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All Product Recalls
49,209 recalls (high severity)
High RiskFDA
Tenderneeds Fertility Llc
Deluxe At Home Pro Series Insemination Kit (SKU 644042787958)
Medical Devices0 affectedDec 23, 2020
High RiskFDA
Biomet, Inc.
A.L.P.S. Clavicle Plating System, Plate, Fixation, Bone, Item Number 233500004 - Product Usage: indicated for fixation of fractures, oste...
Medical Devices174 affectedDec 23, 2020
High RiskFDA
Tenderneeds Fertility Llc
Premium At Home Pro Series Insemination Kit (SKU 644042787927)
Medical Devices0 affectedDec 23, 2020
High RiskFDA
Tenderneeds Fertility Llc
Deluxe At-Home Human Artificial Intracervical (ICI) Insemination Kit with Pregnancy & Ovulation Tests, SKU 636391205856
Medical Devices0 affectedDec 23, 2020
High RiskFDA
Tenderneeds Fertility Llc
At Home Artificial Intrauterine Insemination Kit (SKU 636391205825, 636391205894, 636391205900, 636391205924, 636391205863, 636391205931,...
Medical Devices0 affectedDec 23, 2020
High RiskFDA
Tenderneeds Fertility Llc
Professional Clinical Artificial Intrauterine Insemination Kit (SKU 636391205962, 636391206013)
Medical Devices0 affectedDec 23, 2020
High RiskFDA
Draegar Medical Systems, Inc.
Infinity Acute Care System (IACS) Monitoring Solution: The IACS is intended for multi-parameter, physiologic patient monitoring of adult...
Medical Devices19,802 affectedDec 23, 2020
High RiskFDA
Tenderneeds Fertility Llc
At Home Artificial Intrauterine Insemination Flex Set (SKU 636391205870)
Medical Devices0 affectedDec 23, 2020
High RiskFDA
Tenderneeds Fertility Llc
Home Artificial Insemination Kit Human IUI ICI Pregnancy & Ovulation Tests, SKU midiuikt
Medical Devices0 affectedDec 23, 2020
High RiskFDA
Rich Products Corp
OUR SPECIALTY; Cake Truffles; Variety; Chocolate; Cookies 'N Creme; NO: Artificial Colors, Flavors, or High Fructose Corn Syrup; Net Wt....
Bakery & Grains589 affectedDec 22, 2020
High RiskFDA
Country Fresh Orlando, Llc
Party Tray Vegetables with Ranch Dip, packaged in 40 oz (2.5 LBS) plastic tray with lid, UPC 3825911509.
Produce200 affectedDec 22, 2020
High RiskFDA
Abbott Point Of Care Inc.
Abbott i-STAT CG8+ cartridges - IVD Intended for quantitative measurement of sodium, potassium, ionized calcium, glucose, pH, pCO2, pO2 a...
Diabetes Devices2,820,000 affectedDec 22, 2020
High RiskFDA
Cytocell Ltd.
Aquarius LPH 511-A CRLF2 Distal Probe Green, model no. LPH 511-A The CRLF2 Distal probe, labelled in green, consists of two probes (71...
Medical Devices72 affectedDec 22, 2020
High RiskFDA
Sun Valley Foods Llc
Material Number: 7002 3/8 Diced Green Chile INGREDIENTS: Green Chilies, Citric Acid PRODUCT OF: MEXICO UNIT OF MEASURE: 440 +/- 5 LBS pa...
Food240 affectedDec 21, 2020
High RiskFDA
Merck Sharp & Dohme
Zerbaxa (ceftolozane and tazobactam) 1.5g per vial for injection, Single-Dose vial, Rx only, Manuf. for: Merck Sharp & Dohme Corp. a subs...
Injectable Drugs106,503 affectedDec 21, 2020
High RiskFDA
Hardy Diagnostics
Brain Heart Infusion Agar with 6 ug/ml Vancomycin Cat no: G14 Lot no: 472698 Manufactured: 2020-10-29 Expires: 2020-12-28 Container Type:...
Cardiac Devices820 affectedDec 21, 2020
High RiskFDA
Omnilife Science Inc.
SERF Novae Dual Mobility Cup Insert 49/28-ApeX-LNK Poly Liner. Intended for use with the Apex Modular Acetabular Cup for total hip replac...
Medical Devices2 affectedDec 21, 2020
High RiskFDA
Omnilife Science Inc.
SERF Novae Dual Mobility Cup Insert 51/28- ApeX-LNK Poly Liner. Intended for use with the Apex Modular Acetabular Cup for total hip repla...
Medical Devices3 affectedDec 21, 2020
High RiskFDA
Nihon Kohden America Inc
PSG-1100 Sleep Diagnostic System. Sample product label: JB-110A SERIAL No. 01454 RoHS Compliant; PSG-100 Head Box; UDI (01) 0493192110...
Diagnostic Devices189 affectedDec 21, 2020
High RiskFDA
Water Gardens Confections Llc
Macey's Kong Popcorn, 24 oz., in plastic zip pouch. UPC: 0-41172-00046-7, Manufactured By: Water Gardens Confections, LLC, Orem, Utah, 8...
Snacks & Candy7,736 affectedDec 18, 2020
High RiskFDA
Laerdal Medical (suzhou) Co., Ltd.
Laerdal Compact Suction Unit (LCSU 4), Catalog Numbers 880051, 880061, 881151, 880052, 880062, 881152 - Product Usage: It is intended f...
Respiratory Devices5,035 affectedDec 18, 2020
High RiskFDA
Ansh Labs, Llc
AnshLabs - SARS-CoV2 IgM ELISA (u-Capture), IVD, REF: AL-1002, kit contents, Ab PLATE 1 X ! Plate, IgM Sample DIL 1 x 100 mL, ENZ CONJ CO...
Medical Devices327 affectedDec 18, 2020
High RiskFDA
Smith & Nephew, Inc.
VERSABOND AB 40 GRAMS FORMULATION 2, antibiotic infused bone cement, Product Number: 71271440 - Product Usage: VERSABOND is a medium visc...
Medical Implants5,190 affectedDec 18, 2020
High RiskFDA
Siemens Medical Solutions Usa, Inc
ARTIS Icono biplane Model:11327600 ARTIS Icono floor system Model: 11327700 with software version VE20B - Product Usage: Intended for ...
Diagnostic Devices41 affectedDec 18, 2020
High RiskFDA
Topcon Medical Systems, Inc.
Harmony Referral System (aka Harmony RS)/ Medical Device Data System - Product Usage: intended to be used by trained healthcare professi...
Medical Devices13 affectedDec 18, 2020
High RiskFDA
Sca Pharmaceuticals
HYDROmorphone HCl 10mg/50mL in 0.9% Sodium Chloride Injection, CII, Rx Only, 50 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow ...
Injectable Drugs428 affectedDec 17, 2020
High RiskFDA
Sca Pharmaceuticals
ePHEDrine Sulfate 50 mg/10mL in 0.9% Sodium Chloride Injection, 10 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd.,...
Injectable Drugs7,257 affectedDec 17, 2020
High RiskFDA
Sca Pharmaceuticals
PHENYLephrine HCl 5000 mg/50 mL in Sodium Chloride 0.9% (100 mcg/mL) Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow ...
Drugs3,152 affectedDec 17, 2020
High RiskFDA
Sca Pharmaceuticals
ePHEDrine 25 mg/5 mL in 0.9% Sodium Chloride Injection, Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals 8521 Knoedl Ct., Little R...
Injectable Drugs9,416 affectedDec 17, 2020
High RiskFDA
Sca Pharmaceuticals
fentaNYL 100 mcg/50mL Ropivacaine HCl 0.1% in 0.9% Sodium Chloride 50 mL, 50 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 R...
Drugs1,774 affectedDec 17, 2020
High RiskFDA
Sca Pharmaceuticals
Sodium Citrate 4% 3 mL Anticoagulation Solution (40mg/mL), Rx only, 3 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Wind...
Drugs5,990 affectedDec 17, 2020
High RiskFDA
Sca Pharmaceuticals
morphine sulfate 150 mg/30 mL in 0.9% Sodium Chloride Injection, (5 mg/mL), Rx Only, 30 mL Single Dose Syringe, SCA Pharmaceuticals, 755...
Injectable Drugs50 affectedDec 17, 2020
High RiskFDA
Sca Pharmaceuticals
ePHEDrine Sulfate, 50 mg/5mL in 0.9% Sodium Chloride Injection, 5 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd.,...
Injectable Drugs1,879 affectedDec 17, 2020
High RiskFDA
Sca Pharmaceuticals
Esmolol HCl 100 mg/10 mL (10mg/ mL), 10 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barc...
Drugs952 affectedDec 17, 2020
High RiskFDA
Sca Pharmaceuticals
Glycopyrrolate 1 mg/5mL (0.2mg/mL), 5 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barc...
Drugs1,614 affectedDec 17, 2020
High RiskFDA
Imprimis Njof, Llc
Dexamethasone - Moxifloxacin PF Injection (1/5) mg/mL, Imprimis Rx Volume: 1mL/vial, Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B Ledg...
Injectable Drugs6,520 affectedDec 17, 2020
High RiskFDA
Sca Pharmaceuticals
fentaNYL 100 mcg/2mL Injection for IV or IM Use, 2 mL Single Dose Syringe, CII, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, ...
Injectable Drugs6,710 affectedDec 17, 2020
High RiskFDA
Cipla
Esomeprazole Magnesium for Delayed-Release Oral Suspension 40mg, packaged in unit dose packets, Rx only, Manufactured by: Cipla Ltd., Kur...
Oral Drugs6,491 affectedDec 17, 2020
High RiskFDA
Sca Pharmaceuticals
Atropine Sulfate Injection, 0.8 mg/2 mL (0.4 mg/mL), 2 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT...
Injectable Drugs1,930 affectedDec 17, 2020
High RiskFDA
Sca Pharmaceuticals
Lidocaine HCl 1% 10 mL (10mg/ml), Rx Only, 1 mL Single Dose Syringe, SCA Pharma, Inc., 755 Rainbow Rd., Windsor, CT, 06095, barcode 700...
Drugs1,880 affectedDec 17, 2020
High RiskFDA
Sca Pharmaceuticals
neostigmine methylsulfate 5 mg/5 mL, (1mg/ml), Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 060...
Drugs390 affectedDec 17, 2020
High RiskFDA
Sca Pharmaceuticals
SUCcinylcholine Chloride 100 mg/5mL, Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., WIndsor, CT, 06095, barcode...
Drugs5,067 affectedDec 17, 2020
High RiskFDA
Cipla
Esomeprazole Magnesium for Delayed-Release Oral Suspension 20mg, packaged in unit dose packets, Rx only, Manufactured by: Cipla Ltd., Kur...
Oral Drugs289,350 affectedDec 17, 2020
High RiskFDA
Fresenius Kabi Usa, Llc
Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), packaged in 2 mL Single Dose Vial, Rx only, Fresenius Kabi, Lake Zu...
Injectable Drugs490,633 affectedDec 17, 2020
High RiskFDA
Ascend Laboratories Llc
Ascend Laboratories, llc Cephalexin for Oral Suspension, USP 250 mg per 5 mL 200 ml (when mixed) Rx Only Manufactured by: Alkem Laborator...
Oral Drugs9,524 affectedDec 17, 2020
High RiskFDA
Sca Pharmaceuticals
Lidocaine HCl 2% 5 mL, 20 mg/mL, Rx Only, 5 mL syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 700040...
Drugs7,275 affectedDec 17, 2020
High RiskFDA
Sca Pharmaceuticals
Morphine Sulfate 30 mg/30 mL in 0.9% Sodium Chloride (1mg/ml), CII, Rx Only, 30 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow ...
Drugs116 affectedDec 17, 2020
High RiskFDA
Sca Pharmaceuticals
Ketamine 100 mg/10mL in 0.9% Sodium Chloride Injection (10 mg/mL), CII, Rx Only, 10 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rain...
Injectable Drugs11,075 affectedDec 17, 2020