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High RiskFDA
Remote Diagnostic Technologies Ltd.
Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020
Cardiac Devices·1,147 affected·May 8, 2023
High RiskFDA
Galt Medical Corporation
Tearaway Introducer Set, REF: INT-028-27, INT-105-25, INT-106-09, INT-106-12, INT-106-17, DSS-007-04, DSS-007-05, DSS-010-065, DSS-012-07...
Medical Devices·6,036 affected·May 8, 2023
High RiskFDA
Biofire Diagnostics, Llc
BioFire Respiratory Panel 2.1 (RP2.1), REF: 423742, For FILMARRAY systems, IVD, Rx Only
Respiratory Devices·705 affected·May 8, 2023
High RiskFDA
Biofire Diagnostics, Llc
FilmArray Pneumonia Panel (Pneumo), REF: RFIT-ASY-0145, For FILMARRAY systems, CE 2797, IVD, Rx Only
Medical Devices·24 affected·May 8, 2023
High RiskFDA
Meijer Inc
Meijer Sweet & Salty Trail Mix 12oz. pouch, UPC 7 08820 10371 9
Food·1,824 affected·May 6, 2023
High RiskFDA
Origami Catering, Llc
Multigrain Spicy Salmon Avocado Roll, net wt. 7 oz., Ready to Eat, perishable and refrigerated product. UPC 8 51016 00244 7. Manufactured...
Seafood·89 affected·May 5, 2023
High RiskFDA
Elekta, Inc.
Elekta Medical Linear Accelerator (ELMA) included in the below platforms: a. Elekta Infinity; b. Versa HD; c. Elekta Synergy
Medical Devices·46 affected·May 5, 2023
High RiskFDA
T.a.g. Medical Products Corporation, Ltd.
Betta Link LG Reusable Fishmouth Guide-Intended for use in soft tissue to bone fixation in the repair of the natural ligament or tendon d...
Medical Devices·0 affected·May 4, 2023
High RiskFDA
T.a.g. Medical Products Corporation, Ltd.
BETTA LINK SR REUSABLE PRONGED GUIDE- Intended for use in soft tissue to bone fixation in the repair of the natural ligament or tendon di...
Medical Devices·0 affected·May 4, 2023
High RiskFDA
T.a.g. Medical Products Corporation, Ltd.
BETTA LINK LG KNOTLESS IMPLANT KIT-Intended for use in soft tissue to bone fixation in the repair of the natural ligament or tendon disru...
Medical Implants·0 affected·May 4, 2023
High RiskFDA
T.a.g. Medical Products Corporation, Ltd.
Betta Link LG Reusable ProngED Guide - Intended for use in soft tissue to bone fixation in the repair of the natural ligament or tendon d...
Medical Devices·0 affected·May 4, 2023
High RiskFDA
Olympus Corporation Of The Americas
Single Use Repositionable Clip QUICKCLIP PRO 165 CM 10/BX- Intended for hemostatic metal clip for the GI Tract Catalog Number: HX-202LR.A
Medical Devices·340 affected·May 4, 2023
High RiskFDA
T.a.g. Medical Products Corporation, Ltd.
BETTA LINK SR KNOTLESS IMPLANT KIT-Intended for use in soft tissue to bone fixation in the repair of the natural ligament or tendon disru...
Medical Implants·0 affected·May 4, 2023
High RiskFDA
Olympus Corporation Of The Americas
Single Use Repositionable Clip QUICKCLIP PRO 165CM 5/BX- Intended for hemostatic metal clip for the GI Tract Catalog Number: HX-202LR.B
Medical Devices·45 affected·May 4, 2023
High RiskFDA
Olympus Corporation Of The Americas
Single Use Repositionable Clip QUICKCLIP PRO 230 CM 10/BX- Intended for hemostatic metal clip for the GI Tract Catalog Number: HX-202UR.A
Medical Devices·13,707 affected·May 4, 2023
High RiskFDA
Avery Brewing Company
Gose con Sandia, Sour Ale with watermelon, limes and sea salt, 12 oz. Can 6 pk. (72 oz. total) Can UPC 7 96363 00495 2, Carton UPC 7 ...
Beverages·1,078 affected·May 3, 2023
High RiskFDA
Denison Pharmaceuticals, Llc
Pin-Away PYRENTAL PAMOATE (Pyrantel base 50 mg / mL) Pinworm Treatment, 2 FL OZ (60 mL) bottle, Distributed by: Cara Incorporated, 333 St...
Drugs·4,812 affected·May 3, 2023
High RiskFDA
Sun Pharmaceutical Industries Inc
Buprenorphine Sublingual Tablets, 8 mg, 30 count-bottles, Rx only, Manufactured by: Sun Pharma, NDC 62756-460-83.
Oral Drugs·12,336 affected·May 3, 2023
High RiskFDA
Denison Pharmaceuticals, Llc
Safe tussin PM, NIGHT TIME Cough Relief, (Dextromethorphan HBr, USP 7.5mg, Doxylamine Succinate 3.125mg), 4.0 FL OZ (118mL) bottle, Krame...
Drugs·13,968 affected·May 3, 2023
High RiskFDA
Denison Pharmaceuticals, Llc
Colic Calm, Colic, Gas & Reflux, Homeopathic Medicine, 2 Fl. Oz (59 ml) bottle. Distributed by Ketomi LLC, 1215 Sarasota Center Blvd., Sa...
Drugs·54,222 affected·May 3, 2023
High RiskFDA
Denison Pharmaceuticals, Llc
Safe tussin DM, DAY TIME Cough Relief, (Dextromethorphan HBr, USP 10mg Guaifenesin, USP 100mg), 4.0 FL OZ (118mL) bottle, Kramer Laborato...
Drugs·86,616 affected·May 3, 2023
High RiskFDA
Medline Industries, Lp - Northfield
MEDLINE THERAHONEY GEL, 100% LEPTOSPERMUM SCOPARIUM HONEY, a) REF MNK0005, b) REF MNK0015 wound gel
Medical Devices·851,328 affected·May 3, 2023
High RiskFDA
Bolton Medical Inc.
The TREO ABDOMINAL STENT-GRAFT SYSTEM (TREO) consists of four types of implants, specifically a Main Bifurcated Stent-Graft, a Leg Extens...
Medical Implants·216 affected·May 3, 2023
High RiskFDA
Apollo Care, Llc
FentaNYL 500 mcg (2mcg/mL) and Ropivacaine HCL 250 mg (0.1%) added to 250 mL 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3...
Injectable Drugs·308 affected·May 2, 2023
High RiskFDA
Apollo Care, Llc
Ketamine Injection, 50 mg per 5 mL (10 mg/mL), Single-Use Syringe, Rx only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65...
Injectable Drugs·2,040 affected·May 2, 2023
High RiskFDA
Apollo Care, Llc
VANComycin 1.5g added to 250 mL of 0.9% Sodium Chloride Injection, Rx only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65...
Injectable Drugs·646 affected·May 2, 2023
High RiskFDA
Apollo Care, Llc
Norepinephrine 4 mg added to 250 mL of 5% Dextrose Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. ...
Injectable Drugs·682 affected·May 2, 2023
High RiskFDA
Apollo Care, Llc
VANComycin 1.25g added to 250 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 6...
Injectable Drugs·1,113 affected·May 2, 2023
High RiskFDA
Apollo Care, Llc
VANComycin 1.25g added to 250 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 6...
Injectable Drugs·1,113 affected·May 2, 2023
High RiskFDA
Apollo Care, Llc
VANComycin 750mg added to 250 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 6...
Injectable Drugs·491 affected·May 2, 2023
High RiskFDA
Apollo Care, Llc
VANComycin 1.5g added to 500 mL of 0.9% Sodium Chloride Injection, Rx only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65...
Injectable Drugs·2,040 affected·May 2, 2023
High RiskFDA
Apollo Care, Llc
VANComycin 1 g added to 250 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 652...
Injectable Drugs·1,622 affected·May 2, 2023
High RiskFDA
Apollo Care, Llc
VANComycin 1.75 g added to 500 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO ...
Injectable Drugs·240 affected·May 2, 2023
High RiskFDA
Apollo Care, Llc
Succinylcholine Cl Injection, 100 mg per 5 mL (20 mg/mL), Single-Use Syringe, Rx only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Colu...
Injectable Drugs·90 affected·May 2, 2023
High RiskFDA
Apollo Care, Llc
Norepinephrine 8 mg added to 250 mL 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 6...
Injectable Drugs·1,617 affected·May 2, 2023
High RiskFDA
Apollo Care, Llc
VANComycin 2g added to 500 mL of 0.9% Sodium Chloride Injection, Rx Only. Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 652...
Injectable Drugs·413 affected·May 2, 2023
High RiskFDA
Apollo Care, Llc
FentaNYL 50 mcg/mL (2,500mcg Total Dose), 50 mL Syringe, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 7...
Drugs·790 affected·May 2, 2023
High RiskFDA
Apollo Care, Llc
PHENYLephrine HCl Injection, 1 mg per 10 mL (100 mcg/mL), Single-Use Syringe, Solution for IV Use Only. Apollo Care, LLC, 3801 Mojae Ct....
Injectable Drugs·2,265 affected·May 2, 2023
High RiskFDA
Apollo Care, Llc
VANComycin 2.5 g added to 500 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 6...
Injectable Drugs·54 affected·May 2, 2023
High RiskFDA
Smith & Nephew, Inc.
Smith&Nephew ENGAGE Cementless Partial Knee System, Tibial Anchor Stem, Part Numbers: a) REF 1-10011-100 (SIZE 1-2), b) REF 1-10011-20...
Medical Devices·1,596 affected·May 2, 2023
High RiskFDA
Smith & Nephew, Inc.
Smith&Nephew ENGAGE Cementless Partial Knee System, Porous Femoral components, Part Numbers: a) REF 1-10003-100 (SIZE 1 Right Medial)...
Medical Devices·1,994 affected·May 2, 2023
High RiskFDA
Smith & Nephew, Inc.
Smith&Nephew ENGAGE Cementless Partial Knee System, Coated Tibial Tray, Part Numbers: a) REF 1-10012-100, SIZE 1-LEFT MEDIAL; b) REF 1...
Medical Devices·2,146 affected·May 2, 2023
High RiskFDA
Implant Direct Sybron Manufacturing Llc
LEGACY SMARTBASE, NE 3.0D 1MML, REF: 8730-81NE; LEGACY SMARTBASE, NE 3.0D 2MML, REF 8730-82NE; LEGACY SMARTBASE NARROW NE 3.5D, REF: 87...
Medical Devices·29 affected·May 2, 2023
High RiskFDA
Bakkavor Foods Usa Inc.
Top Label: TRADER JOE'S GENOVA PESTO NET WT. 7 OZ. (198g) Side Label: TRADER JOE'S HUMMUS DIP NET WT. 7 OZ (98g) CONTAINS: SESAME. DIST. ...
Food·290 affected·May 1, 2023
High RiskFDA
Pernod Ricard Usa Inc
Copitas; small ceramic cups; "Del Maguey" embossed on the bottom; distributed by Del Maguey
Food·177,000 affected·May 1, 2023
High RiskFDA
Glenmark Therapeutics, Inc.
Famotidine Tablets, USP, 20mg, 200-count bottle within a carton, Distributed by: Glenmark Therapeutics Inc., USA, Mahwah, NJ 07430, Made...
Oral Drugs·19,968 affected·May 1, 2023
High RiskFDA
Remedyrepack Inc.
Ketotifen Fumarate 0.025 %, Antihistamine eye drops, 5mL bottle, MFG: Akorn, Lake Forrest IL 60045, Repackaged by: RemedyRepack Inc., Ind...
Ophthalmic Drugs·12 affected·May 1, 2023
High RiskFDA
Remedyrepack Inc.
Pyrazinamide, 500 mg Tablet, packaged in a) 29 x 30-count card, NDC # 70518-2534-01; b) 1 x 100 UD box, NDC # 70518-2534-00, MFG: Akorn...
Oral Drugs·29 affected·May 1, 2023