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High RiskFDA
Zoll Circulation, Inc.
Zoll, REF 8700-0695-40 (IC-3893AE), ICY Intravascular Heat Intravascular Heat Exchange Catheter Kit, with central venous infusion capabil...
Surgical Devices·3 affected·Aug 6, 2021
High RiskFDA
Johnson & Johnson Surgical Vision Inc
TECNIS Eyhance IOLs are permanent intraocular implants intended for implantation in the capsular bag. The TECNIS Simplicity Delivery Sys...
Medical Implants·1 affected·Aug 6, 2021
High RiskFDA
Zoll Circulation, Inc.
Zoll REF: 8700-0793-14 (SL-2593CO), SOLEX 7 Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens)...
Surgical Devices·98 affected·Aug 6, 2021
High RiskFDA
Zoll Circulation, Inc.
ZOLL, REF 8700-0781-40 (CL-2295AE), COOL LINE Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumen...
Surgical Devices·6,395 affected·Aug 6, 2021
High RiskFDA
Zoll Circulation, Inc.
Zoll, REF 8700-000871-40, Quattro (Heparin) IVTM Disposable Pack and Start UP Kit (6 ft.), EU, New Luer
Medical Devices·579 affected·Aug 6, 2021
High RiskFDA
Zoll Circulation, Inc.
Zoll, REF 8700-000866-01, ICY IVTM Disposable Pack and Start UP Kit (6 ft.)
Medical Devices·42 affected·Aug 6, 2021
High RiskFDA
Zoll Circulation, Inc.
Zoll, REF: 8700-0791-01 (IC-4593), Premium Access Kit QUATTRO, Intravascular Heat exchange Catheter Kit (Heparin), with central venous in...
Surgical Devices·1,253 affected·Aug 6, 2021
High RiskFDA
Zoll Circulation, Inc.
Zoll, REF 8700-0781-03 (CL-2295AE), COOLINE Intravascular Heat Intravascular Heat Exchange Catheter Kit, with central venous infusion cap...
Surgical Devices·2,833 affected·Aug 6, 2021
High RiskFDA
Medline Industries Inc
NAMIC Stopcocks: (1) NAMIC STOPCOCK, 200 psi (14 bar), REF 70015002, UPN H965700150021, Three-way Stopcock with Rotating Collar, Rx on...
Medical Devices·816,420 affected·Aug 6, 2021
High RiskFDA
Ge Healthcare, Llc
Centricity PACS-IW with Universal Viewer - Product Usage: Is a device that displays medical images (including mammograms) and data from v...
Medical Devices·392 affected·Aug 6, 2021
High RiskFDA
Zoll Circulation, Inc.
Zoll REF: 8700-0782-14 (IC-3893CO), ICY Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens), HE...
Surgical Devices·1,256 affected·Aug 6, 2021
High RiskFDA
Intuitive Surgical, Inc.
Ion Flexison Biopsy Needle, 19G, Extension Range : 0-3 cm, Ref: 490104-09 and 49004-10, 5-pack, Sterile EO, Rx only, UDI:00886874115978
Medical Devices·1,625 affected·Aug 6, 2021
High RiskFDA
Zoll Circulation, Inc.
Zoll, REF 8700-000870-40, ICY (Heparin) IVTM Disposable Pack and Start UP Kit (6 ft.), EU, New Luer
Medical Devices·1,122 affected·Aug 6, 2021
High RiskFDA
Zoll Circulation, Inc.
Zoll, REF 8700-000865-01, Cool Line IVTM Disposable Pack and Start UP Kit (6 ft.)
Medical Devices·55 affected·Aug 6, 2021
High RiskFDA
Heartware, Inc.
Medtronic HVAD Pump Implant Kits
Medical Implants·11,851 affected·Aug 6, 2021
High RiskFDA
Zoll Circulation, Inc.
Zoll, REF: 8700-0783-03 (IC-4593AE) QUATTRO Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens...
Surgical Devices·1,733 affected·Aug 6, 2021
High RiskFDA
Zoll Circulation, Inc.
Zoll, REF 8700-000867-01, Quattro IVTM Disposable Pack and Start UP Kit (6 ft.)
Medical Devices·334 affected·Aug 6, 2021
High RiskFDA
Zoll Circulation, Inc.
ZOLL, REF 8700-0793-01 (SL-2593) Premium Access Kit SOLEX 7, Intravascular Heat Exchange catheter Kit, with central venous infusion capab...
Surgical Devices·5,524 affected·Aug 6, 2021
High RiskFDA
Zoll Circulation, Inc.
ZOLL, REF: 8700-0781-01 (CL-2295), COOL LINE, Intravascular Heat Exchange Catheter Kit Applause Custom Luer Heparin, STERILE EO, Rx only,...
Surgical Devices·4,812 affected·Aug 6, 2021
High RiskFDA
Zoll Circulation, Inc.
ZOLL, REF 8700-0781-14 (CL-2295CO), COOL LINE Intravascular Heat Exchange Catheter kit with central venous infusion capabilities (3 lumen...
Surgical Devices·11 affected·Aug 6, 2021
High RiskFDA
Zoll Circulation, Inc.
Zoll REF: 8700-0782-40 (IC-3893AE), ICY Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens),HEP...
Surgical Devices·33,066 affected·Aug 6, 2021
High RiskFDA
Dupont Nutrition Usa, Inc
Avicel, Mirocrystalline cellulose, packaged in bulk as PH101 NF, PH102 NF, PH200 NF, Manufactured by: DuPont Nutrition USA, Inc., 1301 Og...
Drugs·2,384,720 affected·Aug 5, 2021
High RiskFDA
C.r. Bard Inc
Catalog A319416AM, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine Meter, Temperature Sensing, StatLock" Stabilization Device
Medical Devices·5,950 affected·Aug 5, 2021
High RiskFDA
C.r. Bard Inc
Catalog A800360, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray
Surgical Devices·1,140 affected·Aug 5, 2021
High RiskFDA
C.r. Bard Inc
Catalog A899916, SureStep" Foley Tray, Lubricath", Drainage Bag, StatLock" Stabilization Device
Medical Devices·960 affected·Aug 5, 2021
High RiskFDA
M.d.l. S.r.l.
Soft Tissue Biopsy Needles
Medical Devices·20,129 affected·Aug 5, 2021
High RiskFDA
M.d.l. S.r.l.
Mammary Nodules Localization
Medical Devices·320 affected·Aug 5, 2021
High RiskFDA
C.r. Bard Inc
Catalog A942216, SureStep" Foley Tray, Bard LubricathTM, Urine Meter, StatLock" Stabilization Device
Medical Devices·1,440 affected·Aug 5, 2021
High RiskFDA
C.r. Bard Inc
Catalog A897514, SureStep" Foley Tray, Silicone, Drainage Bag, StatLock" Stabilization Device
Medical Devices·1,710 affected·Aug 5, 2021
High RiskFDA
C.r. Bard Inc
Catalog A902616, SureStep" Foley Tray, Bardex" I.C., Lubricath", Urine Meter
Medical Devices·80 affected·Aug 5, 2021
High RiskFDA
C.r. Bard Inc
Catalog A800061, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray
Surgical Devices·2,660 affected·Aug 5, 2021
High RiskFDA
C.r. Bard Inc
Catalog A119216M, SureStep" Foley Tray, Lubri-Sil", Urine Meter, Temperature Sensing Dual, StatLock" Stabilization Device
Medical Devices·10,150 affected·Aug 5, 2021
High RiskFDA
C.r. Bard Inc
Catalog A303318A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine Meter, StatLock" Stabilization Device
Medical Devices·420 affected·Aug 5, 2021
High RiskFDA
C.r. Bard Inc
Catalog A300318A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Drainage Bag, StatLock" Stabilization Device
Medical Devices·350 affected·Aug 5, 2021
High RiskFDA
C.r. Bard Inc
Catalog A303316A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine Meter, StatLock" Stabilization Device
Medical Devices·11,600 affected·Aug 5, 2021
High RiskFDA
C.r. Bard Inc
Catalog A943216, SureStep" Foley Tray, Lubricath", Urine Meter, StatLock" Stabilization Device
Medical Devices·40 affected·Aug 5, 2021
High RiskFDA
C.r. Bard Inc
Catalog A800361, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray
Surgical Devices·33,380 affected·Aug 5, 2021
High RiskFDA
C.r. Bard Inc
Catalog A800365, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray
Surgical Devices·18,060 affected·Aug 5, 2021
High RiskFDA
M.d.l. S.r.l.
General Manual surgical instrument
Surgical Devices·4,120 affected·Aug 5, 2021
High RiskFDA
Olam Edible Nuts-blakely,ga
Raw Shelled Peanuts, Skins Removed, Split Nut Blanched Runner Peanuts, Net. Wt. 2000# Olam Edible Nuts - Blakely, GA
Food·15,718 affected·Aug 4, 2021
High RiskFDA
Molly And Me Pecans
MOLLY & ME PECANS all natural PRALINE PECANS, 4 oz., 7 oz., and 12 oz packages, INGREDIENTS: Pecans, Brown Sugar, Evaporated Milk, Margar...
Dairy·1,221 affected·Aug 4, 2021
High RiskFDA
Roche Molecular Systems, Inc.
cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas Liat System, Catalog Number 09211101190
Medical Devices·211 affected·Aug 4, 2021
High RiskFDA
Abbott Molecular, Inc.
Vysis CLL FISH Probe Kit with the following components: Vysis LSI p53 SpectrumOrange/ATM, SpectrumGreen and LSI D13S319, SpectrumOrange/ ...
Medical Devices·186 affected·Aug 4, 2021
High RiskFDA
Cocanu Llc
Moonwalk 70% dark chocolate bar. It is packaged in white shiny paper with blue print. Net Weight: 1.2 oz / 35gr. No UPC. The label is ...
Dairy·852 affected·Aug 3, 2021
High RiskFDA
The Harvard Drug Group
Fexofenadine Hydrochloride Tablets, 60 mg, 500 Tablets per bottle, Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Drive, Sui...
Oral Drugs·2,239 affected·Aug 3, 2021
High RiskFDA
Olympus Corporation Of The Americas
Arc Endocuff Vision as follows: ARV110 ENDOCUFF-V M BLUE PK8, Part Number: E0420501; ARV120 ENDOCUFF-V L GREEN PK8, Part Number: E0420...
Medical Devices·711,157 affected·Aug 3, 2021
High RiskFDA
Fresenius Medical Care Holdings, Inc.
AquaBplus Water Purification System, Part Number 24-2000-0, AquaBplus 2500 - Typ USA (G02040108-US), AquaBplus 2000 - Typ USA (G02040114-...
Medical Devices·2 affected·Aug 3, 2021
High RiskFDA
Luminex Corporation
Verigene EP Amplification Reagent Kit Test
Diagnostic Devices·4,579 affected·Aug 3, 2021