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 7, 2024 | RX Series CYSC- Cystatin C Reagent -Intended for in vitro diagnostic (IVD) us... | Cystatin C Reagent marketed without a 510 (k) | Class II | Randox Laboratories Ltd. |
| 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 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 | OMTech Desktop Laser Engraver | Lack of redundant interlocks, missing required labels and certification labels as required by 21 ... | Class II | Rygel Advanced Machines d/b/a Omtech Laser |
| 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 |
| Jun 5, 2024 | Synergetics I Pack Injection Kit- Tray for use with Ophthalmic injections ... | Could not confirm products were exposed to the proper sterilization cycle can potentially cause p... | Class II | MICROspecialties, Inc. |
| Jun 5, 2024 | Synergetics I Pack Injection Kit with Wire Speculum- Tray for use in Opthalm... | Could not confirm products were exposed to the proper sterilization cycle can potentially cause p... | Class II | MICROspecialties, Inc. |
| Jun 5, 2024 | Synergetics I-Pack Injection Kit with Drape -For use with Ophthalmic injecti... | Could not confirm products were exposed to the proper sterilization cycle can potentially cause p... | Class II | MICROspecialties, Inc. |
| Jun 5, 2024 | Synergetics I Pack Injection Kit Custom-Tray for use with Ophthalmic injectio... | Could not confirm products were exposed to the proper sterilization cycle can potentially cause p... | Class II | MICROspecialties, Inc. |
| 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. 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 | DxC 500 AU Clinical Chemistry Analyzer, REF C63520 is an automated chemist... | There are two software bug issues with the analyzer. Issue 1: When a dedicated rack is reserved f... | Class II | Beckman Coulter Mishima K.K. |
| Jun 4, 2024 | Zyno Medical Z800, Z800F, Z800W, and Z800WF Infusion Pumps | Zyno Medical has found that certain Z800, Z800F, Z800W, and Z800WF pumps have faulty power supply... | Class II | Zyno Medical LLC |
| Jun 4, 2024 | Dxl 9000 Access Immunoassay Analyzer, Catalog #C11137. | The analyzers were built with nonconforming USB cables made with brass contacts instead of specif... | Class II | Beckman Coulter, Inc. |
| Jun 4, 2024 | VidiaPort carrying arm, mount for auxiliary products, model numbers: a) 40... | Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction due to customer repo... | Class II | Baxter Healthcare Corporation |
| Jun 4, 2024 | iLED 7 surgical lights, Model Numbers: a) 4068110 (Ceiling Single Surgical... | Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction due to customer repo... | Class II | Baxter Healthcare Corporation |
| Jun 4, 2024 | Brand Name: Meridian Angled Awl Fixed Product Name: Angled Awl Fixed Model/... | Insufficient weld around the cap component of the instrument is insufficient to withstand impact... | Class II | SEASPINE ORTHOPEDICS CORPORATION |
| Jun 4, 2024 | Trulight 5000/3000 Surgical Light, model numbers: a) 4038210 (Duo Surgical... | Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction due to customer repo... | Class II | Baxter Healthcare Corporation |
| Jun 3, 2024 | Transfer Device, REF 2008S. Packaged on a form, fill and seal machine with a ... | During sterile barrier testing performed on the decanter product line, the samples were identifie... | Class II | Microtek Medical Inc. |
| Jun 3, 2024 | C-Flow Bag Decanter, REF 2000S. Packaged on a form, fill and seal machine wit... | During sterile barrier testing performed on the decanter product line, the samples were identifie... | Class II | Microtek Medical Inc. |
| Jun 3, 2024 | RTL190828: 2008K@HOME HEMODIALYSIS SYSTEM - Blood Pump Rotor spare part, Mode... | 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 | Bottle Decanter, REF 2004S. Packaged on a form, fill and seal machine with a ... | During sterile barrier testing performed on the decanter product line, the samples were identifie... | Class II | Microtek Medical Inc. |
| Jun 3, 2024 | 191014: 2008K@HOME HD SYSTEM W/BIBAG (CANADA) - 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 | Curved, super elastic cement delivery needle that passes through the cannula ... | Expired Products distributed to customers | Class II | Stryker Corporation |
| Jun 3, 2024 | This product is a single use sterile device that is used to direct the lesion... | Expired Products distributed to customers | Class II | Stryker Corporation |
| Jun 3, 2024 | Vial Decanter, REF 2006S. Packaged on a form, fill and seal machine with a po... | During sterile barrier testing performed on the decanter product line, the samples were identifie... | Class II | Microtek Medical Inc. |
| Jun 3, 2024 | Bag Decanter II, REF 2002S. Packaged on a form, fill and seal machine with a ... | During sterile barrier testing performed on the decanter product line, the samples were identifie... | Class II | Microtek Medical Inc. |
| Jun 3, 2024 | RTL190904: 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - 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 3, 2024 | 190828: 2008K@HOME HEMODIALYSIS SYSTEM - Blood Pump Rotor spare part, Model N... | 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 | 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 |
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.