Browse Device Recalls
3,428 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,428 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 3,428 FDA device recalls — Class I.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 25, 2024 | Vivo 45 LS, pressure and volume ventilator capable of delivering continuous o... | There is a potential for short term (<7 days) elevated levels of formaldehyde emitted from the de... | Class I | Breas Medical, Inc. |
| Jul 24, 2024 | FreeStyle Libre 3 Sensors, REF: 72081-01, component of the FreeStyle Libre 3 ... | Users of the FreeStyle Libre 3 sensors reported situations where they were receiving erroneously ... | Class I | Abbott Diabetes Care, Inc. |
| Jul 19, 2024 | ClotTriever XL Catheter, 30 mm, REF: 41-102, used with Instructions for Use ... | Thrombectomy system catheter instructions for use updated to reduce adverse events due to the fol... | Class I | Inari Medical - Oak Canyon |
| Jul 16, 2024 | CADD-Solis Li-ion Rechargeable Battery Packs, REF 21-2160-XX, which are also ... | Damage to the battery pack may have caused a short to a capacitor within the battery pack. While... | Class I | Smiths Medical ASD Inc. |
| Jul 16, 2024 | Trilogy Evo EV300 -- Model Number/ Model Description: BL2200X15B Trilogy Ev... | Firm has released a mandatory software update Version 1.05.10.00 and a User Manual addendum for a... | Class I | Philips Respironics, Inc. |
| Jul 16, 2024 | Trilogy Evo Universal Ventilator, Model No. DS2000X11B | Firm has released a mandatory software update Version 1.05.10.00 and a User Manual addendum for a... | Class I | Philips Respironics, Inc. |
| Jul 16, 2024 | Trilogy Evo; Model No./Model Description -- AU2110X15B Trilogy Evo, Aust... | Firm has released a mandatory software update Version 1.05.10.00 and a User Manual addendum for a... | Class I | Philips Respironics, Inc. |
| Jul 12, 2024 | Avance. This anesthesia gas machine is intended to provide general inhalation... | Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected... | Class I | Datex-Ohmeda, Inc. |
| Jul 12, 2024 | Amingo. OUS only. | Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected... | Class I | Datex-Ohmeda, Inc. |
| Jul 12, 2024 | Auxiliary Common Gas Outlet (ACGO) conversion/install kits sold under product... | Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected... | Class I | Datex-Ohmeda, Inc. |
| Jul 12, 2024 | Avance CS2 and Avance CS2 Pro. These anesthesia gas machines are intended to ... | Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected... | Class I | Datex-Ohmeda, Inc. |
| Jul 12, 2024 | Aespire 7100, 7100 (Variant), and Aespire 7100 S/5 Protiva configurations. Th... | Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected... | Class I | Datex-Ohmeda, Inc. |
| Jul 12, 2024 | RMU-2000 Automated Chest Compression Device | Problem in the device's motor may cause the device to stop compressions. This may lead to a delay... | Class I | Defibtech, LLC |
| Jul 12, 2024 | Aespire 100. This anesthesia gas machine is intended to provide general inhal... | Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected... | Class I | Datex-Ohmeda, Inc. |
| Jul 12, 2024 | Aisys CS2. This anesthesia gas machine is intended to provide general inhalat... | Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected... | Class I | Datex-Ohmeda, Inc. |
| Jul 12, 2024 | Aespire 7900. This anesthesia gas machine is intended to provide general inha... | Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected... | Class I | Datex-Ohmeda, Inc. |
| Jul 12, 2024 | Aisys. This anesthesia gas machine is intended to provide general inhalation ... | Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected... | Class I | Datex-Ohmeda, Inc. |
| Jul 12, 2024 | Aisys CS2 with Et Control. This anesthesia gas machine is intended to provide... | Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected... | Class I | Datex-Ohmeda, Inc. |
| Jul 12, 2024 | Aespire View. This anesthesia gas machine is intended to provide general inha... | Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected... | Class I | Datex-Ohmeda, Inc. |
| Jul 9, 2024 | McGRATH" MAC EMS Video Laryngoscope, REF: 300-200-000 , Non-Sterile, Rx Only | Battery management system within Laryngoscope devices may deplete below the deign threshold which... | Class I | Covidien |
| Jul 9, 2024 | McGrath Mac Video Laryngoscope, REF: 300-000-000 , Non-Sterile, Rx Only | Battery management system within Laryngoscope devices may deplete below the deign threshold which... | Class I | Covidien |
| Jun 24, 2024 | Puritan Bennett 500 Series Ventilators (Description/REF): PURITAN BENNETT 56... | Any single affected ventilator should only be used for the 10- year labelled service life, but if... | Class I | Covidien |
| Jun 24, 2024 | NIM Vital Nerve Monitoring systems (all serial numbers manufactured) with NIM... | Potential for false negative response on the NIM Vital Nerve Monitoring System | Class I | Medtronic Xomed, Inc. |
| Jun 17, 2024 | Brand Name: MEGADYNE" MEGA 2000" Patient Return Electrode Product Name: MEGA... | 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 | 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 | Brand Name: MEGADYNE" MEGA SOFT" Dual Reusable Patient Return Electrode Prod... | 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 12, 2024 | BAUSCH+LOMB, I-PACK Injection Kit Custom, REF 18069, for the administration ... | Sterilization certificates could not be validated by the supplier | Class I | Synergetics Inc |
| Jun 12, 2024 | BAUSCH+LOMB, I-PACK Injection Kit with Wire Speculum, REF 18069W, for the ad... | Sterilization certificates could not be validated by the supplier | Class I | Synergetics Inc |
| Jun 12, 2024 | BAUSCH+LOMB, I-PACK Injection Kit, REF 18060, for the administration of intra... | Sterilization certificates could not be validated by the supplier | Class I | Synergetics Inc |
| Jun 12, 2024 | BAUSCH+LOMB, I-PACK Injection Kit with Drape, REF 18061, for the administrati... | Sterilization certificates could not be validated by the supplier | Class I | Synergetics Inc |
| Jun 7, 2024 | smiths medical portex BLUperc Percutaneous Diliation Procedural Trays with BL... | There is the potential for a disconnection of the pilot balloon from the tracheostomy inflation l... | Class I | Smiths Medical ASD Inc. |
| Jun 7, 2024 | smiths medical portex BLUselect, tracheostomy tube, labeled as follows: 1) ... | There is the potential for a disconnection of the pilot balloon from the tracheostomy inflation l... | Class I | Smiths Medical ASD Inc. |
| Jun 7, 2024 | smiths medical portex BLUgriggs Percutaneous Dilation Procedural Trays with B... | There is the potential for a disconnection of the pilot balloon from the tracheostomy inflation l... | Class I | Smiths Medical ASD Inc. |
| Jun 5, 2024 | SENSE XL TORSO COIL 1.5T. 16-element receive only coil for torso and abdomen ... | Potential for coils to heat up and harm patients (burn). | Class I | Philips North America Llc |
| Jun 5, 2024 | SENSE XL TORSO COIL 3.0T. 16-element receive only coil for torso and abdomen ... | Potential for coils to heat up and harm patients (burn). | Class I | Philips North America Llc |
| Jun 5, 2024 | SENSE XL TORSO COIL 1.5T Mk2. 16-element receive only coil for torso and abdo... | Potential for coils to heat up and harm patients (burn). | Class I | Philips North America Llc |
| May 31, 2024 | paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N | Smiths Medical became aware of an issue related to a potential for the patient outlet connector t... | Class I | Smiths Medical ASD Inc. |
| May 31, 2024 | Impella CP with SmartAssist, Product No.: 1000080 (REF 0048-0003). left hear... | Nine (9) Impella CP pumps failed inspection and were inadvertently released. | Class I | Abiomed, Inc. |
| May 31, 2024 | Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NXX | There is a potential for inadvertent tidal volume knob movement from the original setting when se... | Class I | Smiths Medical ASD Inc. |
| May 31, 2024 | paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N | Smiths Medical became aware of an issue related to a potential for the patient outlet connector t... | Class I | Smiths Medical ASD Inc. |
| May 31, 2024 | Pneupac paraPAC plus 300 ventilator kit, REF P300NXX | There is a potential for inadvertent tidal volume knob movement from the original setting when se... | Class I | Smiths Medical ASD Inc. |
| May 30, 2024 | Volara System. Single Patient Use (SPU) Circuit 5kit for Volara and Single Pa... | Potential of the handset plug to disconnect from the nebulizer port on the blue ventilator adapte... | Class I | Baxter Healthcare Corporation |
| May 30, 2024 | Volara System. Blue Ventilator Adapter Module. Intermittent positive pressur... | Potential of the handset plug to disconnect from the nebulizer port on the blue ventilator adapte... | Class I | Baxter Healthcare Corporation |
| May 29, 2024 | PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOS... | Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... | Class I | Smiths Medical ASD Inc. |
| May 29, 2024 | PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACH TU... | Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... | Class I | Smiths Medical ASD Inc. |
| May 29, 2024 | PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 2.5MM UNCUFFED NEONA... | Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... | Class I | Smiths Medical ASD Inc. |
| May 29, 2024 | PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOM... | Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... | Class I | Smiths Medical ASD Inc. |
| May 29, 2024 | Life2000 Ventilator, Product Code: MS-01-0118, which is contained in the Life... | Potential for certain Life2000 ventilator systems to either fail to charge or have intermittent c... | Class I | Baxter Healthcare Corporation |
| May 29, 2024 | PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOS... | Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... | Class I | Smiths Medical ASD Inc. |
| May 29, 2024 | PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 2.5 UNCUFFED NEON... | Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... | Class I | Smiths Medical ASD 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.