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 461–480 of 1,000 recalls

Class IITerminated

PIVO Blood Collection Device 20G, REF: 202-0005

Velano Vascular

Incomplete sealing of blood collection device unit packages may produce a breach in the sterile barrier enclosing the product. This could lead to microbial contamination of the device prior to use. The health effects range from no clinical effect up to bloodstream infection.

November 10, 2021 · DeviceView details →

Class IITerminated

Torosa Saline-Filled Testicular Prosthesis (Size Small)

Coloplast Manufacturing US, LLC

Product is mislabeled for size.

November 9, 2021 · DeviceView details →

FDA Device Recalls

PIVO Blood Collection Device 20G, REF: 202-0005

Torosa Saline-Filled Testicular Prosthesis (Size Small)

Amplatzer Steerable Delivery Sheath

Miami J Select Collar, Item: MJS-101, and Miami J Select Collar Set, Item: MJSR-101 Instructions for Use

RAPID 20 E, REF 20701, System for the identification of Enterobacteriaceae in 4 hours, 25 strips/package, IVD.

QIAstat-Dx Respiratory SARS-CoV-2 Panel (US IVD under FDA EUA 200075); REF 691223

Boston Scientific ROTAPRO, Rotational Atherectomy System Console, Model numbers H74939309010 (US) and H74939309030 (EU).

Medical Device Identification Cards associated with Sprint Quattro Lead, Product/CFN 6935M72

Medical Device Identification Cards associated with Astra XT DR Implantable pulse generator

GE Vscan Extend, being sold as "Vscan Extend Sector DICOM"

GE Vscan Extend, being sold as "Vscan Extend Dual USB"

INBONE Total Ankle System, INBONE POLY INSERT SZ 2+ 14mm SULCUS

GE Vscan Extend, being sold as "Vscan Extend Dual Wi-Fi"

GE Vscan Extend, being sold as "Vscan Extend Sector USB"

GE Vscan Extend, being sold as "Vscan Extend Sector Wi-Fi"

GE Vscan Extend, being sold as "Vscan Extend Console"

GE Vscan Extend, being sold as "Vscan Extend Dual DICOM"

regard Clinical Packaging Solutions Item Number 830096005, OB01054E - Newborn Kit, containing 2 25GA x .625IN needles.

INBONE Total Ankle System, INBONE POLY INSERT SZ 2 10mm SULCUS