Skip to content
Recall Observatory FDA recall evidence

Core noun

Recalled products

The canonical enforcement rows. Everything else groups, enriches, or interprets these records.

Indexed record set

86,536 products

Page 3420 of 3462

Product Firm Event Initiated
Guzzler Lemonade 20 fl. oz. PET plastic bottle with a sports cap, American Beverage Corporation, Verona PA. American Beverage Corp Event 62763 May 15, 2012
Guzzler Kiwi-Strawberry, 20 fl. oz. PET plastic bottle with a sports cap, American Beverage Corporation, Verona PA. American Beverage Corp Event 62763 May 15, 2012
Big Hug Fruit Barrel Kiwi Strawberry, in a 16 oz plastic bottle with a sports cap, American Beverage Corp., Verona PA. American Beverage Corp Event 62763 May 15, 2012
Big Hug Fruit Barrel Fruit Punch in a 16 oz plastic bottle with a sports cap, American Beverage Corp., Verona PA. American Beverage Corp Event 62763 May 15, 2012
Guzzler Iced Tea 20 fl. oz. PET plastic bottle with a sports cap, American Beverage Corporation, Verona PA. American Beverage Corp Event 62763 May 15, 2012
Big Burst Fruit Punch Drink, in a 16 oz PET plastic bottle with a sports cap, American Beverage Corp., Verona PA. American Beverage Corp Event 62763 May 15, 2012
Hartmann Sterilux Ref 56910000 Sterile Premium gauze sponge 4"x4" 12-ply 24 boxes/case 1200 total sponges For use in wound cleansing, debriding of wounds, wound packing, covering and swabbing Hartmann USA, Inc Event 61899 May 14, 2012
Hartmann Econolux Ref 416 105 Sterile Gauze sponge 4"x4" 12-ply 24 boxes/case 1200 total sponges For use in wound cleansing, debriding of wounds, wound packing, covering and swabbing Hartmann USA, Inc Event 61899 May 14, 2012
Alere Triage Tox+MTD Drug Screen, PN 94400 Product Usage: The Alere Triage TOX Drug Screen is a fluorescence immunoassay to be used with the Alere Triage Meters for the qualitative determination of the presence of drug and/or the major metabolites above the threshold concentrations of up to 10 distinct drug classes, including assays for acetaminophen/paracetamol, amphetamines, methamphetamines, barbiturates, benzodiazepines, cocaine, methadone, opiates, phencyclidine, THC and tricyclic antidepressants in urine. The acetaminophen/paracetamol assay will yield positive results when acetaminophen/paracetamol is ingested at or above therapeutic doses. This test provides only a preliminary result. Clinical consideration and professional judgment must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/Mass Spectrometry (GC/MS), Liquid Chromatography/ Mass Spectrometry/ Mass Spectrometry (LC/MS/MS) and High Performance Liquid Chromatography (HPLC) are common confirmatory methods. A quantitative serum acetaminophen/paracetamol measurement is the common confirmatory method for preliminary positive acetaminophen/paracetamol results. Alere San Diego, Inc. Event 62293 May 14, 2012
Zemplar (paricalcitol) Injection, 5 mcg/mL in 2 mL multi-dose vials, 25 vial carton, Rx only, Manufactured by Hospira, Inc. For Abbott Laboratories, North Chicago, IL 60064, USA, NDC 0074-1658-05 Abbott Laboratories Event 61878 May 14, 2012
BriteField illuminated Suction Device; Model numbers 8Fr, 10Fr and 12Fr, Kit (included 8Fr, 10Fr and 12Fr and a sterilization tray. The Invuity Brite Field Illuminated Suction Device is intended to aspirate from the surgical site and to provide illumination from a high intensity light source. Invuity, Inc. Event 62966 May 12, 2012
Bigliani/Flatow The Complete Shoulder Solution Trabecular Metal Glenoid Instrument Drill with Stop, 6 mm; the products are medical instruments intended for use when performing surgery of the shoulder. Zimmer, Inc. Event 61952 May 12, 2012
HYDROmorphone HCl Injection, USP, 1 mg/mL, 1 mL fill in a 2.5 mL Carpuject prefilled cartridge unit, packaged in 10-count Carpujects per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1283-31, Barcode (01) 1 030409 128331 9 (carton), (01) 0 030409 128331 2 (cartridge unit). Hospira Inc. Event 61847 May 12, 2012
ACUSON SC2000 volume imaging ultrasound systems at software versions VA16C, VA16D and VA16E. Model 10433816. Product Usage: The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Abdominal, Abdominal Intraoperative, Intraoperative Neurological, Musculo-skeletal Conventional, and Musculo-skeletal Superficial applications. The system also provides the ability to measure anatomical structures and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes. Typical examination performed using the SC2000 Ultrasound System are: Cardiac Imaging Applications and Analysis; Vascular Imaging Applications and Analysis; Superficial Imaging Applications; Intraoperative Imaging Applications; Transcranial Imaging Applications; Siemens Medical Solutions USA, Inc. Event 71116 May 11, 2012
The product is Pathfinder SL, version 1.6.0.3057 software used with the Spacelabs Healthcare Pathfinder SL Holter Analyzer, version 1.6.0. Product Usage: The Holter Analyzer analyzes information collected from ambulatory electrocardiogram recorders worn by patients and used to assist physicians in diagnosis and patient monitoring. In addition, incorrect QTc values are reported after moving the cursor. QTc values are timing events between labeled points of interest in the ECG signal that the physician can mark with the cursor. The software is used to edit a family of events and upon conclusion the software crashes with an error message. Spacelabs Healthcare, Llc Event 61913 May 11, 2012
Philips Easy Diagnost Product Usage: Stationary Fluoroscopic system Philips Healthcare Inc. Event 61877 May 11, 2012
Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 141HF7J. For use in patients who require hemodynamic monitoring. Edwards Lifesciences, LLC Event 62278 May 11, 2012
Churchill Medical Systems, Inc. A VYGON Company PICC INSERTION TRAY Kit Prefilled syringes included in the kit are used to maintain the patency of indwelling catheter lumens Vygon Corporation Event 61945 May 11, 2012
Vygon VY(TM)Flush Heparin Lock Flush Syringes, 100 Units per mL, 3mL in a 10mL Flush Syringe, 30 syringes per box, Rx only Prefilled syringes are used to maintain the patency of indwelling catheter lumens Vygon Corporation Event 61945 May 11, 2012
Churchill Medical Systems, Inc. VAD ACCESS TRAY Kit Prefilled syringes included in the kit are used to maintain the patency of indwelling catheter lumens Vygon Corporation Event 61945 May 11, 2012
Churchill Medical Systems, Inc. VAD ACCESS TRAY Kit Prefilled syringes included in the kit are used to maintain the patency of indwelling catheter lumens Vygon Corporation Event 61945 May 11, 2012
Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 151F7. For use in patients who require hemodynamic monitoring. Edwards Lifesciences, LLC Event 62278 May 11, 2012
Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131HF7J. For use in patients who require hemodynamic monitoring. Edwards Lifesciences, LLC Event 62278 May 11, 2012
Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 141HF7P. For use in patients who require hemodynamic monitoring. Edwards Lifesciences, LLC Event 62278 May 11, 2012
Churchill Medical Systems, Inc. PORT-A-CATH Tray Kit Prefilled syringes included in the kit are used to maintain the patency of indwelling catheter lumens Vygon Corporation Event 61945 May 11, 2012

Field note

Send feedback

We'll only use this to respond to your feedback.