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High RiskFDA
Depuy Orthopaedics, Inc.
TRUMATCH CT PIN GUIDE KIT R- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation t...
Surgical Devices·6 affected·Aug 10, 2021
High RiskFDA
Roi Cps Llc
REGARD Basic Cataract tray
Medical Devices·126 affected·Aug 10, 2021
High RiskFDA
B. Braun Medical, Inc.
PUMP SET, 15 DR, 3 CARESITE, 127 in.single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of pa...
Medical Devices·13,320 affected·Aug 10, 2021
High RiskFDA
B. Braun Medical, Inc.
Outlook Pump Measured Volume Solution Set/ w/ Auto Shut-Off. Single-use for use with the Outlook Safety Infusion System and/or Horizon NX...
Medical Devices·940 affected·Aug 10, 2021
High RiskFDA
B. Braun Medical, Inc.
15 drops/ml, Priming Volume: 27ml, Length: 129 in. Single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for...
Medical Devices·978,876 affected·Aug 10, 2021
High RiskFDA
B. Braun Medical, Inc.
Outlook Pump Primary Administration Set w/ micro Tubing for Epidural Administration-single use, for use with the Outlook Safety Infusion ...
Medical Devices·1,080 affected·Aug 10, 2021
High RiskFDA
B. Braun Medical, Inc.
OUTLOOK PUMP SET 3 CARESITE LADS 133 IN.-single use, for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion...
Medical Devices·768 affected·Aug 10, 2021
High RiskFDA
Depuy Orthopaedics, Inc.
TRUMATCH CT FEM CUT TIB PIN R- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation...
Surgical Devices·2 affected·Aug 10, 2021
High RiskFDA
B. Braun Medical, Inc.
OUTLOOK PUMP IV SET W/UNIVERSAL SPIKE-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of ...
Medical Devices·12,216 affected·Aug 10, 2021
High RiskFDA
Roi Cps Llc
REGARD Newborn Tray
Medical Devices·12 affected·Aug 10, 2021
High RiskFDA
B. Braun Medical, Inc.
Y-Type Blood, Outlook Pump Set, Caresite-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion ...
Medical Devices·1,752 affected·Aug 10, 2021
High RiskFDA
Roi Cps Llc
REGARD Core Biopsy Tray
Medical Devices·1,200 affected·Aug 10, 2021
High RiskFDA
Roi Cps Llc
REGARD Ultrasound Tray
Medical Devices·240 affected·Aug 10, 2021
High RiskFDA
B. Braun Medical, Inc.
60 drops/ml, Priming volume: 25 ml, Length: 120 in.in-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump ...
Medical Devices·1,960 affected·Aug 10, 2021
High RiskFDA
Depuy Orthopaedics, Inc.
TRUMATCH CT PIN GUIDE FEM R- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation t...
Surgical Devices·2 affected·Aug 10, 2021
High RiskFDA
B. Braun Medical, Inc.
Outlook Pump Blood Administration Set with SAFELINE Injection Site-single use, for use with the Outlook Safety Infusion System and/or Hor...
Medical Devices·336 affected·Aug 10, 2021
High RiskFDA
Roi Cps Llc
REGARD Stereotactic Tray
Medical Devices·175 affected·Aug 10, 2021
High RiskFDA
B. Braun Medical, Inc.
ET82HP OUTLOOK PUMP EXTENSION SET-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of pare...
Medical Devices·200 affected·Aug 10, 2021
High RiskFDA
B. Braun Medical, Inc.
10 drops/ml, Priming volume: 46ml, Length: 130 in.-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for...
Medical Devices·55,584 affected·Aug 10, 2021
High RiskFDA
Ad-tech Medical Instrument Corporation
Ad-Tech Lightweight TECH ATTACH Cable - Product Usage: Designed for the purpose of connecting these electrodes to third party monitors/st...
Medical Devices·10 affected·Aug 9, 2021
High RiskFDA
Beckman Coulter Inc.
Access hsTnI High Sensitivity Troponin I, REF B52699 Access Immunoassay System REAGENT PACK
Diagnostic Devices·293,640 affected·Aug 9, 2021
High RiskFDA
Convatec, Inc
DuoDERM CGF Dressing 10x10CM (1x5PK) (ICC 187660) DuoDERM Extra Thin Dressing 15X15CM (1X10PK) (ICC 187957) DuoDERM Extra Thin Dressing...
Medical Devices·2,734,830 affected·Aug 9, 2021
High RiskFDA
Smiths Medical Asd Inc.
Bivona Aire-Cuf Endotracheal Tube
Medical Devices·7,136 affected·Aug 9, 2021
High RiskFDA
Ad-tech Medical Instrument Corporation
Ad-Tech Lightweight CABRIO Cable - Product Usage: Designed for the purpose of connecting these electrodes to third party monitors/stimula...
Medical Devices·69 affected·Aug 9, 2021
High RiskFDA
Able Groupe Inc
HiPP HA Germany Hypoallergenic Stage 1 Combiotic Infant Milk Formula
Dairy·76,000 affected·Aug 8, 2021
High RiskFDA
Able Groupe Inc
Holle Goat Stage 1 Organic Infant Milk Formula
Dairy·76,000 affected·Aug 8, 2021
High RiskFDA
Able Groupe Inc
HiPP Dutch Stage 2 Combiotic Follow-on Milk Formula
Dairy·76,000 affected·Aug 8, 2021
High RiskFDA
Able Groupe Inc
Lebenswert Folgemilch Stage 3 Organic Toddler Formula
Baby Food & Formula·76,000 affected·Aug 8, 2021
High RiskFDA
Able Groupe Inc
Holle Bio Stage 2 Organic Follow-On Infant Milk Formula
Dairy·76,000 affected·Aug 8, 2021
High RiskFDA
Able Groupe Inc
Kendamil Organic Stage 2 Follow on Milk Formula
Dairy·76,000 affected·Aug 8, 2021
High RiskFDA
Able Groupe Inc
Holle Goat Stage 2 Organic Follow-On Infant Milk Formula
Dairy·76,000 affected·Aug 8, 2021
High RiskFDA
Able Groupe Inc
HiPP HA Germany Hypoallergenic Stage 2 Combiotic Follow-On Infant Milk Formula
Dairy·76,000 affected·Aug 8, 2021
High RiskFDA
Able Groupe Inc
HiPP UK Stage 2 Combiotic Follow-On Infant Milk Formula
Dairy·76,000 affected·Aug 8, 2021
High RiskFDA
Able Groupe Inc
Lebenswert Folgemilch Stage 2 Organic Follow-On Infant Milk Formula
Dairy·76,000 affected·Aug 8, 2021
High RiskFDA
Able Groupe Inc
HiPP AR Germany Anti-Reflux Milk Formula
Dairy·76,000 affected·Aug 8, 2021
High RiskFDA
Gem City Fine Foods, Llc
Flourless Chocolate Torte, 14 oz., in recyclable plastic circular container with black base and clear lid, Gem City Fine Foods, 3403 S 14...
Snacks & Candy·51 affected·Aug 7, 2021
High RiskFDA
Ingredion
Fermentation Derived Pepsin Product packaging: 5 individual LDPE bags with a net weight of 5kg each and 2.5kg sample bags packaged in 25...
Food·370 affected·Aug 6, 2021
High RiskFDA
The Harvard Drug Group
Carbamazepine 200mg Tablets, USP, 200 mg, 100 Count Unit Dose Cartons, Rx only, Manufactured by: Torrent Pharmaceuticals Ltd., Bharuch-39...
Oral Drugs·4 affected·Aug 6, 2021
High RiskFDA
Xellia Pharmaceuticals Usa, Llc
Micafungin for Injection, 100 mg/vial, Single-Dose Vial, Sterile, Rx Only, For Intravenous Infusion Only, Manufactured for: Xellia Pharma...
Injectable Drugs·9,161 affected·Aug 6, 2021
High RiskFDA
Xellia Pharmaceuticals Usa, Llc
Micafungin for Injection, 50 mg/vial, Single-Dose Vial, Sterile, Rx Only, For Intravenous Infusion Only, Manufactured for: Xellia Pharmac...
Injectable Drugs·9,161 affected·Aug 6, 2021
High RiskFDA
Zoll Circulation, Inc.
ZOLL, REF 8700-0793-40 (SL-2593AE) SOLEX 7, Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens)...
Surgical Devices·5 affected·Aug 6, 2021
High RiskFDA
Zoll Circulation, Inc.
ZOLL, REF 8700-0787-40 (IC-3893AE), ICY Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens), S...
Surgical Devices·333 affected·Aug 6, 2021
High RiskFDA
Ge Healthcare, Llc
Centricity Universal Viewer and Viewer 6.0 - Product Usage: Is a device that displays medical images (including mammograms) and data from...
Medical Devices·462 affected·Aug 6, 2021
High RiskFDA
Zoll Circulation, Inc.
Zoll, REF 8700-0657-40 (IC-3893AE), ICY Intravascular Heat Intravascular Heat Exchange Catheter Kit, with central venous infusion capabil...
Surgical Devices·58 affected·Aug 6, 2021
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