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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 801–820 of 1,000 recalls

Class IIOngoing

Medtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64001; Stimulator, electrical, implanted, for parkinsonian tremor

Medtronic Neuromodulation

A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By-Dates.

May 13, 2026 · DeviceView details →

Class IIOngoing

Medtronic 2x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64002; Stimulator, electrical, implanted, for parkinsonian tremor

Medtronic Neuromodulation

A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By-Dates.

May 13, 2026 · DeviceView details →

Class IIOngoing

Oncology sets with drip chambers

ICU Medical, Inc.

Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber wall that does not enter the fluid path, which if seen by a healthcare provider may lead to replacement of product before use, which could result in a delay in therapy.

May 12, 2026 · DeviceView details →

Class IIOngoing

Oncology sets with drip chambers

ICU Medical, Inc.

Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber wall that does not enter the fluid path, which if seen by a healthcare provider may lead to replacement of product before use, which could result in a delay in therapy.

May 12, 2026 · DeviceView details →

Class IIOngoing

IV Sets with drip chambers

ICU Medical, Inc.

Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber wall. The presence of discoloration and particulate matter in the fluid path has not been ruled out.

May 12, 2026 · DeviceView details →

Class IIOngoing

Octopus Evolution AS Tissue Stabilizer, Model TS2500

Medtronic Perfusion Systems

During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the top, contrary to the intended design.

May 12, 2026 · DeviceView details →

Class IIOngoing

Plum administration sets

ICU Medical, Inc.

Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber wall. The presence of discoloration and particulate matter in the fluid path has not been ruled out.

May 12, 2026 · DeviceView details →

Class IIOngoing

Octopus 4 Tissue Stabilizer, Model 29400

Medtronic Perfusion Systems

During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the top, contrary to the intended design.

May 12, 2026 · DeviceView details →

Class IIOngoing

IV Sets with drip chambers

ICU Medical, Inc.

Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber wall. The presence of discoloration and particulate matter in the fluid path has not been ruled out.

May 12, 2026 · DeviceView details →

Class IIOngoing

IV Non-Dedicated Gravity Administration Sets with drip chambers

ICU Medical, Inc.

Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber wall that does not enter the fluid path, which if seen by a healthcare provider may lead to replacement of product before use, which could result in a delay in therapy.

May 12, 2026 · DeviceView details →

Class IIOngoing

Octopus Evolution Tissue Stabilizer, Model TS2000

Medtronic Perfusion Systems

During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the top, contrary to the intended design.

May 12, 2026 · DeviceView details →

Class IIOngoing

IV Sets with drip chambers

ICU Medical, Inc.

Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber wall. The presence of discoloration and particulate matter in the fluid path has not been ruled out.

May 12, 2026 · DeviceView details →

Class IIOngoing

Bicarby" Dialysate; Model Numbers: RFP-400-G, RFP-401-G, RFP-402-G, RFP-404-G, RFP-407-G, and RFP-456-G;

Fresenius Medical Care Holdings, Inc.

Given the increased number of leaks reported by users, it was determined to be the appropriate course of action to notify users of the potential for the occurrence of Bicarby luer-lock leaks during manipulation of the frangible and tubing when preparing the product for use for treatment. This issue presents the potential of a slip and fall hazard associated with fluid on the floor.

May 12, 2026 · DeviceView details →

Class IIOngoing

IV Sets with drip chambers

ICU Medical, Inc.

Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber wall. The presence of discoloration and particulate matter in the fluid path has not been ruled out.

May 12, 2026 · DeviceView details →

Class IIOngoing

Orca Single Use Air/Water and Suction Valves, Material Number (UPN) SUV-617-50; The Orca Air/Water Valve is intended to be used to control the air/water function on an endoscope during a GI (gastrointestinal) endoscopic procedure.

Boston Scientific Corporation

Boston Scientific is initiating a medical device removal of Orca Sterile, Single Use Air/Water and Suction Valves due to a higher than anticipated occurrence of the suction button sticking.

May 12, 2026 · DeviceView details →

Class IIOngoing

Merlin" Patient Care System (PCS) software Merlin" PCS 3650 programmer Model 3330 software

Abbott Medical

Software malfunction may occur during pacing capture threshold test of pacemaker resulting in programmer not successfully communicating the command to terminate the test.

May 12, 2026 · DeviceView details →

Class IIOngoing

Brand Name: Inspire Medical Systems, Inc. Product Name: Inspire stimulation Lead Model/Catalog Number: 4063 Product Description: The Inspire¿ Stimulation Lead (Model 4063) is designed to deliver stimulation to the hypoglossal nerve for the treatment of obstructive sleep apnea. The lead features a flexible, self-sizing cuff. Electrodes in the inner surface of the cuff deliver stimulation to the nerve. The lead incorporates a standard connector for coupling to the implantable pulse generator (IPG). Component: N/A

Inspire Medical Systems Inc.

Products are labeled with incorrect Use By Date, extending beyond the validated three-year shelf life from date of manufacturer. Material degradation of a product past its Use By Date may result in unplanned or premature revision surgery.

May 11, 2026 · DeviceView details →

Class IIOngoing

NeoSpan¿ SuperElastic Compression Staple w/Instruments Catalog Number and Product Name T50 SN010 NeoSpan¿ SuperElastic Compression Staple w/Instruments, Size 10x10x10 UDI-DI Code: 00817906020083 T50 SN012 NeoSpan¿ SuperElastic Compression Staple w/Instruments, Size 12x12x12 UDI-DI Code: 00817906020090 T50 SN020 NeoSpan¿ SuperElastic Compression Staple w/Instruments, Size 20x20x20 UDI-DI Code: 00817906020151 T50 SN110 NeoSpan¿ SuperElastic Compression Staple w/Instruments, Size 10x15x13 UDI-DI Code: 00817906020113 T50 SN115 NeoSpan¿ SuperElastic Compression Staple w/Instruments, Size 15Wx15x15 UDI-DI Code: 00817906020137 T50 SN118 NeoSpan¿ SuperElastic Compression Staple w/Instruments, Size 18x14x14 UDI-DI Code: 00810021861364 Single/multiple component metallic bone fixation appliances and accessories The In2Bones USA NeoSpan" Compression Staple Implant w/instruments is indicated for hand and foot bone fragments, osteotomy fixation and joint arthrodesis.

In2bones USA, LLC

Due to the Magnetic Resonance Conditional Symbol missing on the carton, inner tray, and patient label.

May 11, 2026 · DeviceView details →

Class IIOngoing

Brand Name: Persona Revision Product Name: Persona Revision¿ Trabecular Metal¿ Femoral Distal Augment Model/Catalog Number: 42-5572-066-10 Software Version: N/A Product Description: Persona Revision¿ Trabecular Metal¿ Femoral Distal Augment Size 9, 9+ 10mm Thicknes Component: N/A

Zimmer, Inc.

Firm received a complaint with no clinical impact in which a posterior augment was found within the distal augment package.

May 11, 2026 · DeviceView details →

Class IIOngoing

Brand Name: Inspire Medical Systems, Inc. Product Name: Inspire Respiratory Sensing Lead Model/Catalog Number: 4340 Software Version: N/A Product Description: The Inspire¿ Respiratory Sensing Lead (Model 4340) is designed to detect respiratory effort. The lead features a pressure sensitive membrane that converts the mechanical energy of respiration into an electrical signal. The lead incorporates a standard connector for coupling to the implantable pulse generator (IPG). Component: N/A

Inspire Medical Systems Inc.

Products are labeled with incorrect Use By Date, extending beyond the validated three-year shelf life from date of manufacturer. Material degradation of a product past its Use By Date may result in unplanned or premature revision surgery.

May 11, 2026 · DeviceView details →

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