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High RiskFDA
Zavation
11G BEVELED TROCAR/CANNULA. For use in Orthopedic / spinal procedures.
Medical Devices·0 affected·Mar 25, 2021
High RiskFDA
Zavation
ZVplasty Direct Access Beveled Tip Trocar, 10 Gauge, REF VCF-1022. For use in Orthopedic / spinal procedures.
Medical Devices·335 affected·Mar 25, 2021
High RiskFDA
Zavation
ZVplasty Drill, 10 Gauge, REF VCF-1006. For use in Orthopedic / spinal procedures.
Medical Devices·38 affected·Mar 25, 2021
High RiskFDA
Zavation
ZVplasty Direct Access Diamond Tip Trocar, 11 Gauge, REF VCF-1023-11. For use in Orthopedic / spinal procedures.
Medical Devices·113 affected·Mar 25, 2021
High RiskFDA
Zavation
VERTEBREX SINGLE BALLOON KIT, REF VBRX-15-SBK-10. For use in Orthopedic / spinal procedures.
Medical Devices·140 affected·Mar 25, 2021
High RiskFDA
Zavation
10G DIRECT DOUBLE BONE ACCESS KIT. For use in Orthopedic / spinal procedures.
Medical Devices·0 affected·Mar 25, 2021
High RiskFDA
Zavation
10 GAUGE SINGLE CEMENT DELIVERY 4 FILLERS 4 SYRINGES STERILE. For use in Orthopedic / spinal procedures.
Medical Devices·0 affected·Mar 25, 2021
High RiskFDA
Zavation
10G DIRECT SINGLE - ACCESS, CODE: INTV-DWCb. For use in Orthopedic / spinal procedures.
Medical Devices·24 affected·Mar 25, 2021
High RiskFDA
Bard Peripheral Vascular Inc
PowerPort duo M.R.I. Implantable Port, with attachable 9.5F Polurethane Open-Ended Dual-Lumen Venous Catheter, REF 1829570, UDI: (01) 008...
Medical Implants·189 affected·Mar 25, 2021
High RiskFDA
Raysearch Laboratories Ab
RayStation Model Number: (9A)9.0.0.113, 9B (9.1.0.933), 9B Service pack (9.2.0.483), 10A (10.0.0.1154), 10A Service pack (10.0.1.52), 10B...
Medical Devices·1 affected·Mar 25, 2021
High RiskFDA
Zavation
InterV 11G Kyphoplasty Kit, REF Numbers: a) INTVMN-10-DSK b) INTVMN-15-DSK c) INTVMN-15-DSKC d) INTVMN-20-DSK. For use in Orthope...
Medical Devices·119 affected·Mar 25, 2021
High RiskFDA
Zavation
ZVplasty Direct Access Bevel Tip Trocar, 11 Gauge, REF VCF-1022-11. For use in Orthopedic / spinal procedures.
Medical Devices·98 affected·Mar 25, 2021
High RiskFDA
Zavation
11G DIRECT WORKING CANNULA DIAMOND TIP MINI, CODE: INTVMN-DWCD. For use in Orthopedic / spinal procedures.
Medical Devices·58 affected·Mar 25, 2021
High RiskFDA
Zavation
10 GAUGE CEMENT DELIVERY CANNULA, CODE: INTVM-CDC. For use in Orthopedic / spinal procedures.
Medical Devices·130 affected·Mar 25, 2021
High RiskFDA
Zavation
ZVplasty Directional Cement Cannula Long, REF VCF-1080-L. For use in Orthopedic / spinal procedures.
Medical Devices·27 affected·Mar 25, 2021
High RiskFDA
Zavation
10 GAUGE DRILL STERILE. For use in Orthopedic / spinal procedures.
Medical Devices·0 affected·Mar 25, 2021
High RiskFDA
Zavation
10G BEVELED TROCAR/CANNULA. For use in Orthopedic / spinal procedures.
Medical Devices·0 affected·Mar 25, 2021
High RiskFDA
Zavation
ZVplasty Direct Bipedicular Bone Access Kit with Drill, 11 Gauge, REF VCF-DDBAK-11. For use in Orthopedic / spinal procedures.
Medical Devices·15 affected·Mar 25, 2021
High RiskFDA
Zavation
10G SINGLE CEMENT DELIVERY KIT (5 FILLERS). For use in Orthopedic / spinal procedures.
Medical Devices·0 affected·Mar 25, 2021
High RiskFDA
Zavation
10G DIRECT SINGLE - ACCESS, CODE INTVM-DSBAK. For use in Orthopedic / spinal procedures.
Medical Devices·2 affected·Mar 25, 2021
High RiskFDA
Zavation
ZVplasty Biopsy Device, 10 Gauge, REF VCF-1010. For use in Orthopedic / spinal procedures.
Medical Devices·162 affected·Mar 25, 2021
High RiskFDA
Zavation
ZVplasty 10G, FLEX KYPHOPLASTY, REF VCF-1015-FLEX. For use in Orthopedic / spinal procedures.
Medical Devices·19 affected·Mar 25, 2021
High RiskFDA
Zavation
10 GAUGE CEMENT DELIVERY CANNULA, INTVM-CDC. For use in Orthopedic / spinal procedures.
Medical Devices·130 affected·Mar 25, 2021
High RiskFDA
Zavation
ZVplasty Unipedicular Cement Delivery Cannula Kit, 10 Gauge, REF VCG-SCDK. For use in Orthopedic / spinal procedures.
Medical Devices·72 affected·Mar 25, 2021
High RiskFDA
Zavation
10G DIRECT SINGLE BONE ACCESS KIT. For use in Orthopedic / spinal procedures.
Medical Devices·0 affected·Mar 25, 2021
High RiskFDA
Zavation
ZVplasty, Bipedicular Cement Delivery Cannula Kit, 10 Gauge, REF VCF-DCDK. For use in Orthopedic / spinal procedures.
Medical Devices·14 affected·Mar 25, 2021
High RiskFDA
Zavation
ZVplasty 10G, 15mm, Additional Level Kit, REF VCF-1015-1A. For use in Orthopedic / spinal procedures.
Medical Devices·3 affected·Mar 25, 2021
High RiskFDA
Zavation
10 GAUGE DIRECT UNILATERAL STYLET(1 X DIAMOND 1 X BEVEL), INTVM-DSSKBD. For use in Orthopedic / spinal procedures.
Medical Devices·56 affected·Mar 25, 2021
High RiskFDA
Zavation
ZVplasty Direct Access Diamond Tip Trocar, 11 Gauge, REF VCF-1023-11. For use in Orthopedic / spinal procedures.
Medical Devices·113 affected·Mar 25, 2021
High RiskFDA
Trident Seafoods Corporation
Trident Seafoods Pacific Salmon Burgers (# 414469), frozen. Costco item #502497. Each retail bag contains of 12/4oz. pieces. Retail bag...
Seafood·1,223 affected·Mar 24, 2021
High RiskFDA
Bit & Bet Llc
Thumbs Up 7 Blue 69K, 10 capsules, Distributed by Ummzy LLC., Made in USA, UPC 617135894673. Packaged in blister foil sheets in a box....
Oral Drugs·3,894 affected·Mar 24, 2021
High RiskFDA
Covidien Llc
Covidien Tri-Staple 2.0 Reinforced Intelligent Reload 60 mm Medium/Thick-For use with Signia stapling system. Staple line reinforcement h...
Medical Devices·222 affected·Mar 23, 2021
High RiskFDA
Bioseal Corporation
Bioseal, Central Line Dressing Kit, containing ChloraPREP Applicator 3 mL, REF: CVC009/20, Sterile EO, Single Use Only, UDI: (01)0063009...
Medical Devices·580 affected·Mar 23, 2021
High RiskFDA
Sunstar Americas, Inc.
SUNSTAR Butler Clear Dip, 16 FL OZ, SKU #716PA
Medical Devices·19,471 affected·Mar 23, 2021
High RiskFDA
Bioseal Corporation
Bioseal, Central Line Dressing Kit, containing ChloraPREP Applicator 3 mL, REF: CVC015/20, Sterile EO, UDI: (01)00630094430157
Medical Devices·1,560 affected·Mar 23, 2021
High RiskFDA
Philips North America, Llc
Philips SureSigns VM4, VM6 and VM8 - Product Usage: patient monitors-for monitoring, recording and alarming of multiple physiological par...
Medical Devices·31,773 affected·Mar 23, 2021
High RiskFDA
Grace Kennedy Foods Usa Llc
La Fe Brand Frozen Peppers and Onions 16 oz bags.
Produce·187 affected·Mar 22, 2021
High RiskFDA
Land O'lakes, Inc.
Land O Lakes Queso Bravo White Cheese Dip with Jalapeno and Red Peppers. Net Wt 5 lbs. (2.26kg), UPC 34500-48238. Shipping Case: 6 - ...
Dairy·3,780 affected·Mar 22, 2021
High RiskFDA
Novo Nordisk Inc
Saxenda (liraglutide) Injection, 18 mg/3 mL (6 mg/mL), 1 x 3 mL Prefilled Pen, Sample. Not for Resale., Rx only, Novo Nordisk Inc., Plain...
Injectable Drugs·0 affected·Mar 22, 2021
High RiskFDA
Novo Nordisk Inc
OZEMPIC (semaglutide) injection, 2 mg/1.5 mL (1.34 mg/mL) Prefilled pen, 1 pen, Sample. Not for Resale, Rx only, Novo Nordisk Inc, Plains...
Injectable Drugs·0 affected·Mar 22, 2021
High RiskFDA
Novo Nordisk Inc
ViCTOZA (liraglutide) injection, 18 mg/3 mL (6 mg/mL), contains: 1 Victoza Pen, Sample Not for Resale, Rx only, Manufactured by: Novo Nor...
Injectable Drugs·0 affected·Mar 22, 2021
High RiskFDA
Biopsybell S.r.l.
BPB medica CEMIX, PRODUCT NUMBER KVTMIXN, Vertebroplasty-Kyphoplasty cement mixing system
Medical Devices·5 affected·Mar 22, 2021
High RiskFDA
Biopsybell S.r.l.
11G DIRECT SINGLE - DELIVERY (4 FILLERS-4 SYRINGES), CODE INTVMN-SCDK
Medical Devices·160 affected·Mar 22, 2021
High RiskFDA
Biopsybell S.r.l.
11G DIRECT SINGLE - ACCESS, CODE INTVMN-DSBAK
Medical Devices·50 affected·Mar 22, 2021
High RiskFDA
Biopsybell S.r.l.
CEMENT MIXING SYSTEM, VERTEBROPLASTY-KYPHOPLASTY, REF VCF-1051
Medical Devices·500 affected·Mar 22, 2021
High RiskFDA
Biopsybell S.r.l.
RENOVA SPINE BONE FILLER 10G 12CM CENTIM. STERILE, RESFIL1112C1-US
Medical Devices·60 affected·Mar 22, 2021
High RiskFDA
Biopsybell S.r.l.
10G DIRECT SINGLE - ACCESS, CODE INTVM-DSBAK
Medical Devices·330 affected·Mar 22, 2021
High RiskFDA
Biopsybell S.r.l.
BPB medica OSTEOBELL EXPLANT NEEDLE FOR BONE MARROW EXPLANT, 110 mm, 11 G, REF OBE1111
Medical Devices·50 affected·Mar 22, 2021