Browse Device Recalls
35,290 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 35,290 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 35,290 FDA device recalls, Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jun 11, 2024 | Various Merit Medical convenience kits that contain recalled Jiangsu Shenli M... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | Merit Medical Systems, Inc. |
| Jun 11, 2024 | Various Merit Medical convenience kits that contain recalled Jiangsu Shenli M... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | Merit Medical Systems, Inc. |
| Jun 11, 2024 | Product Name: HIGH FLOW INSUFFLATION TUBING (with Filter) Model/Catalog Numb... | A customer found product with incomplete seals of P/N 20400161S, lot #185198 which can lead to no... | Class II | Canadian Hospital Specialties Ltd. |
| Jun 11, 2024 | Various Merit Medical convenience kits that contain recalled Jiangsu Shenli M... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | Merit Medical Systems, Inc. |
| Jun 11, 2024 | Various Merit Medical convenience kits that contain recalled Jiangsu Shenli M... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | Merit Medical Systems, Inc. |
| Jun 10, 2024 | BIOFIRE FILMARRAY Pneumonia Panel plus, REF: RFIT-ASY-0143 | Pneumonia panels have an increased risk of control failures due to an issue in the manufacturing ... | Class II | BioFire Diagnostics, LLC |
| Jun 10, 2024 | BIOFIRE FILMARRAY Pneumonia Panel, REF: RFIT-ASY-0144 | Pneumonia panels have an increased risk of control failures due to an issue in the manufacturing ... | Class II | BioFire Diagnostics, LLC |
| 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 | AURORA Surgiscope System. Sterile, single use device that contains a Sheath, ... | Potential sheath damage that could lead to tissue damage and/or track hemorrhage. | Class II | Integra LifeSciences Corp. |
| 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 | 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 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 | 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 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- 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 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 | 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 | 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 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 | 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 | 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 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Curved, super elastic cement delivery needle that passes through the cannula ... | Expired Products distributed to customers | Class II | Stryker Corporation |
| 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 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 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 | 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 | 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 | 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 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 | 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 | 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 | 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 | 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 |
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.