Browse Device Recalls
48 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 48 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 48 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jan 3, 2025 | Brand Name: SenTiva DUO" Product Name: VNS Therapy¿ SenTiva DUO", Model 1000... | Their is a potential that implanted pulse generators may stop delivering therapy due to an intern... | Class II | LivaNova USA, Inc. |
| Jan 3, 2025 | Brand Name: SenTiva" Product Name: VNS Therapy" SenTiva", Model 1000 Model/... | Their is a potential that implanted pulse generators may stop delivering therapy due to an intern... | Class II | LivaNova USA, Inc. |
| Dec 12, 2024 | SenTiva, REF: 1000C, Generators Part of the VNS Therapy System with Microburs... | Vagus nerve stimulator generators may stop delivering stimulation due to an internal, mechanicall... | Class II | LivaNova USA, Inc. |
| Dec 12, 2024 | SenTiva, REF: 1000; SenTiva Duo, REF: 1000-D; Generators Part of the VNS Ther... | Vagus nerve stimulator generators may stop delivering stimulation due to an internal, mechanicall... | Class II | LivaNova USA, Inc. |
| Dec 2, 2021 | Vagus Nerve Stimulation (VNS) Therapy Leads, PerenniaDURA, Model: 303. Mode... | A manufacturing issue may cause the silicone tubing wall thickness of vagus nerve stimulation lea... | Class II | LivaNova USA, Inc. |
| 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 9, 2018 | Perfusion Pack, Rx only, Sterile EO | 4-way stopcocks and stopcock manifold assembled in certain perfusion tubing systems, indicated fo... | Class II | LivaNova USA |
| 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. |
| Apr 20, 2018 | Sorin Stockert Heater-Cooler System 3T, a) Item #: 16-02-81, 240 v/60 Hz;... | Firm is notifying customers that the Deep-Cleaning Service is now available in the United States.... | Class II | LivaNova USA |
| Mar 13, 2018 | Inspire 6 Integrated Phisio OXY w/ HVR Reservoir, Sterile EO, Catalog # 05071... | Some integrated sterile INSPIRE family products contain an incorrect expiration date printed in t... | Class II | LivaNova USA |
| Mar 13, 2018 | Inspire 8 Integrated Phisio OXY w/ HVR Reservoir, Sterile EO, Catalog # 05071... | Some integrated sterile INSPIRE family products contain an incorrect expiration date printed in t... | Class II | LivaNova USA |
| 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 |
| Dec 19, 2017 | Sorin Group Smart Perfusion Pack E-Pack, REF 088511400, Rev: L, Single Use, S... | The product is labeled with the incorrect expiration date. | Class III | LivaNova USA |
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.