--- title: "Alcon Custom Pak Surgical Procedure Pack — FDA record Z-0354-2023 | Is It on Recall" description: "Due to difficulty removing the liner on the adhesive components of the affected drapes and as a result may render the product unusable. In addition, the manufac" url: https://isitonrecall.com/recall/fda-device-z-0354-2023-alcon-custom-pak-surgical-procedure-pack/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement # Alcon Custom Pak Surgical Procedure Pack — FDA record Z-0354-2023 Reported ongoing Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice. Source date Oct 31, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## What the record says - **Product**: Alcon Custom Pak Surgical Procedure Pack - **Reason**: Due to difficulty removing the liner on the adhesive components of the affected drapes and as a result may render the product unusable. In addition, the manufacturer of the drapes has observed an increase in reported adhesive related skin injuries for these affected lots. - **Classification**: Class II - **Recalling firm**: Alcon Research, LLC - **Quantity**: 308,610 kits - **Agency-reported status**: Ongoing - **Source record identifier**: Z-0354-2023 [Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0354-2023%22) [What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice. ## Lot and product identifiers | Label field | Details supplied by the agency | | --- | --- | | Lot, code or applicability | UDI Codes for: UDI for Latex Free Custom Pak: H5301ALCON1CPAK10B UDI for Latex Free Custom Pak: H5302ALCON2CPAK20E Custom Pak # / Lot #: Custom Pak # Lot # 100007214 14ACYR 100007214 14C8KP 100007214 14CFP3 100011843 149HV5 100011843 150DMH 100012716 150CX9 100060730 2538660H 100060730 2540367H 100060730 14UWK4 100060730 14XTYA 100060730 14YHL2 100060730 150LWW 100064778 14DEM2 100064778 14FY9L 100064778 14NFK2 100064778 14TX0N 100064778 14TX0V 100064778 JZ5141146 100064778 14X73C 100072572 149WDA 100072572 149YF1 100072572 14C6LE 100082908 JZ5120745 100082908 JZ5121811 100082908 JZ5123118 100082908 JZ5123538 100082908 JZ5125017 100082908 JZ5126725 100082908 JZ5141666 100083383 JZ5125990 100083383 JZ5125085 100083383 JZ5128291 100083383 JZ5128981 100083383 JZ5137217 100083383 JZ5141156 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JZ5122566 100219326 JZ5122564 100219326 JZ5122560 100219326 JZ5122562 100219326 JZ5122568 100219326 14AVNH 100219326 14AVR0 100219326 14C3Y3 100219326 14C404 100219326 14C40C 100219326 14C442 100219326 JZ5122558 100219326 14LV2D 100219326 14LWRN 100219326 14MXPD 100219326 14N0XW 100219326 14N0Y4 100219326 14N1HF 100219326 14R65V 100219326 14R66D 100219326 14R66E 100219326 14R66R 100219326 14R67M 100219326 14R67N 100219326 14R9EU 100219326 14UAYP 100219326 14UAYR 100219326 14UC05 100219326 14UC1M 100219326 JZ5137014 100219326 JZ5137007 100219326 JZ5137024 100219326 JZ5137009 100219326 JZ5137016 100219326 JZ5137011 100219326 JZ5137020 100219326 JZ5137018 100219326 JZ5137022 100219326 JZ5137676 100219326 JZ5137678 100219326 JZ5137680 100219326 JZ5140009 100219326 JZ5140011 100219326 JZ5147436 100219326 JZ5147177 100219326 JZ5147183 100219326 JZ5147175 100219326 JZ5147191 100219326 JZ5147187 100219326 JZ5147171 100219326 JZ5147173 100219326 JZ5147185 100219326 JZ5147169 100219326 JZ5147181 100219326 JZ5147189 100219326 JZ5147195 100219326 JZ5147432 100219326 JZ5147199 100219326 JZ5147193 100219326 JZ5147197 100219326 JZ5147434 100219559 149A48 100219559 14ETFD 100219559 14M6TV 100219559 14UU4T 100219559 152JJT 100219677 ... | The agency lot list is longer than this excerpt. [Read the complete list at the official source](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0354-2023%22). Match all identifying details in the current notice. A brand name alone is not enough. ## Distribution Worldwide Distribution: U.S.(nationwide) to states of: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY; and O.U.S. (foreign) to countries of: Australia, Canada, France, Germany, Italy, Mexico, New Zealand, Portugal and United Kingdom. States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address. - [Alaska](https://isitonrecall.com/state/alaska/) - [Alabama](https://isitonrecall.com/state/alabama/) - [Arkansas](https://isitonrecall.com/state/arkansas/) - [Arizona](https://isitonrecall.com/state/arizona/) - [California](https://isitonrecall.com/state/california/) - [Colorado](https://isitonrecall.com/state/colorado/) - [Connecticut](https://isitonrecall.com/state/connecticut/) - [Delaware](https://isitonrecall.com/state/delaware/) - [Florida](https://isitonrecall.com/state/florida/) - [Georgia](https://isitonrecall.com/state/georgia/) - [Hawaii](https://isitonrecall.com/state/hawaii/) - [Iowa](https://isitonrecall.com/state/iowa/) - [Idaho](https://isitonrecall.com/state/idaho/) - [Illinois](https://isitonrecall.com/state/illinois/) - [Indiana](https://isitonrecall.com/state/indiana/) - [Kansas](https://isitonrecall.com/state/kansas/) - [Kentucky](https://isitonrecall.com/state/kentucky/) - [Louisiana](https://isitonrecall.com/state/louisiana/) - [Massachusetts](https://isitonrecall.com/state/massachusetts/) - [Maryland](https://isitonrecall.com/state/maryland/) - [Maine](https://isitonrecall.com/state/maine/) - [Michigan](https://isitonrecall.com/state/michigan/) - [Minnesota](https://isitonrecall.com/state/minnesota/) - [Missouri](https://isitonrecall.com/state/missouri/) - [Mississippi](https://isitonrecall.com/state/mississippi/) - [Montana](https://isitonrecall.com/state/montana/) - [North Carolina](https://isitonrecall.com/state/north-carolina/) - [North Dakota](https://isitonrecall.com/state/north-dakota/) - [Nebraska](https://isitonrecall.com/state/nebraska/) - [New Hampshire](https://isitonrecall.com/state/new-hampshire/) - [New Jersey](https://isitonrecall.com/state/new-jersey/) - [New Mexico](https://isitonrecall.com/state/new-mexico/) - [Nevada](https://isitonrecall.com/state/nevada/) - [New York](https://isitonrecall.com/state/new-york/) - [Ohio](https://isitonrecall.com/state/ohio/) - [Oklahoma](https://isitonrecall.com/state/oklahoma/) - [Oregon](https://isitonrecall.com/state/oregon/) - [Pennsylvania](https://isitonrecall.com/state/pennsylvania/) - [Rhode Island](https://isitonrecall.com/state/rhode-island/) - [South Carolina](https://isitonrecall.com/state/south-carolina/) - [South Dakota](https://isitonrecall.com/state/south-dakota/) - [Tennessee](https://isitonrecall.com/state/tennessee/) - [Texas](https://isitonrecall.com/state/texas/) - [Utah](https://isitonrecall.com/state/utah/) - [Virginia](https://isitonrecall.com/state/virginia/) - [Vermont](https://isitonrecall.com/state/vermont/) - [Washington](https://isitonrecall.com/state/washington/) - [Wisconsin](https://isitonrecall.com/state/wisconsin/) - [West Virginia](https://isitonrecall.com/state/west-virginia/) - [Wyoming](https://isitonrecall.com/state/wyoming/) ## Dates in the source - **Report date**: Dec 7, 2022 - **Recall initiation date**: Oct 31, 2022 - **Center classification date**: Dec 1, 2022 FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable. ## What to do next Read the official notice for the action that applies to your exact product. [Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0354-2023%22) ## Related records [Medical devices records](https://isitonrecall.com/category/medical-devices/) [Alcon Research, LLC records](https://isitonrecall.com/brand/alcon-research-llc/)