Browse Device Recalls
18 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 18 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 18 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 1, 2017 | Healon V, Part No. 10290045 | Remote possibility that certain solutions in these lots may contain microscopic glass particles d... | Class II | Abbott Medical Optics Inc. (AMO) |
| Apr 1, 2017 | Healon Duet, Part No. 10290080, 10220010, 10220011 and 10220012 | Remote possibility that certain solutions in these lots may contain microscopic glass particles d... | Class II | Abbott Medical Optics Inc. (AMO) |
| Apr 1, 2017 | Healon, Part No. 10290953, 10295210, 10200011, 10200012, 10201012, 10203012, ... | Remote possibility that certain solutions in these lots may contain microscopic glass particles d... | Class II | Abbott Medical Optics Inc. (AMO) |
| Apr 1, 2017 | Healon 5 Pro, Part No. 10270015 | Remote possibility that certain solutions in these lots may contain microscopic glass particles d... | Class II | Abbott Medical Optics Inc. (AMO) |
| Apr 1, 2017 | Healon Pro, Part No. 10270012 | Remote possibility that certain solutions in these lots may contain microscopic glass particles d... | Class II | Abbott Medical Optics Inc. (AMO) |
| Apr 1, 2017 | Healon GV, Part No. 10294701, 10294801, 10200014, 10201014, 10202014, 10203014 | Remote possibility that certain solutions in these lots may contain microscopic glass particles d... | Class II | Abbott Medical Optics Inc. (AMO) |
| Mar 30, 2017 | AMO 25GA Vitrectomy Cutter (Model Number NGP0025) and AMO 20GA Vitrectomy Cut... | Packaging error. 20GA Vitrectomy Cutters may be found in a 25GA package and 25GA Vitrectomy Cut... | Class II | Abbott Medical Optics Inc. (AMO) |
| 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) |
| 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. |
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.