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 |
|---|---|---|---|---|
| Jun 21, 2013 | LeGoo¿ Endovascular Occlusion Gel-0.25 mL LeGoo with 3 Cannula Pouch Product... | Product contains particulates (fibers) | Class II | Genzyme Corporation, A Sanofi Company |
| Jun 21, 2013 | LeGoo¿ Endovascular Occlusion Gel-2.5 mL LeGoo w/ no Cannula Product Number:... | Product contains particulates (fibers) | Class II | Genzyme Corporation, A Sanofi Company |
| Jun 21, 2013 | LeGoo¿ Endovascular Occlusion Gel- 1.0 mL LeGoo with 3 Cannula Pouch Produ... | Product contains particulates (fibers) | Class II | Genzyme Corporation, A Sanofi Company |
| Jun 21, 2013 | LeGoo Internal Vessel Occluder .5mL Product Number: 10-0050 LeGoo is a w... | Product contains particulates (fibers) | Class II | Genzyme Corporation, A Sanofi Company |
| Jun 21, 2013 | LeGoo¿ Endovascular Occlusion Gel-0.5 mL LeGoo with 3 Cannula Pouch Produc... | Product contains particulates (fibers) | Class II | Genzyme Corporation, A Sanofi Company |
| Jun 21, 2013 | LeGoo¿ Endovascular Occlusion Gel-2.5 mL LeGoo with 1 Cannula Pouch Produc... | Product contains particulates (fibers) | Class II | Genzyme Corporation, A Sanofi Company |
| Jun 21, 2013 | LeGoo Internal Vessel Occluder 1mL Product Number: 10-0100 LeGoo is a wa... | Product contains particulates (fibers) | Class II | Genzyme Corporation, A Sanofi Company |
| Jun 21, 2013 | LeGoo Endovascular Occlusion Gel 2.5 mL Product Number: LG250IT LeGoo is... | Product contains particulates (fibers) | Class II | Genzyme Corporation, A Sanofi Company |
| Jun 21, 2013 | Indus Invue Screw Caddy, Model: SI70097 The caddy holds, in an organized f... | Difficulty removing screws from the Invue caddies. | Class II | SpineFrontier, Inc. |
| Jun 21, 2013 | LeGoo Endovascular Occlusion Gel 1.0 mL Product Number: LG100IT LeGoo is... | Product contains particulates (fibers) | Class II | Genzyme Corporation, A Sanofi Company |
| Jun 21, 2013 | LeGoo¿ Endovascular Occlusion Gel- 1.0 mL LeGoo w/ no Cannula Product Numb... | Product contains particulates (fibers) | Class II | Genzyme Corporation, A Sanofi Company |
| Jun 21, 2013 | LeGoo Endovascular Occlusion Gel 0.5 mL Product Number: LG50IT LeGoo is ... | Product contains particulates (fibers) | Class II | Genzyme Corporation, A Sanofi Company |
| Jun 21, 2013 | Picis ED Pulsecheck - EMR Software Application - 2125, Software Versions: 5.2... | Notes associated with prescription are not printed to the prescription or to the patient chart. | Class II | Picis Inc. |
| Jun 21, 2013 | LeGoo¿ Endovascular Occlusion Gel- 0.5 mL LeGoo with 3 Cannula Pouch Produ... | Product contains particulates (fibers) | Class II | Genzyme Corporation, A Sanofi Company |
| Jun 21, 2013 | LeGoo Internal Vessel Occluder 5mL Product Number: 10-0500 LeGoo is a wat... | Product contains particulates (fibers) | Class II | Genzyme Corporation, A Sanofi Company |
| Jun 21, 2013 | LeGoo¿ Endovascular Occlusion Gel-1.0 mL LeGoo with 3 Cannula Pouch Produc... | Product contains particulates (fibers) | Class II | Genzyme Corporation, A Sanofi Company |
| Jun 21, 2013 | LeGoo Internal Vessel Occluder 10mL Product Number: 10-1000 LeGoo is a wa... | Product contains particulates (fibers) | Class II | Genzyme Corporation, A Sanofi Company |
| Jun 21, 2013 | LeGoo Internal Vessel Occluder 2.5mL Product Number: 10-0250 LeGoo is a w... | Product contains particulates (fibers) | Class II | Genzyme Corporation, A Sanofi Company |
| Jun 21, 2013 | LeGoo Internal Vessel Occluder .25mL Product Number: 10-0025 LeGoo is ... | Product contains particulates (fibers) | Class II | Genzyme Corporation, A Sanofi Company |
| Jun 21, 2013 | LeGoo¿ Endovascular Occlusion Gel-0.5 mL LeGoo w/ no Cannula Product Numbe... | Product contains particulates (fibers) | Class II | Genzyme Corporation, A Sanofi Company |
| Jun 20, 2013 | TEG 5000 Thromboelastograph Coagulation Analyzer Product Usage: Multipurp... | Research Use Only (RUO) parameters were included in TEG 5000 User Manual. | Class II | Haemonetics Corporation |
| Jun 19, 2013 | Philips HeartStart MRx Monitor/Defibrillator, Model numbers M3535A, M3536A,... | The MRx may deliver a non-synchronized cardioversion shock resulting in the delivery of incorrect... | Class II | Philips Healthcare Inc. |
| Jun 17, 2013 | AlboGraft Knitted with Collagen, Bifurcate 14x08 Catalog Number: AMC1408 ... | Blood blushing/leaking from the surface of the graft after implantation | Class I | LeMaitre Vascular, Inc. |
| Jun 17, 2013 | AlboGraft Knitted with Collagen, Straight 15x06 Catalog Number: AMC1506 ... | Blood blushing/leaking from the surface of the graft after implantation | Class I | LeMaitre Vascular, Inc. |
| Jun 17, 2013 | AlboGraft Woven with Collagen, Straight 30x24 Catalog Number: ATC3024 Alb... | Blood blushing/leaking from the surface of the graft after implantation | Class I | LeMaitre Vascular, Inc. |
| Jun 17, 2013 | AlboGraft Woven with Collagen, Straight 30x16 Catalog Number: ATC3016 Alb... | Blood blushing/leaking from the surface of the graft after implantation | Class I | LeMaitre Vascular, Inc. |
| Jun 17, 2013 | AlboGraft Knitted with Collagen, Straight 60x07 Catalog Number: AMC6007 A... | Blood blushing/leaking from the surface of the graft after implantation | Class I | LeMaitre Vascular, Inc. |
| Jun 17, 2013 | AlboGraft Knitted with Collagen, Bifurcate 18x10 Catalog Number: AMC1810 ... | Blood blushing/leaking from the surface of the graft after implantation | Class I | LeMaitre Vascular, Inc. |
| Jun 17, 2013 | AlboGraft Knitted with Collagen, Bifurcate 18x09 Catalog Number: AMC1809 ... | Blood blushing/leaking from the surface of the graft after implantation | Class I | LeMaitre Vascular, Inc. |
| Jun 17, 2013 | AlboGraft Woven with Collagen, Straight 30x26 Catalog Number: ATC3026 Alb... | Blood blushing/leaking from the surface of the graft after implantation | Class I | LeMaitre Vascular, Inc. |
| Jun 17, 2013 | AlboGraft Woven with Collagen, Straight 15x26 Catalog Number: ATC1526 Alb... | Blood blushing/leaking from the surface of the graft after implantation | Class I | LeMaitre Vascular, Inc. |
| Jun 17, 2013 | AlboGraft Knitted with Collagen, Bifurcate 20x10Catalog Number: AMC2010 ... | Blood blushing/leaking from the surface of the graft after implantation | Class I | LeMaitre Vascular, Inc. |
| Jun 17, 2013 | AlboGraft Knitted with Collagen, Straight 60x06 Catalog Number: AMC6006 A... | Blood blushing/leaking from the surface of the graft after implantation | Class I | LeMaitre Vascular, Inc. |
| Jun 17, 2013 | AlboGraft Knitted with Collagen, Straight 40x07 Catalog Number: AMC4007 A... | Blood blushing/leaking from the surface of the graft after implantation | Class I | LeMaitre Vascular, Inc. |
| Jun 17, 2013 | AlboGraft Woven with Collagen, Straight 30x18 Catalog Number: ATC3018 Alb... | Blood blushing/leaking from the surface of the graft after implantation | Class I | LeMaitre Vascular, Inc. |
| Jun 17, 2013 | AlboGraft Woven with Collagen, Straight 15x30 Catalog Number: ATC1530 AlboG... | Blood blushing/leaking from the surface of the graft after implantation | Class I | LeMaitre Vascular, Inc. |
| Jun 17, 2013 | AlboGraft Knitted with Collagen, Straight 60x08 Catalog Number: AMC6008 A... | Blood blushing/leaking from the surface of the graft after implantation | Class I | LeMaitre Vascular, Inc. |
| Jun 17, 2013 | AlboGraft Knitted with Collagen, Straight 40x08 Catalog Number: AMC4008 A... | Blood blushing/leaking from the surface of the graft after implantation | Class I | LeMaitre Vascular, Inc. |
| Jun 17, 2013 | Albo Graft Knitted with Collagen, Bifurcate 16x08 Catalog Number: AMC1608 ... | Blood blushing/leaking from the surface of the graft after implantation | Class I | LeMaitre Vascular, Inc. |
| Jun 11, 2013 | Philips Healthcare MobileDiagnostwDR system. Mobile Digital radiography X-Ra... | The Instructions for Use (IFU) for the MobileDiagnost wDR fails to comply with a Federal standard... | Class II | Philips Healthcare Inc. |
| Jun 7, 2013 | MedStream Programmable Infusion Pump , Implantable for the intrathecal delive... | Miscalibrated Fill Level Sensor may affect dosing level | Class I | Codman & Shurtleff, Inc. |
| Jun 7, 2013 | Philips HeartStart MRx Monitor/Defibrillator Models: M3536A Options A20 - A2... | Error in the printing of the therapy energy setting labels on Philips HeartStart M3536A MRx Monit... | Class II | Philips Medical Systems, Inc. |
| Jun 7, 2013 | MedStream Programmable Infusion Pump- Implantable for the intrathecal deliver... | Miscalibrated Fill Level Sensor may affect dosing level | Class I | Codman & Shurtleff, Inc. |
| Jun 3, 2013 | Fresenius Liberty Cycler Set Single Conn./Ext DL Product Number: 050-87216 ... | Cassette may leak during set up or during peritoneal dialysis treatment | Class II | Fresenius Medical Care Holdings, Inc. |
| May 31, 2013 | 27023WU Balloon Catheter, 3 Fr., 2/pkg, sterile, contains latex. The RUS... | Karl Storz Endoscopy-America has initiated the recall of the 27023WU Balloon Catheter because the... | Class II | Karl Storz Endoscopy America Inc |
| May 28, 2013 | NephroMax high Pressure Nephrostomy Balloon Catheter. Material Number/Catalog... | Incorrect sized renal sheath was packaged with the NephroMax high pressure nephrostomy Balloon Ca... | Class II | Boston Scientific Corporation |
| May 28, 2013 | Alair Bronchial Thermoplasty Catheter, Bronchial Thermoplasty System; Materia... | Boston Scientific has discovered an inconsistent "Use By" expiration date on a single lot/batch o... | Class II | Boston Scientific Corporation |
| May 28, 2013 | NephroMax high Pressure nephrostomy Balloon Catheter Kit. Material Number/Ca... | Incorrect sized renal sheath was packaged with the NephroMax high pressure nephrostomy Balloon Ca... | Class II | Boston Scientific Corporation |
| May 28, 2013 | RigiflexTM 11 Single-Use Achalasia Balloon Dilator, Material Number (UPN) M00... | Product labeled with incorrect expiration date. | Class III | Boston Scientific Corporation |
| May 24, 2013 | S-LIFT Inserter Outer Sleeve Product Usage: The Inserter Sleeve is an op... | The outer sleeve would not fit over the S-LIFT Inserter assembly because the hole at the top of t... | Class II | SpineFrontier, 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.