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Browse Device Recalls

22 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 22 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 22 FDA device recalls.

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DateProductReasonClassFirm
Dec 29, 2020 REFRESH CONTACTS¿ Contact Lens Comfort Drops 0.4 fl oz (12 mL) Sterile Missing Instruction For Use insert. Class II Allergan PLC
Nov 6, 2019 NATRELLE Resterilizable Sizers for the styles and sizes: Style 15, Style 20, ... The firm has became aware that 2D barcodes on breast implants and sizers may be unreadable by GS-... Class III Allergan PLC
Nov 6, 2019 Natrelle Inspira Sillicone-Filled Breast Implants for the following Styles an... The firm has became aware that 2D barcodes on breast implants and sizers may be unreadable by GS-... Class III Allergan PLC
Nov 6, 2019 Natrelle Saline-Filled Breast Implant, for the following Styles and sizes, St... The firm has became aware that 2D barcodes on breast implants and sizers may be unreadable by GS-... Class III Allergan PLC
Nov 6, 2019 Natrelle Silicone Filled Breast Implants for the following Styles and Sizes: ... The firm has became aware that 2D barcodes on breast implants and sizers may be unreadable by GS-... Class III Allergan PLC
Oct 30, 2019 XEN Gel Stent, REF 5513-001(US Model), Sterile, RX Only, (01)10888628032439 ;... Residual polishing compounds, that are used in the needle sleeve manufacturing process, may be pr... Class II Allergan PLC
Jul 24, 2019 RITZ PRINCESS, BIOCELL, INTRASHIEL, BioDIMENSIONAL Breast Implant, Styles RML... The action was initiated following notification by the U.S. FDA of their recently updated, global... Class I Allergan PLC
Jul 24, 2019 McGhan BioDIMENSIONAL silicone-Filled Breast Implants, style 153 Product... The action was initiated following notification by the U.S. FDA of their recently updated, global... Class I Allergan PLC
Jul 24, 2019 Natrelle 510, TruForm, Dual-Gel, BIOCELL, Styles LX, MX, FX Product Usag... The action was initiated following notification by the U.S. FDA of their recently updated, global... Class I Allergan PLC
Jul 24, 2019 Natrelle 410, Highly Cohesive Anatomically Shaped Silicone-Filled Breast Impl... The action was initiated following notification by the U.S. FDA of their recently updated, global... Class I Allergan PLC
Jul 24, 2019 Natrelle 133 Tissue Expanders (also named style 133 BIOSPAN Tissue Expander a... The action was initiated following notification by the U.S. FDA of their recently updated, global... Class I Allergan PLC
Jul 24, 2019 Natrelle 133 Tissue Expanders w/Suture Tabs BIOCELL Full Height Variable Proj... The action was initiated following notification by the U.S. FDA of their recently updated, global... Class I Allergan PLC
Jul 24, 2019 Natrelle and McGhan Silicone-Filled Breast Implant BioCell Round Moderate Pro... The action was initiated following notification by the U.S. FDA of their recently updated, global... Class I Allergan PLC
Jul 24, 2019 McGhan Croissant-Shaped Tissue Expanders, Style 134 Product Usage: intende... The action was initiated following notification by the U.S. FDA of their recently updated, global... Class I Allergan PLC
Jul 24, 2019 Natrelle and McGhan Silicone-Filled Breast Implants, TruForm 2 (Soft Touch), ... The action was initiated following notification by the U.S. FDA of their recently updated, global... Class I Allergan PLC
Jul 24, 2019 Natrelle Inspira, Silicone-Filled Breast Implants, Sterile, for the following... The action was initiated following notification by the U.S. FDA of their recently updated, global... Class I Allergan PLC
Jul 24, 2019 Natrelle and McGhan 410 TruForm 2 (Soft Touch) BIOCELL breast implant, Styles... The action was initiated following notification by the U.S. FDA of their recently updated, global... Class I Allergan PLC
Jul 24, 2019 Natrelle 150 Full Height and Short Height Implants, BIOCELL, INTRASHIEL, BioD... The action was initiated following notification by the U.S. FDA of their recently updated, global... Class I Allergan PLC
Jul 24, 2019 Komuro, Soft Touch, BIOCELL, INTRASHIEL, BioDIMENSIONAL breast implants, Styl... The action was initiated following notification by the U.S. FDA of their recently updated, global... Class I Allergan PLC
Jul 24, 2019 Natrelle133 Plus Tissue Expander With/Without Suture Tabs, BioCell Full Heigh... The action was initiated following notification by the U.S. FDA of their recently updated, global... Class I Allergan PLC
Jul 24, 2019 Natrelle, Saline-Filled Breast Implant Biocell Full Height with Fill Tube, St... The action was initiated following notification by the U.S. FDA of their recently updated, global... Class I Allergan PLC
Aug 8, 2017 REVOLVE ADVANCED ADIPOSE SYSTEM, for aspiration, harvesting, filtering, and t... Presence of bacterial endotoxins levels above the acceptable limit Class II LifeCell Corporation, A Wholly Owned Subsidiary...

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.