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Esa Biosciences, Inc.

Esa Biosciences, Inc. Recalls

All product recalls associated with Esa Biosciences, Inc..

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Recall Summary

Total Recalls

710

Past Year

Class I (Serious)

Most Recent

Dec 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 621–640 of 710 recalls

Esa Biosciences, Inc.: ESA LeadCare II Blood Test Kit containing Level 1 and Lev...

Level 1 and Level 2 Control values were incorrectly assigned.

FDASep 20, 2007Nationwide• Esa Biosciences, Inc.

BD Biosciences, Systems & Reagents: CellQuest Pro SW, version 4.0.2. and later; Becton Dickin...

Results and gates could be mismatched if you utilize the undo function to undo a gate that was deleted.

FDASep 7, 2007Nationwide• BD Biosciences, Systems & Reagents

BD Biosciences: BD Biosciences MultiSET Flow Cytometry Software Versions ...

Inaccurate results: Software error results in inaccurate display result statistics. If the user adjusts the lymph gate or attractors in the Lab Report view without using the Manual Gate function (as described in the system manual), the statistic results will not be updated to match the adjusted gate.

1...30 313233 34...36

Page 32 of 36Next

FDA

Sep 6, 2007

• BD Biosciences

Children's Earrings (Uncas) – Lead Poisoning (2007)

This recall involves the Sleeping Beauty Crown and the Cinderella Star Earring sets. The Sleeping Beauty Crown set contains two pairs of earrings; one pair is shaped as pink crowns and the other pair is shaped as the Sleeping Beauty character. The Cinderella Star Earring set contains two pairs of earrings; one pair is shaped as blue stars and the other one is shaped as the Cinderella character. The packaging is shaped as a pink heart and "The Wonderful World of Disney" is printed in the front.

CPSCJul 17, 2007Nationwide• Uncas Manufacturing Company, of Providence, RI

Pacific Bioscience Lab, Inc.: Clarisonic Skin Care System - A hand held cleansing devic...

Fire/Burn Risk

Overheating: The handle or charger/cradle can overheat, melting the plastic, which potentially can lead to smoke and fire and has caused mild user burns.

FDAJul 3, 2007IN• Pacific Bioscience Lab, Inc.

Tosoh Bioscience Inc: 4 glass vials per box. 2/4ml vials of Sample Diluting Sol...

Firm discovered that a deterioration value of approximately 20% was found when the product of this lot was measured. Tosoh AIA confirmed that deterioration of the product occurred over time and resulted in a deviation from the assigned value.

FDAJun 22, 2007Nationwide• Tosoh Bioscience Inc

Medtronic Emergency Response Systems, Inc.: biphasic LIFEPAK 500 automated external defibrillators (A...

Reduced Shock- the device may deliver 100 Joule (J) to a patient, which is less than the recommended factory minimum default setting of 200 J.

FDAJun 13, 2007Nationwide• Medtronic Emergency Response Systems, Inc.

Brainlab AG Ammerthalstrasse 8 Kirchheim B. Muenchen Germany: BrainLAB Target Positioner for Leksell Headring used with...

Target Alignment Error : A mechanical component/software incompatibility caused by a specific combination of the BrainLAB Target Positioner version 40700-3A for Leksell headrings and BrainLAB planning software resulted in a 1.25 mm shift in target area alignment during radiosurgery treatment.

FDAJun 5, 2007OH, WA• Brainlab AG Ammerthalstrasse 8 Kirchheim B. Muenchen Germany

Edwards Lifesciences, Llc: Edwards Vigilance II Continuous Cardiac Output/Oximetry/V...

MAP offset errors: If users are "slaving" mean arterial pressure (MAP) from the bedside monitor into the Vigilance II Monitor for the purpose of the continuous calculation of systemic vascular resistance (SVR), at times, on some bedside monitors, the Vigilance II monitor may display a MAP offset of as much as 25mmHg. Since the MAP is used in calculations of various patient parameters such as SVR,

FDAMay 17, 2007Nationwide• Edwards Lifesciences, Llc

Heated Massage Recliners (Berkline) – Burn Hazard (2007)

Fire/Burn Risk

This recall involves the Berkline heated massage recliners with model number 13071 and piece code number 2700. The brand name, the model number, and the piece code can be found on the bill of sale and/or product packaging. The recliners were sold in brown and burgundy.

CPSCMay 11, 2007Nationwide• Berkline Benchcraft LLC, of Morristown, Tenn.

Integra LifeSciences Corp.: Endura No-React Dural Substitute 2 cm x 10 cm

Integra LifeSciences Corporation d/b/a Integra NeuroSciences, the distributor of EnDura No-React Dural Substitute, manufactured by Shelhigh, Inc., Union, NJ, is recalling this product based on an FDA Public Health Notification and FDA requested recall letter to Shelhigh citing sterility and other manufacturing concerns regarding this product manufactured by Shelhigh. Integra is a distributor of t

FDAMay 4, 2007Nationwide• Integra LifeSciences Corp.

Medtronic Emergency Response Systems, Inc.: LIFEPAK 20 defibrillator/monitor. The device is an AC pow...

White Screen Lock up: LifePak 20 defibrillators with software version 48 or version 52 may experience an intermittent timing issue during the power on sequence. This may lock up the device resulting in the monitor screen going white, and may cause a potential delay or prevention of shock treatment.

FDAApr 27, 2007IN, OR• Medtronic Emergency Response Systems, Inc.

BD Biosciences: FACSDiva Software Versions 4.0.1 to 5.0.2, Flow Cytometry...

When data file containing one or no fluoresence parameters is exported, the software will automatically apply compensation to this file and all subsequently exported files.

FDAApr 5, 2007AL, AZ, CA +28 more• BD Biosciences

Medtronic Emergency Response Systems, Inc.: Batteries used with the LIFEPAK 20 defibrillator/monitor

Defibrillator internal battery cell may contain a short which could reduce battery capacity and cause the device to shut down without warning while operating on backup (DC) battery power.

FDAMar 30, 2007IN• Medtronic Emergency Response Systems, Inc.

Medtronic Emergency Response Systems, Inc.: LIFEPAK 20 defibrillator/monitor. The device is an AC po...

Defibrillator internal battery cell may contain a short which could reduce battery capacity and cause the device to shut down without warning while operating on backup (DC) battery power.

FDAMar 30, 2007IN• Medtronic Emergency Response Systems, Inc.

Edwards Lifesciences, Llc: Edwards Lifesciences LifeStent FlexStar Bilary Stent Syst...

Failure to deploy.

FDAMar 19, 2007Nationwide• Edwards Lifesciences, Llc

Medtronic Emergency Response Systems, Inc.: LIFEPAK CR Plus defibrillator. The device is a battery o...

LIFEPAK CR Plus defibrillators with software version 1.16 or lower may miscalculate the HLC battery capacity and result in the CHARGE-PAK battery charger icon/indicator to display and falsely indicate battery needs replacement.

FDAMar 2, 2007IN, OR• Medtronic Emergency Response Systems, Inc.

Edwards Lifesciences Technology SARL: Edwards Lifesciences-Swan-Ganz,Thermodilution Venous Infu...

Misbranding-One lot of Swan-Ganz Thermodilution VIP Catheters, Model 831HF75, lot 246HC197 was labeled with different model information (831F75) on the edge label . The edge label states the model is 831F75 which incorrectly indicates that product does NOT contain an antimicrobial heparin coating. (The tray lid label correctly states the model is 831HF75, containing the heparin coating)

FDANov 27, 2006Nationwide• Edwards Lifesciences Technology SARL

Integra LifeSciences Corp.: BOLD/INI-CLIP 2.2mm Drill Bit with AO Attachment.

Incorrect drill length-Cannulated drill bits were manufactured to incorrect specifications (shorter length) resulting in inadequate preparation of bone prior to insertion of the UNI-CLIP Staple.

FDANov 10, 2006Nationwide• Integra LifeSciences Corp.

Edwards Lifesciences Corporation of Puerto Rico: Edwards Lifesciences VANTEX Central Venous Catheter Set w...

Lack of Assurance of Sterility-Device packaging was manufactured with an incorrect lid that could compromise the sterility of the product.

FDANov 2, 2006Nationwide• Edwards Lifesciences Corporation of Puerto Rico