Browse Device Recalls

28 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 28 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 28 FDA device recalls.

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DateProductReasonClassFirm
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.
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.
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 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.

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.