Q6 Edge 2.0 (ilevel) Model/Catalog ... | If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appe... | Class II | Pride Mobility Products Corp. |
| Jun 25, 2026 | Brand Name: Quantum Rehab Product Name: Q6 Edge 4 Model/Catalog Number: Q6 ... | If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appe... | Class II | Pride Mobility Products Corp. |
| Jun 25, 2026 | Brand Name: Quantum rehab Product Name: Q6 Edge 2.0 Model/Catalog Number: Q... | If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appe... | Class II | Pride Mobility Products Corp. |
| Jun 25, 2026 | Brand Name: Quantum Rehab Product Name: Q6 Edge 3 Model/Catalog Number: Q6 ... | If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appe... | Class II | Pride Mobility Products Corp. |
| Jun 25, 2026 | Brand Name: Quantum Rehab Product Name: R-TRAK Model/Catalog Number: R-TRAK... | If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appe... | Class II | Pride Mobility Products Corp. |
| Jun 25, 2026 | Brand Name: Quantum Rehab Product Name: Quantum Rival Model/Catalog Number:... | If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appe... | Class II | Pride Mobility Products Corp. |
| Jun 25, 2026 | Brand Name: Quantum Rehab Product Name: Q6 Edge HD Model/Catalog Number: Q6... | If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appe... | Class II | Pride Mobility Products Corp. |
| Jun 25, 2026 | Brand Name: Quantum Rehab Product Name: Quantum 1450 Model/Catalog Number: ... | If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appe... | Class II | Pride Mobility Products Corp. |
| Jun 25, 2026 | Brand Name: Quantum Rehab Product Name: 4Front Model/Catalog Number: 4Front... | If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appe... | Class II | Pride Mobility Products Corp. |
| Jun 25, 2026 | Brand Name: Quantum Rehab Product Name: Quantum 4Front 2 Model/Catalog Numb... | If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appe... | Class II | Pride Mobility Products Corp. |
| Jun 25, 2026 | Brand Name: Quantum Rehab Product Name: Quantum Outback Model/Catalog Numbe... | If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appe... | Class II | Pride Mobility Products Corp. |
| Jun 25, 2026 | Brand Name: Quantum Rehab Product Name: Q6 Edge 3 Stretto Model/Catalog Num... | If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appe... | Class II | Pride Mobility Products Corp. |
| Jun 16, 2026 | Olympus High Flow Insufflation Unit - UHI-4. Model Number: UHI-4 | Potential for unexpected instances where the front panel display turns off unexpectedly, and air ... | Class II | Olympus Corporation of the Americas |
| Jun 8, 2026 | ARTIS icono ceiling. Model Number: 11328100. | Potential issue with the Display ceiling suspension (DCS Fix XL) that holds the monitor in place.... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 5, 2026 | Olympus Single Use Distal Cover, Catalog Number MAJ-2315, Used with: EVIS EXE... | Olympus has developed and released newly designed version of the Distal Cover (MAJ-2315) to repla... | Class II | Olympus Corporation of the Americas |
| May 20, 2026 | ARTIS icono ceiling. Model Number: 11328100. | Potential for loss of movement capability after adjusting the detector lift height to its maximum... | Class II | Siemens Medical Solutions USA, Inc |
| May 20, 2026 | ARTIS icono biplane. Model Number: 11327600. | Potential for loss of movement capability after adjusting the detector lift height to its maximum... | Class II | Siemens Medical Solutions USA, Inc |
| May 20, 2026 | ARTIS icono floor. Model Number: 11327700. | Potential for loss of movement capability after adjusting the detector lift height to its maximum... | Class II | Siemens Medical Solutions USA, Inc |
| May 7, 2026 | Atlan A350. Model Number: 8211500. anesthesia workstation | The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use o... | Class I | Draeger, Inc. |
| May 7, 2026 | Atlan A350XL. Model Number: 8621600. anesthesia workstation | The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use o... | Class I | Draeger, Inc. |
| May 6, 2026 | Design Options Spinal Tray Spinal Needle Anesthesia procedure kits: Materia... | These procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP. The manufactur... | Class I | B Braun Medical Inc |
| May 6, 2026 | Spinal Needle procedure kits: Material Description (Material Number) 24GA.... | These procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP. The manufactur... | Class I | B Braun Medical Inc |
| May 6, 2026 | Spinocan Spinal Needle procedure kits: Material Description (Material Numbe... | These procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP. The manufactur... | Class I | B Braun Medical Inc |
| May 5, 2026 | Olympus Toomey Evacuator 50cc with Adaptor. Model Number: 188A. | Some sterilization parameters included in the IFU may not consistently render the devices adequat... | Class II | Olympus Corporation of the Americas |
| May 5, 2026 | Olympus Glass Body for 194 Ellik Evacuator. Model Number: 190A. | Some sterilization parameters included in the IFU may not consistently render the devices adequat... | Class II | Olympus Corporation of the Americas |
| May 5, 2026 | Olympus Toomey Evacuator 30cc with Adaptor. Model Number: 188. | Some sterilization parameters included in the IFU may not consistently render the devices adequat... | Class II | Olympus Corporation of the Americas |
| May 5, 2026 | Olympus Ellik Evacuator Includes Glass Body, Male Connecting Tubing & Latex B... | Some sterilization parameters included in the IFU may not consistently render the devices adequat... | Class II | Olympus Corporation of the Americas |
| Apr 24, 2026 | Avanta Multi-Patient Administration Tube Sets (AVA 500 MPAT (Part 2 of 2)) us... | Supplier changes resulted in a fit issue with the Contrast Flow Control Valve (CFCV) interface on... | Class II | Bayer Medical Care, Inc. |
| Mar 25, 2026 | Rolls of label stock used with the Omnicell i.v.Station. 1. Part Number ... | Potential for mislabeled syringe produced by the i.v.STATION device. | Class I | Omnicell, Inc. |
| Mar 25, 2026 | OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2... | Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely. | Class II | Olympus Corporation of the Americas |
| Mar 25, 2026 | OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2... | Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely. | Class II | Olympus Corporation of the Americas |
| Mar 25, 2026 | OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2111 | Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely. | Class II | Olympus Corporation of the Americas |
| Mar 25, 2026 | OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2... | Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely. | Class II | Olympus Corporation of the Americas |
| Mar 25, 2026 | OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2... | Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely. | Class II | Olympus Corporation of the Americas |
| Mar 25, 2026 | OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2112 | Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely. | Class II | Olympus Corporation of the Americas |
| Mar 25, 2026 | OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2... | Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely. | Class II | Olympus Corporation of the Americas |
| Mar 25, 2026 | OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2... | Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely. | Class II | Olympus Corporation of the Americas |
| Mar 25, 2026 | OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2... | Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely. | Class II | Olympus Corporation of the Americas |
| Mar 25, 2026 | OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2... | Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely. | Class II | Olympus Corporation of the Americas |
| Mar 25, 2026 | OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2... | Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely. | Class II | Olympus Corporation of the Americas |
| Mar 25, 2026 | OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2... | XXX | Class II | Olympus Corporation of the Americas |
| Mar 23, 2026 | Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 25cm. Model Number: TB2... | Potential for detachment of a distal tip component of the device during use. | Class II | Olympus Corporation of the Americas |
| Mar 23, 2026 | Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 35cm. Model Number: TB2... | Potential for detachment of a distal tip component of the device during use. | 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.