Browse Device Recalls
2,602 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,602 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 2,602 FDA device recalls in 2020.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 29, 2020 | Samco Bio-Tite Sterile Specimen Container, 120mL/53mm, Bio-Tite Blue Cap Cat... | Product was not irradiated; therefore, they are not sterile and do not meet product specification. | Class II | Thermo Fisher Scientific (Monterrey) |
| Apr 28, 2020 | Giraffe OmniBed with installed Servo Oxygen module. Infant incubator and warmer. | Potential for certain Giraffe Incubators and Giraffe OmniBeds to deliver a different environmenta... | Class II | GE Healthcare, LLC |
| Apr 28, 2020 | Giraffe Incubator with installed Servo Oxygen module. Infant incubator. | Potential for certain Giraffe Incubators and Giraffe OmniBeds to deliver a different environmenta... | Class II | GE Healthcare, LLC |
| Apr 27, 2020 | DDU-2400EN Lifeline PRO, UDI 00815098020270 - Product Usage: Automated Extern... | A component issue may cause the AED to abort a shock delivery or reset unexpectedly, which may ca... | Class II | Defibtech, LLC |
| Apr 27, 2020 | Philips HeartStart MRx Monitor/Defibrillators Model numbers M3535A, M3536A,... | HeartStart XL MonitorlDefibrillators may not have been included in prior field actions and receiv... | Class II | Philips North America, LLC |
| Apr 27, 2020 | DDU-2300 Lifeline/ReviveR View, Model Numbers DDU-C2300EN, DDU-C2300CA, DDU-A... | A component issue may cause the AED to abort a shock delivery or reset unexpectedly, which may ca... | Class II | Defibtech, LLC |
| Apr 27, 2020 | DDU-2450 Lifeline ECG Model Numbers DDU-A2450EN DDU-E2450DE DDU-E2450EN ... | A component issue may cause the AED to abort a shock delivery or reset unexpectedly, which may ca... | Class II | Defibtech, LLC |
| Apr 26, 2020 | Skater Introducer Set 6F x 18cm. REF/UDI: 651506300/(01)00886333005000; 65550... | Tungsten coils of the guidewire included in the introducer kit were detaching. | Class II | Argon Medical Devices, 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 | ARCHITECT iGentamicin Reagent Kit - Product Usage: The measurements obtained ... | Abbott identified that samples tested for ARCHITECT STAT High Sensitive Troponin I and STAT High... | Class II | Abbott Gmbh & Co. KG |
| 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 | AngioDynamics NanoKnife Disposable Single Electrode Probes, Irreversible Ele... | Programming issue affected RFID function of a single lot and did not allow the NanoKnife probes t... | Class II | Angiodynamics, Inc. |
| Apr 24, 2020 | Infant/Child Reduced Energy Defibrillation Electrodes, Part Number: 3202380-0... | Packaging of infant child reduced energy electrodes was not properly sealed. | Class II | Physio-Control, 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 | Infant Child Starter Kits, Part Number: 3202784-009, containing Infant/Child... | Packaging of infant child reduced energy electrodes was not properly sealed. | Class II | Physio-Control, 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 | Medtronic Bone Void Filler, Large - Product Usage: is an injectable, moldab... | Product may not maintain its setting characteristics for the labeled shelf-life duration. Use may... | Class II | Medtronic Sofamor Danek USA Inc |
| Apr 24, 2020 | Extremities, Large Kit Assy, US, 15/3 - Product Usage: is an injectable, mold... | Product may not maintain its setting characteristics for the labeled shelf-life duration. Use may... | Class II | Medtronic Sofamor Danek USA Inc |
| Apr 24, 2020 | Medtronic Bone Void Filler, Small - Product Usage: is an injectable, moldab... | Product may not maintain its setting characteristics for the labeled shelf-life duration. Use may... | Class II | Medtronic Sofamor Danek 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 | DeRoyal Sterile Custom Kits packaged as a Piggy Back with the BD PosiFlush SF... | DeRoyal manufactured procedure packs using BDPosiFlush syringes which were subsequently recalled... | Class II | DeRoyal Industries 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. |
| Apr 23, 2020 | BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 10cm Max ... | Saline Flush Syringe compromised sterility due to holes in the packaging. | Class II | Access Scientific LLC |
| Apr 23, 2020 | BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 3Fr 6cm Quick... | Saline Flush Syringe compromised sterility due to holes in the packaging. | Class II | Access Scientific LLC |
| Apr 23, 2020 | ProxiDiagnost N90, UDI 706100 | The thermo switches in the three-phase transformer, which normally aid in powering down the Syste... | Class II | Philips North America, LLC |
| Apr 23, 2020 | BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 8cm Max B... | Saline Flush Syringe compromised sterility due to holes in the packaging. | Class II | Access Scientific LLC |
| Apr 23, 2020 | BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 8cm Quick... | Saline Flush Syringe compromised sterility due to holes in the packaging. | Class II | Access Scientific LLC |
| Apr 23, 2020 | OLYMPUS ShockPulse-SE Lithotripsy System, Model SPL-T Transducer | A component of the Olympus ShockPulse Transducer was manufactured with non-conforming material th... | Class II | Olympus Corporation of the Americas |
| Apr 23, 2020 | BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 10cm Quic... | Saline Flush Syringe compromised sterility due to holes in the packaging. | Class II | Access Scientific LLC |
| Apr 23, 2020 | BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND" ED Quick Kit 3F... | Saline Flush Syringe compromised sterility due to holes in the packaging. | Class II | Access Scientific LLC |
| Apr 23, 2020 | BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 5Fr 8cm Quick... | Saline Flush Syringe compromised sterility due to holes in the packaging. | Class II | Access Scientific LLC |
| Apr 23, 2020 | BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 10cm Exte... | Saline Flush Syringe compromised sterility due to holes in the packaging. | Class II | Access Scientific LLC |
| Apr 23, 2020 | BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 5Fr 10cm Quic... | Saline Flush Syringe compromised sterility due to holes in the packaging. | Class II | Access Scientific LLC |
| Apr 23, 2020 | BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND"XL Alternate Sit... | Saline Flush Syringe compromised sterility due to holes in the packaging. | Class II | Access Scientific 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.