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 |
|---|---|---|---|---|
| Jul 1, 2024 | The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm ... | Fractures and breakages in packaging trays and Tyvek covers, which may result in a sterility breach | Class II | Olympus Corporation of the Americas |
| Jul 1, 2024 | The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm ... | Fractures and breakages in packaging trays and Tyvek covers, which may result in a sterility breach | Class II | Olympus Corporation of the Americas |
| Jun 21, 2024 | ESG-410 Electrosurgical Generator- In conjunction with electrosurgical access... | Electrosurgical Generators ESG-410 does not power on upon use, may result in delays in initiating... | Class II | Olympus Corporation of the Americas |
| Jun 17, 2024 | Infusomat SPACE PUMP IV SET, 2 CARESITES, ASV-Used with an electrically-power... | Potential for the backcheck valve to malfunction, resulting in backflow of medication from second... | Class II | B. Braun Medical, Inc. |
| Jun 17, 2024 | Infusomat SPACE PUMP IV SET W/2 CARESITE, CKVLV -Used with an electrically-... | Potential for the backcheck valve to malfunction, resulting in backflow of medication from second... | Class II | B. Braun Medical, Inc. |
| Jun 17, 2024 | OUTLOOK IV SET 15DROP W/3 CARESITE-Used with an electrically-powered infusion... | Potential for the backcheck valve to malfunction, resulting in backflow of medication from second... | Class II | B. Braun Medical, Inc. |
| Jun 17, 2024 | Infusomat UNIV. 15 DROP PUMP SET W/2 CARESITE CV- Used with an electrically-p... | Potential for the backcheck valve to malfunction, resulting in backflow of medication from second... | Class II | B. Braun Medical, Inc. |
| Jun 17, 2024 | Infusomat UNIV. 15 DR PUMP SET, 1.2 FIL, 2 CRSITE-Used with an electrically-p... | Potential for the backcheck valve to malfunction, resulting in backflow of medication from second... | Class II | B. Braun Medical, Inc. |
| Jun 17, 2024 | Infusomat SPACE PUMP IV SET 15D, 90 IN. Used with an electrically-powered in... | Potential for the backcheck valve to malfunction, resulting in backflow of medication from second... | Class II | B. Braun Medical, Inc. |
| Jun 17, 2024 | Infusomat UNIV. 15 DROP PUMP SET, 3 ULTRASITE, ASV-Used with an electrically... | Potential for the backcheck valve to malfunction, resulting in backflow of medication from second... | Class II | B. Braun Medical, Inc. |
| Jun 17, 2024 | Infusomat UNIV.15DROP PUMP SET W/3 SAFELINE LL-Used with an electrically-pow... | Potential for the backcheck valve to malfunction, resulting in backflow of medication from second... | Class II | B. Braun Medical, Inc. |
| Jun 17, 2024 | Infusomat UNIV 60 DROP PUMP SET, W/2 CARESITE INJ. -Used with an electrically... | Potential for the backcheck valve to malfunction, resulting in backflow of medication from second... | Class II | B. Braun Medical, Inc. |
| Jun 17, 2024 | Infusomat SPACE PUMP IV SET 15D, 110 IN. -Used with an electrically-powered ... | Potential for the backcheck valve to malfunction, resulting in backflow of medication from second... | Class II | B. Braun Medical, Inc. |
| Jun 17, 2024 | Outlook OUTLOOK PUMP SET,3 CARESITE LADS,115 IN. Used with an electrically-po... | Potential for the backcheck valve to malfunction, resulting in backflow of medication from second... | Class II | B. Braun Medical, Inc. |
| Jun 17, 2024 | Infusomat UNIV. 15 DROP PUMP SET W 3 CARESITE L.L. Used with an electricall... | Potential for the backcheck valve to malfunction, resulting in backflow of medication from second... | Class II | B. Braun Medical, Inc. |
| Jun 17, 2024 | Infusomat 60 DROP METRISET PUMP SET, 3 CARESITES Used with an electrically... | Potential for the backcheck valve to malfunction, resulting in backflow of medication from second... | Class II | B. Braun Medical, Inc. |
| Jun 17, 2024 | Infusomat UNIV. 15 DROP PUMP SET, 3 CARESITE, ASV-Used with an electrically-p... | Potential for the backcheck valve to malfunction, resulting in backflow of medication from second... | Class II | B. Braun Medical, Inc. |
| Jun 17, 2024 | OUTLOOK IV SET 15DROP W/2 CARESITE-Used with an electrically-powered infusion... | Potential for the backcheck valve to malfunction, resulting in backflow of medication from second... | Class II | B. Braun Medical, Inc. |
| Jun 17, 2024 | Infusomat SPACE PUMP SET 15 DROP W/2 SAFEDAY-Used with an electrically-powere... | Potential for the backcheck valve to malfunction, resulting in backflow of medication from second... | Class II | B. Braun Medical, Inc. |
| Jun 17, 2024 | Infusomat 60 DROP METRISET PUMP SET,3 SFLINE ASV-Used with an electrically-po... | Potential for the backcheck valve to malfunction, resulting in backflow of medication from second... | Class II | B. Braun Medical, Inc. |
| Jun 17, 2024 | Infusomat UNIV. 15 DROP PUMP SET W/ 0.2 FILTER- Used with an electrically-pow... | Potential for the backcheck valve to malfunction, resulting in backflow of medication from second... | Class II | B. Braun Medical, Inc. |
| Jun 17, 2024 | Infusomat UNIV. 15 DROP PUMP SET W/ 3 ULTRASITE LL-Used with an electrically-... | Potential for the backcheck valve to malfunction, resulting in backflow of medication from second... | Class II | B. Braun Medical, Inc. |
| Jun 17, 2024 | Infusomat UNIV. 15 DROP PUMP SET, 2 CARESITE, ASV-Used with an electrically-... | Potential for the backcheck valve to malfunction, resulting in backflow of medication from second... | Class II | B. Braun Medical, Inc. |
| Jun 17, 2024 | Infusomat 60DROP METRISET PUMP, 3 CARESITES, ASV-Used with an electrically-p... | Potential for the backcheck valve to malfunction, resulting in backflow of medication from second... | Class II | B. Braun Medical, Inc. |
| Jun 17, 2024 | Infusomat SPACE PUMP IV SET , 120 IN.- Used with an electrically-powered infu... | Potential for the backcheck valve to malfunction, resulting in backflow of medication from second... | Class II | B. Braun Medical, Inc. |
| Jun 17, 2024 | Infusomat UNIV. 15 DROP PUMP SET W/3 SAFELINE, ASV-Used with an electrically-... | Potential for the backcheck valve to malfunction, resulting in backflow of medication from second... | Class II | B. Braun Medical, Inc. |
| Jun 17, 2024 | Infusomat SPACE PUMP IV SET, 127 IN.-Used with an electrically-powered infus... | Potential for the backcheck valve to malfunction, resulting in backflow of medication from second... | Class II | B. Braun Medical, Inc. |
| Jun 17, 2024 | Infusomat UNIV. 15 DR PUMP SET, 1.2FIL, 2CRSTE ASV-Used with an electrically... | Potential for the backcheck valve to malfunction, resulting in backflow of medication from second... | Class II | B. Braun Medical, Inc. |
| Jun 17, 2024 | Infusomat UNIV. 60 DROP PUMP SET, 2 CARESITES, ASV-Used with an electrically-... | Potential for the backcheck valve to malfunction, resulting in backflow of medication from second... | Class II | B. Braun Medical, Inc. |
| Jun 17, 2024 | Infusomat 60DROP METRISET PUMP SET, 3 SAFELINE-Used with an electrically-pow... | Potential for the backcheck valve to malfunction, resulting in backflow of medication from second... | Class II | B. Braun Medical, Inc. |
| Jun 17, 2024 | Infusomat UNIV. 15 DROP PUMP SET, 3 CARESITE, ASV-Used with an electrically-p... | Potential for the backcheck valve to malfunction, resulting in backflow of medication from second... | Class II | B. Braun Medical, Inc. |
| Jun 17, 2024 | OUTLOOK PUMP SET 3 CARESITE LADS 133 IN.-Used with an electrically-powered in... | Potential for the backcheck valve to malfunction, resulting in backflow of medication from second... | Class II | B. Braun Medical, Inc. |
| Jun 14, 2024 | Brand Name: Perfusor Space Product Name: Perfusor Space Syringe Pump, Non-Wi... | Perfusor Space Syringe Pump's instructions for use previously identified Monoject syringes as an ... | Class II | B Braun Medical Inc |
| Jun 14, 2024 | Brand Name: Perfusor Space Product Name: Perfusor Space Infusion Pump System... | Perfusor Space Syringe Pump's instructions for use previously identified Monoject syringes as an ... | Class II | B Braun Medical Inc |
| Jun 14, 2024 | Brand Name: Perfusor Space Product Name: PERFUSOR SPACE ACM-KIT Model/Catal... | Perfusor Space Syringe Pump's instructions for use previously identified Monoject syringes as an ... | Class II | B Braun Medical Inc |
| Jun 14, 2024 | Brand Name: Perfusor Space Product Name: Perfusor PCA Syringe Pump Model/Ca... | Perfusor Space Syringe Pump's instructions for use previously identified Monoject syringes as an ... | Class II | B Braun Medical Inc |
| Jun 14, 2024 | Brand Name: Perfusor Space Product Name: Perfusor Space Syringe Pump, Wirele... | Perfusor Space Syringe Pump's instructions for use previously identified Monoject syringes as an ... | Class II | B Braun Medical Inc |
| May 31, 2024 | Soltive Pro SuperPulsed Laser System, Model TFL-SLS | Difficulties in pairing the wireless footswitch with the Soltive Laser, potentially delaying the ... | Class II | Olympus Corporation of the Americas |
| May 31, 2024 | Soltive SuperPulsed Laser System Wireless Footswitch, Model TFL-AFSWL | Difficulties in pairing the wireless footswitch with the Soltive Laser, potentially delaying the ... | Class II | Olympus Corporation of the Americas |
| May 31, 2024 | ZE for Vertix Solitaire - The AXIOM Vertix Solitaire is a component and has b... | Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire | Class II | Siemens Medical Solutions USA, Inc |
| May 31, 2024 | AXIOM MULTIX MT - Intended Radiographic X ray Table is a patient table used i... | Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire | Class II | Siemens Medical Solutions USA, Inc |
| May 31, 2024 | AXIOM MULTIX MT - Intended Radiographic X ray Table is a patient table used i... | Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire | Class II | Siemens Medical Solutions USA, Inc |
| May 31, 2024 | AXIOM Vertix Solitaire - The Vertix MD Trauma has been specially designed for... | Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire | Class II | Siemens Medical Solutions USA, Inc |
| May 31, 2024 | AXIOM MULTIX MP - Intended Radiographic X ray Table is a patient table used i... | Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire | Class II | Siemens Medical Solutions USA, Inc |
| May 31, 2024 | MULTIX TOP - Intended Use: The Multix TOP I PRO Radiographic X ray Table is a... | Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire | Class II | Siemens Medical Solutions USA, Inc |
| May 31, 2024 | AXIOM MULTIX MP - Inended Radiographic X ray Table is a patient table used in... | Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire | Class II | Siemens Medical Solutions USA, Inc |
| May 31, 2024 | Soltive Premium SuperPulsed Laser System, Model TFL-PLS | Difficulties in pairing the wireless footswitch with the Soltive Laser, potentially delaying the ... | Class II | Olympus Corporation of the Americas |
| May 31, 2024 | MULTIX TOP - Intended Use: The Multix TOP I PRO Radiographic X ray Table is a... | Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire | Class II | Siemens Medical Solutions USA, Inc |
| May 31, 2024 | AXIOM Vertix MD - The Vertix MD Trauma has been specially designed for examin... | Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire | Class II | Siemens Medical Solutions USA, Inc |
| May 30, 2024 | Titan Blis-Sonic Scaler packaged with the Titan Scaler Tip - Perio (part numb... | Tip holder portion of the scaler tip assembly may have an oversized condition that will not allow... | Class II | Dental EZ Group Star Dental Division |
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.