Browse Device Recalls

58 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 58 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 58 FDA device recalls.

Clear
DateProductReasonClassFirm
Nov 24, 2025 Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog... Ophthalmic procedure packs may have incomplete seals affecting sterility. Class I Alcon Research LLC
Sep 30, 2025 Alcon PRECISION1 One-Day Contact Lenses, -2.25D. Potential for a weak seal in some units resulting in compromise in sterility. Class II Alcon Research LLC
Sep 15, 2025 CONSTELLATION ULTRAVIT 10K and CONSTELLATION HYPERVIT 20K, Description/REF: ... XXX Class II Alcon Research LLC
Aug 5, 2025 Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Uni... Due to incomplete seals in the pouch which provide the sterile barrier. Class II Alcon Research LLC
Aug 5, 2025 Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Uni... Due to incomplete seals in the pouch which provide the sterile barrier. Class II Alcon Research LLC
Aug 5, 2025 Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Uni... Due to incomplete seals in the pouch which provide the sterile barrier. Class II Alcon Research LLC
Aug 5, 2025 Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Uni... Due to incomplete seals in the pouch which provide the sterile barrier. Class II Alcon Research LLC
Aug 5, 2025 Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Uni... Due to incomplete seals in the pouch which provide the sterile barrier. Class II Alcon Research LLC
Apr 28, 2025 Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog... Due to the potential that some units within specific lots were damaged during the manufacturing p... Class II Alcon Research LLC
Apr 28, 2025 Brand Name: Alcon Laboratories, Inc. Product Name: Constellation Vision Syst... Due to the potential that some units within specific lots were damaged during the manufacturing p... Class II Alcon Research LLC
Apr 28, 2025 Brand Name: Alcon Laboratories, Inc. Product Name: Constellation Vision Syst... Due to the potential that some units within specific lots were damaged during the manufacturing p... Class II Alcon Research LLC
Feb 10, 2025 Alcon Custom Pak with Non-Latex Symbol, Pak: 12771-18, 18050-10, 18252-17, 12... Customer-designed sterile surgical procedure packs contain latex components as specified; but, th... Class II Alcon Research LLC
Nov 13, 2024 Brand Name: Alcon Product Name: Monarch¿ III D Delivery Cartridge Model/Cat... Increase in complaints associated with a molding defect within the inner lumen of delivery cartri... Class II Alcon Research LLC
Oct 15, 2024 a) Alcon Custom-Pak CONSTELLATION 25G PLUS CHRISTIANA CARE HLTH SERV, # 15340... Reported breakage in the tubing Anti-Reflux Valve (ARV) due to improper use. As a result, changes... Class III Alcon Research LLC
Aug 8, 2024 DAILIES TOTAL1, DAILIES TOTAL1 for Astigmatism, DAILIES TOTAL1 Multifocal, ... Material with a quality issue was used in contact lens production, so contact lenses may not meet... Class II Alcon Research LLC
Jul 15, 2024 Product Desc: Product Name: CLEARCUT SB INTREPID 2.2 ANG Model/Catalog Numbe... Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... Class II Alcon Research LLC
Jul 15, 2024 Product Desc: Product Name: CLEARCUT SATINSLIT FULL HANDLE2.75MM AN Model/Ca... Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... Class II Alcon Research LLC
Jul 15, 2024 Product Name: 25+ TTL PLUS VPAK 20000CPM BWV Model/Catalog Number: 806583007... Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... Class II Alcon Research LLC
Jul 15, 2024 Product Desc: Product Name: CLEARCUT SAFETY INTREPID DB,2.2 Model/Catalog Nu... Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... Class II Alcon Research LLC
Jul 15, 2024 Product Desc: Product Name: CLEARCUT SAFETY INTREPID DB,2.4 Model/Catalog Nu... Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... Class II Alcon Research LLC
Jul 15, 2024 Product Desc: Product Name: CLEARCUT SAFETY INTREPID SB,2.2 Model/Catalog Nu... Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... Class II Alcon Research LLC
Jul 15, 2024 Product Desc: Product Name: CLEARCUT SAFETY INTREPID SB,2.4 Model/Catalog Nu... Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... Class II Alcon Research LLC
Jul 15, 2024 Product Name: 25+ CMB PAK 7.5CPM,V,STD 0.9 Model/Catalog Number: 8065751767 ... Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... Class II Alcon Research LLC
Jul 15, 2024 Product Name: TOTAL PLUS,25+,10K VALVE STD Model/Catalog Number: 8065752437 ... Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... Class II Alcon Research LLC
Jul 15, 2024 Product Name: 25+ TOTALPLUS CP PAK 20K CPM BV .9 IU Model/Catalog Number: 80... Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... Class II Alcon Research LLC
Jul 15, 2024 Product Desc: Product Name: ClearCut Sideport Knife Dual Bevel 1.2mm Angled ... Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... Class II Alcon Research LLC
Jul 15, 2024 Product Name: 25+ CMB PAK 10K CPM,V,STD 0.9 Model/Catalog Number: 8065752450... Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... Class II Alcon Research LLC
Jul 15, 2024 Product Name: 25+ TOTALPLUSr CP PAK 20K CPM BWV .9 IU Model/Catalog Number: ... Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... Class II Alcon Research LLC
Jul 15, 2024 Product Desc: Product Name: CLEARCUT SATINSLIT FULL HANDLE3.0MM ANG Model/Ca... Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... Class II Alcon Research LLC
Jul 15, 2024 Product Name: ClearCut S Safety Sideport Knife 1.0mm Dual Bevel Model/Catalo... Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... Class II Alcon Research LLC
Jul 15, 2024 Product Name: Alcon Custom Pak Model/Catalog Number: Many Software Version:... Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... Class II Alcon Research LLC
Jul 15, 2024 Product Name: 25+ CMB PAK 10K CPM,V,WA 0.9 Model/Catalog Number: 8065752451 ... Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... Class II Alcon Research LLC
Jul 15, 2024 Product Name: 25+TTLPL VPK 20000CPM BEV VAL Model/Catalog Number: 8065753106... Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... Class II Alcon Research LLC
Jul 15, 2024 Product Name: 25GA VALVED ENTRY SYSTEM,3CT Model/Catalog Number: 8065751658 ... Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... Class II Alcon Research LLC
Jul 15, 2024 Product Name: TOTAL PLUS,25+,10K VALVE WD Model/Catalog Number: 8065752438 ... Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... Class II Alcon Research LLC
Jul 15, 2024 Product Desc: Product Name: A-OK SATINSLIT FULL HANDLE2.75MM ANG SG Model/Ca... Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... Class II Alcon Research LLC
Jul 15, 2024 Product Desc: Product Name: CLEARCUT SLIT FULL HANDLE3.0MM ANG DUAL Model/Ca... Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... Class II Alcon Research LLC
Jul 15, 2024 Product Name: TOTALPLUS,25+ 7.5CPM VALV WD6 Model/Catalog Number: 8065751618... Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... Class II Alcon Research LLC
Jul 15, 2024 Product Desc: Product Name: CLEARCUT HP2 DB SLIT 3.2MM ANGCE Model/Catalog N... Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... Class II Alcon Research LLC
Jul 15, 2024 Product Desc: Product Name: 20 Gauge V-Lance Knife Model/Catalog Number: 806... Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... Class II Alcon Research LLC
Jul 15, 2024 Product Desc: Product Name: ClearCut S Safety Sideport Knife 1.2mm Dual Bevel... Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... Class II Alcon Research LLC
Jul 15, 2024 Product Desc: Product Name: CLEARCUT SAFETY SLIT SB,2.75MMANG Model/Catalog ... Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... Class II Alcon Research LLC
Jul 15, 2024 Product Desc: Product Name: A-OK SATINCRESCENT FULL HANDLE2.3MM ANG Model/Ca... Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... Class II Alcon Research LLC
Jul 15, 2024 Product Desc: Product Name: CLEARCUT SB INTREPID 2.2 ANG Model/Catalog Numbe... Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... Class II Alcon Research LLC
Jul 15, 2024 Product Desc: Product Name: ClearCut Sideport Knife Dual Bevel 1.2mm Angled ... Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... Class II Alcon Research LLC
Jul 15, 2024 Product Desc: Product Name: CLEARCUT HP2 DB SLIT 3.0MM ANGCE Model/Catalog N... Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... Class II Alcon Research LLC
Jul 15, 2024 Product Desc: Product Name: A-OK 19G V-LANCE FULL HANDLE1.6MM SATIN Model/Ca... Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... Class II Alcon Research LLC
Jul 15, 2024 Product Desc: Product Name: CLEARCUT SLIT FULL HANDLE2.75MM ANG DUA Model/Ca... Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... Class II Alcon Research LLC
Jul 15, 2024 Product Desc: Product Name: CLEARCUT SLIT FULL HANDLE2.6MM ANG DUAL Model/Ca... Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... Class II Alcon Research LLC
Jul 15, 2024 Product Name: TOTAL PLUS,25+ 7.5CPM VALVE Model/Catalog Number: 8065751617 ... Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... Class II Alcon Research LLC

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.