Recall archive
78 recalls · page 3 of 4
Reported Nov 1, 2017
ChloraPrep OneStep (Clear) (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)), 3 mL applicator,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Company
Matched: Brand — Labeling; Label Mixup; the immediate package is labeled incorrectly as Chloroprep Onestep (Clear), however, the correct label should be Chloroprep…
FDA (openFDA drug enforcement)
Reported Sep 20, 2017
BD Needle 22GA 1-1/2in SafetyGlide(TM) Non Sterile, Bulk, REF 301701 The BD SafetyGlide(TM) needle is intended to be…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Company
Matched: Brand — Presence of loose polypropylene foreign matter above release specification.
FDA (openFDA device enforcement)
Reported Jul 26, 2017
BD 5ml Syringe Luer-Lok" Tip with Blunt Fill Needle 18G x 1 1/2 (1.2mm x 40mm) Catalog #305062
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Company
Matched: Brand — BD identified that several lots did not receive the specified dose of irradiation necessary to meet the Sterility Assurance Level (SAL) required.
6 more products in this recall
FDA (openFDA device enforcement)
Reported May 10, 2017
BD FlowSmart Set MiniMed Pro-set Rx Only Distributed by Medtronic MiniMed Inc. 8006464633 8185765555 Legal Manufacturer…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Company
Matched: Brand · Product details — Patients are reporting high blood glucose (HBG) levels while using the MiniMed Pro-set and also noticed the catheter of the infusion set was…
FDA (openFDA device enforcement)
Reported Apr 12, 2017
BD Vacutainer Buffered Sodium Citrate: (9NC) Blood Collection Tubes, 4.5 mL, 13 x 75 mm, Mfd: Becton Dickinson and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Company
Matched: Brand · Product · Product details — BD is initiating this product correction of multiple lots of BD Vacutainer Buffered Sodium Citrate: (9NC) Blood Collection Tube (13x75 mm x 4.5 mL).…
FDA (openFDA device enforcement)
Reported Mar 22, 2017
Eclipse Hypodermic Needle
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Company
Matched: Brand — BD is initiating a Product Advisory for the Eclipse Hypodermic Needle because of safety complaints covering disengagement and needlestick injuries.
FDA (openFDA device enforcement)
Reported Feb 22, 2017
BD Vacutainer Buffered Sodium Citrate: (9NC) Blood Collection Tube (4.5 ml x 13 x 75 mm) Catalog Number: 369714 Product…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Company
Matched: Brand — A portion of this lot of blood collection tubes was manufactured with approximately twice the expected amount of buffered sodium citrate additive, an…
FDA (openFDA device enforcement)
Reported Dec 21, 2016
BD Spinal Anesthesia Tray The BD Spinal Anesthesia Tray is intended for use by professional anesthesiologists to…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Company
Matched: Brand — BD is conducting a voluntary product recall of the BD Spinal Anesthesia Tray, Cat (Ref) 405671, lot B01K089D since a very low number of trays are…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 16, 2016
catalog # 405612 BD Spinal Anesthesia Tray 22G x 3.5 in. BD" Quincke Spinal Needle Lidocaine HCL (5%) with Dextrose…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Company
Matched: Brand — A recall was initiated by Hospira, Inc. for several lots of 5% Lidocaine HCI and 7.5% Dextrose Injection, USP, 2mL Ampul, NDC # 0409-4712-01. Some…
FDA (openFDA device enforcement)
Reported Sep 7, 2016
BD Vacutainer Push Button Blood Collection Set, Sterile, Rx only, 0.6 x 19 mm x 305 mm, 23G x 3/4" x 12", REF 367342.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Company
Matched: Brand · Reason for recall — Becton Dickinson is recalling various lot numbers of BD Vacutainer Push Button Blood Collection Set because of reports that specific lots exhibit…
FDA (openFDA device enforcement)
Reported Jun 15, 2016
Henry Schein Single Use Syringe Luer-Lock, 10 mL, Intended for use by health care professionals for general purpose…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Company
Matched: Brand — BD 10 mL Syringe Luer-Lok Tip with BD PrecisionGlide Needle 21G x 1 (0.8 mm x 25 mm) and Henry Schein 10 mL Single Use Syringe Luer-Lock are being…
1 more product in this recall
FDA (openFDA device enforcement)
Reported May 25, 2016
1) 24 G x 0.75 in. BD Angiocath" Autoguard" shielded IV catheter (0.7 mm x 19 mm) made of FEP polymer catalog number…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Company
Matched: Brand — The device may have a defect in the catheter. In some instances this defect could result in catheter separation or breakage.
FDA (openFDA device enforcement)
Reported Mar 16, 2016
BD Intelliport Medication Management System Sensor The system is indicated for use by healthcare professionals in a…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Company
Matched: Brand — The sterility of the product cannot be assured. This may result in increased risk of infection.
FDA (openFDA device enforcement)
Reported Jan 6, 2016
BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x 2.0 mL (Pink) BD Hemogard Additive: K2EDTA (spray dried), 3.6mg…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Company
Matched: Brand — Some of the Blood Collection Tubes in these lots were manufactured with insufficient EDTA additive. An insufficient EDTA additive may lead to…
4 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 30, 2015
BD Vacutainer K2 EDTA (K2E) 5.4mg Plus Blood Collection Tubes. Product Usage: BD Vacutainer¿ tubes are used to collect,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Company
Matched: Brand — Some tubes were manufactured with the stopper not fully inserted into the tube. This may result in the stopper popping-off in a small number of…
FDA (openFDA device enforcement)
Reported Aug 26, 2015
BD Vacutainer SST Plus Blood Collection Tubes, 5.0 mL, 13 x 100 mm, Sterile. Provides a means of collecting,…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Becton Dickinson & Company
Matched: Brand — Some of the tubes were manufactured with stoppers that did not meet current manufacturing specifications. Stoppers were manufactured with a reduced…
FDA (openFDA device enforcement)
Reported Apr 1, 2015
BD Q-Syte Luer Access Split Septum, 0.16 ml, Sterile, Rx only, Catalog REF #385100, Manufacturer: Becton Dickinson…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Company
Matched: Brand · Product · Product details · Reason for recall — Becton Dickinson received an elevated number of complaints for blood or infusate/medication leakage due to tearing of the silicone septum.
FDA (openFDA device enforcement)
Reported Feb 11, 2015
BD 10 mL Syringe BD Luer-Lok Tip with Blunt Plastic Cannula, Not for Skin Injection ; Catalog #303348, BD 10 mL Syringe…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Company
Matched: Brand — The stopper of the 10mL BD Luer-Lok syringe is not properly seated in the syringe.
FDA (openFDA device enforcement)
Reported Dec 17, 2014
BD Insyte Autoguard Catheter An active safety engineered peripheral IV catheter with a retracting needle to reduce…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Company
Matched: Brand — BD Insyte Autoguard may have potential damage along the body of the catheter.
FDA (openFDA device enforcement)
Reported Oct 1, 2014
BD PosiFlush SF Saline Flush Syringe 0.9 Sodium Chloride Injection, USP 10 mL REF 306553. Intended to be used only for…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Company
Matched: Brand — BD received some reports of open seals found on the BD Posiflush SF Flush Syringe 10 mL (Ref #306553).
FDA (openFDA device enforcement)
Reported Sep 3, 2014
BD Vacutainer CPT Cell Preparation Tube with Sodium Heparin, 8 mL, 16 x 125 mm, Catalog #REF 362753, Lot #4063409 with…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Company
Matched: Brand — BD has initiated the recall of its Vacutainer CPT Cell Preparation Tube due to poor separation, resulting in a reduced number of recovered…
FDA (openFDA device enforcement)
Reported Jan 22, 2014
BD Interlink threaded lock cannula This is a locking blunt plastic cannula specifically designed for IV connection to…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Company
Matched: Brand — BD Interlink Threaded Lock Cannula REF# 303369 and lot #3021392 is being recalled due to the potential that a small percentage of the lot may exhibit…
FDA (openFDA device enforcement)
Reported Oct 2, 2013
BD Epilor Syringe BD Franklin Lakes, NJ 07417 BD EDC Laagstraat 57, B-9140 Temse-Belgium The Epilor syringe is used in…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Company
Matched: Brand — BD has received several reports indicating that the plunger of the 7 mL BD Epilor plastic BD Luer-Lok Loss of Resistance Syringe may stall or stick…
FDA (openFDA device enforcement)
Reported Sep 18, 2013
BD Microtainer Quikheel Lancet 1.0 mm incision Depth 2.5 mm Incision Length REF 368101 Rx Only Becton, Dickinson and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Company
Matched: Brand · Product · Product details — The Lancet will not retract after activation thus creating a potential for exposure to a used sharp.
FDA (openFDA device enforcement)
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