Browse Device Recalls
3,505 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,505 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 3,505 FDA device recalls in MA.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Dec 7, 2018 | Siemens Atellica IM aTG (100 test kit) Siemens Material Number (SMN): 10995461 | Positive bias anti-thyroglobulin with ADVIA Centaur aTG kit lots ending in 316 and lower and Atel... | Class II | Siemens Healthcare Diagnostics, Inc |
| Dec 7, 2018 | SiemensADVIA Centaur aTG (500 test kit) Siemens Material Number (SMN): 10492399 | Positive bias anti-thyroglobulin with ADVIA Centaur aTG kit lots ending in 316 and lower and Atel... | Class II | Siemens Healthcare Diagnostics, Inc |
| Dec 3, 2018 | iTotal CR Total Knee Replacement System, TCR-121-1111 (Catalog No.) / TCR-121... | The kits were prepared with incorrect patient ID labels and may contain incorrect components. | Class II | Conformis, Inc. |
| Nov 30, 2018 | BVI Visitec Soft Tip Cannula, 0.8MM .50 x 33mm (25G x 1.3 in). The BVI Sof... | Certain lots are missing a protective sheath component over the silicone tip, which may result in... | Class II | Beaver Visitec |
| Nov 29, 2018 | OMNI K1 Broach Handle, Product Code HS-10054 | There is a potential for the inner pin of the handle to become loose and fall out. | Class II | OMNIlife science Inc. |
| Nov 28, 2018 | IntellaTip MiFi Open-Irrigated Ablation Catheter Product Usage: Open Irri... | Supplier had changed its resin sub-suppliers three (3) times without notifying BSC. These change... | Class III | Boston Scientific Corporation |
| Nov 28, 2018 | Blazer Open-Irrigated Ablation Batch Catheter Product Usage: Open Irrig... | Supplier had changed its resin sub-suppliers three (3) times without notifying BSC. These change... | Class III | Boston Scientific Corporation |
| Nov 28, 2018 | IntellaNav MiFi Open-Irrigated Ablation Catheter Product Usage: Open Irri... | Supplier had changed its resin sub-suppliers three (3) times without notifying BSC. These change... | Class III | Boston Scientific Corporation |
| Nov 15, 2018 | Xper Flex Cardio Physiomonitoring System, Software versions 1.5.16.0322 and 1... | There are 3 issues: 1) Under certain conditions, real time waveforms may not be accurately plott... | Class II | Philips Electronics North America Corporation |
| Nov 5, 2018 | Optiflux F160NR Capillary High Flux Dialyzer Single Use Only, Product Code 05... | Potential for external blood leaks from the dialyzer header | Class II | Fresenius Medical Care Renal Therapies Group, LLC |
| Nov 5, 2018 | 8Fr SAFE GRAD CAT W/Valve (Argyle Suction Catheter Kits with Chimney Valve), ... | The product was released into commercial distribution while subject to importation refusal. | Class II | COVIDIEN LLC |
| Oct 31, 2018 | Salem Sump Dual Lumen Stomach Tube 10 Fr/Ch (3.3 mm) x 36" (91 cm), Product C... | This voluntary recall is being conducted due to incorrect packaging. In one lot of Salem Sump Dua... | Class II | COVIDIEN LLC |
| Oct 31, 2018 | FoundationOne CDx Test Results | An incorrect test result for a single analyte may have been reported for up to 800 physician reports | Class II | Foundation Medicine, Inc. |
| Oct 17, 2018 | NxStage PureFlow B Solution-RFP-403, Premixed Dialysate for Hemodialysis ... | PureFlow B Solution smaller chamber of the two chamber bag can burst electrolyte fluid and cause... | Class II | NxStage Medical, Inc. |
| Oct 17, 2018 | NxStage PureFlow B Solution-RFP-406, Premixed Dialysate for Hemodialysis ... | PureFlow B Solution smaller chamber of the two chamber bag can burst electrolyte fluid and cause... | Class II | NxStage Medical, Inc. |
| Oct 17, 2018 | NxStage PureFlow B Solution-RFP-404, Premixed Dialysate for Hemodialysis ... | PureFlow B Solution smaller chamber of the two chamber bag can burst electrolyte fluid and cause... | Class II | NxStage Medical, Inc. |
| Oct 17, 2018 | NxStage PureFlow B Solution-RFP-RFP-454, Premixed Dialysate for Hemodialysis ... | PureFlow B Solution smaller chamber of the two chamber bag can burst electrolyte fluid and cause... | Class II | NxStage Medical, Inc. |
| Oct 17, 2018 | NxStage PureFlow B Solution-RFP-401, Premixed Dialysate for Hemodialysis ... | PureFlow B Solution smaller chamber of the two chamber bag can burst electrolyte fluid and cause... | Class II | NxStage Medical, Inc. |
| Oct 17, 2018 | NxStage PureFlow B Solution-RFP-RFP-456, Premixed Dialysate for Hemodialysis ... | PureFlow B Solution smaller chamber of the two chamber bag can burst electrolyte fluid and cause... | Class II | NxStage Medical, Inc. |
| Oct 17, 2018 | NxStage PureFlow B Solution-RFP-400, Premixed Dialysate for Hemodialysis. ... | PureFlow B Solution smaller chamber of the two chamber bag can burst electrolyte fluid and cause... | Class II | NxStage Medical, Inc. |
| Oct 17, 2018 | NxStage PureFlow B Solution-RFP-402, Premixed Dialysate for Hemodialysis ... | PureFlow B Solution smaller chamber of the two chamber bag can burst electrolyte fluid and cause... | Class II | NxStage Medical, Inc. |
| Oct 16, 2018 | iTotal Hip Replacement System, Total Hip Replacement System, Catalog Number H... | The stage 1 and 2 reamer instruments used to prepare fixation for the cup in the acetabulum had a... | Class II | Conformis, Inc. |
| Oct 10, 2018 | IntelliVue MX40 Patient Monitor, Model Nos. 865350, 865351, 865352, 867146 - ... | A problem has been detected in the Philips IntelliVue MX4O that, if it were to occur, could affec... | Class II | Philips Electronics North America Corporation |
| Oct 9, 2018 | Fresenius Granuflo Dry Acid Concentrate- 3K 2.5 Ca 1 Mg 16.5 GAL Catalog ... | Discolored powder has confirmed the presence of a foreign substance | Class III | Fresenius Medical Care Renal Therapies Group, LLC |
| Oct 9, 2018 | Fresenius Granuflo Dry Acid Concentrate- 2K 2.5 Ca 1 Mg 16.5 GAL Catalog Num... | Discolored powder has confirmed the presence of a foreign substance | Class III | Fresenius Medical Care Renal Therapies Group, LLC |
| Oct 9, 2018 | Fresenius Granuflo Dry Acid Concentrate- 2K 2.0 Ca 1 Mg 16.5 GAL Catalog Num... | Discolored powder has confirmed the presence of a foreign substance | Class III | Fresenius Medical Care Renal Therapies Group, LLC |
| Oct 2, 2018 | Neodent¿ GM Mini Conical Abutment - Product Usage: Mini Conical Abutments are... | Laser engraved label does not match with the item in the package | Class II | Straumann Manufacturing, Inc. |
| Oct 1, 2018 | MEVION S250i | Treatment is allowed to continue (via partials) in situations where dDose1 interlock has tripped | Class II | Mevion Medical Systems, Inc. |
| Oct 1, 2018 | LeMaitre Vascular Pruitt F3¿-S Polyurethane Outlying Carotid Shunt, Sterile ... | Pouches from this lot are not sealed compromising the sterility | Class II | LeMaitre Vascular, Inc. |
| Sep 18, 2018 | Puritan Bennett 980 (PB980) ventilator series: Puritan Bennett" 980 Pediatri... | Software Update: External USB Drive performance and its impact on Graphic User Interface (GUI) fu... | Class I | COVIDIEN LLC |
| Sep 17, 2018 | Medtronic Navigation 0-arm 02 Imaging System interventional fluoroscopic x-ra... | O-arm 02 Imaging Systems correction to software version 4.1.0; new version of the user manual and... | Class II | Medtronic Navigation, Inc.-Littleton |
| Sep 10, 2018 | DeltaVision OMX SR Imaging System Model Number: 29115476 The DeltaVision ... | Non-conformance with the DeltaVision OMX SR, the interlocks are not wired in a redundant fashion ... | Class II | GE Healthcare Biosciences |
| Aug 30, 2018 | O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027GER SYS PRODUCT GE... | Software anomalies were reported to affect the following system functionalities: startup and shut... | Class II | Medtronic Navigation, Inc.-Littleton |
| Aug 30, 2018 | O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027230 SYSTEM 230V, M... | Software anomalies were reported to affect the following system functionalities: startup and shut... | Class II | Medtronic Navigation, Inc.-Littleton |
| Aug 30, 2018 | O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027100 SYSTEM lOOV, M... | Software anomalies were reported to affect the following system functionalities: startup and shut... | Class II | Medtronic Navigation, Inc.-Littleton |
| Aug 30, 2018 | O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027100R SYSTEM lOOV R... | Software anomalies were reported to affect the following system functionalities: startup and shut... | Class II | Medtronic Navigation, Inc.-Littleton |
| Aug 30, 2018 | Mitek Screw and Washer Depth Gauge, Product Code 219024 | The device has an offset in the design that results in a reading approximately 3.2mm shorter than... | Class II | DePuy Mitek, Inc., a Johnson & Johnson Co. |
| Aug 30, 2018 | O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027120 SYSTEM 120V, M... | Software anomalies were reported to affect the following system functionalities: startup and shut... | Class II | Medtronic Navigation, Inc.-Littleton |
| Aug 30, 2018 | O-arm 1000 2nd Edition Imaging System, BASE BASE OARM Bl70000027120R SYSTEM 1... | Software anomalies were reported to affect the following system functionalities: startup and shut... | Class II | Medtronic Navigation, Inc.-Littleton |
| Aug 30, 2018 | O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027230R SYSTEM 230V R... | Software anomalies were reported to affect the following system functionalities: startup and shut... | Class II | Medtronic Navigation, Inc.-Littleton |
| Aug 30, 2018 | O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027GERR SYS PRODUCT R... | Software anomalies were reported to affect the following system functionalities: startup and shut... | Class II | Medtronic Navigation, Inc.-Littleton |
| Aug 30, 2018 | O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027R SYS PRODUCT RWK,... | Software anomalies were reported to affect the following system functionalities: startup and shut... | Class II | Medtronic Navigation, Inc.-Littleton |
| Aug 30, 2018 | O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027 SYSTEM PRODUCT, M... | Software anomalies were reported to affect the following system functionalities: startup and shut... | Class II | Medtronic Navigation, Inc.-Littleton |
| Aug 17, 2018 | EEA Circular Stapler with Tri-Staple Technology, Part No. TRIEEA28MT TRIEEA28... | The firm identified the potential for a device to have an incorrect tissue gap. Use of a device w... | Class II | COVIDIEN LLC |
| Aug 16, 2018 | Medtronic DxTerity(TM) TRA 5F, Diagnostic Catheter, REF U5TRAN35 | Medtronic has determined that the French size indicator on the inner pouch may incorrectly reflec... | Class III | Medtronic Vascular |
| Aug 8, 2018 | Magellan LeadCare¿ II Blood Lead Test Kit. In Vitro Test for the measurement ... | Defect with the calibration button for lot 1808M. Level 1 and Level 2 Quality Control (QC) values... | Class II | Magellan Diagnostics, Inc. |
| Aug 1, 2018 | Kerlix Gauze Roll, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m) Stretched, ... | Potential for product sterility breach due to a compromised or pinched seal defect | Class II | COVIDIEN LLC |
| Aug 1, 2018 | Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), ... | Potential for product sterility breach due to a compromised or pinched seal defect | Class II | COVIDIEN LLC |
| Aug 1, 2018 | Dermacea Gauze Fluff Roll, 6 Ply, 4-1/2 x 4-1/8 yd (11.4 cm x 3.7 m), REF 441... | Potential for product sterility breach due to a compromised or pinched seal defect | Class II | COVIDIEN LLC |
| Aug 1, 2018 | Kerlix Bandage Roll, 100% Cotton, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.... | Potential for product sterility breach due to a compromised or pinched seal defect | Class II | COVIDIEN LLC |
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.