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Abbott Laboratories Inc.

Abbott Laboratories Inc. Recalls

All product recalls associated with Abbott Laboratories Inc..

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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 3881–3900 of 4465 recalls

Abbott Laboratories Inc.: ABBOTT Clinical Chemistry Phenytoin, List Number: 1E07-2...

An Abbott investigation has determined that the phenytoin reagent does not maintain an onboard stability of 28 days as stated in the phenytoin package insert. In addition, the 14 day calibration interval is also not being met. Further investigation is required to determine the root cause of this issue. Until the cause has been determined and a corrective action defined, specific instructions ar

FDAFeb 15, 2008Nationwide• Abbott Laboratories Inc.

Abbott Spine: Sequoia Spinal System Surgical Kits; Pedicle screw spinal...

Screw Head Dissociation: The polyaxial screw head may dissociate from screw shaft during surgery. Also, the polyaxial screw driver is experiencing difficulty (broken/bent driver shafts, difficulty attaching screws to the driver and jamming of the collet.)

FDAFeb 13, 2008Nationwide• Abbott Spine

Boston Scientific Corporation One Boston: Boston Scientific Mach 1 Guide Catheter 6F, IM Internal M...

1...193 194195196 197...224

Page 195 of 224Next

Mislabeled: Seven lots/ batches of Boston Scientific Mach 1 Guide Catheter may be mislabeled with the incorrect device length.

FDAFeb 7, 2008AL, AZ, AR +21 more• Boston Scientific Corporation One Boston

Boston Scientific Corporation One Boston: Boston Scientific Mach 1 peripheral Guide Catheter 6F, H...

Mislabeled: Seven lots/ batches of Boston Scientific Mach 1 Guide Catheter may be mislabeled with the incorrect device length.

FDAFeb 7, 2008AL, AZ, AR +21 more• Boston Scientific Corporation One Boston

Biogenex Laboratories: Xmatrx FISH (fluorescent in situ hybridization) Automated...

Bulk reagent dispensing mechanism may break resulting in reagent spill and possible exposure to chemicals.

FDAJan 24, 2008Nationwide• Biogenex Laboratories

Serene Float Tanks (Brian Smith) – electrocution hazard (2008)

Laceration Risk

This recall involves Serene Float Tanks, a water tank that is light- and soundproof, temperature insulated and ventilated. The heated tanks are filled with water and a dissolvent that allows a person to float effortlessly.

CPSCJan 24, 2008Nationwide• Brian Smith, dba Serene Float Tanks, of Lakewood, Calif.

Abbott Laboratories: AxSYM Drugs of Abuse/Toxicology Assay Disk Version 8.0; L...

Laceration Risk

Error Message: If the Positive and Negative Interpretation Cutoff parameters (116/117) are edited after installation of the revised assay file, VRTX error #0002 in Task 40 is generated and the instrument locks up when it attempts to report an AxSYM Amphetamine/Methamphetamine II patient result.

FDAJan 21, 2008PR• Abbott Laboratories

Abbott Laboratories: CELL-DYN Hemoglobin Reagent Syringe used on the CELL-DYN ...

Count may be out of specification--Hemoglobin background count may be out of specification (high) after installation of new CELL-DYN Sapphire Hemoglobin Reagent Syringes with packaging dates between May 8, 2007 and November 29, 2007.

FDAJan 15, 2008AZ, AR, CA +27 more• Abbott Laboratories

Cannondale Scalpel Mountain Bikes – Frame Failure (2008)

The 2008 model year Scalpel is a cross-country racing mountain bike, made from carbon fiber and aluminum. They were sold in Black/White, Blue/Black and Black. The recall includes the following models: Model # Product Retail Price 8AVPFR Scalpel Frameset about $3,200 8VPO Scalpel Team about $6,900 8VP1 Scalpel 1 about $6,400 8VP2 Scalpel 2 about $4,300 Only certain serial numbers are affected.

CPSCJan 8, 2008Nationwide• Cannondale Bicycle Corporation, of Bethel, Conn.

Bio-Rad Laboratories: Bio-Rad MONOLISA Anti-HBc EIA, Catalog Number 26186. In ...

Incorrect result: Elevated reactivity with a kit lot 232BGG. Patient samples that are negative for antibodies to anti-HBc could be assigned a positive result.

FDAJan 7, 2008Nationwide• Bio-Rad Laboratories

Abbott Point Of Care Inc.: i-STAT CK-MB cartridge Abbott Point of Care, Princeton, N...

i-Stat cartridges may not fill, cartridge labels or channels may appear discolored, cartridges may have fluid visible in the cartridge channel, and cartridge packaging may be distended.

FDAJan 1, 2008Nationwide• Abbott Point Of Care Inc.

Abbott Point Of Care Inc.: i-STAT cTnl cartridge Abbott Point of Care, Princeton, NJ...

i-Stat cartridges may not fill, cartridge labels or channels may appear discolored, cartridges may have fluid visible in the cartridge channel, and cartridge packaging may be distended.

FDAJan 1, 2008Nationwide• Abbott Point Of Care Inc.

Abbott Point Of Care Inc.: i-STAT BNP cartridge Abbott Point of Care, Princeton, NJ ...

i-Stat cartridges may not fill, cartridge labels or channels may appear discolored, cartridges may have fluid visible in the cartridge channel, and cartridge packaging may be distended.

FDAJan 1, 2008Nationwide• Abbott Point Of Care Inc.

BD Biosciences: BD FACSDiva Software v6.0 and 6.1 with the HP XW4400 Comp...

Values might not update in statistics views after certain functions are performed in a worksheet.

FDADec 21, 2007Nationwide• BD Biosciences

Abbott Laboratories: White Blood Cell (WBC) Reagent-Part A used with the CELL-...

Microbial Contamination: The WBC (White Blood Cell) Reagent Part A was confirmed positive for Pseudomonas contamination.

FDADec 19, 2007AL, AK, AZ +35 more• Abbott Laboratories

Abbott Spine: Comfort T-Handle Hudson Connector with Impactor Cap; Part...

Dislodged Collar Spring; The collar spring binding on the shaft of generic handle used with multiple surgical instruments has the potential to release the device's internal bearings during use.

FDADec 19, 2007AZ, AR, CA +20 more• Abbott Spine

Ski-Doo Snowmobiles (BRP) – Crash Hazard (2007)

The recall involves Ski-Doo model year 2008 MXZ X 600 RS snowmobiles. The model name is located on the side panels. The snowmobiles were sold in yellow or black/slate.

CPSCDec 19, 2007Nationwide• Bombardier Recreational Products Inc. (BRP), of Quebec, Canada

Viasys Respiratory Care, Inc.dba Bird Products: VIASYS AVEA Ventilator, Catalog numbers: 17210-00 (USA Co...

Alarm Failure -- There is a potential of alarms not being activated subsequent to specific electronic faults that may cause INOP condition.

FDADec 17, 2007AL, CA, MA +3 more• Viasys Respiratory Care, Inc.dba Bird Products

Biosense Webster, Inc.: EZ STEER Catheter D-1267-04-S / 8mm Non-Navigation Bi-Dir...

The recall was initiated because the catheter unit was shipped with a label expiration date of 9/30/2010, which is 11 months beyond the correct expiration date of 10/31/2009.

FDADec 15, 2007Nationwide• Biosense Webster, Inc.

B. Braun Medical, Inc.: Diapact CRRT Assembled Kit HF/HD with Manifold and Standa...

Faulty tubing does not prime machine as intended.

FDADec 10, 2007Nationwide• B. Braun Medical, Inc.