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High RiskFDA
The Anspach Effort, Inc.
6.5 cm Pediatric Craniotome Attachment. Use with XMax¿, microMax, and eMax¿ Systems Ref: CRANI-P Intended for cutting and shaping b...
Medical Devices·6,059 affected·Dec 7, 2022
High RiskFDA
Zimmer, Inc.
Identity Shoulder System Resection Planer 35mm Resection Planer
Medical Devices·84 affected·Dec 7, 2022
High RiskFDA
It'll Be Pizza, Llc.
22 oz Blonde; 20 oz Blonde EZ; 24 oz Blonde EZ frozen pizza dough manufactured by It'll Be Pizza
Frozen Food·1,678 affected·Dec 6, 2022
High RiskFDA
It'll Be Pizza, Llc.
EGA 22 oz Pizza Dough Ball, 20 ct/ case; frozen pizza dough
Frozen Food·1,678 affected·Dec 6, 2022
High RiskFDA
It'll Be Pizza, Llc.
Take 2 Classic 18 oz, 24 ct/case; Take 2 Classic 20 oz, 22 ct/case; Take 2 Specialty Traditional 20oz, 22ct/case frozen pizza dough manuf...
Frozen Food·1,678 affected·Dec 6, 2022
High RiskFDA
It'll Be Pizza, Llc.
24 oz Beer, frozen pizza dough manufactured by It'll Be Pizza
Frozen Food·1,678 affected·Dec 6, 2022
High RiskFDA
It'll Be Pizza, Llc.
Brava, 20 oz, 22 ct/case and Brava, 24 oz, 18 ct/case frozen pizza dough
Frozen Food·1,678 affected·Dec 6, 2022
High RiskFDA
It'll Be Pizza, Llc.
Circle K 22 oz Blonde Pizza Dough balls, 20 ct/case; frozen pizza dough
Frozen Food·1,678 affected·Dec 6, 2022
High RiskFDA
It'll Be Pizza, Llc.
20 oz Garlic and 24 oz Garlic frozen pizza dough manufactured by It'll Be Pizza
Frozen Food·1,678 affected·Dec 6, 2022
High RiskFDA
Zimmer, Inc.
NexGen Option Stemmed Tibial Component Size 7, Item Number 00-5986-057-01
Medical Devices·1,049 affected·Dec 6, 2022
High RiskFDA
Zimmer, Inc.
NexGen Option Stemmed Tibial Component Size 5, Item Number 00-5986-047-01
Medical Devices·2,460 affected·Dec 6, 2022
High RiskFDA
Zimmer, Inc.
NexGen Option Stemmed Tibial Component Size 4, Item Number 00-5986-037-02
Medical Devices·2,092 affected·Dec 6, 2022
High RiskFDA
Zimmer, Inc.
NexGen Option Stemmed Tibial Component Size 6, Item Number 00-5986-047-02
Medical Devices·1,366 affected·Dec 6, 2022
High RiskFDA
Future Diagnostics Solutions B.v.
Future Diagnostics STAT-IntraOperative-Intact-PTH (STAT-IO-I-PTH) Immunoassay kit REF 4K-IPT-00. in vitro diagnostic.
Diagnostic Devices·342 affected·Dec 6, 2022
High RiskFDA
Remedyrepack Inc.
Desmopressin Acetate Tablet, 0.2 mg, 100-count box, Rx only, Source NDC: 23155-0490-01; MFG: Avet Pharmaceuticals Inc., East Brunswick, N...
Oral Drugs·9 affected·Dec 5, 2022
High RiskFDA
Turbett Surgical, Inc.
Turbett Surgical Container, TS1000: Indicated for enclosing other medical devices that are to be sterilized by a healthcare provider
Surgical Devices·6 affected·Dec 5, 2022
High RiskFDA
Turbett Surgical, Inc.
Turbett Surgical Container, TS1200: Indicated for enclosing other medical devices that are to be sterilized by a healthcare provider
Surgical Devices·61 affected·Dec 5, 2022
High RiskFDA
Medtronic Neuromodulation
Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900C
Medical Devices·18 affected·Dec 3, 2022
High RiskFDA
Medtronic Neuromodulation
Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900E
Medical Devices·22 affected·Dec 3, 2022
High RiskFDA
Medtronic Neuromodulation
Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900B
Medical Devices·362 affected·Dec 3, 2022
High RiskFDA
Medtronic Neuromodulation
Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900D
Medical Devices·1,337 affected·Dec 3, 2022
High RiskFDA
Lidl Us Trading
Chef Select 2 Herb Baguettes Filled With Herb Butter 175 g Barcode: 4056489447566
Dairy·0 affected·Dec 2, 2022
High RiskFDA
Lidl Us Trading
Chef Select 2 Garlic Baguettes filled With Garlic Butter 175 g Barcode: 4056489447559
Dairy·0 affected·Dec 2, 2022
High RiskFDA
Glaxosmithkline Consumer Healthcare Holdings Llc
TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Berries flavor, Chewable Tablets, packaged in 72-count bottles, Dist. by: GSK CH, W...
Oral Drugs·0 affected·Dec 2, 2022
High RiskFDA
Glaxosmithkline Consumer Healthcare Holdings Llc
TUMS Antacid, Calcium Carbonate USP 1000 mg, Peppermint flavor, chewable tablets, 72-count bottle, Dist. by: GSK CH, Warren, NJ 07059. ND...
Oral Drugs·0 affected·Dec 2, 2022
High RiskFDA
Glaxosmithkline Consumer Healthcare Holdings Llc
TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Berries flavor, chewable tablets, 72-count bottle, Dist. by: GSK CH, Warren, NJ 070...
Oral Drugs·0 affected·Dec 2, 2022
High RiskFDA
Glaxosmithkline Consumer Healthcare Holdings Llc
TUMS Antacid, Calcium Carbonate USP 1000 mg, Peppermint flavor, chewable tablets, packaged in 12-count roll, Dist. by: GSK CH, Warren, NJ...
Oral Drugs·0 affected·Dec 2, 2022
High RiskFDA
Glaxosmithkline Consumer Healthcare Holdings Llc
TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Fruit flavor, Chewable Tablets, packaged in 160-count bottles, Dist. by: GSK CH, W...
Oral Drugs·0 affected·Dec 2, 2022
High RiskFDA
Glaxosmithkline Consumer Healthcare Holdings Llc
TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Berries flavor, Chewable Tablets, packaged in 265-count bottle, Dist. by: GSK CH, W...
Oral Drugs·0 affected·Dec 2, 2022
High RiskFDA
Glaxosmithkline Consumer Healthcare Holdings Llc
TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Berries flavor, Chewable Tablets, packaged in 12-count roll, Dist. by: GSK CH, Warr...
Oral Drugs·0 affected·Dec 2, 2022
High RiskFDA
Covidien, Lp
Surgilon Braided Nylon suture Product Description: 88861883-51 SURGILON* 2-0 BLK 75CM C16 88861915-71 SURGILON* 1 BLK 75CM GS11 88861...
Medical Devices·87,708 affected·Dec 2, 2022
High RiskFDA
Covidien, Lp
Dermalon Monofilament Nylon Suture: (1) 88861741-11 DERMALON* 6-0 BLU 45CM C1 (2) 88861747-11 DERMALON* 6-0 BLU 45CM C12 (3) 8886174...
Medical Devices·9,606 affected·Dec 2, 2022
High RiskFDA
Covidien, Lp
Custom Suture Pack Product Description: US1638 CUSTOM SUTURE PACK US1756 CUSTOM SUTURE PACK
Medical Devices·9,606 affected·Dec 2, 2022
High RiskFDA
Remington Medical, Inc.
Remington MEDICAL, Automatic Cutting Needle, 18ga (1.3mm) x 20cm, REF NAC-1820M (1)
Medical Devices·290 affected·Dec 2, 2022
High RiskFDA
Covidien, Lp
Ti-Cron Coated Braided Polyester Suture Product Description 88862775-31 TICRON* 4-0 BLU 75CM CV327DA 88862880-41 TICRON* 3-0 WHI 75CM ...
Medical Devices·40,152 affected·Dec 2, 2022
High RiskFDA
Covidien, Lp
Surgidac Uncoated Braided Polyester suture Product Description D-1764K SURGIDAC* 5-0 WHI 45CM SS24DA
Medical Devices·2,070 affected·Dec 2, 2022
High RiskFDA
Tomy International Inc.
Lamaze Chill Teether, Fluid-Filled Teething Ring, Model No. Y5288L
Medical Devices·55,000 affected·Dec 2, 2022
High RiskFDA
Covidien, Lp
Sofsilk Coated Braided Silk Suture Product Description CS-211 SOFSILK* 4-0 BLK 45CM CVF21 X36 CS211 CS-490 SOFSILK* 2-0 BLK 75...
Medical Devices·271,800 affected·Dec 2, 2022
High RiskFDA
Covidien, Lp
Monosof Monofilament Nylon sutures: Product Description CN-724 MONOSOF* 1 BLK 100CM GS25 X36 CN-791 MONOSOF* 2-0 BLK 100CM ...
Medical Devices·54,288 affected·Dec 2, 2022
High RiskFDA
Integra Lifesciences Corp.
Codman Surgical Patties, Part number 801400; SURG PATXRAY 1/2X1/2-200; Lot 6396457
Surgical Devices·168 affected·Dec 2, 2022
High RiskFDA
Covidien, Lp
Surgipro II Monofilament Polypropylene Sutures Product Description Model Number VP-421X SURGIPRO*II 4-0 90CM V20 DA7P VP421X VP-435-X ...
Medical Devices·322,152 affected·Dec 2, 2022
High RiskFDA
Sun Pharmaceutical Industries Inc
Oxcarbazepine Tablets 600mg, packaged in a) 100- count bottles (NDC 62756-185-88), b) 500-count bottles (NDC 62756-185-13), c)1000-count ...
Oral Drugs·1,474 affected·Dec 1, 2022
High RiskFDA
Altimate Medical, Inc.
ActiveAid 922, Shower/Commode Chair
Medical Devices·1 affected·Nov 30, 2022
High RiskFDA
Beaver Visitec International, Inc.
Beaver EdgeAhead Stiletto/MVR Knife .90mm Straight (20G)-for ocular paracentesis incisions in cataract procedures. Part Number: 376630
Medical Devices·599 affected·Nov 30, 2022
High RiskFDA
Ourpharma Llc
FentaNYL Citrate 2.5 mg/50 mL (50mcg/ml) Injection Solution, Preservative Free, Single Use 50 ml Cassette, Rx Only, Repackaged by OurPhar...
Injectable Drugs·691 affected·Nov 29, 2022
High RiskFDA
Heartware, Inc.
HeartWare Model 1100
Cardiac Devices·45 affected·Nov 29, 2022
High RiskFDA
Heartware, Inc.
HeartWare HVAD Pump Kit, REF 1104CA-CLIN
Cardiac Devices·6 affected·Nov 29, 2022
High RiskFDA
Heartware, Inc.
HeartWare Model 1101
Cardiac Devices·82 affected·Nov 29, 2022