Recall archive
78 recalls · page 2 of 4
Reported Nov 13, 2019
MaxZero Extension Sets with Needle-less Connector, Product codes MZ1000 MZ1000-07 MZ5301 MZ5302 MZ5303 MZ5304 MZ5305…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Company
Matched: Brand — BD has decided to initiate a voluntary recall due to a confirmed complaint trend for droplets of fluid separating from the sealed surface of the…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 6, 2019
BD Vacutainer Eclipse Blood Collection Needles 22Gx1.25, cat. no. 368608
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Company
Matched: Brand — BD PAS received customer complaints indicating the absence of the bevel on the non-patient needle end of the product, causing blood leakage.
FDA (openFDA device enforcement)
Reported Oct 30, 2019
BD Vacutainer¿ Push Button Blood Collection Set with Pre-Attached Holder Catalog number 368356 - Product Usage: This…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Company
Matched: Brand — Separation of front and rear barrels upon activation of the safety feature that retracts the needle
FDA (openFDA device enforcement)
Reported Oct 16, 2019
CareFusion MaxPlus Clear Needleless Connector. Intended for Positive Displacement Connector for needleless access to…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Company
Matched: Brand — After disconnection of a luer, the valve of the connector remains recessed; not fully closing, either temporarily or permanently. The risks of blood…
8 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 4, 2019
8 G x 10 CM Jamshidi Crown Bone Marrow biopsy/Aspiration Needle with MAC Catalog Number: TMJ4008
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Company
Matched: Brand — Product Pouches may not be sealed properly and compromise the sterility of the device
FDA (openFDA device enforcement)
Reported Aug 28, 2019
BD Vacutainer Lithium HeparinN (LH) 37 USP Units Blood Collection Tubes, Catalog Number 366664
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Company
Matched: Brand — False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood gas samples collected with tubes analyzed with the IL…
14 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 21, 2019
BD Vacutainer Fluoride Tubes for Blood Alcohol determinations Part Number: 367001 Product Usage: Blood Alcohol…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Company
Matched: Brand — Lot has been confirmed to have no additive within the tube. Sample processed without the preservative (additive) in the tube, testing has yielded…
FDA (openFDA device enforcement)
Reported Jul 31, 2019
3mL Luer-Lok Syringe, Catalog Number 309657, UDI 30382903096573
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Company
Matched: Brand — The syringes have scale markings that were printed incorrectly. The scale is skewed to varying degrees, resulting in missing and/or partially printed…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 24, 2019
BD Microtainer Tube w/ BD Microgard Closure, K2EDTA additive, Model Numbers 365974 and 365975 Product Usage: The…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Company
Matched: Brand — The products have been confirmed to have reduced or no additive within the tube reservoir. The tubes may develop visible clots within the tube…
FDA (openFDA device enforcement)
Reported Jul 17, 2019
Alaris Pump Infusion Set, Model Codes 10010453, 10010454, 10012144, 10015294, 10015414, 10933805, 11171447, 11404930,…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Becton Dickinson & Company
Matched: Brand — An incomplete occlusion can be caused by a variation in the wall thickness of the pumping segment of the affected infusion sets used with the. The…
FDA (openFDA device enforcement)
Reported Jul 3, 2019
SmartSite Syringe Administration Set-Product Package Size 50, Catalog Number: 10798696
High riskUsing this product could cause serious injury, illness or death — stop using it now.Becton Dickinson & Company
Matched: Brand — Leaking of the Smartsite Syringe Administration Set. May result in delay or interruption of infusion, under-infusion, contamination of the fluid path…
FDA (openFDA device enforcement)
Reported Jun 12, 2019
BD Nexiva Dual Port 20GA 1.00IN -Closed IV Catheter System intended for use in the peripheral vascular system Catalog…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Company
Matched: Brand — Leak from the septum assembly or the canister may burst under high pressure which could result in blood exposure to a health care worker.
FDA (openFDA device enforcement)
Reported Apr 17, 2019
Gravity IV Set with 3-port Closed Stopcock Manifold Model CS42522E-07
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Company
Matched: Brand — The firm has initiated a recall due to a confirmed complaint trend for kinked tubing on the specified lots of the product.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 28, 2018
BD Vacutainer Urine Collection Cups, Cat. No. 364941
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Company
Matched: Brand — BD Vacutainer Urine Collection Cups may contribute to a slight elevation of Red Blood Cell (RBC) counts when used with the Sysmex UF Series…
3 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 14, 2018
BD NEXIVA Closed IV Catheter System Dual Port 18GA 1.25 IN (BD Nexiva Catheter), Catalog Number 383539 Product Usage:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Company
Matched: Brand — One lot of the specified needles is not performing as intended due to a failure in the needle tip shield/safety mechanism, which may lead to an…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 27, 2018
The BD Vacutainer Plus Plastic Citrate Blood Collection Tube is an evacuated blood collection tube that provides a…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Company
Matched: Brand — Approximately 3.4% of BD Vacutainer Plus Plastic Citrate Blood Collection Tubes (2.7mL) (light blue top tube) will exhibit over fill draw volumes…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 13, 2018
BD VACUTAINER PLUS SST Tube with HEMOGARD closure 13x75mm 3.5ml PLBL Gold, Catalog No. 367983
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Company
Matched: Brand — Tubes may exhibit stopper creepout/pullout, where the stopper dissociates from the tube
1 more product in this recall
FDA (openFDA device enforcement)
Reported May 2, 2018
BD Vacutainer¿ Push Button Blood Collection Set 0.6 x 19 mm x 305 mm 23G x ¿ x 12 (Catalog no 367342)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Company
Matched: Brand — Products do not meet the labeled sterility claim of a Sterility Assurance Level (SAL) 10-6.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 4, 2018
BD Vacutainer¿ Barricor" Lithium Heparin Plasma Blood Collection Tubes for Invitro Diagnostic Use, Catalog Numbers:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Company
Matched: Brand — Increased amount of residual blood present on the top of stopper well after venipuncture
FDA (openFDA device enforcement)
Reported Mar 28, 2018
BD Vacutainer¿ EDTA Lavender Top Tubes: Catalog Numbers: 1. 366401 (UDI: 50382903664011); 2. 366450 (UDI:…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Becton Dickinson & Company
Matched: Brand — BD Vacutainer EDTA Lavender, Tan, and Pink Top Tubes and BD Vacutainer Lithium Heparin Green Top Tubes can cause an underestimation of lead in blood…
3 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 21, 2018
BD Vacutainer¿ K2 EDTA (K2E) 3.6mg Blood Collection Tube (13 x 75 mm x 2.0 mL). Catalog Number: 367841. Used for whole…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Company
Matched: Brand — A limited portion of the lot was manufactured with less than the required amount of K2EDTA additive, an anticoagulant, which may cause erroneous…
FDA (openFDA device enforcement)
Reported Dec 13, 2017
BD Precision Glide Needle 18G x 1 RB, Catalog 305195 Product Usage: These needles are intended for general purpose…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Company
Matched: Brand — Hub damage resulting in breakage and/or leakage during use.
FDA (openFDA device enforcement)
Reported Dec 6, 2017
BD Insulin Syringes with the BD Ultra-Fine(TM) needle ¿ mL 12.7mm 30G, Catalog/REF 328466 BD Insulin Syringes are…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Company
Matched: Brand — Product mislabel. Lot 6291768 of the BD Insulin Syringes with the BD Ultra-Fine needle ¿mL 12.7mm 30G, Cat (Ref) 328466, was found to have some…
FDA (openFDA device enforcement)
Reported Nov 15, 2017
BD Vacutainer Sodium Polyanetholesulfonate 5.95 mg Sodium Chloride 14.4 mg Blood Collection Tubes for Microbiological…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Company
Matched: Brand — After a receiving a customer complaint for incorrect labeling, BD has confirmed that a portion of SPS tubes associated with catalog 364960, lot…
FDA (openFDA device enforcement)
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