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Vit Kit-Freeze is intended for use in assisted reproductive procedures for vitrification and storage of human oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos. This kit is designed for use with CryoTip (Catalog #40709), and Vitrification Thaw Kit (Vit Kit-Thaw) for optimal recovery of specimens. Vitrification Freeze kit (which includes the VS Vitrification Solution) are cryopreservation media intended for use in the vitrification of oocytes (MII) and pronuclear (PN) zygotes, cleavage stage embryos, and blastocyst stage embryos. Catalog numbers: 90133-SO Vitrification Freeze kit, contained 9x1 mL. Vitrification solution, VS, Catalog #90132. Product form: Liquid. Equilibration Solution-ES is a HEPES buffered solution of Medium-199 containing gentamicin sulfate, 7.5% (v/v) of each DMSO and ethylene glycol and 20% (v/v) Dextran Serum Supplement (DSS). Vitrification Solution-VS is a HEPES buffered solution of Medium-199 containing gentamicin sulfate, 15% (v/v) of each DMSO and ethylene glycol, 20% (v/v) DSS and 0.5 M sucrose. DSS is a protein supplement consisting of 50 mg/mL therapeutic grade Human Serum Albumin (HSA) and 20 mg/mL Dextran. DSS is used at 20% (v/v) in Vit Kit-Freeze for a final concentration of 10 mg/mL HSA and 4 mg/mL Dextran. These two solutions are to be used in sequence according to the step-wise microdrop vitrification protocol. Vitrification Solution-VS Aseptically filtered. Test results reported on C of A Vit Kit -Freeze (Vitrification Freeze Kit) with Gentamycin and DSS Contains 2 x 1 mL Equilibration Solution- ES; 2 X 1 mL Vitrification Solution-VS ...90133-DCOS...RX Only...Sterile ...20YY-MM-DD

FDA Recall
Open, Classified ·Fujifilm Irvine Scientific, Inc.·Product code MQL·September 8, 2021

Vit Kit-Freeze is intended for use in assisted reproductive procedures for vitrification and storage of human oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos. This kit is designed for use with CryoTip (Catalog #40709), and Vitrification Thaw Kit (Vit Kit-Thaw) for optimal recovery of specimens. Vitrification Freeze kit (which includes the VS Vitrification Solution) are cryopreservation media intended for use in the vitrification of oocytes (MII) and pronuclear (PN) zygotes, cleavage stage embryos, and blastocyst stage embryos. Catalog numbers: 90133-DCOS Vitrification Freeze kit, contained 9x1 mL. Vitrification solution, VS, Catalog #90132. Product form: Liquid. Equilibration Solution-ES is a HEPES buffered solution of Medium-199 containing gentamicin sulfate, 7.5% (v/v) of each DMSO and ethylene glycol and 20% (v/v) Dextran Serum Supplement (DSS). Vitrification Solution-VS is a HEPES buffered solution of Medium-199 containing gentamicin sulfate, 15% (v/v) of each DMSO and ethylene glycol, 20% (v/v) DSS and 0.5 M sucrose. DSS is a protein supplement consisting of 50 mg/mL therapeutic grade Human Serum Albumin (HSA) and 20 mg/mL Dextran. DSS is used at 20% (v/v) in Vit Kit-Freeze for a final concentration of 10 mg/mL HSA and 4 mg/mL Dextran. These two solutions are to be used in sequence according to the step-wise microdrop vitrification protocol. Vitrification Solution-VS Aseptically filtered. Test results reported on C of A Vit Kit -Freeze (Vitrification Freeze Kit) with Gentamycin and DSS Contains 9 x 1 mL Equilibration Solution- ES; 9 X 1 mL Vitrification Solution-VS ...90133-DCOS...RX Only...Sterile ...20YY-MM-DD

FDA Recall
Open, Classified ·Fujifilm Irvine Scientific, Inc.·Product code MQL·September 8, 2021

Vysis LSI ATM/p53: D13S319 /CEP 12/13q34 DNA Probe Set; fluorescence in situ hybridization (FISH) analyte specific reagents, in vitro diagnostic; Abbott Molecular Inc., Des Plaines, IL 60018 USA; list 05J83-001; The probe set consists of a 200 microliter vial of Vysis LSI D13S319 SO/LSI 13q34 SA/CEP 12 SG Probe, reference 30-191024, and a 200 microliter vial of Vysis LSI ATM SG/p 53 SO Probe, reference 30-191025.

FDA Recall
Terminated ·Abbott Molecular·Product code MVU·December 22, 2006

LeadCare Blood Lead Testing System Kits Catalog Number: 70-2233

FDA Recall
Terminated ·Esa Biosciences, Inc.·Product code DOF·May 19, 2005

ESA LeadCare II Blood Test Kit, 6 test Kit containing Level 1 and Level 2 Control Vials with lot number: 0704A Catalog Number: 70-7142

FDA Recall
Terminated ·Esa Biosciences, Inc.·Product code DOF·September 20, 2007

ESA LeadCare II Blood Test Kit containing Level 1 and Level 2 Control Vials with lot number: 0704A Catalog Number: 70-6762

FDA Recall
Terminated ·Esa Biosciences, Inc.·Product code DOF·September 20, 2007

MEDISTIM VERIQ SYSTEM, MODEL VQ4122 An intraoperative diagnostic system that utilizes ultrasonography to guide surgeons to successfully plan and accomplish surgical interventions.

FDA Recall
Terminated ·Medistim Asa Okernveien·Product code DPW·April 25, 2017

Brand Name: Medistim MiraQ System Product Name: Medistim MiraQ System Model/Catalog Number: MQC04001, MQC14001, MQU14011, MQV12011 Software Version: Not applicable Product Description: Ultrasound device for intraoperative use Component: No

FDA Recall
Open, Classified ·Medistim Asa Okernveien·Product code DPW·September 26, 2025

namic convenience kits labeled as: 1) MTS,4 VALVE,LFT,HRT,KIT-AHS-A*,NW, REF 60010468; 2) MTS,RIGHT HEART,KIT,W/TRANS,ST. *, REF 60010511; 3) MTS,LT,HT,KIT-BRYAN,LGH,M.C.,EAST, REF 60020323; 4) MTO,RIGHT,KIT-BRONSON,M* HOSP PG, REF 60020676; 5) MTS,LEFT HEART,KIT-C*,MEM HLTHCARE, REF 60035977; 6) MTS,LEFT HEART,KIT,J*,M*,C*, REF 60040273; 7) MTS,LEFT HEART,KIT,C*,C*, REF 60100313; 8) MTS,3V,KIT-M*,MEMORIAL, REF 60131208; 9) MTS,3V,KIT-M*,MEMORIAL, REF 60131208; 10) MTO,LEFT HEART,KIT,-,N* HOSPITAL PG, REF 60140101; 11) MTO,LEFT HEART,KIT,-,N* HOSPITAL PG, REF 60140101; 12) MTS,LEFT HEART,MAN,KIT,S*-BALTIMORE, REF 60190947; 13) MTS-LEFT HEART,KIT-W*,H* HOSP PG, REF 60231052; 14) MTO,3-VALVE,KIT-T*,A*-PG, REF 65190182; 15) MTO,LEFT HEART,KIT,-,S* F*,-,PG, REF 65190474; 16) MTS,DR.,MCKAYS,4V,KIT,-,H* HOSP PG, REF 600800516; 17) MTS,EP,KIT,-,S*,TEACHING HOSPITAL PG, REF 601309013; 18) MTS,RHT,HRT-S* HOSP &,MC, REF 601905413; 19) MTS,PEDS,LFT,&,RT,HRT-S* HOSP, REF 601905414; 20) MTO,SCH,BEL,J*,H*-ST-PAUL,-,PG, REF 606604328; 21) LHK,-,MID,3VCOMP,OFF,PS,S10RA, REF 613000122; 22) MTS,LHK,W* HOSPITAL, REF 6010034281; 23) MTS,LHK,W* HOSPITAL, REF 6010034281; 24) MTS,LHK,P*,P* MED CTR, REF 6010171931; 25) MTS,LHK,M* HEALTHCARE,MGMT, REF 6061073001; 26) TVR US B* INTEGRATED SERVICE CENT, REF 601316711A; 27) LHK-S* MEDICAL CENTER,A*, REF 60190776A; 28) LHK,-,S*,AND,W* HOSPITAL, REF 60191118A.

FDA Recall
Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code OEZ·February 12, 2025

Venue Go Standard Carts Ref: (H45181VC and H45103VCW), used with Venue Go R2, R3, R4 systems R2, R3, and R4 systems; pulsed doppler imaging system

FDA Recall
Open, Classified ·GE MEDICAL SYSTEMS, ISRAEL LTD. Nativ Haa??or Street no.·Product code IYN·September 6, 2023

Flite Clip Slings; patient specific disposable sling; Manufactured in Belgium for Medibo NV, Heikant 5, 3930 Hamont Achel, Belgium; these slings are intended for use with Arjo and BHM Passive Patient Lifts and Ceiling Lifts with four-point hanger bars intended for use with clip slings. The slings are used to assist with the lifting and transportation of a patient in the horizontal or other required position from one place to another and used only by appropriately trained caregivers.

FDA Recall
Terminated ·ArjoHuntleigh·Product code FSA·February 26, 2009

Codman 1/4 x 1/4" Surgical Patties (20 pouches of 10 patties per box) Product code: 80-1399

FDA Recall
Terminated ·Codman & Shurtleff, Inc.·Product code HBA·July 16, 2010

Sling Rope/Connector Assembly Kits for the Sara and Sara Nova standing and raising aids; the kit is comprised of 2 x 200 cm ropes, 2 knobs, 2 sling connectors, 2 socket cap screws, 2 nylon nuts and 2 spacers; Arjo Inc., 50 N. Gary Avenue, Roselle, IL 60172; Model KS1006

FDA Recall
Terminated ·Arjo, Inc.·Product code FSA·October 30, 2006

Universal SlingBar 350 Product Number: 3156074 Used with the: Viking XS, Viking S, Viking M, Viking L Patient Lifts

FDA Recall
Terminated ·Liko AB Alvik·Product code FSA·July 1, 2008

Maxi Move Patient Lift with Lock & Load System (Combi Hanger); Manufactured by Arjo Hospital Equipment AB, Eslov, Sweden; Models KMBB4CLU2FUS, KMBB4MLU2FUS, KMBB4MSU2FUS, KMBB4NLX2FUS, KMBB4NSX2FUS, KMBB4OLU2FUS, KMBB4OSU2FUS, KMBB4PLX2FUS, KMBB4PSX2FUS, KMBB4QLU2FUS, and KMBB4RLX2FUS. The lifter is intended to be used under the direct supervision of trained personnel for the transfer of residents from one location to another.

FDA Recall
Terminated ·Arjo, Inc.·Product code FSA·September 8, 2008

Liko Sabina Comfort Lift, Liko, Sweeden. The Sabina and Capella sit-to-stand lifts are especially designed for people who have difficulty in standing on their own. The lifts are intended to be used with patients who are able to bear weight on their legs and actively participate in the standing exercise.

FDA Recall
Terminated ·Hill-Rom, Inc. 125 E Pearl St 1069 State Route 46 East Batesville IN 47006·Product code FSA·January 27, 2011

Liko Sabina 200 Lift, Liko, Sweeden. The Sabina and Capella sit-to-stand lifts are especially designed for people who have difficulty in standing on their own. The lifts are intended to be used with patients who are able to bear weight on their legs and actively participate in the standing exercise.

FDA Recall
Terminated ·Hill-Rom, Inc. 125 E Pearl St 1069 State Route 46 East Batesville IN 47006·Product code FSA·January 27, 2011

Liko Sabina EM Lift, Liko, Sweeden. The Sabina and Capella sit-to-stand lifts are especially designed for people who have difficulty in standing on their own. The lifts are intended to be used with patients who are able to bear weight on their legs and actively participate in the standing exercise.

FDA Recall
Terminated ·Hill-Rom, Inc. 125 E Pearl St 1069 State Route 46 East Batesville IN 47006·Product code FSA·January 27, 2011

Molift Smart 150

FDA Recall
Terminated ·Moller Vital Hadelandsvegan 2·Product code FSA·February 15, 2013

SlingBar 360. Designed to meet the needs for lifting humans.

FDA Recall
Terminated ·Hill-Rom, Inc.·Product code FSA·April 30, 2013