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FDA Recalls
›Device Recalls

FDA Device Recalls

Recalls of medical devices, diagnostic equipment, implants, and surgical instruments.

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 421–440 of 1,000 recalls

Class ITerminated

Medtronic TurboHawk Plus Directional Atherectomy System 6F, Small Vessel, Catalog number THP-S. For use in peripheral vasculature.

ev3 Inc.

The device has similarities in design to another device that the firm recently issued a field correction on due to instances of tip detachment and embolization.

February 4, 2022 · DeviceView details →

Class IIITerminated

TCL1 Breakapart Probe, Fluorescence in situ hybridisation (FISH) is a technique allows the visualisation of DNA sequences upon chromosome Catalog Number: LPH046-A

Cytocell Ltd.

May show unexpected locus specific signals in addition to those at 14q32.

February 4, 2022 · DeviceView details →

Class ITerminated

Medtronic TurboHawk Plus Directional Atherectomy System 6F, Multi-vessel, Catalog number THP-M. For use in peripheral vasculature.

ev3 Inc.

The device has similarities in design to another device that the firm recently issued a field correction on due to instances of tip detachment and embolization.

February 4, 2022 · DeviceView details →

Class IITerminated

Cardiovascular Procedure Kit catalog # 76645 & 73806

Terumo Cardiovascular Systems Corp

Potential for Cardiovascular Procedure Kit packaging damage that occurred during shipping.

February 3, 2022 · DeviceView details →

Class IITerminated

Philips StentBoost Live R2.0 application, when used with the Philips Azurion with software release R2.x

Philips Healthcare

Due to an incorrect configuration setting in the EPX database of StentBoost Live, acquisition does not stop automatically as it should. When the user selects the StentBoost Live protocol on the Philips Azurion system, the following on-screen message is displayed to the user in the Philips StentBoost Live application: "Press the cine pedal until the acquisition stops". However, due to the incorrect configuration of the EPX database, the acquisition does not stop after 40 images, but instead it continues as long as the pedal is pressed.

February 2, 2022 · DeviceView details →

Class IITerminated

Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC M/L, Part ID 17037

BioPro, Inc.

There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the BioPro MPJ Implant has been tested for safety and compatibility in the MR Environment and is MR Conditional. MR Testing has not been conducted on the titanium version of the MPJ.

February 1, 2022 · DeviceView details →

Class IITerminated

Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC MD, Part ID 16814

BioPro, Inc.

There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the BioPro MPJ Implant has been tested for safety and compatibility in the MR Environment and is MR Conditional. MR Testing has not been conducted on the titanium version of the MPJ.

February 1, 2022 · DeviceView details →

Class IITerminated

Titanium MPJ (Toe Implant)TOE JOINT TITANIUM NPC LG, Part ID 16816

BioPro, Inc.

There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the BioPro MPJ Implant has been tested for safety and compatibility in the MR Environment and is MR Conditional. MR Testing has not been conducted on the titanium version of the MPJ.

February 1, 2022 · DeviceView details →

Class IITerminated

Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC MS, Part ID 17197

BioPro, Inc.

There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the BioPro MPJ Implant has been tested for safety and compatibility in the MR Environment and is MR Conditional. MR Testing has not been conducted on the titanium version of the MPJ.

February 1, 2022 · DeviceView details →

Class IITerminated

(1) JOBST Compri2, REF 76271-01, containing 2 components, one plastic-wrapped padding and one plastic-wrapped compression bandage with compression of approximately 40 mmHg packaged into a pouch and then both components are packaged into a folding box. Shipping case contains 10 folding boxes. (2) JOBST Compri2 lite, REF 76271-02, containing 2 components, one plastic-wrapped padding (as is contained in REF 76271-01) and one plastic wrapped compression bandage with a compression of approximately 20-30mmHg packaged into a pouch and then both components are packaged into a folding box. Shipping case contains 10 folding boxes.

BSN Medical Inc

The folding boxes within the shipping case are mislabeled. The shipping case and immediate packages within the folding boxes are correctly labeled.

February 1, 2022 · DeviceView details →

Class IITerminated

Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC SM, Part ID 16813

BioPro, Inc.

There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the BioPro MPJ Implant has been tested for safety and compatibility in the MR Environment and is MR Conditional. MR Testing has not been conducted on the titanium version of the MPJ.

February 1, 2022 · DeviceView details →

Class IITerminated

Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC LG, Part ID 17038

BioPro, Inc.

There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the BioPro MPJ Implant has been tested for safety and compatibility in the MR Environment and is MR Conditional. MR Testing has not been conducted on the titanium version of the MPJ.

February 1, 2022 · DeviceView details →

Class IITerminated

Titanium MPJ (Toe Implant)TOE JOINT TITANIUM PC SM, Part ID 17035

BioPro, Inc.

There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the BioPro MPJ Implant has been tested for safety and compatibility in the MR Environment and is MR Conditional. MR Testing has not been conducted on the titanium version of the MPJ.

February 1, 2022 · DeviceView details →

Class IITerminated

Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC ML, Part ID 16815

BioPro, Inc.

There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the BioPro MPJ Implant has been tested for safety and compatibility in the MR Environment and is MR Conditional. MR Testing has not been conducted on the titanium version of the MPJ.

February 1, 2022 · DeviceView details →

Class IITerminated

Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC MS, Part ID 17198

BioPro, Inc.

There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the BioPro MPJ Implant has been tested for safety and compatibility in the MR Environment and is MR Conditional. MR Testing has not been conducted on the titanium version of the MPJ.

February 1, 2022 · DeviceView details →

Class IITerminated

Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC MD, Part ID 17036

BioPro, Inc.

There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the BioPro MPJ Implant has been tested for safety and compatibility in the MR Environment and is MR Conditional. MR Testing has not been conducted on the titanium version of the MPJ.

February 1, 2022 · DeviceView details →

Class IITerminated

Dispensing Pins for Air Inlet Filter, Product Catalog No. 412005, DP2500 Dispensing Pin W/Valve. A valve for aspiration or injection of medication or enteral feeding solution from inverted multi-dose vials.

B. Braun Medical, Inc.

This lot may have an elevated risk of leakage from the Air-Inlet Filter of the device. Leakage of the Air-Inlet Filter may increase the risk of decreasing the dose of medication delivered to the patient, cause delays in treatment due to the need to replace the device or may cause contamination of the fluid path that can lead to bloodstream infection.

January 31, 2022 · DeviceView details →

Class IITerminated

Conductivity Sensors utilized on Dialog and Dialog+ Hemodialysis Systems. Conductivity Sensor (END) - VERSION 2, Article Code Number 3456103A. These conductivity sensors may be used as spare parts for the following dialysis machines: 710200L (UDI 04046963686345), 710200S (UDI 04046964285608), 710200U (UDI 04046964285615), 710200K (UDI 04046963686338), 710500L (UDI Not applicable) and 710500K (UDI Not applicable).

B Braun Medical Inc

Firm learned of the potential for cracks to form in the conductivity sensors during use, which may lead to a leak in the dialysate circuit. This could result in excessive ultrafiltration or insufficient ultrafiltration depending on whether the dialysis machine is equipped with a Dialysis Fluid filter.

January 28, 2022 · DeviceView details →

Class IITerminated

SAM CHEST SEAL REF CS203-EN Combo LOT Y060321-09

Sam Medical Products

Due to partially assembled valved dressing that has a hole within it instead of the intended non-valved dressing in the package resulting in that the dressing cannot be centered over the open chest wound and create an occlusive seal due to the hole being present.

January 28, 2022 · DeviceView details →

Class IITerminated

Conductivity Sensors utilized on Dialog and Dialog+ Hemodialysis Systems. Conductivity Sensor (BIC) - VERSION 2, Article Code Number 3456102A. These conductivity sensors may be used as spare parts for the following dialysis machines: 710200L (UDI 04046963686345), 710200S (UDI 04046964285608), 710200U (UDI 04046964285615), 710200K (UDI 04046963686338), 710500L (UDI Not applicable) and 710500K (UDI Not applicable).

B Braun Medical Inc

Firm learned of the potential for cracks to form in the conductivity sensors during use, which may lead to a leak in the dialysate circuit. This could result in excessive ultrafiltration or insufficient ultrafiltration depending on whether the dialysis machine is equipped with a Dialysis Fluid filter.

January 28, 2022 · DeviceView details →

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