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FDA Recalls
›Device Recalls

FDA Device Recalls

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

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Date

All time Past 30 days Past 12 months

Showing 521–540 of 1,000 recalls

Kirwan Surgical Products LLC Disposable 25-gauge bipolar pencil, straight. Model/Catalog Number: 14-5011 The Disposable Microsurgical Bipolar Pencil are designed for use in eye surgery, and other soft tissue procedures. For instance, the pencils are designed for cauterization of the retinal area during surgical procedures. The current line of pencils all have the same molded handle. The pencils' tip outer diameter is 25 gauge.

Kirwan Surgical Products, LLC

Potential for the outer stainless-steel tube to break or detach.

November 14, 2024 · DeviceView details →

Exacta External Drainage and Monitoring System: 27581 KIT 27581 EXACTA W/EDM VCATH 35CM 27636 EDM 27636 EXACTA W/BRAIDED CORD LOCK 27666 EDM 27666 EXCTA W GLUE STPCK GR PT LN 27732 EDM 27732 EXACTA W/NDL-LS INJ. ST W/CAP 27785 EDMS 27785 EXACTA 50ML BC NDLESS INJ 27795 EDMS 27795 EXACTA 100ML CATH 27861 EDMS 27861 EXACTA 50ML ANTIRFLUX GRNPL 46700 SYSTEM 46700 EXACTA DISP. DRAINAGE 46705 SYSTEM 46705 EXACTA DRAINAGE 100ML The Exacta external drainage and monitoring system (EDMS) is a system for externally draining and monitoring cerebrospinal fluid (CSF) and monitoring intracranial pressure (ICP).

Medtronic Neurosurgery

Due to complaints received reporting cracks and/or leaks of the stopcocks associated with the external drainage and monitoring system (EDMS).

November 1, 2024 · DeviceView details →

Becker External Drainage and Monitoring System: 24146 EDMS 24146 BECKER NO Y-SITE 25120 EDMS II 25120 BECKER W/1-WAY VALVE 26040 KIT 26040 BECKER EDMS II 27609 BECKER 27609 W/NEEDLESLESS INJ. SITE 27670 BECKER 27670 STOP BELOW DC NDL-LS IN 27672 BECKER 27672 ONEWAY VLV Y-SITE PT LN 27702 EDMS 27702 EURO BECKER II GR PT LN 27761 BECKER 27761 STOP BCNDLESS PATLN 24 27767 BECKER 27767 NO STPCOCK ON PTLN 63 27779 EDMS 27779 BECKER BC NDLESS BOND CONN 27811 EDMS 27811 BECKER GRN PL VCATH 27931 EDMS 27931 BECKER GS TUBING SMARTSITES 46128 EDMS 46128 BECKER II BLUE PT LN 46129 EDMS 46129 EURO BECKER II BLUE PT LN The Becker External Drainage and Monitoring System (Becker EDMS) is a closed system for: 1. Draining cerebrospinal fluid (CSF) from the lateral ventricles of the brain or the lumbar subarachnoid space. 2. Monitoring CSF pressure and flow rate from the lateral ventricles of the brain and the lumbar subarachnoid space.

Medtronic Neurosurgery

Due to complaints received reporting cracks and/or leaks of the stopcocks associated with the external drainage and monitoring system (EDMS).

November 1, 2024 · DeviceView details →

Allegedly counterfeit batteries manufactured by CSB batteries being used with Plum Infusion Systems: Plum 360" Infusion System, Pump List Number 30010; Plum A+ & Plum A+3" Infusion Systems, Pump List Numbers: 11005, 11971, 12391, 12618, 20678, 20679, 20792, 60529, 12348, 1197

ICU Medical, Inc.

ICU Medical has received reports of allegedly counterfeit CSB batteries being used with Plum Infusion Systems. While these non-OEM batteries are visually similar to the Plum batteries supplied by ICU Medical, they are in fact not the same batteries and have not been tested or validated for use with Plum Infusion Systems. Preliminary reports suggest that these non-OEM batteries fail to hold their charge and the pump may display messages to replace batteries earlier than expected. OSI Batteries and their customers are distributing these non-OEM CSB batteries without authorization from ICU Medical.

October 22, 2024 · DeviceView details →

Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482; use in Peritoneal Dialysis

Baxter Healthcare Corporation

Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) when using certain peritoneal dialysis and hemodialysis devices.

October 21, 2024 · DeviceView details →

Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482S; use in Peritoneal Dialysis

Baxter Healthcare Corporation

Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) when using certain peritoneal dialysis and hemodialysis devices.

October 21, 2024 · DeviceView details →

Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4482; use in Peritoneal Dialysis

Baxter Healthcare Corporation

Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) when using certain peritoneal dialysis and hemodialysis devices.

October 21, 2024 · DeviceView details →

Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4483; use in Peritoneal Dialysis

Baxter Healthcare Corporation

Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) when using certain peritoneal dialysis and hemodialysis devices.

October 21, 2024 · DeviceView details →

Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4482E; use in Peritoneal Dialysis

Baxter Healthcare Corporation

Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) when using certain peritoneal dialysis and hemodialysis devices.

October 21, 2024 · DeviceView details →

Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp EX Short, Part Number T5C4484; use in Peritoneal Dialysis

Baxter Healthcare Corporation

Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) when using certain peritoneal dialysis and hemodialysis devices.

October 21, 2024 · DeviceView details →

Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4483; use in Peritoneal Dialysis

Baxter Healthcare Corporation

Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) when using certain peritoneal dialysis and hemodialysis devices.

October 21, 2024 · DeviceView details →

Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number T5C4482; use in Peritoneal Dialysis

Baxter Healthcare Corporation

Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) when using certain peritoneal dialysis and hemodialysis devices.

October 21, 2024 · DeviceView details →

Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482EJ; use in Peritoneal Dialysis

Baxter Healthcare Corporation

Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) when using certain peritoneal dialysis and hemodialysis devices.

October 21, 2024 · DeviceView details →

Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4484; use in Peritoneal Dialysis

Baxter Healthcare Corporation

Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) when using certain peritoneal dialysis and hemodialysis devices.

October 21, 2024 · DeviceView details →

Baxter AK 98 Dialysis Machine, Hemodialysis Delivery System, Product Code 955607. As of February 2025, the firm name is Vantive.

Baxter Healthcare Corporation

Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) when using certain peritoneal dialysis and hemodialysis devices.

October 16, 2024 · DeviceView details →

Brand Name: Atlan Product Name: Atlan A300XL Model/Catalog Number: 8621400 The Atlan is an anesthesia workstation intended for use in anesthetizing adults, pediatrics, and neonates.

Draeger Medical, Inc.

The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.

October 15, 2024 · DeviceView details →

Brand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number: 8621600 Software Version: Not Applicable Component: Not applicable

Draeger Medical, Inc.

The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.

October 15, 2024 · DeviceView details →

Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: Not applicable Component: Not applicable

Draeger Medical, Inc.

The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.

October 15, 2024 · DeviceView details →

Brand Name: Atlan Product Name: Atlan A300 Model/Catalog Number: 8211300 The Atlan is an anesthesia workstation intended for use in anesthetizing adults, pediatrics, and neonates.

Draeger Medical, Inc.

The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.

October 15, 2024 · DeviceView details →

Boston Scientific POLARx BALLOON CATHETER LT 28MM OUS, Material Number M004CRBS2100

Boston Scientific Corporation

Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.

October 10, 2024 · DeviceView details →

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