Browse Device Recalls
3,276 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,276 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 3,276 FDA device recalls in 2024.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 | Afinion 2 Analyzer, model #1116986, US refurbished, CLIA waived. | Five Afinion 2 (AF2) Analyzer were incorrectly market configured as Moderate Complexity and distr... | Class II | Abbott Diagnostics Technologies AS |
| 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 | Medtronic Handset with Communicator, Model TH90Q01, InterStim Smart Programm... | A subset of the handsets within the kit may not be able to complete the pairing process with the ... | Class II | Medtronic Neuromodulation |
| 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 | Brand Name: MEGADYNE" MEGA SOFT" Reusable Patient Return Electrode Product N... | To limit the use of the Mega Soft Pads to patients aged 12 or older to mitigate the potential ris... | Class I | Megadyne Medical Products, 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 | Brivo MR355, with affected software versions: SV20.3, SV23.3, MR30.0, MR30.1... | GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... | Class II | GE Medical Systems, LLC |
| 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 | Nitro Glide Knee Walker-offers users recovering from a below-the-knee injury ... | The tiller separates from the base/front caster assembly. If the knee walker fails, a user may fa... | Class II | Medical Depot Inc. |
| Jun 14, 2024 | Discovery MR750w 3.0T, with affected software versions: DV24.0, DV25.0, DV25... | GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... | Class II | GE Medical Systems, LLC |
| Jun 14, 2024 | SIGNA Pioneer, with affected software versions: PX25.0 to PX25.5, PX26.0, PX... | GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... | Class II | GE Medical Systems, LLC |
| Jun 14, 2024 | SIGNA Prime, with affected software versions: MR30.1; Nuclear Magnetic Reson... | GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... | Class II | GE Medical Systems, LLC |
| Jun 14, 2024 | Nitro Glide Knee Walker-offers users recovering from a below-the-knee injury ... | The tiller separates from the base/front caster assembly. If the knee walker fails, a user may f... | Class II | Medical Depot Inc. |
| Jun 14, 2024 | 1.5T SIGNA HDxt Family, with affected software versions: HD16.0_V03 to HD16.... | GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... | Class II | GE Medical Systems, LLC |
| 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 | SIGNA MAGNUS, with affected software versions: MR29.1, RX29.1; Nuclear Magne... | GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... | Class II | GE Medical Systems, LLC |
| Jun 14, 2024 | SIGNA Premier, with affected software versions: RX27.0 to RX27.3, RX28.0, RX... | GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... | Class II | GE Medical Systems, LLC |
| Jun 14, 2024 | L-CATH PICC S/L Peripherally Inserted Central Catheter, 26Ga (1.9F) 0.60mm x ... | Peripherally Inserted Central Catheter (PICC) is labeled 26G/1.9Fr x 30cm but package contains in... | Class II | Argon Medical Devices, Inc |
| Jun 14, 2024 | SIGNA Hero, with affected software versions: PX29.1, MR30.0, MR30.1; Nuclear... | GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... | Class II | GE Medical Systems, LLC |
| Jun 14, 2024 | SIGNA Artist, with affected software versions: DV26.0, DV27.1, DV28.1, DV29.... | GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... | Class II | GE Medical Systems, LLC |
| Jun 14, 2024 | Discovery MR950, with affected software versions: 7T23.0; Nuclear Magnetic R... | GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... | Class II | GE Medical Systems, LLC |
| Jun 14, 2024 | SIGNA Victor, with affected software versions: MR30.1; Nuclear Magnetic Reso... | GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... | Class II | GE Medical Systems, LLC |
| Jun 14, 2024 | 3.0T SIGNA HDxt Family, with affected software versions: RX27.0 to RX27.3, R... | GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... | Class II | GE Medical Systems, LLC |
| Jun 14, 2024 | SIGNA 7.0T, with affected software versions: 7T29.1, MR30.1; Nuclear Magneti... | GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... | Class II | GE Medical Systems, LLC |
| Jun 14, 2024 | Discovery MR750 3.0T, with affected software versions: DV24.0, DV25.0, DV25.... | GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... | Class II | GE Medical Systems, LLC |
| Jun 14, 2024 | SIGNA Creator, with affected software versions: HD16.0_V03 to HD16.4, HD23.0... | GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... | Class II | GE Medical Systems, LLC |
| Jun 14, 2024 | Optima MR450w 1.5T, with affected software versions: DV24.0, DV25.0, DV25.1,... | GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... | Class II | GE Medical Systems, LLC |
| Jun 14, 2024 | SIGNA MR360, with affected software versions: SV25.5, SV25.6; Nuclear Magnet... | GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... | Class II | GE Medical Systems, LLC |
| Jun 14, 2024 | SIGNA MR380, with affected software versions: SV25.5, SV25.6; Nuclear Magnet... | GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... | Class II | GE Medical Systems, LLC |
| 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 | SIGNA UHP, with affected software versions: RX28.0, MR30.1; Nuclear Magnetic... | GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... | Class II | GE Medical Systems, LLC |
| 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 | Baxter SIGMA Spectrum Infusion Pump, Product Code: 35700BAX2 | Improperly performed testing prior to release | Class II | Baxter Healthcare Corporation |
| Jun 14, 2024 | Optima MR360, with affected software versions: SV20.3, SV23.3, MR30.0, MR30.... | GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... | Class II | GE Medical Systems, LLC |
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.