FDA recalls, December 2022: 99 published

41 different companies appear this month.

Risk classification: Class I: 10 · Class II: 84 · Class III: 5

Same month, other agencies:CPSC 33 recallsFSIS 3 recallsNHTSA 79 recalls

Recalls this month

DateProduct
December 28, 2022HeartWare Model 1100Z-0742-2023Heartware, Inc.
December 28, 2022ConvaTec AQUACEL Foam Ag Adhesive, wound dressing advesiveZ-0723-2023ConvaTec, Inc
December 28, 2022Quinapril Tablets USP, 40 mg (90 pack), Rx Only, Manufactured for: Lupin Pharmaceuticals,…D-0088-2023Lupin Pharmaceuticals Inc.
December 28, 2022EGA 22 oz Pizza Dough Ball, 20 ct/ case; frozen pizza doughF-0197-2023It'll Be Pizza, LLC.
December 28, 2022Oxcarbazepine Tablets 600mg, packaged in a) 100- count bottles (NDC 62756-185-88), b) 500…D-0085-2023SUN PHARMACEUTICAL INDUSTRIES INC
December 28, 2022Revaclear 400 dialyzers. Indicated for treatment of chronic and acute renal failure …Z-0763-2023Baxter Healthcare Corporation
December 28, 2022Quinapril Tablets USP, 20 mg (90 pack), Rx Only, Manufactured for: Lupin Pharmaceuticals,…D-0089-2023Lupin Pharmaceuticals Inc.
December 28, 2022Vivid S6 ultrasound. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Ab…Z-0753-2023GE Medical Systems, LLC
December 28, 2022Red Button Vintage Creamery French Silk Pie, Net Wt. 31.88 oz. (904g), in a clear plastic…F-0206-2023Rocky Mountain Pies, LLC
December 28, 2022Glycopyrrolate Tablets, USP, 1 mg, 100 tablets, Rx Only, Distributed by: Aurobindo Pharma…D-0087-2023Aurolife Pharma, LLC
December 28, 2022Revaclear 300 dialyzers. Indicated for treatment of chronic and acute renal failure …Z-0762-2023Baxter Healthcare Corporation
December 28, 202222 oz Blonde; 20 oz Blonde EZ; 24 oz Blonde EZ frozen pizza dough manufactured by It'll B…F-0200-2023It'll Be Pizza, LLC.
December 28, 2022VADER Pedicle System Torque Wrench, Hudson Coupling, 12 Nm, REF 42-702Z-0728-2023Icotec Ag
December 28, 2022Gamesa Arcoiris Marshmallow Cookies, Naturally and Artificially Flavored 15.5 Oz, 6 Coun…F-0205-2023Comercializadora Pepsico Mexico,
December 28, 2022Full Dose CE Simplex P Single Bone Cement - Indicated for the fixation of prostheses to l…Z-0736-2023Howmedica Osteonics Corp.
December 28, 2022Denticator PICK-A-DENT, periodontal aid - intradental pick, REF 621714Z-0725-2023Young Dental Manufacturing I, LLC
December 21, 2022FentaNYL Citrate 2.5 mg/50 mL (50mcg/ml) Injection Solution, Preservative Free, Single Us…D-0078-2023OurPharma LLC
December 21, 2022Neuroquell, A Homeopathic Drug, Calendula Oil, packaged in1/8 Fl. oz. (3.5 g) bottles, Mf…D-0082-2023Atlantic Management Resources Ltd.
December 21, 2022HENRY SCHEIN, UNIVERSAL TRAY, Item No.570-2787Z-0517-2023Stradis Medical, LLC dba Stradis Healthcare
December 21, 2022DeRoyal RETINAL PACK, REF 89-7336.07Z-0594-2023DeRoyal Industries Inc
December 21, 2022DeRoyal MYELOGRAM PACK, REF 89-9304.05Z-0647-2023DeRoyal Industries Inc
December 21, 2022Menastil, A Homeopathic Formula, Calendula Oil packaged in 1/8 Fl. oz. (3.5 g) bottles, M…D-0084-2023Atlantic Management Resources Ltd.
December 21, 2022ProSirona, A Homeopathic Formula, Calendula Oil packaged in 1/8 Fl. oz. (3.5 g) bottles, …D-0083-2023Atlantic Management Resources Ltd.
December 21, 2022DeRoyal TRACECART POSTEROR LUMBAR FUSION TRACECART, REF 53-1961.02Z-0707-2023DeRoyal Industries Inc
December 21, 2022STRADIS HEALTHCARE, Surg Pk, Item No.40714IES, oral surgery trayZ-0490-2023Stradis Medical, LLC dba Stradis Healthcare
December 21, 2022DeRoyal CNRV PERIPHERAL VAS PACK, REF 89-10530.03Z-0689-2023DeRoyal Industries Inc
December 21, 2022DeRoyal LUMBAR/CERVICAL PACK, REF 89-9521.11Z-0659-2023DeRoyal Industries Inc
December 21, 2022GEO-MED PLASTIC HAND PACK RF, REF 89-6667.09Z-0576-2023DeRoyal Industries Inc
December 21, 2022DeRoyal TRACECART POSTEROR LAMI MICRODISC TRACECART, REF 53-1960.02Z-0708-2023DeRoyal Industries Inc
December 21, 2022STRADIS HEALTHCARE, VENOUS ACCESS PACK, Item No.682-1993R1,Z-0546-2023Stradis Medical, LLC dba Stradis Healthcare
December 21, 2022HENRY SCHEIN, SINGLE SHOT EPIDURAL, Item No.570-3089Z-0530-2023Stradis Medical, LLC dba Stradis Healthcare
December 21, 2022Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-05001 (IP…Z-0455-2023ARROW INTERNATIONAL Inc.
December 21, 2022DeRoyal LAPAROSCOPIC ROBOTIC TRAY, REF 89-7063.11Z-0584-2023DeRoyal Industries Inc
December 21, 20228.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, p…D-0080-2023Exela Pharma Sciences LLC
December 21, 2022HENRY SCHEIN, Vas Reversal Pack, Item No.888-2549,Z-0557-2023Stradis Medical, LLC dba Stradis Healthcare
December 21, 2022DeRoyal CATARACT PACK CSM, REF 89-6863Z-0580-2023DeRoyal Industries Inc
December 21, 2022DeRoyal MYELOGRAM PACK, REF 89-9304.06Z-0648-2023DeRoyal Industries Inc
December 21, 2022GEO-MED TOTAL KNEE PACK A & B PGYK, REF 89-5796.13Z-0567-2023DeRoyal Industries Inc
December 21, 2022DeRoyal PEDI ORTHO PACK, REF 89-5323.20Z-0565-2023DeRoyal Industries Inc
December 21, 2022DeRoyal PAIN TRAY, REF 89-10464.03Z-0688-2023DeRoyal Industries Inc
December 21, 2022DeRoyal FOOT PACK, REF 89-9252.08Z-0640-2023DeRoyal Industries Inc
December 21, 2022HENRY SCHEIN, Novasure Pack, Item No.570-1462, general surgery trayZ-0504-2023Stradis Medical, LLC dba Stradis Healthcare
December 21, 2022STRADIS HEALTHCARE, Angioplasty, Item No.682-1937,Z-0544-2023Stradis Medical, LLC dba Stradis Healthcare
December 21, 2022HENRY SCHEIN, BASIC PACK, Item No.570-2719, UDI/DI (case) H65857027191, UDI/DI (kit)M7525…Z-0512-2023Stradis Medical, LLC dba Stradis Healthcare
December 21, 2022Iohexol (300 mg Iodine/mL), 2.4 g Iodine/8 ml, Total Volume 8 ml in 10 ml syringe, 5-coun…D-0086-2023BayCare Integrated Service Center, LLC /dba BayCare Central Pharmacy
December 21, 2022DeRoyal VIT RD PACK 86ST, REF 89-7308.09Z-0593-2023DeRoyal Industries Inc
December 21, 2022Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/EMEA, REF IAP-0700 (IPN…Z-0438-2023ARROW INTERNATIONAL Inc.
December 21, 2022GEO-MED OPTHALMOLOGY CSTM PCK, REF 89-6387.09Z-0572-2023DeRoyal Industries Inc
December 21, 2022Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT2 WAVE REFURBISHED, REF IAP-0535X (…Z-0432-2023ARROW INTERNATIONAL Inc.
December 21, 2022DeRoyal SHOULDER KIT, REF 89-9497.08Z-0655-2023DeRoyal Industries Inc

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