Browse Device Recalls
3,419 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,419 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 3,419 FDA device recalls in MA.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jan 9, 2019 | PageWriter TC30 w/o trolley Government Bundle, Product 860355, Software revis... | Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing ... | Class II | Philips North America, LLC |
| Jan 9, 2019 | PageWriter TC30, Product 860306, Software revisions up to and including A.07.... | Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing ... | Class II | Philips North America, LLC |
| Jan 9, 2019 | PageWriter TC20, Product 860332, Software revisions up to and including A.07.... | Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing ... | Class II | Philips North America, LLC |
| Jan 9, 2019 | PageWriter TC50, Product 860310, Software revisions up to and including A.07.... | Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing ... | Class II | Philips North America, LLC |
| Jan 9, 2019 | PageWriter TC70, Product 860315, Software revisions up to and including A.07.... | Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing ... | Class II | Philips North America, LLC |
| Jan 4, 2019 | iTotal Posterior Stabilized (PS) Knee Replacement System, Catalog Number TPS-... | The labeling of the boxes and sterile pouches did not match the contents. | Class II | Conformis, Inc. |
| Dec 27, 2018 | Curity All Purpose Sponges, Non-woven, 4 Ply, 4" x 4" (10.2 cm x 10.2 cm) Pr... | Curity All Purpose Sponges were not sterilized and distributed | Class II | Cardinal Health 200, LLC |
| Dec 26, 2018 | Flexima Duodenal Bend Biliary Stent with Delivery System, 7F (2.3mm) x10cm, M... | The sterile barrier may contain packaging seal defects. | Class II | Boston Scientific Corporation |
| Dec 26, 2018 | Flexima Duodenal Bend Biliary Stent with Delivery System, 7F (2.3mm) x7cm, Ma... | The sterile barrier may contain packaging seal defects. | Class II | Boston Scientific Corporation |
| Dec 21, 2018 | DigitalDiagnost C50, Stationary X-ray System | During recent evaluations of the Philips DigitalDiagnost C50 system, Philips identified a missing... | Class II | Philips Healthcare |
| Dec 19, 2018 | Fungitell Kit, Catalog FT001 - Product Usage: The Fungitell assay is a poteas... | The kits may contain the incorrect number of components or the kits may be missing components. | Class II | Associates of Cape Cod, Inc. |
| Dec 18, 2018 | Omnipod DASH Insulin Management System, Product Catalog Number 18239 M/D: ... | There is a potential for a communication interruption following a bolus command that may result i... | Class II | Insulet Corporation |
| Dec 7, 2018 | Siemens ADVIA Centaur aTG (100 test kit) Siemens Material Number (SMN): 1049... | 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 | Atellica IM aTG (500 test kit) Siemens Material Number (SMN): 10995462 | 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 | 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 |
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.