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.

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DateProductReasonClassFirm
Mar 31, 2016 American Surgical Ultracot 30 mm x 90 mm (Glassine) Ref Number: 23-15G Prod... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Americot White 1.5 cm x 5.5 cm Ref Number: 20-31SW Produ... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Americot Blue 1/4" x 1/4" Ref Number: 20-01S Product Usag... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Cylindrical Sponges-Strung 1/2" x 1.5" Ref Number: 70-02 ... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Ray-Cot 1/2" x 1" Ref Number: 60-07 Product Usage: Neuro... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Cotton Balls-Strung 3/4" Ref Number: 30-03 Product Usage:... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Americot Blue 1/2" x 1.5" Ref Number: 20-06S Product Us... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Uniqcot 1/2" x 1.5" Ref Number: 67-08 Product Usage: Neu... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Cotton Balls-Strung 1" Ref Number: 30-04 Product Usage: ... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Americot Blue 1/2" x 2" Ref Number: 20-32S Product Usage:... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Ray-Cot 1/2" x 1/2" Ref Number: 60-06 Product Usage: Neu... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Uniqcot 1/2" x 2" Ref Number: 67-29 Product Usage: Neuro... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Ray-Cot 1.5" x 3" Ref Number: 60-22 Product Usage: Neuro... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Ultracot 30 mm x 70 mm Ref Number: 23-10 Product Usage... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Delicot 4 mm x 50 mm Ref Number: 63-05 Product Usage: ... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Ultracot 20 mm x 60 mm (Glassine) Ref Number: 23-09G Prod... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Ray-Cot 1/4" x 1/4" Ref Number: 60-02 Product Usage: Neu... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Delicot-J 30 mm x 70 mm Ref Number: 63-10J (Japan Only) ... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Delicot 5 mm x 8 mm Ref Number: 63-01 Product Usage: Neu... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Uniqcot 1/4" x 1/4" Ref Number: 67-02 Product Usage: Neu... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Telfa 3/4" x 3" Ref Number: 80-11 Product Usage: Neuro... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Delicot 6 mm x 50 mm Ref Number: 63-06 Product Usage: Ne... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Telfa 3/8" x 3" Ref Number: 80-05 Product Usage: Neuro... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Delicot non-xray 5 mm x 13 mm Ref Number: 63-02 non-xray ... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Americot Blue 1" x 3" Ref Number: 20-10S Product Usage: ... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Americot Blue 1/4" x 1.5" Ref Number: 20-30S Product Us... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Delicot non-xray 10 mm x 13 mm Ref Number: 63-03 non-xray ... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Delicot 10 mm x 13 mm Ref Number: 63-03 Product Usage: N... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Delicot X 9 mm x 50 mm Ref Number: 63x07 Product Usage: ... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Ultracot 10 mm x 13 mm (Glassine) Ref Number: 23-03G Prod... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Ultracot 5 mm x 13 mm (Glassine) Ref Number: 23-02G Produ... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Uniqcot 1/2" x 1/2" Ref Number: 67-06 Product Usage: Neu... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Americot Blue 3/8" x 2" Ref Number: 20-26S Product Usage:... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Americot Blue 1/2" x 1/2" Ref Number: 20-04S Product Usag... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Ultracot 70 mm x 10090 mm Ref Number: 23-24 Product Usag... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Ray-Cot 1/2" x 3" Ref Number: 60-09 Product Usage: Neuro... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Ultracot 15 mm x 15 mm (Glassine) Ref Number: 23-12G Prod... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Policot 1/2" x 1/2" Ref Number: 90-06 Product Usage: N... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Cotton Balls-Strung 1/2" Ref Number: 30-02 Product Usage:... Product packaging defective compromising sterility Class II American Surgical Company
Mar 25, 2016 AB Sciex Triple Quad 4500MD LC/MS/MS System, Part No. 5031257; and QTRAP 4500... Under certain conditions, mass spectrometers may report incorrect quantitative results. Class II Ab Sciex
Mar 18, 2016 Boston Scientific Ultraflex Tracheobronchial Distal Release Stent System 12mm... Mislabeled: 10mm diameter x 30mm length Ultraflex Tracheobronchial stents were labeled as 12mm di... Class II Boston Scientific Corporation
Mar 17, 2016 Medtronic 0-arm Imaging mobile x-ray system. Model Numbers - B1-700-00027,... It has been discovered that replacement x-ray generator and system motion batteries could become ... Class II Medtronic Navigation, Inc.-Littleton
Mar 17, 2016 Medtronic Navigation O-arm 02 surgical x-ray imaging system Review of on-system electronic product labeling and Instr uctions for Use in response to an inter... Class II Medtronic Navigation, Inc.-Littleton
Mar 15, 2016 Philips Healthcare System X-ray Tomography Computed : It was discovered the patient support tabletop may fail to move in the horizontal direction when... Class II Philips Electronics North America Corporation
Mar 15, 2016 MEVION S250 for Proton Radiation Therapy Possibility of Gantry Motion with Aperture or Compensator only partially inserted. An Aperture m... Class II Mevion Medical Systems, Inc.
Mar 15, 2016 Philips Healthcare System X-ray Tomography Computed : It was discovered the patient support tabletop may fail to move in the horizontal direction when... Class II Philips Electronics North America Corporation
Mar 10, 2016 Fresenius 2008 Series Hemodialysis Delivery Systems: 2008T, 2008K2, 2008K an... Added Warning Statement: Fresenius 2008 Series Hemodialysis Machines False Blood Leak Alarm When ... Class II Fresenius Medical Care Renal Therapies Group, LLC
Feb 29, 2016 ENDOSCOPE BRUSH- KARL STORZ Flexible Cleaning Brush single-use, non-sterile ... Endoscope cleaning brush 11276CL may not fit resulting in an inability to insert the brush in to... Class II Karl Storz Endovision, Inc.
Feb 26, 2016 Fresenius Hemoflow F3 Dialyzer Part Number: 0520165A Indicated for Acute ... Dialyzer header leak due to possible improper torque Class II Fresenius Medical Care Renal Therapies Group, LLC
Feb 24, 2016 Analyst¿ MD Version 1.6.1 and 1.6.2 Software used with the following instrume... Wrong quantitative results may be displayed in a report from the device, which may potentially le... Class II Ab Sciex

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.