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High RiskFDA
Howmedica Osteonics Corp.
TRIDENTII PSL CLUSTER58F-Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-1...
Medical Devices·0 affected·Feb 27, 2024
High RiskFDA
Howmedica Osteonics Corp.
TRIDENTII PSL CLUSTER48D- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-11-48D
Medical Devices·0 affected·Feb 27, 2024
High RiskFDA
Howmedica Osteonics Corp.
TRIDENTII HEMI CLUSTER66H- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-66H
Medical Devices·0 affected·Feb 27, 2024
High RiskFDA
Howmedica Osteonics Corp.
TRIDENTII HEMI CLUSTER48D-indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-48D
Medical Devices·45 affected·Feb 27, 2024
High RiskFDA
Howmedica Osteonics Corp.
TRIDENTII PSL CLUSTER52E- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-11-52E
Medical Devices·3 affected·Feb 27, 2024
High RiskFDA
Convatec, Inc
ConvaTec CarboFlex, 15cm x 20cm, 6 in. x 8 in., Order No. 403204, Odor Control Dressing, Sterile. Packaged 1 dressing/immediate package,...
Medical Devices·63 affected·Feb 27, 2024
High RiskFDA
Karl Storz Endoscopy
Karl Storz SE & CO. KG, REF 723014, Uvula Retractor, For Veterinary Use Only, Rx Only
Medical Devices·147 affected·Feb 27, 2024
High RiskFDA
Howmedica Osteonics Corp.
TRIDENTII PSL CLUSTER64H- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-11-64H
Medical Devices·0 affected·Feb 27, 2024
High RiskFDA
Ortho-clinical Diagnostics
VITROS Performance Verifier I
Medical Devices·10,911 affected·Feb 27, 2024
High RiskFDA
Howmedica Osteonics Corp.
TRIDENTII HEMI CLUSTER50D- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-50D
Medical Devices·0 affected·Feb 27, 2024
High RiskFDA
Howmedica Osteonics Corp.
TRIDENTII HEMI CLUSTER52E-Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-52E
Medical Devices·48 affected·Feb 27, 2024
High RiskFDA
Karl Storz Endoscopy
Karl Storz SE & CO. KG, REF 11003MB, Grasping Forceps, Flexible 1 mm, Rx Only
Surgical Devices·190 affected·Feb 27, 2024
High RiskFDA
Howmedica Osteonics Corp.
TRIDENTII HEMI CLUSTER58F- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-58F
Medical Devices·0 affected·Feb 27, 2024
High RiskFDA
Emergency Products & Research
O.T.D - Optimum Traction Device - Street Orange. Single use traction splint.
Medical Devices·190,000 affected·Feb 27, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Centurion manual surgical kits labeled as: a) STERILE 4-1/2" S/S SCISSOR (SS5031), Product Code 65145; b) STERILE S/B SCISSOR 4-1/2" ...
Surgical Devices·568,849 affected·Feb 23, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Centurion DISP.UMBILICAL CORD CLAMP CUTTER(CTR300), Product Code 67335
Medical Devices·1,350 affected·Feb 23, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Centurion STERILE COTTON DENTAL ROLLS 6/PK, Product Code 9125ST6
Medical Devices·100 affected·Feb 23, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Centurion Hemostat kits labeled as: a) STERILE CURV KELLY HEMOSTAT, Product Code 65340; b) STERILE CURV MOSQUITO HEMOSTAT (MHS103), P...
Medical Devices·80,903 affected·Feb 23, 2024
High RiskFDA
Medline Industries, Lp - Northfield
MEDLINE SWABSTICKS PVP 3 PK, Product Code DYNDA2724
Medical Devices·2,458 affected·Feb 23, 2024
High RiskFDA
Siemens Medical Solutions Usa, Inc.
ACUSON Redwood 1.0 Diagnostic Ultrasound System, REF: 11503314, running software version VA10A to VA10G
Diagnostic Devices·628 affected·Feb 23, 2024
High RiskFDA
Medline Industries, Lp - Northfield
MEDLINE M1S0179 STRL TAPE/PEN PACK, Product Code P519582A
Medical Devices·4,200 affected·Feb 23, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Centurion STERILE #16 RUBBER BAND, Product Code EB16
Medical Devices·150 affected·Feb 23, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Centurion retractor kits labeled as: a) STERILE 6-1/2" SENN RETRACTOR (ST7185), Product Code 66795; b) STERILE RAGNELL RETRACTOR (RR60...
Medical Devices·760 affected·Feb 23, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Centurion Clamp kits labeled as: a) STERILE BACKHAUS TOWEL CLAMP (BTC173), Product Code 66520; b) STERILE TOWEL CLAMP, Product Code A...
Medical Devices·12,980 affected·Feb 23, 2024
High RiskFDA
Agfa N.v.
Agfa DX-D 100 system-Digital Radiography mobile X-ray System. A mobile X-Ray modality, consisting of X-Ray console, generator, tube, digi...
Medical Devices·541 affected·Feb 23, 2024
High RiskFDA
Human Care Hc Sweden Ab
Altair 330 lbs w/o Hanger Bar, REF: 55200H-NA, 55220H-NA, and Roomer S 220 kg w/o Hanger Bar, REF: 55300H-NA, patient lifts
Medical Devices·10 affected·Feb 23, 2024
High RiskFDA
Carefusion 303, Inc.
BD Pyxis MedStation 4000 REF: 303. Intended to securely store and dispense medications to a qualified and authorized healthcare provider.
Medical Devices·0 affected·Feb 23, 2024
High RiskFDA
Siemens Medical Solutions Usa, Inc.
ACUSON Maple Diagnostic Ultrasound System, REF: 11711750, ACUSON Maple Select, REF: 11711779, running software version VA10A
Diagnostic Devices·67 affected·Feb 23, 2024
High RiskFDA
Medline Industries, Lp - Northfield
MEDLINE SWABSTICKS ALCOHOL 3PK, Product code DYNDA2723
Medical Devices·0 affected·Feb 23, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Centurion manual surgical kits labeled as: a) STERILE ALLIS TISS FCP 10", Product Code I68905; b) VAGINAL REPAIR KIT, Product Code MN...
Surgical Devices·1,335 affected·Feb 23, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Centurion hook kits labeled as: a) STERILE SKIN HOOK FINE (EA3975F), Product Code 66660; b) STERILE SMALL 2 PRONG SKIN HOOK (25754), P...
Medical Devices·1,520 affected·Feb 23, 2024
High RiskFDA
Barsotti Juice Company, Inc.
Barsotti Organic Carrot Juice 16 oz. and 64 oz. plastic bottles Perishable, Keep Refrigerated Ingredient: Fresh Pressed Organic Carrot Ju...
Beverages·11,499 affected·Feb 22, 2024
High RiskFDA
Eugia Us Llc
Tobramycin for Injection, USP, 1.2 grams per Pharmacy Bulk Package, Rx Only, For Intravenous Use, PHARMACY BULK PACKAGE NOT FOR DIRECT IN...
Injectable Drugs·1,160 affected·Feb 22, 2024
High RiskFDA
Baxter Healthcare Corporation
Surgical Tools and Cardiovascular Specialty marketing brochures, Reference numbers: US-AS18-210002 Surgical Tools Brochure 2021, US-AS18...
Surgical Devices·83,971 affected·Feb 22, 2024
High RiskFDA
Bolton Medical Inc.
RELAY PRO Thoracic Stent-Graft System, containing one endovascular stent-graft system, IFU, and patient tracking card, sterile: (a) Pa...
Medical Implants·21 affected·Feb 22, 2024
High RiskFDA
Baxter Healthcare Corporation
Surgical Tools and Cardiovascular Specialty marketing brochures, Reference numbers: US-AS18-210002 Surgical Tools Brochure 2021, US-AS18...
Surgical Devices·112,760 affected·Feb 22, 2024
High RiskFDA
Baxter Healthcare Corporation
Surgical Tools and Cardiovascular Specialty marketing brochures, Reference numbers: US-AS18-210002 Surgical Tools Brochure 2021, US-AS18...
Surgical Devices·82,020 affected·Feb 22, 2024
High RiskFDA
Bruder Healthcare Company, Llc
Thermalon Stye Compress, Item Number 24352
Medical Devices·24 affected·Feb 21, 2024
High RiskFDA
Alcon Research, Llc
SYRINGE,BULB,2OZ/60CC,GREEN, Part: 300055070, packaged inside Alcon Custom-Pak Surgical Procedure Packs, Products: 18018-06, 3865-44, 56...
Surgical Devices·886 affected·Feb 21, 2024
High RiskFDA
Bruder Healthcare Company, Llc
Thermalon Sinus Compress (French), Item Number 24332F
Medical Devices·2,160 affected·Feb 21, 2024
High RiskFDA
Bruder Healthcare Company, Llc
Thermalon Back Wrap, Item Number 24312
Medical Devices·193 affected·Feb 21, 2024
High RiskFDA
Bruder Healthcare Company, Llc
Thermalon Sinus Compress, Item Number 24332
Medical Devices·1,416 affected·Feb 21, 2024
High RiskFDA
Abbott Laboratories
ARCHITECT STAT Myoglobin Reagent Kit, LN 2K43-25 and 2K43-20.
Diagnostic Devices·7,482 affected·Feb 21, 2024
High RiskFDA
Bruder Healthcare Company, Llc
Thermalon Neck Wrap, Item Number 24322
Medical Devices·471 affected·Feb 21, 2024
High RiskFDA
Covidien
Situate Laparotomy Sponge, RF and X-ray Detectable, REF: L1818-04P01C-1
Medical Devices·755,800 affected·Feb 21, 2024
High RiskFDA
Eugia Us Llc
Nicardipine Hydrochloride Injection, USP 25mg/mL (2.5 mg/mL) 10 mL vials, Distributed by: AuroMedics Pharma LLC 279 Princeton-Hightstown ...
Injectable Drugs·43,920 affected·Feb 20, 2024
High RiskFDA
Denver Solutions, Llc Dba Leiters Health
Moxifloxacin 5mg/ml, 1 ml in a Single- Dose Vial, Rx Only, Leiters 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-097-42
Drugs·10,020 affected·Feb 20, 2024
High RiskFDA
Eugia Us Llc
Nicardipine Hydrochloride Injection (2.5mg/mL), US, 25mg per 10mL, 10mL Vial, Rx only, Distributed by: AuroMedics Pharma LLC 279 Princet...
Injectable Drugs·335,940 affected·Feb 20, 2024