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Browse Device Recalls

3,010 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,010 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 3,010 FDA device recalls in 2019.

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DateProductReasonClassFirm
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 Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... The potential compromise of the sterility of products from an undersealed chevron in the packagin... Class II Cook Inc.
Oct 21, 2019 CS5/5+ Fastpacks, 125 mL, 20¿ Res Autotransfusion Device- Product Usage: its ... Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver¿ Elite¿/Elite¿ +1... Class II Haemonetics Corporation
Oct 21, 2019 Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... The potential compromise of the sterility of products from an undersealed chevron in the packagin... Class II Cook Inc.
Oct 21, 2019 Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... The potential compromise of the sterility of products from an undersealed chevron in the packagin... Class II Cook Inc.
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 Japan DISP SET, 263J, 205J, HAR - Product Usage: its related accessory compon... Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver¿ Elite¿/Elite¿ +1... Class II Haemonetics Corporation
Oct 21, 2019 C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Cr... Class II Integra LifeSciences Corp.
Oct 21, 2019 C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Cr... Class II Integra LifeSciences Corp.
Oct 21, 2019 C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Cr... Class II Integra LifeSciences Corp.
Oct 21, 2019 CS Elite Fastpack, 225 mL, 150 Res Autotransfusion Device - Product Usage: it... Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver¿ Elite¿/Elite¿ +1... Class II Haemonetics Corporation
Oct 21, 2019 C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Cr... Class II Integra LifeSciences Corp.
Oct 21, 2019 C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Cr... Class II Integra LifeSciences Corp.
Oct 21, 2019 Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... The potential compromise of the sterility of products from an undersealed chevron in the packagin... Class II Cook Inc.
Oct 21, 2019 Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... The potential compromise of the sterility of products from an undersealed chevron in the packagin... Class II Cook Inc.
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 C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Cr... Class II Integra LifeSciences Corp.
Oct 21, 2019 Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... The potential compromise of the sterility of products from an undersealed chevron in the packagin... Class II Cook Inc.
Oct 21, 2019 JAPAN DISP SET, 261J, 205J, HAR - Product Usage: its related accessory compon... Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver¿ Elite¿/Elite¿ +1... Class II Haemonetics Corporation
Oct 21, 2019 CS5/5+ Fastpacks, 225 mL, 20¿ Res Autotransfusion Device - Product Usage: its... Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver¿ Elite¿/Elite¿ +1... Class II Haemonetics Corporation
Oct 21, 2019 Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... The potential compromise of the sterility of products from an undersealed chevron in the packagin... Class II Cook Inc.
Oct 21, 2019 Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... The potential compromise of the sterility of products from an undersealed chevron in the packagin... Class II Cook Inc.
Oct 21, 2019 C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Cr... Class II Integra LifeSciences Corp.
Oct 21, 2019 Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... The potential compromise of the sterility of products from an undersealed chevron in the packagin... Class II Cook Inc.
Oct 21, 2019 DxM 1096 MicroScan WalkAway Instrument REF B1018-496 WalkAway Instruments may have been assembled with the incorrect AC power entry connector inlet wi... Class II Beckman Coulter Inc.
Oct 21, 2019 C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Cr... Class II Integra LifeSciences Corp.
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 Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... The potential compromise of the sterility of products from an undersealed chevron in the packagin... Class II Cook Inc.
Oct 21, 2019 C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Cr... Class II Integra LifeSciences Corp.
Oct 21, 2019 Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... The potential compromise of the sterility of products from an undersealed chevron in the packagin... Class II Cook Inc.
Oct 21, 2019 JAPAN CELL SAVER ELITE SET - 225ML - Product Usage: its related accessory com... Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver¿ Elite¿/Elite¿ +1... Class II Haemonetics 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 MicroScan WalkAway-40 plus Instrument REF B1018-283 WalkAway Instruments may have been assembled with the incorrect AC power entry connector inlet wi... Class II Beckman Coulter Inc.
Oct 21, 2019 Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... The potential compromise of the sterility of products from an undersealed chevron in the packagin... Class II Cook Inc.
Oct 21, 2019 Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... The potential compromise of the sterility of products from an undersealed chevron in the packagin... Class II Cook Inc.
Oct 21, 2019 C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Cr... Class II Integra LifeSciences Corp.
Oct 21, 2019 C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Cr... Class II Integra LifeSciences Corp.
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 21, 2019 Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... The potential compromise of the sterility of products from an undersealed chevron in the packagin... Class II Cook Inc.
Oct 21, 2019 Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... The potential compromise of the sterility of products from an undersealed chevron in the packagin... Class II Cook Inc.
Oct 21, 2019 Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... The potential compromise of the sterility of products from an undersealed chevron in the packagin... Class II Cook Inc.
Oct 18, 2019 CapsoCAM Plus, UDI: 00867770000209 Capsule Endoscopy System: a defect present in the capsule window may be stressed through the prod... Class II Capso Vision, Inc.
Oct 18, 2019 Niti-S Esophageal Stent, REF ES1806F, ES1808F, ES1810F, ES1815F, ES2006B, ES2... Misprinted IFUs shipped with esophageal stents Class II Taewoong Medical Co., Ltd.
Oct 18, 2019 Aequalis Ascend Flex Humeral Stem: Part Number UDI DWF601A 3700386944475 D... During shipping, it is possible for the Aequalis Ascend Flex humeral stem to become unseated or o... Class II Tornier, Inc
Oct 18, 2019 Energy FX: a) original Aluminum (100-3A) b) sleek (adult and kid & pet) (1... FDA determined that marketing claims surrounding product rendered product a medical device which ... Class II Basic Reset Inc.
Oct 18, 2019 BRASSELER KM166-310-35 Twist Drill Quick Connect Diameter 3.5 mm, Total Lengt... One lot of 3.5 mm twist drills were incorrectly laser etched as 2.5 mm the shaft of the device. Class II Brasseler USA I Lp
Oct 18, 2019 Coated PGA Undyed Polyglycolic Acid Braided Absorbable Suture Sterile EO 18" ... Failed to meet USP minimum average value for knot pull (tensile) strength. Class II CP Medical Inc
Oct 16, 2019 Quantam 2000 Electrosurgical Generator, Part number 909075-05. Potential for the Quantum 2000 Electrosurgery Generator, part numbers 909075, 909075-05 and 90907... Class II CooperSurgical, Inc.
Oct 16, 2019 Hitachi Scenaria Whole-body X-ray CT System There is a possibility that the cables to the controller unit may not be affixed properly, creati... Class II Hitachi Medical Systems America Inc
Oct 16, 2019 HeartStart XL+ Defibrillator/Monitor, Model 861290 The rotary therapy selector switch may fail, resulting in unexpected device behavior. These behav... Class II Philips North America, LLC

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.