Browse Device Recalls

38 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 38 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 38 FDA device recalls.

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DateProductReasonClassFirm
Nov 12, 2020 VNS Therapy SENTIVA DUO # 1000-D - Product Usage: indicated for the treatment... During internal testing, it was found that upon a device reset, the Generator exhibits the incorr... Class II LivaNova USA Inc
Sep 28, 2020 VNS Therapy¿ AspireSR¿ Generator Due to an extra digit being inadvertently added to the serial number of a subset of implantable p... Class II LivaNova USA Inc
Apr 24, 2020 Vein Irrigation Cannula with blunt tip. ASY BIC, STERILE 25/CS REF/ GTIN for ... The firm has identified through internal tests that the sterile barrier of certain Sterile Standa... Class II LivaNova USA Inc.
Apr 24, 2020 Sterile Disposable Connectors ASY CONN Y 1/2X1/2X3/8 STR 24. REF/ GTIN for In... The firm has identified through internal tests that the sterile barrier of certain Sterile Standa... Class II LivaNova USA Inc.
Apr 24, 2020 Sterile Disposable Connectors ASY 1/4 X 3/8 REDUCER W/LL 24. REF/ GTIN for In... The firm has identified through internal tests that the sterile barrier of certain Sterile Standa... Class II LivaNova USA Inc.
Apr 24, 2020 Sterile Disposable Connectors ASY STR CONN 3/16 STRLE 24. REF/ GTIN for Inser... The firm has identified through internal tests that the sterile barrier of certain Sterile Standa... Class II LivaNova USA Inc.
Apr 24, 2020 Sterile Disposable Connectors ASY ASY STR CONN 3/8 STRLE 24 REF/ GTIN for Ins... The firm has identified through internal tests that the sterile barrier of certain Sterile Standa... Class II LivaNova USA Inc.
Apr 24, 2020 1/4X3/16X3/16YCONN,STRL REF/ GTIN for Insert Label:EC2102S/ 00803622129278 The firm has identified through internal tests that the sterile barrier of certain Sterile Standa... Class II LivaNova USA Inc.
Apr 24, 2020 Sterile Disposable Connectors ASY Y CONN 1/4 X 1/4 X 1/4 24 REF/ GTIN for Ins... The firm has identified through internal tests that the sterile barrier of certain Sterile Standa... Class II LivaNova USA Inc.
Apr 24, 2020 Sterile Disposable Connectors ASY S/1/4 TO 3/16 RED 24 REF/ GTIN for Insert L... The firm has identified through internal tests that the sterile barrier of certain Sterile Standa... Class II LivaNova USA Inc.
Apr 24, 2020 1/2 - 3/8 REDUC CONN, STRL REF/ GTIN for Insert Label:EC2145S/ 00803622129322 The firm has identified through internal tests that the sterile barrier of certain Sterile Standa... Class II LivaNova USA Inc.
Apr 24, 2020 Sterile Disposable Connectors ASY 3/16 X 3/16 STR CONNW/LL24. REF/ GTIN for I... The firm has identified through internal tests that the sterile barrier of certain Sterile Standa... Class II LivaNova USA Inc.
Apr 24, 2020 Sterile Disposable Connectors ASY CONN REDUCER 1/2 X 3/8 24 REF/ GTIN for Ins... The firm has identified through internal tests that the sterile barrier of certain Sterile Standa... Class II LivaNova USA Inc.
Apr 24, 2020 Sterile Disposable Connectors ASY CONN REDUCER 3/8 X 1/4 24 REF/ GTIN for Ins... The firm has identified through internal tests that the sterile barrier of certain Sterile Standa... Class II LivaNova USA Inc.
Apr 24, 2020 3/8 STR CONN, STRL REF/ GTIN for Insert Label:EC2130S/ 00803622129292 The firm has identified through internal tests that the sterile barrier of certain Sterile Standa... Class II LivaNova USA Inc.
Apr 24, 2020 1/4X3/8 REDUC CONN, STRL REF/ GTIN for Insert Label:EC2140S/ 00803622129315 The firm has identified through internal tests that the sterile barrier of certain Sterile Standa... Class II LivaNova USA Inc.
Apr 24, 2020 3/8X3/8X3/8 Y CONN, STRL REF/ GTIN for Insert Label:EC2105S/ 00803622129285 XXX Class II LivaNova USA Inc.
Apr 24, 2020 Sterile Disposable Connectors ASY CONN EQUAL 3/16 WYE 24 REF/ GTIN for Insert... The firm has identified through internal tests that the sterile barrier of certain Sterile Standa... Class II LivaNova USA Inc.
Apr 24, 2020 Sterile Disposable Connectors ASY Y CONN 3/8 X 3/8 X 3/8 24 REF/ GTIN for Ins... The firm has identified through internal tests that the sterile barrier of certain Sterile Standa... Class II LivaNova USA Inc.
Apr 24, 2020 Sterile Disposable Connectors ASY S CONN 3/16X1/8 RDR ANLD24 REF/ GTIN for In... The firm has identified through internal tests that the sterile barrier of certain Sterile Standa... Class II LivaNova USA Inc.
Apr 24, 2020 Sterile Disposable Connectors ASY STR CONN 1/4 STRLE 24. REF/ GTIN for Insert... The firm has identified through internal tests that the sterile barrier of certain Sterile Standa... Class II LivaNova USA Inc.
Apr 24, 2020 Sterile Disposable Connectors ASY RDC Y 1/2X3/8X3/8 STR 24 REF/ GTIN for Inse... The firm has identified through internal tests that the sterile barrier of certain Sterile Standa... Class II LivaNova USA Inc.
Apr 24, 2020 Vein Irrigation Cannula with blunt tip. ASY VIC, STERILE 25/CS REF/ GTIN for ... The firm has identified through internal tests that the sterile barrier of certain Sterile Standa... Class II LivaNova USA Inc.
Apr 24, 2020 Sterile Disposable Connectors ASY 1/2 CONN W/LL STRLE 24 REF/ GTIN for Insert... The firm has identified through internal tests that the sterile barrier of certain Sterile Standa... Class II LivaNova USA Inc.
Feb 24, 2020 LivaNova Heater-Cooler System 3T - Product Usage: The Heater-Cooler 3T System... The firm is providing validated cleaning and disinfection instructions in their revised operating... Class II LivaNova USA Inc.
Feb 4, 2020 VNS Therapy Programmer, Model 3000 used with Models 103, 104, 105, 106, or 81... False positive warning may occur after: 1) VNS Generator interrogated at 0mA normal output curren... Class II LivaNova USA Inc
Nov 18, 2019 LivaNova USA Sterile Disposable Connector,1/2x1/2, 20 units per case Some packages of sterile disposable connectors contained a 3/8x1/4 reducer instead of the specif... Class III LivaNova USA Inc.
Aug 22, 2019 VNS Therapy, SenTiva, Model # 1000, (01)05425025750405, Rx Only for vagal ne... Sentiva generators may reset and become disabled within 60 days of enabling. Physicians can re-en... Class I LivaNova USA Inc
Aug 13, 2019 VNS Therapy SENTIVA Generator Model # 1000 Labeling 26-0009-6800 Model 1... Firm identified a subset of its generators that were sterilized one additional sterilization cycl... Class II LivaNova USA Inc
Jul 3, 2019 LivaNova SMART PERFUSION PACK INSPIRE 8S - Product Usage: The affected produc... Perfusion tubing pack was packaged with the incorrect cuvette. Class III LivaNova USA Inc.
Jan 28, 2019 LivaNova Sorin Connect DPIII KOMPL. S5 REF 96-415-130, 2017-08-15, IPX1, RXOn... Incorrect labeling; it was identified that some Datapad devices contained incorrect labels. Speci... Class III LivaNova USA Inc.
Nov 16, 2018 Cyberonics VNS Therapy AspireHC Model 105 Generator, 26-0007-4000/3. The fir... This recall is an expansion of Z-3019-2017 and Z-3020-2017, which was initiated to fix the device... Class II LivaNova USA Inc
Nov 16, 2018 Cyberonics VNS Therapy AspireSR, Model 106 Generator, 26-0007-8400/1. The fi... This recall is an expansion of Z-3019-2017 and Z-3020-2017, which was initiated to fix the device... Class II LivaNova USA Inc
Nov 16, 2018 The LivaNova VNS Therapy System, used for Vagus Nerve Stimulation (VNS), cons... Lead impedance values reported by the affected VNS generator will be higher compared to those rep... Class II LivaNova USA Inc
Nov 16, 2018 VNS Therapy Program GMDN: 44077 Model # 3000 V1.5.2, RxOnly This recall is being initiated due to reports that that the therapy programming tablet with softw... Class II LivaNova USA Inc
Nov 1, 2018 SORIN Heater-Cooler System 3T 120V~/60Hz REF 16-02-85 Description of prod... The firm has become aware that due to a chemical reaction, the disinfectant/water preservative us... Class II LivaNova USA Inc.
Sep 14, 2018 SORIN Heater-Cooler System 3T, REF 16-02-85 Intended for use with a Stocke... For six units, the post-deep cleaning (DC) water sample tested positive for nontuberculous mycoba... Class II LivaNova USA Inc.
Jan 24, 2018 VNS Therapy Programming System, Rx Only, Model 3000, v1.0.2.2 Unintended warning message displayed on generators programmed with a Model 3000 v.1.0.2.2 program... Class II LivaNova USA 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.