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 |
|---|---|---|---|---|
| Sep 9, 2020 | TWINFIX ULTRA HA 5.5 W/2 UB BLUE & BLK- Absorbable Suture anchor Product Num... | Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... | Class II | Smith & Nephew, Inc. |
| Sep 9, 2020 | ULTRA FAST-FIX AB ASSEMBLY-REVERSE CURVE-Absorbable Suture anchor Product Nu... | Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... | Class II | Smith & Nephew, Inc. |
| Sep 9, 2020 | OSTEORAPTOR 2.3 W/ 1 UB COBRAID BLACK-Absorbable Suture anchor Product Numbe... | Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... | Class II | Smith & Nephew, Inc. |
| Sep 9, 2020 | TWINFIX 5.0MM AB SUTURE ANCHOR-Absorbable Suture anchors Product Number: 721... | Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... | Class II | Smith & Nephew, Inc. |
| Sep 9, 2020 | OSTEORAPTOR 2.9 W. 2 UB WHITE / BLACK -Absorbable Suture anchor Product Num... | Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... | Class II | Smith & Nephew, Inc. |
| Sep 9, 2020 | ULTRA FAST-FIX AB ASSEMBLY - STRAIGHT-Absorbable Suture anchors Product Numb... | Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... | Class II | Smith & Nephew, Inc. |
| Sep 9, 2020 | MICRORAPTOR REGENESORB SUTURE ANCHOR- Absorbable Suture anchor Product Numbe... | Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... | Class II | Smith & Nephew, Inc. |
| Sep 9, 2020 | OSTEORAPTOR CRVD 2.3 SA UB COBRD BLUE- Absorbable Suture anchor Product Numb... | Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... | Class II | Smith & Nephew, Inc. |
| Sep 9, 2020 | OSTEORAPTOR 2.9 W 1UB II BLUE--Absorbable Suture anchor Product Number: 7220... | Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... | Class II | Smith & Nephew, Inc. |
| Sep 9, 2020 | TWINFIX ULTRA PLLA HA 5.5MM W/ NEEDLES- Absorbable Suture anchor Product Num... | Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... | Class II | Smith & Nephew, Inc. |
| Sep 9, 2020 | TWINFIX 5.0MM AB SUTURE ANCHOR WITH TWO Absorbable Suture anchors Product ... | Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... | Class II | Smith & Nephew, Inc. |
| Sep 9, 2020 | TWINFIX 5.0MM AB SUTURE ANCHOR WITH TWO- Absorbable Suture anchors Product ... | Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... | Class II | Smith & Nephew, Inc. |
| Sep 9, 2020 | OSTEORAPTOR 2.3 W. UB COBRAID BLUE-Absorbable Suture anchor Product Number: ... | Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... | Class II | Smith & Nephew, Inc. |
| Sep 1, 2020 | AquaBplus and AquaBplus B2 Water Purification System. For use with a hemodia... | Incorrectly crimped connectors were installed on the main protective earth conductor on these mac... | Class II | Fresenius Medical Care Holdings, Inc. |
| Aug 28, 2020 | Siemens epoc BGEM Test Card-In vitro diagnostic device for the quantitative t... | Sporadically inconsistent discrepant (low bias) glucose results on card lot 01-20095-10. Potentia... | Class II | Siemens Healthcare Diagnostics Inc |
| Aug 25, 2020 | Atellica IM HER-2/neu (H2n) assay, 50 Test Kit, Catalog No. SMN 10995591, UDI... | Siemens confirmed that the Upper Limit of Normal (ULN) as claimed in the Instructions for Use (IF... | Class II | Siemens Healthcare Diagnostics, Inc |
| Aug 25, 2020 | Rashkind Balloon Septostomy Catheter, 5F, Closed end, 50 cm, Pediatric, Singl... | Subsequent failure of catheters in the field and failed quality testing | Class I | Medtronic Vascular |
| Aug 25, 2020 | Rashkind Balloon Septostomy Catheter, 4F, Closed end, 50 cm, Pediatric, Singl... | Subsequent failure of catheters in the field and failed quality testing | Class I | Medtronic Vascular |
| Aug 25, 2020 | Rashkind Balloon Septostomy Catheter, 6F, Recess Balloon, Closed end, 50 cm, ... | Subsequent failure of catheters in the field and failed quality testing | Class I | Medtronic Vascular |
| Aug 24, 2020 | Opticross 35 15 MHz Peripheral Imaging Catheter 8F (2.74 mm) X 105 cm Expirat... | Opticross 35 Peripheral Imaging Catheter is being recalled because the incremental telescoping le... | Class II | Boston Scientific Corporation |
| Aug 7, 2020 | WallFlexTM Biliary RX Fully Covered Stent System RMV (10mmx60mm Stent) UPN: M... | Mislabeled: WallFlex Biliary RX Uncovered Stent System 10x60mm devices labeled as WallFlexTM Bil... | Class II | Boston Scientific Corporation |
| Jul 24, 2020 | Barricaid Annual Closure Device (ACD) BAR-A8-8MM - Product Usage: The Barrica... | The catalog ( REF ) number on the peelable inner labels (patient sticker) that is on the inner co... | Class II | Intrinsic Therapeutics, Inc. |
| Jul 20, 2020 | Conformis iTotal Cruciate Retaining (CR) Knee Replacement System- Orthopedic ... | Outer box labels for kit 0469247 correct, however the boxes contained the implants and jigs for 0... | Class II | Conformis, Inc. |
| Jul 16, 2020 | Philips HeartStart MRx, Monitor/Defibrillators with model numbers M3535A, M35... | The therapy switch may fail, resulting in the device exhibiting the following behaviors: the devi... | Class II | Philips North America, LLC |
| Jul 15, 2020 | OmniTom Computed tomography x-ray system, Model NL5000, all NL5000 systems wi... | There are potential issues related to the operational state of the scanner, specifically for tran... | Class II | NeuroLogica Corporation |
| Jul 6, 2020 | Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flex... | BSC has noted a potential inability to cut and remove polyps for these lots/batches. potential c... | Class II | Boston Scientific Corporation |
| Jul 6, 2020 | Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flex... | BSC has noted a potential inability to cut and remove polyps for these lots/batches. potential c... | Class II | Boston Scientific Corporation |
| Jul 6, 2020 | Captiflex Snares, Single-Use Polypectomy Snare consists of a flexible wire ca... | BSC has noted a potential inability to cut and remove polyps for these lots/batches. potential c... | Class II | Boston Scientific Corporation |
| Jul 6, 2020 | Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flex... | BSC has noted a potential inability to cut and remove polyps for these lots/batches. potential c... | Class II | Boston Scientific Corporation |
| Jul 6, 2020 | Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flex... | BSC has noted a potential inability to cut and remove polyps for these lots/batches. potential c... | Class II | Boston Scientific Corporation |
| Jul 6, 2020 | Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flex... | BSC has noted a potential inability to cut and remove polyps for these lots/batches. potential c... | Class II | Boston Scientific Corporation |
| Jul 6, 2020 | Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flex... | BSC has noted a potential inability to cut and remove polyps for these lots/batches. potential c... | Class II | Boston Scientific Corporation |
| Jun 30, 2020 | IntelliVue MX700 patient monitor, model no. 865241 | Some Intellivue MX700/MX800 Patient Monitors were delivered with defective power supplies. The de... | Class II | Philips North America, LLC |
| Jun 30, 2020 | IntelliVue MX800 patient monitor, model no. 865240 | Some Intellivue MX700/MX800 Patient Monitors were delivered with defective power supplies. The de... | Class II | Philips North America, LLC |
| Jun 26, 2020 | Beacon EUS Access System Preloaded Access 90degree Needle sterile, single-us... | This voluntary recall is being conducted following three customer reports of the device cannula d... | Class II | Covidien Llc |
| Jun 26, 2020 | Beacon EUS Access System Preloaded Access 135degree Needle sterile, single-u... | This voluntary recall is being conducted following three customer reports of the device cannula d... | Class II | Covidien Llc |
| Jun 25, 2020 | IntelliVue G7m Anesthesia Gas Module, Model no. 866173, Firmware Version 04.1... | The device may experience an interruption of gas measurement due to a firmware issue, ceasing mea... | Class II | Philips North America, LLC |
| Jun 24, 2020 | Smith & Nephew T-F1X0 RCG Drill Pac, 2 mm Drill & (2) Sleeves - Product Usage... | The T-Fix sterile package contains only one sleeve instead of two, The device will not perform a... | Class II | Smith & Nephew, Inc. |
| Jun 24, 2020 | SUTUREFIX ULTRA Suture, Product number 72203855 | A packaging error resulted in a XL drill being presented for use instead of the S drill. The XL d... | Class II | Smith & Nephew, Inc. |
| Jun 23, 2020 | MEVION S250 Proton Radiation Treatment System; intended to deliver proton rad... | The perforated screen that divides the inside of the process water tank has a very sharp edge ac... | Class II | Mevion Medical Systems, Inc. |
| Jun 18, 2020 | Phillips Charging Station, Product #: 989803191021 - Product Usage: This char... | A problem has been detected with the Philips LI-Polymer rechargeable battery when used with its a... | Class II | Philips North America, LLC |
| Jun 18, 2020 | Phillips 3.7V Rechargeable Li-Polymer Battery, Product #: 989803191341 - Prod... | A problem has been detected with the Philips LI-Polymer rechargeable battery when used with its a... | Class II | Philips North America, LLC |
| Jun 18, 2020 | Phillips Module Charger, Product #: 989803191031 - Product Usage: This Module... | A problem has been detected with the Philips LI-Polymer rechargeable battery when used with its a... | Class II | Philips North America, LLC |
| Jun 8, 2020 | Philips M3015A Microstream CO2 Extension Model No. 862393 -used with an lnte... | Affected M3015A extensions are incompatible with the lntelliVue X3 Patient Monitor (Model No. 867... | Class II | Philips North America, LLC |
| Jun 4, 2020 | Ablation Galil Technology, IceFORCE 2.1 CX Needle Cryoablation Needle, Prescr... | The needle surface deteriorated due to unexpected electrolysis during procedure. | Class II | Boston Scientific Corporation |
| Jun 4, 2020 | Ablation Galil Technology, Three IceFORCE 2.1 Prostate Cyroablation Kit Visu... | The needle surface deteriorated due to unexpected electrolysis during procedure. | Class II | Boston Scientific Corporation |
| Jun 4, 2020 | Ablation Galil Technology, IcePearl 2.1 CX 90 Cyroablation Needles, Prescript... | The needle surface deteriorated due to unexpected electrolysis during procedure. | Class II | Boston Scientific Corporation |
| Jun 4, 2020 | Ablation Galil Technology, IcePearl 2.0 CX 90 Cryoablation Needle, Prescripti... | The needle surface deteriorated due to unexpected electrolysis during procedure. | Class II | Boston Scientific Corporation |
| Jun 4, 2020 | Ablation Galil Technology, IceFORCE 2.1 CX Prostate Kit Visual ICE System, Pr... | The needle surface deteriorated due to unexpected electrolysis during procedure. | Class II | Boston Scientific Corporation |
| Jun 4, 2020 | Ablation Galil Technology, IceForce 2.1 CX 90 Cyroablation Needles, Prescript... | The needle surface deteriorated due to unexpected electrolysis during procedure. | Class II | Boston Scientific Corporation |
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.