Medical device recalls reported in 2021

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Reported	Recall	Class	Product	Firm
2021-01-20	Z-0825-2021	Class II	NaturaLyte Liquid Acid concentrate drums	Fresenius Medical Care Holdings, Inc.
2021-01-20	Z-0826-2021	Class II	NaturaLyte Liquid Acid concentrate drums	Fresenius Medical Care Holdings, Inc.
2021-01-20	Z-0827-2021	Class II	Citrasate Liquid Acid concentrate bottles	Fresenius Medical Care Holdings, Inc.
2021-01-20	Z-0828-2021	Class II	Citrasate Liquid Acid concentrate drums	Fresenius Medical Care Holdings, Inc.
2021-01-20	Z-0829-2021	Class II	Citrasate Liquid Acid concentrate drums	Fresenius Medical Care Holdings, Inc.
2021-01-20	Z-0830-2021	Class II	Medisafe Distal Duck Kit and Duck Bag	Steris Corporation
2021-01-20	Z-0831-2021	Class II	Naturalyte Liquid Acid concentrate bottles	Fresenius Medical Care Holdings, Inc.
2021-01-20	Z-0832-2021	Class II	Naturalyte Liquid Acid concentrate bottles	Fresenius Medical Care Holdings, Inc.
2021-01-20	Z-0833-2021	Class II	Naturalyte Liquid Acid concentrate bottles	Fresenius Medical Care Holdings, Inc.
2021-01-20	Z-0834-2021	Class II	Citrasate Liquid Acid concentrate bottles	Fresenius Medical Care Holdings, Inc.
2021-01-20	Z-0835-2021	Class II	Naturalyte Liquid Acid concentrate bottles	Fresenius Medical Care Holdings, Inc.
2021-01-20	Z-0836-2021	Class II	Naturalyte Liquid Acid concentrate bottles	Fresenius Medical Care Holdings, Inc.
2021-01-20	Z-0837-2021	Class II	Naturalyte Liquid Acid concentrate bottles	Fresenius Medical Care Holdings, Inc.
2021-01-20	Z-0838-2021	Class II	Naturalyte Liquid Acid concentrate bottles	Fresenius Medical Care Holdings, Inc.
2021-01-20	Z-0839-2021	Class II	Naturalyte Liquid Acid concentrate drums	Fresenius Medical Care Holdings, Inc.
2021-01-20	Z-0840-2021	Class II	Naturalyte Liquid Acid concentrate drums	Fresenius Medical Care Holdings, Inc.
2021-01-20	Z-0841-2021	Class II	Citrasate Liquid Acid concentrate drums	Fresenius Medical Care Holdings, Inc.
2021-01-20	Z-0842-2021	Class II	AnshLabs	Ansh Labs, LLC
2021-01-20	Z-0843-2021	Class II	CareLink Personal Software Therapy Management Software Tool for…	Medtronic Inc.
2021-01-20	Z-0844-2021	Class II	VITROS Chemistry Products TP Slides- IVD measure total protein	Ortho Clinical Diagnostics Inc
2021-01-20	Z-0845-2021	Class II	VITROS XT Chemistry Products ALB-TP Slides	Ortho Clinical Diagnostics Inc
2021-01-20	Z-0846-2021	Class II	The cobas z 480 analyzer including dedicated software for IVD use is…	Roche Molecular Systems, Inc.
2021-01-20	Z-0847-2021	Class II	visby medical COVID-19 Test kit *** An in vitro diagnostic for the…	VISBY MEDICAL INC
2021-01-20	Z-0852-2021	Class II	Emission Computed Tomography System Image Process System	Philips North America, LLC
2021-01-20	Z-0853-2021	Class II	GE NM/CT 850 system Model Number H3907AD	GE Healthcare, LLC
2021-01-20	Z-0854-2021	Class II	GE NM/CT 860 system Model Number H3908AD	GE Healthcare, LLC
2021-01-20	Z-0855-2021	Class II	GE NM/CT 870 CZT system Model Number H3906CW	GE Healthcare, LLC
2021-01-20	Z-0856-2021	Class II	Discovery NM 630	GE Healthcare, LLC
2021-01-20	Z-0857-2021	Class II	Discovery 670 DR	GE Healthcare, LLC
2021-01-20	Z-0858-2021	Class II	Optima NM/CT 640	GE Healthcare, LLC
2021-01-20	Z-0859-2021	Class II	icumedical Cogent" Hemodynamic Monitoring System	ICU Medical, Inc.
2021-01-20	Z-0860-2021	Class II	Medtronic Intellis Spinal Cord Stimulator	Medtronic Neuromodulation
2021-01-20	Z-0861-2021	Class II	Atellica CH 930 Analyzer	Siemens Healthcare Diagnostics, Inc.
2021-01-20	Z-0862-2021	Class II	Atellica IM 1300 Analyzer	Siemens Healthcare Diagnostics, Inc.
2021-01-20	Z-0863-2021	Class II	Atellica IM 1600 Analyzer	Siemens Healthcare Diagnostics, Inc.
2021-01-20	Z-0864-2021	Class II	All EPIQ and Affiniti Ultrasound systems	Philips Ultrasound Inc
2021-01-13	Z-0767-2021	Class II	Eleganza 5	Linet Spol. S.r.o.
2021-01-13	Z-0768-2021	Class II	MiniCap Extended Life PD Transfer Set	Baxter Healthcare Corporation
2021-01-13	Z-0770-2021	Class II	VITROS Chemistry Products CKMB Slides:	Ortho Clinical Diagnostics Inc
2021-01-13	Z-0772-2021	Class II	Bone fixation nail	Smith & Nephew, Inc.
2021-01-13	Z-0773-2021	Class II	AXIOS Stent and Electrocautery	Boston Scientific Corporation
2021-01-13	Z-0774-2021	Class II	AXIOS Stent and Electrocautery	Boston Scientific Corporation
2021-01-13	Z-0775-2021	Class II	AXIOS Stent and Electrocautery	Boston Scientific Corporation
2021-01-13	Z-0776-2021	Class II	Hot AXIOS Stent and Electrocautery	Boston Scientific Corporation
2021-01-13	Z-0777-2021	Class II	Hot AXIOS Stent and Electrocautery	Boston Scientific Corporation
2021-01-13	Z-0778-2021	Class II	Hot AXIOS Stent and Electrocautery	Boston Scientific Corporation
2021-01-13	Z-0779-2021	Class II	Resect	Medline Industries Inc
2021-01-13	Z-0780-2021	Class II	Simple Neck Dissection	Medline Industries Inc
2021-01-13	Z-0781-2021	Class II	Thyroid Pack CKHA-LF	Medline Industries Inc
2021-01-13	Z-0782-2021	Class II	Greffe Aorte-LF	Medline Industries Inc
2021-01-13	Z-0783-2021	Class II	Cardiac Pack	Medline Industries Inc
2021-01-13	Z-0784-2021	Class II	TomoTherapy Treatment System	Accuray Incorporated
2021-01-13	Z-0785-2021	Class II	TomoTherapy Treatment Delivery System with iDMS	Accuray Incorporated
2021-01-13	Z-0786-2021	Class II	Vis-U-All High Temperature Tubing 3"x100'	Steris Corporation
2021-01-13	Z-0787-2021	Class II	Vis-U-All High Temperature Tubing 4"x100'	Steris Corporation
2021-01-13	Z-0788-2021	Class II	Vis-U-All High Temperature Tubing 6"x100'	Steris Corporation
2021-01-13	Z-0789-2021	Class II	Vis-U-All High Temperature Tubing 9"x100'	Steris Corporation
2021-01-13	Z-0790-2021	Class II	Vis-U-All High Temp 4	Steris Corporation
2021-01-13	Z-0791-2021	Class II	Vis-U-All High Temp 6"x10" Heat Seal Pouch 200 pouches per box	Steris Corporation
2021-01-13	Z-0792-2021	Class II	Vis-U-All High Temp 7	Steris Corporation
2021-01-13	Z-0793-2021	Class II	Vis-U-All High Temp 3	Steris Corporation
2021-01-13	Z-0794-2021	Class II	Vis-U-All High Temp 13"x18" Self Seal Pouch 100 pouches per box	Steris Corporation
2021-01-13	Z-0795-2021	Class II	Vis-U-All High Temp 4"x11" Self Seal Pouch 200 pouches per box	Steris Corporation
2021-01-13	Z-0796-2021	Class II	Vis-U-All High Temp 5	Steris Corporation
2021-01-13	Z-0797-2021	Class II	Vis-U-All High Temp 5"x15" Self Seal Pouch 200 pouches per box	Steris Corporation
2021-01-13	Z-0798-2021	Class II	Vis-U-All High Temp 7	Steris Corporation
2021-01-13	Z-0799-2021	Class II	Vis-U-All High Temp 8"x16" Self Seal Pouch 200 pouches per box	Steris Corporation
2021-01-13	Z-0800-2021	Class II	enGen Laboratory Automation System	Ortho-Clinical Diagnostics, Inc.
2021-01-13	Z-0801-2021	Class II	VITROS Automation Solutions	Ortho-Clinical Diagnostics, Inc.
2021-01-13	Z-0802-2021	Class II	Pinnacle Cups	DePuy Orthopaedics, Inc.
2021-01-13	Z-0803-2021	Class II	CoaguChek XS Prof	Roche Diagnostics Operations, Inc.
2021-01-13	Z-0804-2021	Class II	CoaguChek XS PST Meters- IVD	Roche Diagnostics Operations, Inc.
2021-01-06	Z-0726-2021	Class II	PORTEX Bivona Cuffless Neonatal/Pediatric FlexTend Tracheostomy Tube	Smiths Medical ASD Inc.
2021-01-06	Z-0737-2021	Class II	Custom procedure packs	ROi CPS LLC
2021-01-06	Z-0738-2021	Class II	Medtronic Ares Antibiotic-Impregnated Catheter	Medtronic Neurosurgery
2021-01-06	Z-0739-2021	Class II	Medtronic Ares Antibiotic-Impregnated Catheter	Medtronic Neurosurgery
2021-01-06	Z-0740-2021	Class II	Medtronic Ares Antibiotic-Impregnated Catheter	Medtronic Neurosurgery
2021-01-06	Z-0741-2021	Class II	REF 3102-E	Westmed, Inc.
2021-01-06	Z-0742-2021	Class II	Westmed DISPOSABLE RESPIRATORY PRODUCTS NON-REBREATHER MASK	Westmed, Inc.
2021-01-06	Z-0743-2021	Class II	REF 0930 Adult Elongated CO2/O2 Mask	Westmed, Inc.
2021-01-06	Z-0744-2021	Class II	REF 0562F	Westmed, Inc.
2021-01-06	Z-0745-2021	Class II	REF 0562K	Westmed, Inc.
2021-01-06	Z-0746-2021	Class II	REF 0562	Westmed, Inc.
2021-01-06	Z-0747-2021	Class II	Covidien TA Auto Suture Vascular Stapler with DST Series Technology…	Covidien Llc
2021-01-06	Z-0748-2021	Class II	Covidien TA Auto Suture Vascular Loading Unit with DST Series…	Covidien Llc
2021-01-06	Z-0749-2021	Class II	Product Code: K05T-02533	Merit Medical Systems, Inc.
2021-01-06	Z-0750-2021	Class II	Product Code: K12T-02871	Merit Medical Systems, Inc.
2021-01-06	Z-0751-2021	Class II	Custom Procedure Kit	Merit Medical Systems, Inc.
2021-01-06	Z-0752-2021	Class II	cobas pro integrated solutions -cobas c 503	Roche Diagnostics Operations, Inc.
2021-01-06	Z-0753-2021	Class II	Smoothbore breathing system with exhalation port 22 mm Device REF #:…	Intersurgical Inc
2021-01-06	Z-0754-2021	Class II	Roche cobas 8000 modular analyzer series	Roche Diagnostics Operations, Inc.
2021-01-06	Z-0755-2021	Class II	Roche cobas pro integrated solutions	Roche Diagnostics Operations, Inc.
2021-01-06	Z-0756-2021	Class II	CM 50-001-01 Injectate Kit	Lidco Ltd
2021-01-06	Z-0757-2021	Class II	Contour VL Variable Length Ureteral Stent	Boston Scientific Corporation
2021-01-06	Z-0758-2021	Class II	Contour VL Variable Length Ureteral Stent Set	Boston Scientific Corporation
2021-01-06	Z-0759-2021	Class II	BD Phoenix PMIC/ID-105: IVD is intended for the in vitro rapid…	Becton Dickinson & Co.
2021-01-06	Z-0760-2021	Class II	BD Phoenix PMIC/ID-107: IVD is intended for the in vitro rapid…	Becton Dickinson & Co.
2021-01-06	Z-0761-2021	Class II	BD Phoenix PMIC-107: IVD is intended for the in vitro rapid…	Becton Dickinson & Co.
2021-01-06	Z-0762-2021	Class II	BD Phoenix PMIC/ID-108: IVD is intended for the in vitro rapid…	Becton Dickinson & Co.
2021-01-06	Z-0763-2021	Class II	BD Phoenix PMIC-108: IVD is intended for the in vitro rapid…	Becton Dickinson & Co.
2021-01-06	Z-0764-2021	Class II	BD Phoenix PMIC/ID-109: IVD is intended for the in vitro rapid…	Becton Dickinson & Co.
2021-01-06	Z-0765-2021	Class II	BD Phoenix" PMIC-109: IVD is intended for the in vitro rapid…	Becton Dickinson & Co.
2021-01-06	Z-0766-2021	Class II	BD Phoenix PMIC-110: IVD is intended for the in vitro rapid…	Becton Dickinson & Co.

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