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High RiskFDA
Medline Industries, Lp - Northfield
Sterile Procedural Trays, labeled as the following: a. BASIC EYE PACK-LF b. VITRECTOMY PACK-LF c. EYE PACK-EAST-LF d. OSC OCULAR ...
Medical Devices·260 affected·Nov 17, 2022
High RiskFDA
Medline Industries, Lp - Northfield
Sterile Procedural Trays, labeled as the following: a. UNIVERSAL PLASTIC b. KNEE ARTHROSCOPY PACK
Medical Devices·26 affected·Nov 17, 2022
High RiskFDA
Medline Industries, Lp - Northfield
Non-sterile procedural trays labeled as MAJOR/MINOR, 3 per case
Medical Devices·160 affected·Nov 17, 2022
High RiskFDA
Medline Industries, Lp - Northfield
Sterile Procedural Trays, labeled as the following: a. MAJOR CDS-LF b. BURN PACK-LF c. BURN PACK d. SMALL BURN
Medical Devices·100 affected·Nov 17, 2022
High RiskFDA
Medline Industries, Lp - Northfield
Sterile Procedural Trays, labeled as the following: MINOR BASIC PACK-LF
Medical Devices·50 affected·Nov 17, 2022
High RiskFDA
Medline Industries, Lp - Northfield
Non-sterile procedural trays labeled as ORTHO TRAUMA, 1 per case
Medical Devices·216 affected·Nov 17, 2022
High RiskFDA
Medline Industries, Lp - Northfield
Sterile Procedural Trays, labeled as the following: a. ORAL SURGERY PACK-LF b. EXTRACTION PACK c. ORAL SURGERY PACK d. DENTAL MINOR...
Medical Devices·174 affected·Nov 17, 2022
High RiskFDA
Medline Industries, Lp - Northfield
Sterile Procedural Trays, labeled as the following: a. GYN ABD CDS b. LAVH PROCEDURE c. TAH CDS d. CUH LITHOTOMY CDS e. LAVH CDS...
Medical Devices·1,258 affected·Nov 17, 2022
High RiskFDA
Medline Industries, Lp - Northfield
Sterile Procedural Trays, labeled as the following: a. WOUND CLOSURE TRAY b. WOUND PACK
Medical Devices·36 affected·Nov 17, 2022
High RiskFDA
Medline Industries, Lp - Northfield
Sterile Procedural Trays, labeled as the following: GENERAL ENDOSCOPY
Medical Devices·48 affected·Nov 17, 2022
High RiskFDA
Medline Industries, Lp - Northfield
Sterile Procedural Trays, labeled as the following: a. CARDIAC CATH PACK-LF; b. ANGIOGRAPHY-NS-LF; c. EP BASIC SET UP PACK; ...
Medical Implants·314 affected·Nov 17, 2022
High RiskFDA
Medline Industries, Lp - Northfield
Sterile Procedural Tray, labeled as the following: a. PAIN SERVICE PACK-LF; b. LOCAL BASIC
Medical Devices·12 affected·Nov 17, 2022
High RiskFDA
Medline Industries, Lp - Northfield
Sterile Procedural Trays, labeled as the following: a. GYN LAPAROTOMY HARPER PACK-LF b. OB GYN LAP PACK-LF c. VAGINAL HYSTERECTOMY...
Medical Devices·194 affected·Nov 17, 2022
High RiskFDA
Medline Industries, Lp - Northfield
Sterile Procedural Trays, labeled as the following: a. BASIN SET-UP PACK b. LAP CHOLE CDS c. MAJOR CDS d. UROLOGY MINOR CDS e. UROLOGY ...
Medical Implants·62,930 affected·Nov 17, 2022
High RiskFDA
Medline Industries, Lp - Northfield
Non-sterile procedural trays labeled as CRANI, 2 per case
Medical Devices·12 affected·Nov 17, 2022
High RiskFDA
Medline Industries, Lp - Northfield
Non-sterile procedural trays labeled as TOTAL KNEE KIT, 1 per case
Medical Devices·16 affected·Nov 17, 2022
High RiskFDA
Medline Industries, Lp - Northfield
Sterile Procedural Trays, labeled as the following: LS MS PACK
Medical Devices·159 affected·Nov 17, 2022
High RiskFDA
Medline Industries, Lp - Northfield
Sterile Procedural Trays, labeled as the following: DR MOTT DRAPE PACK
Medical Devices·5 affected·Nov 17, 2022
High RiskFDA
Medline Industries, Lp - Northfield
TRACH PACK. Sterile Procedural Tray.
Medical Devices·28 affected·Nov 17, 2022
High RiskFDA
Medline Industries, Lp - Northfield
Sterile Procedural Trays, labeled as the following: a. GYN-URO LAPSCP CDS-LF b. ROBOTIC CDS c. GYN LAPAROSCOPY CDS-LF d. GYN LAPA...
Medical Devices·8,064 affected·Nov 17, 2022
High RiskFDA
Medline Industries, Lp - Northfield
ANCILLARY PACK-LF. Sterile Procedural Tray.
Medical Devices·48 affected·Nov 17, 2022
High RiskFDA
Fudgeamentals Llc
Fudgeamentals Chocolate Fudge Bites (8 oz); packaged in clear plastic container
Snacks & Candy·194 affected·Nov 16, 2022
High RiskFDA
Taylor Farms Northwest, Llc
Taylor Farms Carrot - Celery Sticks, Refrigerated & Ready To Eat product, packaged in a plastic clear clamshell container, net wt. 14 oz....
Food·537 affected·Nov 16, 2022
High RiskFDA
Taylor Farms Northwest, Llc
Taylor Farms Guacamole Tray - Large, Refrigerated & Ready To Eat product, packaged in a plastic round container, net wt. 61 oz. The tray...
Baby Food & Formula·161 affected·Nov 16, 2022
High RiskFDA
Noven Pharmaceuticals Inc
Daytrana (methylphenidate transdermal system), Delivers 15 mg over 9 hours, (1.6 mg/hr), 30 patches per box, Rx only, Manufactured for No...
Topical Drugs·3,977 affected·Nov 16, 2022
High RiskFDA
Siemens Medical Solutions Usa, Inc
Programmable Diagnostic Computer
Diagnostic Devices·2,213 affected·Nov 16, 2022
High RiskFDA
Ge Medical Systems, Llc
B105P Patient Monitor (with E-module slot option), REF 6160000-001-XXXXXX,
Medical Devices·826 affected·Nov 16, 2022
High RiskFDA
Ge Medical Systems, Llc
B125M Patient Monitor, REF 6160000-004-XXXXXX
Medical Devices·5,962 affected·Nov 16, 2022
High RiskFDA
A C Calderoni & Co. Inc.
ORGEAT ALMOND SYRUP; 32 fl oz (946 ml); Glass bottle with screw-top lid; Contains: Sugar, Water, Citric Acid Natural Flavor, Sodium Benzo...
Beverages·68 affected·Nov 15, 2022
High RiskFDA
Convatec, Inc
ConvaTec AQUACEL Foam Ag Adhesive, wound dressing advesive
Medical Devices·5,300 affected·Nov 15, 2022
High RiskFDA
Lidl Us Trading
ACME Everything Bagel Smoked Salmon Net Wt. 4 OZ (113G) UPC:2338410420
Seafood·11,391 affected·Nov 14, 2022
High RiskFDA
Lidl Us Trading
ACME Smoked Nova Salmon Net Wt. 4 OZ (113G) UPC: 23384104065
Seafood·534 affected·Nov 14, 2022
High RiskFDA
Stryker Medical Division Of Stryker Corporation
Power-PRO 2, Model No. 6507, Item No. 650705550001 (US); 650700000000 (International)
Medical Devices·465 affected·Nov 11, 2022
High RiskFDA
Abbott Molecular, Inc.
Abbott Alinity m System, REF 08N53-002, containing Amplification Detetction Unit (ADU) #4.
Medical Devices·1 affected·Nov 11, 2022
High RiskFDA
Carrying International Food Corp.
RED SUN TARO FLAVOR POWDER NET WT 1000g (2.2 LBS) packaged in PEP and aluminum foil bag
Food·88 affected·Nov 10, 2022
High RiskFDA
Par Formulations Private Limited
Phenoxybenzamine Hydrochloride Capsules, USP 10mg, 100-count bottles, RX only Dist. by: Par Pharmaceutical Chestnut Ridge, NY 10977 U.S.A...
Oral Drugs·218 affected·Nov 10, 2022
High RiskFDA
Nephron Sterile Compounding Center Llc
PF-Neostigmine Methylsulfate Injection, USP 3 mg/3 mL (1 mg/mL) vial, Rx Only, Nephron 503B Outsourcing Facility 4500 12th Street Extensi...
Injectable Drugs·56,220 affected·Nov 10, 2022
High RiskFDA
Nephron Sterile Compounding Center Llc
PF-Labetalol HCl Injection, USP 20 mg/4 mL (5 mg/mL) vial, Rx Only, Nephron 503B Outsourcing Facility 4500 12th Street Extension West Col...
Injectable Drugs·34,020 affected·Nov 10, 2022
High RiskFDA
Imprimisrx Nj
Timolol-Latanoprost (0.5/0.005%) ophthalmic drops, Compounded, 5 mL bottle, Imprimis Rx, Ledgewood, NJ.
Ophthalmic Drugs·960 affected·Nov 9, 2022
High RiskFDA
Icu Medical Inc
0.9% Sodium Chloride Injection, USP, 100 mL flexible container bag, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 09...
Injectable Drugs·137,120 affected·Nov 9, 2022
High RiskFDA
Discovery Pharma Llc
Conzerol zero molluscum contagiosum, Homeopathic treatment for Molluscum Contagiosum, Topical Cream, Net weight 0.78 oz (22g) tube, UPC 8...
Topical Drugs·21,892 affected·Nov 9, 2022
High RiskFDA
Biomerieux Inc
PPM LOMBARD PRODUCTS TSA 10PLT, CATALOG M1040
Medical Devices·1 affected·Nov 9, 2022
High RiskFDA
Biomerieux Inc
VIDAS CLINICAL VIDAS LISTERIA 60T, CATALOG 30700
Medical Devices·10 affected·Nov 9, 2022
High RiskFDA
Biomerieux Inc
VIDAS CLINICAL VIDAS HCG 60 TESTS, CATALOG 30405-01
Medical Devices·4 affected·Nov 9, 2022
High RiskFDA
Biomerieux Inc
PPM INDUSTRY COMBOURG CHROMID CARBA US 20 PLT, CATALOG 414012
Medical Devices·1 affected·Nov 9, 2022
High RiskFDA
Biomerieux Inc
VITEK 2 REAGENT AST-GN80 TEST KIT 20 CARDS, CATALOG 413437
Diagnostic Devices·15 affected·Nov 9, 2022
High RiskFDA
Biomerieux Inc
ETEST CLINICAL AMIKACIN AK 256 US S30, CATALOG 412218
Medical Devices·0 affected·Nov 9, 2022
High RiskFDA
Biomerieux Inc
ETEST CLINICAL RIFAMPICIN RI 32 US S30, CATALOG 412449
Medical Devices·2 affected·Nov 9, 2022