Browse Device Recalls
39,949 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 39,949 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 39,949 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jun 3, 2024 | Endoscopic Kittner Blunt Dissecting Instrument, Intended to be used for blunt... | The affected products may have been packaged with a defect in the sterile barrier seal. As a resu... | Class II | ASPEN SURGICAL |
| Jun 3, 2024 | Neurostimulation Kit (Ported, Dual 8, 40 cm), REF: 71005-US Peripheral Nerve... | Neurostimulation Systems have a manufacturing non-conformance that may reduce the efficiency of t... | Class II | Nalu Medical, Inc. |
| Jun 3, 2024 | The Non-Sterile Flyte hood covers the user s head and neck region and is inte... | Expired Products distributed to customers | Class II | Stryker Corporation |
| Jun 3, 2024 | 190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part... | An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) a... | Class II | Fresenius Medical Care Holdings, Inc. |
| Jun 3, 2024 | 190904 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare part,... | An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) a... | Class II | Fresenius Medical Care Holdings, Inc. |
| Jun 3, 2024 | RTLR190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare ... | An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) a... | Class II | Fresenius Medical Care Holdings, Inc. |
| Jun 3, 2024 | QIAcube Connect MDx - IVD Instrument designed to perform automated isolation ... | Heater shaker module does not perform heating if the temperature is set below 40¿C for static inc... | Class II | Qiagen Sciences LLC |
| Jun 3, 2024 | Welch Allyn CP150 Electrocardiograph with Spirometry Option, Product Code: CP... | During manufacturing, the step to install an Electromagnetic Interference (EMI) Absorber was omit... | Class II | Baxter Healthcare Corporation |
| Jun 3, 2024 | RTL190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare p... | An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) a... | Class II | Fresenius Medical Care Holdings, Inc. |
| Jun 2, 2024 | Nanoplasty 3D Bunion Correction System Implant, Model Number: SK57. System co... | Potential issue causing a higher frequency of interference with locking screws and/or inserter ro... | Class II | Treace Medical Concepts, 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 | 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 31, 2024 | The VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System is designed for us... | There were 27 complaints between March 22, 2024, and April 30, 2024, related to VH-3500 and VH-40... | Class II | Maquet Cardiovascular, LLC |
| May 31, 2024 | ZOLL Powerheart G5 AED, Semi-Automatic, G5Sxxx Family -Automated external def... | G5 Semi-Automatic AED is shipped, with a protective film over its front panel, to protect the scr... | Class II | Zoll Medical Corporation |
| 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 | 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 | 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 | 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 | 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 | 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 | 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 31, 2024 | MIC-KEY* Gastric-Jejunal Feeding Tube Kit, Endoscopic / Radiologic Placement,... | The IFU was missing some risk information requested by another country to be contained in the IFU... | Class II | Avanos Medical, Inc. |
| May 31, 2024 | The VASOVIEW HEMOPRO Endoscopic Vessel Harvesting Systems is designed for use... | There were 27 complaints between March 22, 2024, and April 30, 2024, related to VH-3500 and VH-40... | Class II | Maquet Cardiovascular, LLC |
| May 31, 2024 | REF: 60-7070-005, Zimmer, Tourniquet Cuff 30" (Blue), Luer-Lock Dual Port, si... | Mislabeling; tourniquet cuff packaging labeled as dual port single bladder but contains a tourn... | Class II | Stryker Sustainability Solutions |
| May 31, 2024 | ABL800 FLEX Model Numbers 393-800 and 393-801 The ABL800 FLEX analyzers a... | Issue with analyzer when the pH of the calibration solution decreases during the in-use period po... | Class II | Radiometer Medical ApS |
| 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 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 |
| May 30, 2024 | Titan Scaler Tip - Perio Model/Catalog Number: 261669 The scaler tip is ... | 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 |
| 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 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) PEDIATRIC TRACHE... | 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) TTS PEDIATRIC TRA... | 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 | Presource kits and trays, labeled as: 1) ANGIOGRAPHY PACK, Catalog Number S... | Cardinal Health is following the FDA's recommendations regarding the disposition of affected Jian... | Class II | Cardinal Health 200, LLC |
| May 29, 2024 | PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 6.0MM FLEXTEND PEDIA... | 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) TTS TRACHEOSTOMY ... | Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... | Class I | Smiths Medical ASD Inc. |
| May 29, 2024 | Presource kits and trays, labeled as: 1) Cardiac Catheterization Kit, Cata... | Cardinal Health is following the FDA's recommendations regarding the disposition of affected Jian... | Class II | Cardinal Health 200, LLC |
| 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) 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 | PORTEX Bivona Tracheostomy Silicone Tube, labeled as: TTS NEONATAL TRACHY ... | 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) PEDIATRIC TRACHEO... | 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 TRACHEOS... | 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.