Browse Device Recalls

685 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 685 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 685 FDA device recalls.

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DateProductReasonClassFirm
Dec 17, 2019 AMS 700 100 mL, Spherical Reservoir with InhibiZone, Part No. 72404156 - Prod... A labeling discrepancy incorrectly labeled AMS 700 100mL Conceal Low Profile Reservoir with Inhib... Class II Boston Scientific Corporation
Nov 18, 2019 Habib EUS RFA, 20mm electrode active tip, Material Number/UPN: 6700 - Product... During testing on the Habib EUS RFA device, a temperature increase was observed at the tip of the... Class II Boston Scientific Corporation
Nov 18, 2019 Habib EUS RFA, 10mm electrode active tip, Material Number/UPN: 6500 - Product... During testing on the Habib EUS RFA device, a temperature increase was observed at the tip of the... Class II Boston Scientific Corporation
Nov 8, 2019 AngioJet Ultra Consoles-Thrombectomy System UPN: 105650-001D 105650-001H ... Missing Directions for Use (DFU) - Consoles shipped to customers without the required Operator's ... Class II Boston Scientific Corporation
Oct 24, 2019 Emerge Monorail PTCA Dilatation Catheter. Sterilized using ethylene oxide. P... Certain dilation and extension catheters are being recalled because these catheters may have miss... Class II Boston Scientific Corporation
Oct 24, 2019 Rebel Monorail PtCr Coronary Stent System, REF / Catalog No. H7493927324300, ... Certain dilation and extension catheters are being recalled because these catheters may have miss... Class II Boston Scientific Corporation
Oct 24, 2019 Guidezilla II Guide Extension Catheter Sterilized using ethylene oxide. Pack... Certain dilation and extension catheters are being recalled because these catheters may have miss... Class II Boston Scientific Corporation
Oct 24, 2019 NC Emerge Monorail PTCA Dilatation Catheter. Sterilized using ethylene oxide... Certain dilation and extension catheters are being recalled because these catheters may have miss... Class II Boston Scientific Corporation
Oct 21, 2019 Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 8cm ... Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 3... Class II Boston Scientific Corporation
Oct 21, 2019 Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 7cm ... Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 3... Class II Boston Scientific Corporation
Oct 21, 2019 Advanix Pancreatic Stent, Straight Leading Barb, 10F x 6cm UPN: M00536640 Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 3... Class II Boston Scientific Corporation
Oct 21, 2019 Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 11cm... Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 3... Class II Boston Scientific Corporation
Oct 21, 2019 Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 18cm... Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 3... Class II Boston Scientific Corporation
Oct 21, 2019 Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 3cm... Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 3... Class II Boston Scientific Corporation
Oct 21, 2019 Boston Advanix Pancreatic Stent, Straight Leading Barb, 10F x 4cm UPN: M00... Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 3... Class II Boston Scientific Corporation
Oct 21, 2019 Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 15cm... Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 3... Class II Boston Scientific Corporation
Oct 21, 2019 Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 10cm... Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 3... Class II Boston Scientific Corporation
Oct 21, 2019 Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 13cm... Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 3... Class II Boston Scientific Corporation
Oct 21, 2019 Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 9cm ... Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 3... Class II Boston Scientific Corporation
Oct 21, 2019 Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 5cm ... Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 3... Class II Boston Scientific Corporation
Oct 21, 2019 Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 12cm... Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 3... Class II Boston Scientific Corporation
Oct 9, 2019 Medivators EndoGator REF 100650. Kit for Olympus 140/160/180/190 Series GI E... Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present duri... Class II Medivators, Inc.
Sep 18, 2019 iLab Polaris Multi-Modality Guidance System; iLab Ultraso... Certain iLab Polaris Systems which were upgraded with a previous 2.10 software version (disk batc... Class II Boston Scientific Corporation
Aug 21, 2019 Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled a... Potential need for device replacement - Elective Replacement Indicator (ERI) or End of Life (EOL)... Class II Boston Scientific Corporation
Aug 21, 2019 Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled a... Potential need for device replacement - Elective Replacement Indicator (ERI) or End of Life (EOL)... Class II Boston Scientific Corporation
Jul 19, 2019 AMS 800 Artificial Urinary Sphincter AMS 800 Belt Cuff, 4.5 cm Part Number: ... Mislabled: AMS 800 occlusive cuff labeled as 4.5 cm was a length of 4.0 cm and therefore.. Class II Boston Scientific Corporation
May 30, 2019 Nitinol Thermocouple Electrode, 10 cm - Product Usage: The TCN Electrode is i... The firm initiated a voluntary correction of certain Cosman TCN Electrodes due to an incorrect re... Class II Boston Scientific Neuromodulation Corporation
May 30, 2019 Nitinol Thermocouple Electrode, 10 cm, 3m Cable - Product Usage: The TCN Elec... The firm initiated a voluntary correction of certain Cosman TCN Electrodes due to an incorrect re... Class II Boston Scientific Neuromodulation Corporation
May 30, 2019 Nitinol Thermocouple Electrode, 15 cm, 3m Cable - Product Usage: The TCN Elec... The firm initiated a voluntary correction of certain Cosman TCN Electrodes due to an incorrect re... Class II Boston Scientific Neuromodulation Corporation
May 30, 2019 Nitinol Thermocouple Electrode, 15 cm - Product Usage: The TCN Electrode is i... The firm initiated a voluntary correction of certain Cosman TCN Electrodes due to an incorrect re... Class II Boston Scientific Neuromodulation Corporation
May 30, 2019 Nitinol Thermocouple Electrode, 5cm - Product Usage: The TCN Electrode is ind... The firm initiated a voluntary correction of certain Cosman TCN Electrodes due to an incorrect re... Class II Boston Scientific Neuromodulation Corporation
Apr 24, 2019 ArtisanTM 70 cm 2 x 8 Surgical Lead Kit, part number M365SC8216700. 2 x 8... The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensi... Class II Boston Scientific Neuromodulation Corporation
Apr 24, 2019 The LinearTM 3-4 70 cm 8 Contact Lead Kit, part number M365SC2352700 is part... The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensi... Class II Boston Scientific Neuromodulation Corporation
Apr 24, 2019 Precision TM M8 Adapter, 15 cm, part number M365SC9218150 - Product Usage: Th... The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensi... Class II Boston Scientific Neuromodulation Corporation
Apr 24, 2019 Fifty-five (55) cm 8 Contact Extension Kit, part number M365SC3138550 - Produ... The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensi... Class II Boston Scientific Neuromodulation Corporation
Apr 24, 2019 Fifty-five (55) cm 8 Contact Extension Kit, part number M365NM3138550 - Prod... The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensi... Class II Boston Scientific Neuromodulation Corporation
Apr 24, 2019 LinearTM 3-4 50 cm 8 Contact Lead Kit, part number M365SC2352500. Leads fun... The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensi... Class II Boston Scientific Neuromodulation Corporation
Apr 24, 2019 Thirty-five (35) cm 8 Contact Extension Kit, part number M365SC3138350. Pack... The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensi... Class II Boston Scientific Neuromodulation Corporation
Apr 8, 2019 AURIGA XL 4007 GENERAL - ZERO COST SYSTE UPN: FS4007GZ0 Product Usage: ... Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue... Class II Boston Scientific Corporation
Apr 8, 2019 AURIGA 30 GENERAL - DEMO SYSTEM UPN: M0068S30GD0 Product Usage: The Au... Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue... Class II Boston Scientific Corporation
Apr 8, 2019 AURIGA XL 4007 GENERAL - DEMO SYSTEM UPN: M0068FS4007GD0 Product Usage: ... Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue... Class II Boston Scientific Corporation
Apr 8, 2019 AURIGA XL 4007 GENERAL SYSTEM UPN: M0068FS4007G0 Product Usage: The Aur... Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue... Class II Boston Scientific Corporation
Apr 8, 2019 AURIGA 30 GENERAL SYSTEM UPN: M0068S30G0 Product Usage: The Auriga XL ... Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue... Class II Boston Scientific Corporation
Apr 8, 2019 AURIGA 30 BRAZIL SYSTEM UPN: M0068S30B0 Product Usage: The Auriga XL 4... Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue... Class II Boston Scientific Corporation
Apr 8, 2019 AURIGA XL 4007 BRAZIL SYSTEM Model: M0068FS4007B0 Product Usage: The A... Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue... Class II Boston Scientific Corporation
Apr 8, 2019 AURIGA 30 GENERAL ZERO COST SYSTEM UPN: M0068S30GZ0 Product Usage: The... Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue... Class II Boston Scientific Corporation
Apr 8, 2019 AURIGA 30 BRAZIL ZERO COST SYSTEM UPN: M0068S30BZ0 Product Usage: The A... Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue... Class II Boston Scientific Corporation
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 19, 2018 Stingray" Guidewire, labeled as 300cm. intended to facilitate placement of b... A batch of 185cm Stingray Guidewires are incorrectly labeled as 300cm guidewires. 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.