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  1. FDA Recalls
  2. ›Device Recalls

FDA Device Recalls

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

Classification
AllClass IClass IIClass III
Status
AllOngoingCompletedTerminated
Date
All timePast 30 daysPast 12 months

Showing 441–460 of 1,000 recalls

Class IOngoing

smiths medical ProPort Plastic Venous Access System, Silicone Catheter, 2.8mm (8.4Fr) O.D. x 1.0mm I.D., 9 Fr Introducer, REF 21-4151-24

Smiths Medical ASD, Inc.

The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.

February 13, 2025 · DeviceView details →
Class IOngoing

smiths medical ProPort Plastic Venous Access System, Silicone Catheter, 2.87,,O.D. (8.4Fr) s 1.0mm I.D., REF 21-4150-24

Smiths Medical ASD, Inc.

The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.

February 13, 2025 · DeviceView details →
Class IOngoing

smiths medical ProPort Low Profile Plastic Venous Access System, Silicone Catheter, 2.8mm (8.4Fr) O.D. x 1.0mm I.D., 9Fr Introducer, REF 21-4187-24

Smiths Medical ASD, Inc.

The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.

February 13, 2025 · DeviceView details →
Class IOngoing

smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm O.D. (5.8 Fr) x 1.0mm I.D., REF 21-4152-24

Smiths Medical ASD, Inc.

The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.

February 13, 2025 · DeviceView details →
Class IOngoing

smiths medical ProPort Plastic Venous Access System, PolyFlow Catheter, 2.6 (7.8Fr) O.D. x 1.6mm I.D., 8.5Fr Introducer, REF 21-4171-24

Smiths Medical ASD, Inc.

The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.

February 13, 2025 · DeviceView details →
Class IOngoing

smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 2.6mm O.D. (7.8Fr) x 1.6mm I.D., REF 21-4155-24

Smiths Medical ASD, Inc.

The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.

February 13, 2025 · DeviceView details →
Class IOngoing

smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm (5.8Fr) O.D. x 1.0mm I.D., 6Fr Introducer, REF 21-4153-24

Smiths Medical ASD, Inc.

The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.

February 13, 2025 · DeviceView details →
Class IOngoing

Aortic Root Cannula: 1. DLP Aortic Root Cannula A. CANNULA 11012 AR FLOWGUARD 12GA, model no 11012 B. CANNULA 11014 AR FLOWGUARD 14GA, model no. 11014 2. MiAR Cannula: A. CANNULA 11012L AR FLOWGUARD LONG 12GA, model no 11012L B. CANNULA 11014L AR FLOWGUARD 14FR LONG, model no. 11014L 3. DLP Aortic Root Cannula with Vent Line A. CANNULA 21012 AR VENT FLOW 12GA, model no. 21012 B. CANNULA 21014 AR VENT FLOW 14GA, model no. 21014

Medtronic Perfusion Systems

Unexpected loose material in the male luer used in the aortic root cannula has been identified. Potential harms when identified prior to use - procedure delay. Potential harm if not identified and used - stroke (reversible and irreversible).

February 5, 2025 · DeviceView details →
Class IOngoing

Rotarex Atherectomy System and Instructions for Use, BD SET Rotarex: S 6 F x 110 cm, REF: 80236; S 6 F x 135 cm, REF: 80237; S 8 F x 85 cm, REF: 80238; S 8 F x 110 cm, REF: 80239

Bard Peripheral Vascular Inc

Atherectomy Catheter eIFU updated to clarify and emphasize procedural steps intended to reduce the likelihood of catheter breakage events. Catheter has an outer cylinder connected to a rotating helix, which could fracture and/or break, which would require retrieval, and helix facture/break could cause vessel injury and lead to severe bleeding.

February 5, 2025 · DeviceView details →
Class IOngoing

Baxter Sigma Spectrum Infusion System (V6 Platform), Product Code 35700BAX

Baxter Healthcare Corporation

There is the potential for missing motor mounting screws, which may have occurred during the servicing process.

February 5, 2025 · DeviceView details →
Class IOngoing

Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009

Baxter Healthcare Corporation

There is the potential for missing motor mounting screws, which may have occurred during the servicing process.

February 5, 2025 · DeviceView details →
Class IOngoing

VOCSN Multi-Function Ventilators: VOCSN+Pro (V+O+C+S+N+Pro, English), REF: PRT-00490-001; V+Pro (V+Pro, English), REF: PRT-01185-000, PRT-01185-002

Ventec Life Systems, Inc.

Multi-Function Ventilators were serviced using incorrect parts which have the potential to cause unexpected shutdown, or when using an active circuit could result in inaccurate tidal volume monitor, not triggering on patient efforts, less inspiratory volume, less inspiratory pressure, and less PEEP delivered.

February 3, 2025 · DeviceView details →
Class IOngoing

Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF: PED3-021-350-16, PED3-021-250-14, PED3-021-350-20, PED3-021-250-20, PED3-021-300-16, PED3-021-300-20, PED3-021-275-12, PED3-021-275-16, PED3-021-325-12, PED3-021-325-14, PED3-021-325-16, PED3-021-325-20, PED3-021-250-12, PED3-021-300-14, PED3-021-250-16, PED3-021-300-12, PED3-021-275-14, PED3-021-350-14, PED3-021-350-25, PED3-021-350-12, PED3-021-250-10, PED3-021-275-20, PED3-021-350-18, PED3-021-325-18, PED3-021-275-18, PED3-021-250-18, PED3-021-300-18; and Instructions for Use, Part: M056989CDOC2

Micro Therapeutics, Inc.

Use of embolization device with diameters greater-than-or-equal-to 4mm may lead to incomplete wall apposition and/or braid deformation (fish-mouthing/braid narrowing/braid collapse) noted during procedure and post-procedure, typically noted at 6-12 month imaging follow-up, potentially can lead to thrombosis and/or serious adverse events. Higher risk in females less-than-or-equal-to 45 years of age

January 30, 2025 · DeviceView details →
Class IOngoing

Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF: PED3-027-350-12, PED3-027-350-14, PED3-027-350-16, PED3-027-350-20, PED3-027-350-25, PED3-027-400-12, PED3-027-400-14, PED3-027-400-16, PED3-027-400-18, PED3-027-400-20, PED3-027-400-25, PED3-027-400-30, PED3-027-450-12, PED3-027-450-14, PED3-027-450-16, PED3-027-450-18, PED3-027-450-20, PED3-027-450-25, PED3-027-450-30, PED3-027-450-40, PED3-027-500-14, PED3-027-500-16, PED3-027-500-18, PED3-027-500-20, PED3-027-500-25, PED3-027-500-30, PED3-027-500-40, PED3-027-550-16, PED3-027-550-18, PED3-027-550-20, PED3-027-550-30, PED3-027-550-40, PED3-027-550-50, PED3-027-600-16, PED3-027-600-18, PED3-027-600-20, PED3-027-600-30, PED3-027-600-40, PED3-027-600-50

Micro Therapeutics, Inc.

Use of embolization device with diameters greater-than-or-equal-to 4mm may lead to incomplete wall apposition and/or braid deformation (fish-mouthing/braid narrowing/braid collapse) noted during procedure and post-procedure, typically noted at 6-12 month imaging follow-up, potentially can lead to thrombosis and/or serious adverse events. Higher risk in females less-than-or-equal-to 45 years of age

January 30, 2025 · DeviceView details →
Class IOngoing

Olympus Single Use Guide Sheath Kits with the following product descriptions and model numbers: 1. Single Use Guide Sheath Kit K-201 2.0MM Channel Set: Guide Sheath, Biopsy Forceps, Cytology Brush; Model Number: K-201 2. Single Use Guide Sheath Kit K-202 2.0MM Channel Set: Guide Sheath, Biopsy Forceps; Model Number: K-202 3. Single Use Guide Sheath Kit K-203 2.6MM Channel Set: Guide Sheath, Biopsy Forceps, Cytology Brush; Model Number: K-203 4. Single Use Guide Sheath Kit K-204 2.6MM Channel Set: Guide Sheath, Biopsy Forceps; Model Number: K-204. Used to collect cells or tissue specimens in the respiratory organs.

Olympus Corporation of the Americas

Potential for the radiopaque tip of the guide sheath component to disassociate and fall off into the patient.

January 15, 2025 · DeviceView details →
Class IOngoing

Vaporizer Sevoflurane, Quik-Fil. Model Number: 6682285. Device is a component of Flow-i C20, Flow-i C30, Flow-i C40, Flow-c, Flow-e. For use during anesthesia.

Getinge Usa Sales Inc

Sevoflurane used with the vaporizer may degrade to hydrogen fluoride, which could present a risk to patients or health care providers through inhalation and/or skin exposure. Potential harms include irritation of respiratory tract, which in worst case may lead to lung edema and/or severe hypocalcemia, blistering, superficial ulceration, and/or hypomagnesemia.

January 15, 2025 · DeviceView details →
Class IOngoing

Allura Xper FD20 Biplane; Catalog numbers: (1) 722008, (2) 722013.

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Possibility of the patient falling from the table related to the mattress used on the patient table.

January 13, 2025 · DeviceView details →
Class IOngoing

Azurion 3 M15; Catalog numbers: (1) 722064, (2) 722222 (3) 722280(OUS ONLY).

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Possibility of the patient falling from the table related to the mattress used on the patient table.

January 13, 2025 · DeviceView details →
Class IOngoing

Allura CV20; Catalog numbers: 722031

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Possibility of the patient falling from the table related to the mattress used on the patient table.

January 13, 2025 · DeviceView details →
Class IOngoing

Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Possibility of the patient falling from the table related to the mattress used on the patient table.

January 13, 2025 · DeviceView details →
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