Medical DeviceJun 23, 2021
Radiometer ABL90 FLEX PLUS Analyzer with E3800 PC units recall — FDA Z-1857-2021
Due to an issue with the internal clock of the analyzers with an e3800 PC unit installed.
Class IIFDA: OngoingRadiometer Medical ApS
Latest records
Latest recalls — page 858
The newest recall records with useful source details are listed here.
Medical DeviceJun 23, 2021
Windstone Medical Packaging Angio Pack REF: AMS6908C, Sterile EO, Contents:1 Blade Scalpel # recall — FDA Z-1848-2021
Angio tubing included within Custom Convenience kits may contain insufficient or incomplete weld
Class IIFDA: TerminatedWindstone Medical Packaging, Inc.
Medical DeviceJun 23, 2021
Medtronic HY10Y54R4, Custom Pack HY10Y54R4 ECC PED 1/4, Custom Perfusion System, Sterile, Rx recall — FDA Z-1885-2021
Specific lots may have been manufactured with insufficient or incomplete welds.
Class IIFDA: TerminatedMedtronic Perfusion Systems
Medical DeviceJun 23, 2021
Skytron, Div. The KMW Group Skyton Bracket Flatscreen, Revision 2 & 3-The FS32 is a single recall — FDA Z-1861-2021
Failure of the FS32 Monitor Brackets from the mounting block could potentially loosen over time and eventually detach from the baseplate, result in the display interface dismounting from…
Class IIFDA: OngoingSkytron, Div. The KMW Group, Inc.
Medical DeviceJun 23, 2021
Abbott Laboratories WorkMate Claris v.1.2 Upgrade Kits, Model Numbers H800007 and H800012 recall — FDA Z-1855-2021
Due to a software error, the user may lose functionality of the system or the screen may turn black during operation.
Class IIFDA: TerminatedAbbott Laboratories Inc. (St Jude Medical)
Medical DeviceJun 23, 2021
Bard Peripheral Vascular VENOVO Venous Stent System 8F Product Description(REF)/dimension recall — FDA Z-1898-2021
Reports of the proximal end of the stent not immediately expanding upon deployment and remaining connected to the delivery system.
Class IIFDA: OngoingBard Peripheral Vascular Inc.
Medical DeviceJun 23, 2021
Medtronic HY11B40R1, Custom Pack HY11B40R1 1/4 Respirato, Custom Perfusion System, Sterile recall — FDA Z-1877-2021
Specific lots may have been manufactured with insufficient or incomplete welds.
Class IIFDA: TerminatedMedtronic Perfusion Systems
Medical DeviceJun 23, 2021
Medtronic HY10J00R12, Custom Pack HY10J00R12 ECC Small CA, Custom Perfusion System recall — FDA Z-1883-2021
Specific lots may have been manufactured with insufficient or incomplete welds.
Class IIFDA: TerminatedMedtronic Perfusion Systems
Medical DeviceJun 23, 2021
Medtronic BB7D76R13, Custom Pack BB7D76R13 CORR HL, Custom Perfusion System, Sterile, Rx recall — FDA Z-1893-2021
Specific lots may have been manufactured with insufficient or incomplete welds.
Class IIFDA: TerminatedMedtronic Perfusion Systems
Medical DeviceJun 23, 2021
Medtronic HY10D90R2, Custom Pack HY10D90R2 3/8 ACC, Custom Perfusion System, Sterile, Rx recall — FDA Z-1886-2021
Specific lots may have been manufactured with insufficient or incomplete welds.
Class IIFDA: TerminatedMedtronic Perfusion Systems
Medical DeviceJun 23, 2021
Abbott Laboratories v.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate Claris" System recall — FDA Z-1854-2021
Due to a software error, the user may lose functionality of the system or the screen may turn black during operation.
Class IIFDA: TerminatedAbbott Laboratories Inc. (St Jude Medical)
Medical DeviceJun 23, 2021
Medtronic CB10W65R1, Custom Pack CB10W65R1 CH Access1/4, Custom Perfusion System, Sterile recall — FDA Z-1884-2021
Specific lots may have been manufactured with insufficient or incomplete welds.
Class IIFDA: TerminatedMedtronic Perfusion Systems
Medical DeviceJun 23, 2021
Covidien Electrostatic Filter Angled, Item Code 350S19006 - Product Usage: indicated for recall — FDA Z-1866-2021
The company was notified by their supplier of sterilization services for airway products in Italy of potential deviations from validated parameters for ethylene oxide sterilization.
Class IIFDA: OngoingCovidien, LP
Medical DeviceJun 23, 2021
Medtronic BB9G78R8, Custom Pack BB9G78R8 ECC Supp, Custom Perfusion System, Sterile, Rx recall — FDA Z-1894-2021
Specific lots may have been manufactured with insufficient or incomplete welds.
Class IIFDA: TerminatedMedtronic Perfusion Systems
Medical DeviceJun 23, 2021
Medtronic BB11J14R2, Custom Pack BB11J14R2 Bridge, Custom Perfusion System, Sterile, Rx recall — FDA Z-1874-2021
Specific lots may have been manufactured with insufficient or incomplete welds.
Class IIFDA: TerminatedMedtronic Perfusion Systems
Medical DeviceJun 23, 2021
Anodyne Surgical Hydrodissection Cannula (Chang), 27g, labeled as: anodynesurgical, REF 7018 recall — FDA Z-1852-2021
The product may have a yellowish-brown/greenish-brown residue present at the tip of the cannula.
Class IIFDA: TerminatedAnodyne Surgical
Medical DeviceJun 23, 2021
Medtronic CB7J97R8, Custom Pack CB7J97R8 U14 E Sup, Custom Perfusion System, Sterile, Rx recall — FDA Z-1876-2021
Specific lots may have been manufactured with insufficient or incomplete welds.
Class IIFDA: TerminatedMedtronic Perfusion Systems
Medical DeviceJun 23, 2021
Medtronic HY10Z48R2, Ctr., Custom Pack HY10Z48R2 Adult ECC 1/4, Custom Perfusion System recall — FDA Z-1871-2021
Specific lots may have been manufactured with insufficient or incomplete welds.
Class IIFDA: TerminatedMedtronic Perfusion Systems
Medical DeviceJun 23, 2021
Radiometer ABL90 FLEX Analyzer with E3800 PC units recall — FDA Z-1856-2021
Due to an issue with the internal clock of the analyzers with an e3800 PC unit installed.
Class IIFDA: OngoingRadiometer Medical ApS
Medical DeviceJun 23, 2021
Circulatory Technology The Better-Bladder (BB), part of extracorporeal membrane oxygenation recall — FDA Z-1862-2021
The device is used as part of extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass circuits and may collapse during use which can increase resistance to flow in the venous line…
Class IIFDA: OngoingCirculatory Technology Inc.
Medical DeviceJun 23, 2021
OSSUR MIAMI J SELECT COLLAR - Product Usage: is intended to provide gross immobilization to recall — FDA Z-1896-2021
Due to insufficient column strength of the racks for all load conditions, racks associated with height adjustment functionality have been observed deforming, which may lead to increased…
Class IIFDA: TerminatedOssur Americas
Medical DeviceJun 23, 2021
Bard Peripheral Vascular VENOVO Venous Stent System 9F Product Description(REF)/dimension recall — FDA Z-1899-2021
Reports of the proximal end of the stent not immediately expanding upon deployment and remaining connected to the delivery system.
Class IIFDA: OngoingBard Peripheral Vascular Inc.
Medical DeviceJun 23, 2021
GE Healthcare Innova IGS 3 (GTIN 00840682147378), Innova IGS 5 (GTIN 00840682124621), Innova recall — FDA Z-1864-2021
The IGS system can experience a single vertical line defect where the vertical line divides and horizontally shifts live monitor images into two unequal image parts within the monitor…
Class IIFDA: TerminatedGE Healthcare, LLC
Medical DeviceJun 23, 2021
Medtronic CB10R79R6, Custom Pack CB10R79R6 1/4X1/4 Loop, Custom Perfusion System, Sterile recall — FDA Z-1887-2021
Specific lots may have been manufactured with insufficient or incomplete welds.
Class IIFDA: TerminatedMedtronic Perfusion Systems
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Recent recall archives
Browse recent months with enough recall history for useful comparison.
October 2026111 records · 4 categoriesSeptember 2026364 records · 4 categoriesAugust 2026302 records · 4 categoriesJuly 2026370 records · 4 categoriesJune 2026376 records · 4 categoriesMay 2026340 records · 4 categoriesApril 2026415 records · 4 categoriesMarch 2026190 records · 4 categoriesFebruary 2026331 records · 4 categoriesJanuary 2026212 records · 4 categoriesDecember 2025389 records · 4 categoriesNovember 2025326 records · 4 categories