Browse Device Recalls
3,013 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,013 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 3,013 FDA device recalls in 2018.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 16, 2018 | INTEGRIS CV, System Code 722030 Vascular, cardiovascular and neurovascula... | There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may... | Class II | Philips Electronics North America Corporation |
| Jul 16, 2018 | AIIuraXperFDlO/10, System Code 722011 Vascular, cardiovascular and neurov... | There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may... | Class II | Philips Electronics North America Corporation |
| Jul 13, 2018 | Haemonetics¿ OrthoPAT¿ System-OPAT QuickConnect Reservoirs. Product Code: OP... | OrthoPAT¿ reservoirs are missing the cannula inside the reservoirs. The absence of this cannula p... | Class II | Haemonetics Corporation |
| Jul 13, 2018 | Philips SureSigns VS3 Vital Signs Monitor, 863069 863070 863071 863072 86... | Philips has received several reports in which monitors with lithium ion batteries that had exceed... | Class II | Philips Electronics North America Corporation |
| Jul 13, 2018 | Tibial Alignment Guide, REF 351-10-00 Vantage Fixed Ankle system components f... | Exactech is recalling the Tibial Alignment Guide because the Global Trade Item Number (GTIN) on t... | Class II | Exactech, Inc. |
| Jul 13, 2018 | G8 Automated HPLC Analyzer - 723G8 Product Usage - In vitro diagnostic use... | Analyzers were distributed with software which lacks a 510K | Class II | Tosoh Bioscience Inc |
| Jul 13, 2018 | Philips SureSigns VS2 monitor, 863079 863080 863081 863082 863283 863286... | Philips has received several reports in which monitors with lithium ion batteries that had exceed... | Class II | Philips Electronics North America Corporation |
| Jul 13, 2018 | Portex Pulsator Arterial Blood Sampling Kit with Dry Lithium Heparin for Gase... | The product was mislabeled with the incorrect label. | Class III | Smiths Medical ASD Inc. |
| Jul 13, 2018 | 2008T HEMODIALYSIS SYS, WITH CDX, Part Number 190713, Applicable only with 20... | In the hemodialysis machine during the cleaning/disinfection program, when there is a power failu... | Class II | Fresenius Medical Care Renal Therapies Group, LLC |
| Jul 13, 2018 | 2008T HEMODIALYSIS SYSTEM W/BIBAG, Part Number 190766, Applicable only with 2... | In the hemodialysis machine during the cleaning/disinfection program, when there is a power failu... | Class II | Fresenius Medical Care Renal Therapies Group, LLC |
| Jul 13, 2018 | Regimen 28 Day - Glutaraldehyde Sterilizing and Disinfecting Solution | Immersion time stated on the bottle is 45 minutes while the product instructions say 90 minutes. | Class II | Kerr/Pentron, DBA Kerr Corporation and Pentron ... |
| Jul 13, 2018 | Haemonetics OrthoPAT System-Integrated Set. Product Code: 1150H-00 Ortho... | OrthoPAT¿ reservoirs are missing the cannula inside the reservoirs. The absence of this cannula p... | Class II | Haemonetics Corporation |
| Jul 13, 2018 | Philips SureSigns VS4 Vital Signs Monitor, 863283 863286 The SureSigns V... | Philips has received several reports in which monitors with lithium ion batteries that had exceed... | Class II | Philips Electronics North America Corporation |
| Jul 13, 2018 | Philips SureSigns VSV (Vital Signs Viewer), 863067 Indicated for central m... | Philips has received several reports in which monitors with lithium ion batteries that had exceed... | Class II | Philips Electronics North America Corporation |
| Jul 13, 2018 | Philips SureSigns VM 3/4/6/8 Patient Monitors, 863063 863064 863065 863066... | Philips has received several reports in which monitors with lithium ion batteries that had exceed... | Class II | Philips Electronics North America Corporation |
| Jul 12, 2018 | Duo-Flow Double Lumen Soft Tip CRRT/ABP Catheter Set; DL11/24 . Hemodialysis... | The suture wings have the potential to crack or break. Potential patient injury includes catheter... | Class II | Medical Components, Inc dba MedComp |
| Jul 12, 2018 | OrthoSensor VERASENSE for Zimmer Biomet Persona CR G-H/7-12 Left, REF ZBH-PSN... | Some sensors were reported to have fluid inside the posterior lateral corner post-surgery. | Class II | Orthosensor, Inc. |
| Jul 12, 2018 | Revolution CT systems with the SmartStep Option The system is intended for... | On the Revolution CT systems equipped with the SmartStep Option, the Z location displayed on imag... | Class II | GE Healthcare, LLC |
| Jul 12, 2018 | OrthoSensor VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Left, REF ZBH-PSNC... | Some sensors were reported to have fluid inside the posterior lateral corner post-surgery. | Class II | Orthosensor, Inc. |
| Jul 12, 2018 | power cord for: (a) AMIA Automated PD Cycler, Product Code: 5C9320; (b) Kaguy... | There were instances where the power cord socket detached from the back of the AMIA cycler when t... | Class II | Baxter Healthcare Corporation |
| Jul 12, 2018 | DUO FLOW CUSTOM TRAYS; TRAY #414 TRAY #415 TRAY #67 | The suture wings have the potential to crack or break. Potential patient injury includes catheter... | Class II | Medical Components, Inc dba MedComp |
| Jul 12, 2018 | Duo-Flow XTP Straight Full Set, RMS02105 RMS02108 | The suture wings have the potential to crack or break. Potential patient injury includes catheter... | Class II | Medical Components, Inc dba MedComp |
| Jul 12, 2018 | DUO FLOW DOUBLE LUMEN CATHETER, XTP114CT, XTP114MT, ; RAULERSON DUO FLOW IJ ... | The suture wings have the potential to crack or break. Potential patient injury includes catheter... | Class II | Medical Components, Inc dba MedComp |
| Jul 12, 2018 | Duo-Flow IJ Full Tray; MCDLT114IJ MCDLT116IJ MCDLT118IJ | The suture wings have the potential to crack or break. Potential patient injury includes catheter... | Class II | Medical Components, Inc dba MedComp |
| Jul 12, 2018 | VITROS Immunodiagnostic Products - TSH Reagent Pack (10758750000227) 1912997 | The recalling firm determined that biased results may occur for specific VITROS Immunodiagnostic ... | Class II | Ortho Clinical Diagnostics Inc |
| Jul 12, 2018 | Double Lumen CRRT/ABP Catheter Set; Hemodialysis catheter insertion kits, DL... | The suture wings have the potential to crack or break. Potential patient injury includes catheter... | Class II | Medical Components, Inc dba MedComp |
| Jul 12, 2018 | VITROS Immunodiagnostic Products - Prolactin Reagent Pack (10758750000111) 1... | The recalling firm determined that biased results may occur for specific VITROS Immunodiagnostic ... | Class II | Ortho Clinical Diagnostics Inc |
| Jul 12, 2018 | OrthoSensor VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Right, REF ZBH-PSN... | Some sensors were reported to have fluid inside the posterior lateral corner post-surgery. | Class II | Orthosensor, Inc. |
| Jul 12, 2018 | SOFT-LINE DUO-FLOW DOUBLE LUMEN CATHETER TRAY; T3500 T4000 T4400 T4424 | The suture wings have the potential to crack or break. Potential patient injury includes catheter... | Class II | Medical Components, Inc dba MedComp |
| Jul 12, 2018 | VITROS Immunodiagnostic Products - FSH Reagent Pack (10758750000302) 1931922 | The recalling firm determined that biased results may occur for specific VITROS Immunodiagnostic ... | Class II | Ortho Clinical Diagnostics Inc |
| Jul 12, 2018 | Duo-Flow Double Lumen Catheter Only/Catheter Set; T114C T114M T116C T116M T11... | The suture wings have the potential to crack or break. Potential patient injury includes catheter... | Class II | Medical Components, Inc dba MedComp |
| Jul 12, 2018 | Duo-Flow Catheter Full Tray; MCDLT3500 MCDLT4000 MCDLT4400 MCDLT4424# Hemodi... | The suture wings have the potential to crack or break. Potential patient injury includes catheter... | Class II | Medical Components, Inc dba MedComp |
| Jul 12, 2018 | Duo-Flow XTP Straight Full Set; Hemodialysis catheter insertion kits, AAC0210... | The suture wings have the potential to crack or break. Potential patient injury includes catheter... | Class II | Medical Components, Inc dba MedComp |
| Jul 12, 2018 | SOFT-LINE DUO-FLOW DOUBLE LUMEN CATHETER/CATHETER SET; T94C T94M T96M T98M | The suture wings have the potential to crack or break. Potential patient injury includes catheter... | Class II | Medical Components, Inc dba MedComp |
| Jul 12, 2018 | Enamelast Cool Mint/OT Varnish 5% NaF Mint Label Enamelast Unit Dose 200pk... | Dental varnish has the possibility of having an unpleasant and off flavor. | Class II | Ultradent Products, Inc. |
| Jul 12, 2018 | Peg Fully Threaded, Locking, 2.5mm x 10mm, Item Number 131212610 Orthopedic d... | A size 22mm threaded peg was found in the package of a 10mm unit. | Class II | Zimmer Biomet, Inc. |
| Jul 12, 2018 | OrthoSensor VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Right, REF ZBH-PS... | Some sensors were reported to have fluid inside the posterior lateral corner post-surgery. | Class II | Orthosensor, Inc. |
| Jul 12, 2018 | VITROS Immunodiagnostic Products - Folate Reagent Pack(10758750009237) 1513266 | The recalling firm determined that biased results may occur for specific VITROS Immunodiagnostic ... | Class II | Ortho Clinical Diagnostics Inc |
| Jul 12, 2018 | OrthoSensor VERASENSE for Zimmer Biomet Persona CR G-H/7-12 Right, REF ZBH-PS... | Some sensors were reported to have fluid inside the posterior lateral corner post-surgery. | Class II | Orthosensor, Inc. |
| Jul 12, 2018 | OrthoSensor VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Left, REF ZBH-PSN... | Some sensors were reported to have fluid inside the posterior lateral corner post-surgery. | Class II | Orthosensor, Inc. |
| Jul 11, 2018 | TEMP SENSE SILICONE 14FR5CC2W, Item Code 50514T | The temperature sensor catheters may be defective in that they will show a lower body temperature... | Class II | COVIDIEN LLC |
| Jul 11, 2018 | 400mL, Premium, Urine Meter, 16 FR, Silicone Temperature Sensing Foley Traywi... | The temperature sensor catheters may be defective in that they will show a lower body temperature... | Class II | COVIDIEN LLC |
| Jul 11, 2018 | VITROS Chemistry Products Cl- Slides, Product Code 684 4471 Product Usage:... | The slides failed to meet current claims for Limit of Blank (LoB), Limit of Detection (LoD) and L... | Class III | Ortho-Clinical Diagnostics |
| Jul 11, 2018 | P400 PREM U/M 16FR TMPSNS, Item Code P4P16TS | The temperature sensor catheters may be defective in that they will show a lower body temperature... | Class II | COVIDIEN LLC |
| Jul 11, 2018 | 400mL, Premium, Urine Meter, 16 FR, Silicone Temperature Sensing Foley Traywi... | The temperature sensor catheters may be defective in that they will show a lower body temperature... | Class II | COVIDIEN LLC |
| Jul 11, 2018 | 400mL, Premium, Urine Meter, 14 FR, Silicone Temperature Sensing Foley Traywi... | The temperature sensor catheters may be defective in that they will show a lower body temperature... | Class II | COVIDIEN LLC |
| Jul 11, 2018 | P400 PREM U/M 18FR TMPSNS, Item Code P4P18TS | The temperature sensor catheters may be defective in that they will show a lower body temperature... | Class II | COVIDIEN LLC |
| Jul 11, 2018 | VITROS Chemistry Products Cl- Slides, Product Code 684 4471 Product Usage ... | The slides do not meet the maximum allowable interference (MAI) claims for triglyceride interfere... | Class III | Ortho-Clinical Diagnostics |
| Jul 11, 2018 | VITROS Chemistry Products CREA Slides, Product Code 680 2584 Product Usag... | The slides did not meet the current claims for Limit of Blank (LoB), Limit of Detection (LoD) and... | Class III | Ortho-Clinical Diagnostics |
| Jul 11, 2018 | Arkon Anesthesia Delivery System with Arkon Software Version 2.70, Display Un... | Arkon Anesthesia Delivery System may go into a failed state (mechanical ventilation ceases) while... | Class I | Spacelabs Healthcare, Ltd. |
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.