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    Compensator Slider Lambda 6x20 component (part number 473704-0000-000) utilized on all upright ZEISS microscopes (Axio Imager, Axio Scope. A1, Axio Lab. A1). Component used to determine composition of urinary calculi, urinary sediments, bio-crystallates and diagnosis of pathological characteristics in medical applications (e.g.: testing for gout or pseudogout); also used for non-medical scientific research.

    FDA Recall
    Terminated ·Zeiss, Carl Inc·Product code IBJ·December 20, 2013

    Product is a device used in adenoid surgery and is labeled as Lusk Disposable Adenoid Curettes.

    FDA Recall
    Terminated ·Medtronic Xomed, Inc.·Product code KBJ·January 29, 2004

    Baxter Catheter Stabilization Device; 1 VITAL-HOLD Medium Catheter Stabilization Device with 2 foam tape strips; an Rx sterile convenience kit for IV infusions; 50 units per case; Manufactured by an affiliate of Baxter Healthcare Corp., Deerfield, IL 60015 U.S.A., Made in Costa Rica; catalog 2N8200

    FDA Recall
    Terminated ·Baxter Healthcare Corp. Rt.·Product code LBJ·September 17, 2010

    Baxter V-Link Luer Activated Device with Vitalshield Protective Coating Non-DEHP Catheter Extension Set Kit; 7.6" (19.3 cm), Vol. 1.0 mL, 1 Catheter Extension Set with Luer Activated Device with Silver for IV Access and Male Luer Lock Adapter with Retractable Collar, 1 VITAL-HOLD medium catheter stabilization device, 2 foam tape strips; an Rx sterile convenience kit for IV infusions; 50 units per case; Manufactured by an affiliate of Baxter Healthcare Corp., Deerfield, IL 60015 U.S.A., Made in Costa Rica; catalog 6N8220

    FDA Recall
    Terminated ·Baxter Healthcare Corp. Rt.·Product code LBJ·September 17, 2010

    Baxter CLEARLINK System, Non-DEHP Catheter Extension Set Kit; 8.2" (21.0 cm), Vol. 0.57 mL, 1 Catheter Extension Set with luer activated valve for IV Access and male luer lock adapter, 1 VITAL-HOLD Medium Catheter Stabilization Device, 2 foam tape strips; an Rx sterile convenience kit for IV infusions; 50 units per case; Manufactured by an affiliate of Baxter Healthcare Corp., Deerfield, IL 60015 U.S.A., Made in Costa Rica; catalog 2N8222

    FDA Recall
    Terminated ·Baxter Healthcare Corp. Rt.·Product code LBJ·September 17, 2010

    Baxter INTERLINK System, Non-DEHP Catheter Extension Set Kit; 7.1" (18.0 cm), Vol. 0.85 mL, 1 Catheter Extension Set with injection site and male luer lock adapter with retractable collar, 1 VITAL-HOLD Medium Catheter Stabilization Device, 2 foam tape strips; an Rx sterile convenience kit for IV infusions; 50 units per case; Manufactured by an affiliate of Baxter Healthcare Corp., Deerfield, IL 60015 U.S.A., Made in Costa Rica; catalog 2N8221

    FDA Recall
    Terminated ·Baxter Healthcare Corp. Rt.·Product code LBJ·September 17, 2010

    Baxter V-Link Luer Activated Device with VitalShield Protective Coating Non-DEHP Catheter Extension Set Kit; 8.2" (21.0 cm), Vol. 0.5 mL, 1 Catheter Extension St with luer activated device with silver for IV Access and Male Luer Lock Adapter, 1 VITAL-HOLD medium catheter stabilization device, 2 foam tape strips; an Rx sterile convenience kit for IV infusions; 50 units per case; Manufactured by an affiliate of Baxter Healthcare Corp., Deerfield, IL 60015 U.S.A., Made in Costa Rica; catalog 6N8222

    FDA Recall
    Terminated ·Baxter Healthcare Corp. Rt.·Product code LBJ·September 17, 2010

    Polarizer D Fixed w/Rotating Red 1 lambda plate. Utilized in upright Zeiss microscopes to aid in diagnosis by means of color variation.

    FDA Recall
    Terminated ·Zeiss, Carl Inc·Product code IBJ·May 28, 2013

    SUPER TORQUE MB Angiographic Catheter product is labeled in part: "***5F (1.65 mm)***110 cm .038" (0.97 mm)***MULTIPURPOSE A SUPER TORQUE MB***Max. 1200 psi (8274 kPa)***Markers***OPEN end***Sideholes***SPECIAL***Angiographic Catheter*** REF Cat No.***Lot***Use By***Sterile EO***Assembled in Mexico Cordis Corporation, 14201 NW 60th Ave. Miami Lakes, Florida 33014, USA***EC***REP*** Cordis Cashel, Cahir Road Cashel, Co Tipperary, Ireland***Cordis***a Johnson&Johnson company***" UPN SRD5724MB, No MB 2, Length, cm 100, Sideholes 2. UPN SRD5727MB, No MB 4, Length, cm 80, Sideholes 4. Cordis SUPER TORQUE MB angiographic catheters with Market Bands are designed to provide angiographic visualization and linear measurement of the vasculature when combined with the delivery of radiopaque contrast media to selected sites in the vascular system.

    FDA Recall
    Terminated ·Cordis Corporation·Product code DQO·November 21, 2011

    Antiparietal Antibody, Indirect Immunofluorescent, Antigen, Control

    FDA classification
    FDA Class 2 ·Antiparietal Antibody, Indirect Immunofluorescent, Antigen, Control

    Cord, Electric For Transurethral Surgical Instrument

    FDA classification
    FDA Class 2 ·Cord, Electric For Transurethral Surgical Instrument

    MEDLINE Medical Procedure Kits labeled as: 1) BR L&D PACK, Medline Kit Number/SKU DYNJ47625B; 2) GYN VAGINAL, Medline Kit Number/SKU DYNJ912219; 3) KIT MAJ VAG SET UP, Medline Kit Number/SKU DYNJ907033B; 4) MINOR VAG PACK, Medline Kit Number/SKU DYNJ68663B; 5) OB DELIVERY PACK, Medline Kit Number/SKU DYNJ14099F; 6) OB DELIVERY PACK, Medline Kit Number/SKU DYNJ14099G; 7) OB PACK, Medline Kit Number/SKU DYNJ03387B; 8) OB PACK, Medline Kit Number/SKU DYNJ03387C; 9) OB PACK, Medline Kit Number/SKU DYNJ53543B; 10) RR-D/E PACK, Medline Kit Number/SKU DYNJ62645D; 11) RR-D/E PACK, Medline Kit Number/SKU DYNJ62645F; 12) RR-D/E PACK, Medline Kit Number/SKU DYNJ62645G; 13) VAGINAL DELIVERY PACK, Medline Kit Number/SKU DYNJ04454K; 14) VAGINAL DELIVERY PACK, Medline Kit Number/SKU DYNJ04454L; 15) VAGINAL PACK, Medline Kit Number/SKU DYNJ01830G.

    FDA Recall
    Open, Classified ·Product code MLS·May 4, 2026

    SUPER TORQUE MB Angiographic Catheter product is labeled in part: "***5F (1.65 mm)***110 cm .038" (0.97 mm)***PIG***Max. 1200 psi (8274 kPa)***Markers***Open End 6 Sideholes***Angiographic Catheter*** REF Cat No.***Lot***Use By***Assembled in Mexico Cordis Corporation, 14201 NW 60th Ave. Miami Lakes, Florida 33014, USA***EC***REP*** Cordis Cashel, Cahir Road Cashel, Co Tipperary, Ireland***Cordis***a Johnson&Johnson company***" UPN H739532598A3, Cat No 532-598A, No. MB 10, French Size 5, Shape (PIG), Length cm 110, Flow Rate, ml/sec, 18, Sideholes 6. UPN H739532598B3, Cat No 532-598B, No. MB 20, French Size 5, Shape (PIG), Length cm 110, Flow Rate, ml/sec, 18, Sideholes 6. UPN H73953298C3, Cat No 532-598C, No MB 20 French Size 5, Shape (PIG), Length, cm 65, Flow Rate, ml/sec, 30, Side Holes 6. UPN H73953298D3, Cat No 532-598D, No MB 2 French Size 5, Shape (PIG), Length , cm 70, Flow Rate, ml/sec, 30, Side Holes 10. Cordis SUPER TORQUE MB angiographic catheters with Market Bands are designed to provide angiographic visualization and linear measurement of the vasculature when combined with the delivery of radiopaque contrast media to selected sites in the vascular system.

    FDA Recall
    Terminated ·Cordis Corporation·Product code DQO·November 21, 2011

    Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot System,Integra CAPTURE Screw System & Integra Ti6 Internal Fixation System,Subtalar MBA System,MetaSurg Subtalar Implant,NewDeal BOLD Screw,NewDeal HALLU Lock Plate System,NewDeal HALLU Plates,QWIX Positioning Screw,SPIN Snap-Off Screw,NewDeal TIBIAXYS System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Finapres Medical Systems Portapres with NiMh battery pack Product Usage: Continuously measure blood pressure, The Portapres can be worn on the body with a protective waist belt. The device can be used without mains; in that case a battery pack is used.

    FDA Recall
    Terminated ·FMS, Finapres Medical Systems BV Paasheuvelweg 34A 1105 BJ Amsterdam Netherlands·Product code DXN·July 6, 2012

    MEDLINE Medical Procedure Kits labeled as: 1) BR L&D PACK, Medline Kit Number/SKU DYNJ47625B; 2) GYN VAGINAL, Medline Kit Number/SKU DYNJ912219; 3) KIT MAJ VAG SET UP, Medline Kit Number/SKU DYNJ907033B; 4) MINOR VAG PACK, Medline Kit Number/SKU DYNJ68663B; 5) OB DELIVERY PACK, Medline Kit Number/SKU DYNJ14099F; 6) OB DELIVERY PACK, Medline Kit Number/SKU DYNJ14099G; 7) OB PACK, Medline Kit Number/SKU DYNJ03387B; 8) OB PACK, Medline Kit Number/SKU DYNJ03387C; 9) OB PACK, Medline Kit Number/SKU DYNJ53543B; 10) RR-D/E PACK, Medline Kit Number/SKU DYNJ62645D; 11) RR-D/E PACK, Medline Kit Number/SKU DYNJ62645F; 12) RR-D/E PACK, Medline Kit Number/SKU DYNJ62645G; 13) VAGINAL DELIVERY PACK, Medline Kit Number/SKU DYNJ04454K; 14) VAGINAL DELIVERY PACK, Medline Kit Number/SKU DYNJ04454L; 15) VAGINAL PACK, Medline Kit Number/SKU DYNJ01830G.

    FDA Enforcement
    Class II ·Ongoing·Medline Industries, LP·June 24, 2026

    GE Nuclear Medicine 600/800 series systems, specifically: a) 870, b) 870 DR 3/8 inch NM GANTRY WITH NEW ROTOR - MEA, c) 870 DR / Dismount, d) 870 DR / Dismount / 60HZ, e) 870 DR 3/8 inch WSO, f) 870 DR 3/8 inch NM Gantry, g) 870 DR 3/8 inch, h) 870 DR 3/8 inch CH, i) 870 DR 5/8 inch NM GANTRY, j) 870 DR BJ / Dismount, k) 870 DR CyberDefense 3/8 inch NM Gantry, l) 870 DR NM GANTRY FINAL - NEW ROTOR, m) 870 DR China, n) D670 NM GANTRY WITH NEW ROTOR, o) D670 DR 3/8 inch 16 SL, p) D670 DR 3/8 inch MEA, q) D670 DR 3/8 inch, r) D670 DR 3/8 inch 16SL, s) D670 DR 3/8 inch 16SL NR, t) D670 DR 3/8 inch BJ, u) D670 DR 3/8 inch MEA, v) D670 DR NM Gantry 3/8 inch, w) D670 DR NM Gantry 5/8 inch, x) D670 DR with new rotor, y) D670 ES NM Gantry 3/8 inch, z) D670 ES NM/CT 3/8 inch O540+ NM Gantry, aa) D670 ES NM/CT DR 3/8 inch, bb) D670 GANTRY, cc) D670 PRO NM Gantry 3/8 inch, dd) D670 PRO NM GANTRY 3/8 inch, ee) DISC NM/CT670 DR 3/8 inch, ff) DISC NM/CT870 DR 3/8 inch, gg) DISC NM/CT870 DR 3/8 inch, hh) DISC NM/CT870 DR 5/8 inch, ii) DISCOVERY 670 (TANDEM), jj) DISCOVERY NM 670, kk) DISCOVERY NM/CT 670 3/8 inch PRO, ll) DISCOVERY NM/CT 670 3/8 inch PRO NR, mm) HP Z420 WS Config 1 Hardware Specs Take 3 - E5-1620-8G-1TB-NVS, nn) NM/CT 870 DR, oo) NM/CT 870 DR 3/8 inch CYBER DEFENCE, pp) NM/CT 870 DR 3/8 inch WSO, qq) NM/CT 870 DR O540 3/8 inch, rr) NM/CT 870 DR O540 3/8 inch BJ, ss) NM/CT 870 DR O540 5/8 inch, tt) NM/CT 870 ES 3/8 inch, uu) NM/CT 870DR China for China, vv) NM/CT870 DR 3/8 inch O540, ww) NM/CT D870 DR O540 3/8 inch, xx) TANDEM DISCOVERY 670 INT; Emission Computed Tomography System

    FDA Enforcement
    Class I ·Ongoing·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING·February 15, 2023