Browse Device Recalls
71 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 71 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 71 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 26, 2016 | AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model No. Z9002 Th... | Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they were not being checked ... | Class II | Abbott Medical Optics Inc. (AMO) |
| Aug 26, 2016 | TECNIS Multifocal 1-Piece Intraocular Lens, Model No. ZKB00, ZLB00; The pro... | Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they were not being checked ... | Class II | Abbott Medical Optics Inc. (AMO) |
| Aug 26, 2016 | TECNIS 1-Piece IOL, Model No. ZCB00 The product is indicated for implantatio... | Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they were not being checked ... | Class II | Abbott Medical Optics Inc. (AMO) |
| Aug 26, 2016 | TECNIS OptiBlue 1-Piece IOL with the TECNIS iTec Preloaded Delivery System, ... | Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they were not being checked ... | Class II | Abbott Medical Optics Inc. (AMO) |
| Aug 26, 2016 | TECNIS Multifocal Foldable Acrylic Intraocular Lens, Model No. ZMA00 The pro... | Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they were not being checked ... | Class II | Abbott Medical Optics Inc. (AMO) |
| Aug 26, 2016 | SENSAR 1-Piece IOL, Model No. AAB00 The product is indicated for implantatio... | Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they were not being checked ... | Class II | Abbott Medical Optics Inc. (AMO) |
| Aug 26, 2016 | SENSAR Foldable IOL with OptiEdge Design, Model No. AR40e The product is ind... | Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they were not being checked ... | Class II | Abbott Medical Optics Inc. (AMO) |
| Aug 26, 2016 | TECNIS Symfony Extended Range of Vision IOL, Model No. ZXR00 The product is ... | Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they were not being checked ... | Class II | Abbott Medical Optics Inc. (AMO) |
| Aug 26, 2016 | TECNIS 1-Piece IOL with the TECNIS iTec Preloaded Delivery System, Model No. ... | Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they were not being checked ... | Class II | Abbott Medical Optics Inc. (AMO) |
| Aug 26, 2016 | TECNIS OptiBlue 1-Piece Intraocular Lens (IOL), Model No. ZCB00V The product... | Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they were not being checked ... | Class II | Abbott Medical Optics Inc. (AMO) |
| Feb 20, 2015 | OptiMedica Catalys Precision Laser System; Model No(s). Catalys-U (US), and C... | Device may experience loss of suction during treatment resulting in scoring the cornea during len... | Class II | Abbott Medical Optics, Inc. |
| Nov 6, 2014 | Abbott Healon EndoCoat Ophthalmic Viscosurgical Device 3% sodium hyaluronate... | AMO has received complaints where the finger grip dislodged while depressing the syringe plunger.... | Class II | Abbott Medical Optics Inc (AMO) |
| Sep 16, 2013 | STAR Excimer Laser System, Model STAR S4 IR, Catalog Number: 0030-4864, Produ... | This corrective action will address an identified failure of the lamp and illumination system wit... | Class II | Abbott Medical Optics, Inc. |
| Sep 16, 2013 | STAR Excimer Laser System, Model: STAR S2, Catalog Number: 0030-1479, Product... | This corrective action will address an identified failure of the lamp and illumination system wit... | Class II | Abbott Medical Optics, Inc. |
| Sep 16, 2013 | STAR ActiveTrak Excimer Laser System, Model: STAR S3, Catalog Number: 0030-24... | This corrective action will address an identified failure of the lamp and illumination system wit... | Class II | Abbott Medical Optics, Inc. |
| Sep 16, 2013 | STAR Excimer Laser System with Variable Spot Scanning, Model: STAR S4, Catalo... | This corrective action will address an identified failure of the lamp and illumination system wit... | Class II | Abbott Medical Optics, Inc. |
| May 28, 2013 | STAR S3 ActiveTrack Excimer System (STAR S3) Mfg by AMO Manufacturing USA... | Under specific conditions, there is an unlikely potential to result in inadvertent laser firing o... | Class II | Abbott Medical Optics, Inc. |
| May 28, 2013 | STAR S4 IR Excimer System (STAR S4 IR) Mfg by AMO Manufacturing USA, LLC ... | Under specific conditions, there is an unlikely potential to result in inadvertent laser firing o... | Class II | Abbott Medical Optics, Inc. |
| May 28, 2013 | STAR S4 with Variable Spot Scanning Excimer System (STAR S4) Mfg by AMO M... | Under specific conditions, there is an unlikely potential to result in inadvertent laser firing o... | Class II | Abbott Medical Optics, Inc. |
| May 23, 2013 | Sovereign¿ Compact Phacoemulsification System, v 5.3, Part Number: CMP680300.... | Abbott Medical Optics Inc. (AMO) initiated this Urgent Notice of Medical Device Correction and Ad... | Class II | Abbott Medical Optics, Inc. |
| Dec 20, 2012 | AMO Sensar Intraocular Lenses (IOLs), Model AR40e, Sensar Foldable IOL with... | Two production orders of these IOLs that contain mislabeled IOLs. | Class II | Abbott Medical Optics Inc (AMO) |
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.