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Alcon Laboratories, Inc

Alcon Laboratories, Inc Recalls

All product recalls associated with Alcon Laboratories, Inc.

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Recall Summary

Total Recalls

1000

Past Year

442

Class I (Serious)

138

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 7021–7040 of 7663 recalls

Alcon Laboratories, Inc: MONARCH II IOL Delivery System, Cartridge Model B, part #...

Delivery cartridge for implanting intraocular lenses is mislabeled and may result in complicated insertion and damage to the lens.

FDAJul 7, 2008Nationwide• Alcon Laboratories, Inc

Inverness Medical BioStar Inc.: BioStar OIA FLU AB, Catalog 90007. Packaged 30 devices pe...

Diagnostic kits for flu were distributed with incorrect components.

FDAJul 2, 2008Nationwide• Inverness Medical BioStar Inc.

Paintball Gun Adapters (RAP4) – Impact Hazard (2008)

Laceration Risk

The remote line adapter is used to connect a paintball gun to a pressurized CO2 tank. The adapter is a black cylinder and is attached to a black remote line cord. "RAP4" and the "SN" (serial number) are printed on the adapters.

1...350 351352353 354...384

Page 352 of 384Next

CPSCJul 2, 2008Nationwide• RAP4 (Real Action Paintball Inc.), of San Jose, Calif.

Spacelabs Healthcare, Incorporated: Spacelabs Medical Temperature Probe Adaptor PN-700-0031-0...

Intermittent contact of temperature probe adaptors can cause a loss of temperature monitoring which can cause a delay in care when an alarm is missed.

FDAJul 2, 2008Nationwide• Spacelabs Healthcare, Incorporated

StatSpin, Inc., dba Iris Sample Processing: StatSampler 200 uL, Li Heparin (micro blood collector) Re...

EDTA inadvertently mixed with lithium heparin solution contained in capillary tubes.

FDAJun 20, 2008CA, CO, FL +7 more• StatSpin, Inc., dba Iris Sample Processing

Orthosoft, Inc. dba Zimmer CAS: Navitrack System - OS Knee Universal, Orthopedic Stereota...

ZIMMER CAS voluntarily conducted a retrospective recall of the Navitrack System - OS Knee Universal, due to software anomalies which were corrected with a new revision in version 2.2.1.3.

FDAJun 20, 2008CA, FL, GA +17 more• Orthosoft, Inc. dba Zimmer CAS

Datex Ohmeda, Inc. dba GE Healthcare: Giraffe OmniBed, labeled in part: ***GE Healthcare 8880...

Manufacturer of neonatal incubators changed the device labeling to account for new use and care instructions.

FDAJun 20, 2008Nationwide• Datex Ohmeda, Inc. dba GE Healthcare

Orthosoft, Inc. dba Zimmer CAS: Navitrack¿ System - OS Knee Universal, Orthopedic Stereot...

ZIMMER CAS voluntarily conducted a retrospective recall of the Navitrack System - OS Knee Universal, due to software anomalies which were corrected with a new revision in version 2.2.1.3.

Class IIILow

FDAJun 20, 2008CA, FL, GA +17 more• Orthosoft, Inc. dba Zimmer CAS

Boston Scientific Corporation One Boston: EndoVive Safety PEG Kits 24 F Universal Product Number (...

Mislabeled: Inner box labeled 20 Fr PEG, outer and tray label correctly labeled 24 Fr PEG

FDAJun 17, 2008NJ, SC, TN +2 more• Boston Scientific Corporation One Boston

Boston Scientific Corporation One Boston: EndoVive Safety PEG Kits 20 F Universal Product Number (...

Mislabeled: Inner box labeled 20 Fr PEG, outer and tray label correctly labeled 24 Fr PEG

FDAJun 17, 2008NJ, SC, TN +2 more• Boston Scientific Corporation One Boston

VISX INCORPORATED, A SUBSIDIARY OF AMO INC: AMO WaveScan WaveFront System Version 3.90/3.901, Part Nu...

Inaccurate measurements may be generated by the device, which could result in improper treatment and deterioration of patient eyesight.

FDAJun 9, 2008Nationwide• VISX INCORPORATED, A SUBSIDIARY OF AMO INC

Orthosoft, Inc. dba Zimmer CAS: Sesamoid Plasty, Stereotaxic Instrument The Sesamoid Plas...

Zimmer CAS voluntarily conducted a retrospective recall of the Sesamoid Plasty due to the risk of the top of the workstation to potentially fall over during disassembly.

FDAJun 4, 2008CA, FL• Orthosoft, Inc. dba Zimmer CAS

Orthosoft, Inc. dba Zimmer CAS: Sesamoid Plasty, Stereotaxic Instrument The Sesamoid Pla...

Zimmer CAS voluntarily conducted a retrospective recall of the Sesamoid Plasty due to the risk of the top of the workstation to potentially fall over during disassembly.

Class IIModerate

FDAJun 4, 2008CA, FL• Orthosoft, Inc. dba Zimmer CAS

Sun Biomedical Laboratories, Inc.: VisuaLine Tricyclic Antidepressants: Six Dip (COC-THC-OPI...

Product was sold while the devices were under FDA 510 (k) review, which was subsequently denied.

FDAMay 28, 2008Nationwide• Sun Biomedical Laboratories, Inc.

Sun Biomedical Laboratories, Inc.: VisuaLine Single Dip Oxycodone; intended for in vitro imm...

Product was sold while the devices were under FDA 510 (k) review, which was subsequently denied.

FDAMay 28, 2008Nationwide• Sun Biomedical Laboratories, Inc.

Sun Biomedical Laboratories, Inc.: VisuaLine Propoxyphene; Propoxyphene test system, intend...

Product was sold while the devices were under FDA 510 (k) review, which was subsequently denied.

FDAMay 28, 2008Nationwide• Sun Biomedical Laboratories, Inc.

Gel Candles (M & A Global) - Fire Risk (2008)

Fire/Burn Risk

This recall involves Everlasting Jelly candles. Models include Champagne Glass with Heart, Model #502; Large Oval Bowl with Sand & Shells, Model #109-XL; Tumbler with Sand & Shells, Model #101-S; Round Shape with Curly Top and Red Roses, Model #506; Round Shape with Penguins, Model #604; Tumbler with Blue Roses & Leaves, Model #805-11; and Round Shape with Two Butterflies, Model #806-8. The candles were sold in clear glass containers of various sizes with a smaller glass of gel in the middle of the candle.

CPSCMay 23, 2008Nationwide• M & A Global Technologies Inc., doing business as Spa at Home, of Tallahassee, Fla.

Datex Ohmeda, Inc. dba GE Healthcare: Panda iRes and Giraffe Infant Warmers, labeled in part***...

Medical device software may be subject to signal interference of the Hands Free Alarm Silence feature that could impact patient safety.

FDAMay 20, 2008Nationwide• Datex Ohmeda, Inc. dba GE Healthcare

Genico, Inc., dba Genicon: Genicon, RX Only, Sterile EO. Genicon 6869 Stapoint Cour...

Genicon is recalling the Genicon Disposable Suction Irrigation 5mm 700-005-010 and 10mm 700-005-005 Tube Sets. The caps on the trumpet valves of the devices could fall off, resulting in the malfunction of the Suction Irrigation Device.

FDAMay 8, 2008IA, MO• Genico, Inc., dba Genicon

Playground Swing Sets (Playworld) – Fall Hazard (2008)

Swing sets involved in this recall have the following part numbers: 8 ft 2-Unit Standard Swing 0248 5 in Arch Swing w-8 ft Top Rail 0287 8 ft Standard Duty Swing Add-A-Bay 0230 5 in Arch Swing 2-Unit Add-A-Bay 0370 10 ft 2-Unit Standard Swing 0249 3-1/2 in Arch Swing w-8 ft Top Rail 0288 10 ft Standard Duty Swing Add-A-Bay 0231 3-1/2 in Arch Swing Add-A-Bay 0375 8 ft 2-Unit Heavy Duty Swing 0270 2-3/8 in Arch Swing w-7 ft Top Rail 0120 8 ft heavy duty swing add-a-bay 0232 2-3/8 in Arch Swing Add-A-Bay 0121 10 ft 2-Unit Heavy Duty Swing 0259 7 ft Early Childhood T-Swing 0290 10 ft Heavy Duty Swing Add-A- Bay 0233 8 ft Single Post Swing Assembly 0295 8 ft Single Post Swing Add-A- Bay 0296

CPSCMay 6, 2008Nationwide• Playworld Systems Inc., of Lewisburg, Pa.