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Abbott Laboratories Medisense Products

Abbott Laboratories Medisense Products Recalls

All product recalls associated with Abbott Laboratories Medisense Products.

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Recall Summary

Total Recalls

1000

Past Year

295

Class I (Serious)

116

Most Recent

Jan 2026

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 4181–4200 of 4465 recalls

Abbott Laboratories Medisense Products: Easy Glucose Monitoring System; Recalling Firm/Manufactur...

User may inadvertently change the Units of Measure from mg/dL to mmol/L and the blood glucose results could be misinterpreted. This may lead to under treatment and potential for hyperglycemia.

FDAJun 7, 2005IN• Abbott Laboratories Medisense Products

Abbott Laboratories Medisense Products: SofTrac Glucose Monitoring System; Recalling Firm/Manufac...

User may inadvertently change the Units of Measure from mg/dL to mmol/L and the blood glucose results could be misinterpreted. This may lead to under treatment and potential for hyperglycemia.

FDAJun 7, 2005IN• Abbott Laboratories Medisense Products

B. Braun Medical, Inc.: Locking Tear-Away Sheath Introducer Product Line. ACCUG...

Reports that the tearaway introducer sheaths have cracked hubs/handles and/or improper peeling of the sheath during use.

FDA

1...208 209210211 212...224

Page 210 of 224Next

May 27, 2005

• B. Braun Medical, Inc.

B. Braun Medical, Inc.: Right Heart Catheter Product Line: Catalog Number 601129...

Reports in a small percentage of Right Heart Catheter Products Line related to cracked catheter tips, leaking at the manifold and cracked hubs.

FDAMay 25, 2005Nationwide• B. Braun Medical, Inc.

Carter Brothers Fun-Kart Go-Kart – Safety Issue (2005)

The recall includes one-seater models 1136-3020, 1136-3021, 1136-3420, 1136-3421, 1205-3020 and two-seater models 2336-3021, 2336-3022, 2336-5019, 2575-3020, 2575-3420, 2605-3416, 2605-3515, 2606-3016, 2606-3017, 2606-3416, 2606-3417, 2636-3016, 2636-3017, 2906-3015, 2906-3016, 2906-3017, 2906-4015, 2906-4016, 2906-4017, 2909-3015, 2909-3415, 2909-4015, 2910-3015, 2910-3016, 2910-3415, 2910-4015, 2910-4016, 2910-4415, 2911-4015, 2911-4016, 2946-3015, and 2946-3016. The model number and serial number are located under the seat (on the driver's side if two-seater). The Fun-Karts were produced in several colors, to include red, black, blue, purple and green.

CPSCMay 20, 2005Nationwide• Carter Brothers Manufacturing Co. Inc., of Brundidge, Ala.

BOSCH Circular Saws – Potential Malfunction (2005)

The recalled circular saws include the BOSCH CS10, CS20 and CS20-XC models, which can be identified on the product nameplate mounted on the top of the motor housing. The recalled models do not have an asterisk (*) in the serial number box. The circular saw uses a 7¼-inch blade and has a blue handle and motor enclosure, and a metal guarding system. The name "BOSCH" is printed on the blade guard.

CPSCMay 18, 2005Nationwide• Robert Bosch Tool Corp., of Mount Prospect, Ill.

Dimension Bicycle Stems (Quality Bicycle) – Handlebar Failure (2005)

The recall involves all Dimension-brand road and mountain threadless bicycle stems with a 130 degree rise. The stems are black or silver and have the word "Dimension" painted on the extension. Only models SM2330 to SM2333, SM4555 to SM4558, SM4567, and SM4570 to SM4573 are included in this recall. The model numbers are printed on the original packaging. These handlebar stems all have a 130-degree "high rise" but vary in extension length.

CPSCMay 5, 2005Nationwide• Quality Bicycle Products Inc., of Bloomington, Minn.

My First Crayon-Ball (Baja Products) – Potential Hazard (2005)

Choking Hazard

My First Crayon-Ball™ consists of a round yellow plastic base with small red, blue, yellow, green, black, and brown crayon balls attached. My First Crayon-Ball™ Activity Set contains a round yellow plastic base with small red, blue, yellow, green, black, and brown crayon balls attached, as well as multiple scrolls of paper containing sketches meant for coloring.

CPSCApr 13, 2005Nationwide• Baja Products Inc. of Delray Beach, Fla.

Bombardier DS650 ATVs (Bombardier) – Model Defect (2005)

Model year 2004 and 2005 Bombardier DS650 ATVs under model numbers 0003A5A00, 0003A5B00, 0003B5A00, 0003B5B00, 000799700, 000799500, 000771900, and 000771700 are part of this recall. The ATV model number identification decal is located on the right side of the frame, in front of the engine.

CPSCMar 29, 2005Nationwide• Bombardier Recreational Products Inc., of Quebec, Canada

Abbott Health Products, Inc.: IMx total B-hCG Reagent is composed of one bottle of Coat...

Abbott Diagnostics is investigating a recent increase in customer complaints for IMx calibration error code 157 and controls out of range when using IMx total B-hCG Reagent Lot 25459Q100. Testing has shown that protein aggregates are present in the specimen diluents of both IMx and the AxSYM Total B-hCG reagent kits. This is responsible for the calibration errors and shift in control values.

FDAMar 24, 2005Nationwide• Abbott Health Products, Inc.

Abbott Health Products, Inc.: AxSYM total B-hCG Reagent is composed of one bottle of Co...

Abbott Diagnostics is investigation a recent increase in customer complaints for AxSYM calibration error code 1048 and controls out of range when using AxSYM Total B-hCG reagent lots. Testing has shown that protein aggregates are present in the specimen diluents of both IMx and the AxSYM Total B-hCG reagent kits. This is responsible for the calibration errors and shift in control values.

FDAMar 24, 2005Nationwide• Abbott Health Products, Inc.

Abbott Health Products, Inc. Hwy 2 Km 58.0 Cruze Davila: In vitro Test TDx/TDxFLx Cyclosporine Monoclonal Whole B...

Patient results reported using calibrators made from new primary material may be falsely decreased by 5-8% compared to results using calibrators made from the previous primary material. An Important Product Information Letter with technical information regarding the Whole Blood Calibrators and Controls, implementing new internal reference standards was issued.

FDAMar 23, 2005Nationwide• Abbott Health Products, Inc. Hwy 2 Km 58.0 Cruze Davila

Abbott Laboratories MPG: ABBOTT TestPack +Plus hCG Combo with On Board Controls (O...

False Positive results may be obtained with the identified lots of list 7B34-16 when using a negative patient sample or a negative control.

FDAMar 16, 2005Nationwide• Abbott Laboratories MPG

Abbott Laboratories: i-STAT Celite ACT Cartridge. ACT, activated clotting tim...

Misidentification of Celite ACT cartridge as kaolin ACT Cartridge in the analyzer.

FDAMar 16, 2005Nationwide• Abbott Laboratories

Abbott Laboratories MPG: ARCHITECT Folate Reagent Kit, list 6C12-20 ( 4 x 100 test...

concentrations for normal samples generated with current reagent lots of the ARCHITECT Folate assay are lower than data generated for the package insert.

FDAMar 11, 2005Nationwide• Abbott Laboratories MPG

Titanium Bicycle Frame (Roark) – Structural Weakness (2005)

The recall involves custom titanium bicycle frames for road bicycles manufactured and distributed by Roark. The bicycle frames have a "Titanium" sticker on the top tube and a "Roark" sticker on the down tube. Every bicycle frame is built to the unique specification of each customer and has serial number and manufactured date located on the bottom bracket. Bicycle frames affected have serial numbers 001 through 422.

CPSCMar 11, 2005Nationwide• CF Roark Welding & Engineering Co. Inc., of Brownsburg, Ind.

Abbott Health Products, Inc.: IMx HAVAB Controls In Vitro Test

Abbott identified through investigational studies that IMxHAVAB Controls lot 21059Q100 is generating Negative Control values outside the upper range specified in the IMxHAVAB Package Insert.

FDAMar 4, 2005Nationwide• Abbott Health Products, Inc.

Abbott Laboratories, Inc: ARCHITECT c800 for Conventional Units and for SI Units, V...

Device has incorrect notation associated with therapeutic drug monitoring assays.

FDAFeb 28, 2005AZ, CA, IL +9 more• Abbott Laboratories, Inc

Dishwasher (Whirlpool) – Electrical Malfunction (2005)

Fire/Burn Risk

The recalled products are Whirlpool® brand and Kenmore® brand (made by Whirlpool Corporation) under-the-counter, plastic tall tub dishwashers. The dishwashers come with black, white, biscuit, or stainless front panels. They have the following model and serial numbers located inside the tub on a tag near the left side of the door opening: Brand Product Model Number Begins With Serial Number Range Whirlpool® Under-the-counter plastic tall tub dishwashers DU1, DUL, GU1, GU2, GU6 FR2200000 to FR2499999 Kenmore® Under-the-counter plastic tall tub dishwashers 665.143, 665.160, 665.163, 665.170, 665.173 FR2200000 to FR4599999 Not all dishwashers within the serial number range are included in the recall. Consumers should call Whirlpool to determine if their dishwasher is included in this recall.

CPSCFeb 25, 2005Nationwide• Whirlpool Corporation, of Benton Harbor, Mich.

Bicycle Suspension Seat Post (Cannondale) – Structural Weakness (2005)

The recall involves Lee Chi model 1-X bicycle suspension seat posts. The seat post was manufactured by a component manufacturer for Cannondale and installed on various 2005 model year Cannondale brand bicycles. These seat posts have a natural anodized aluminum finish, a 1-X logo is laser etched on the outer tube, and a black, yellow and red instruction booklet with the 1-X logo is attached. Lee Chi is also known as Promax, but the seat posts are not marked with either name. Specific Cannondale bicycle models with affected seat posts are listed in the table below. Model names are printed on the top tube of the bicycle frame. 2005 Cannondale Bicycle Models Adventure 800 Comfort 600 Feminine Adventure 800 Feminine Road Warrior 800 Adventure 600 Sport Road 1000 Adventure 600 Feminine Sport Road 800 Comfort 800 Sport Road 500 Comfort 800 Feminine Touring 2000 Comfort 600

CPSCFeb 18, 2005Nationwide• Cannondale Bicycle Corporation, of Bethel, Conn.