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Browse Device Recalls

15 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 15 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 15 FDA device recalls.

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DateProductReasonClassFirm
Dec 16, 2025 Vortex Surgical Lindsell Sutured IOL Marker, VS0390 - Scleral Marker There may be voids located in the seal of Tyvek pouches associated with identified catalog number... Class II Vortex Surgical Inc.
Dec 16, 2025 Rumex Disposable Diamond Dusted ILM Elevator, 12-7523 There may be voids located in the seal of Tyvek pouches associated with identified catalog number... Class II Vortex Surgical Inc.
Dec 16, 2025 Volk Single Use Vitrectomy Lenses 1. Flat Vitrectomy Lens, Catalog VFD 2.... There may be voids located in the seal of Tyvek pouches associated with identified catalog number... Class II Vortex Surgical Inc.
Dec 16, 2025 Vortex Disposable Forceps and Cannula 1. 23GA ACTU8 Forceps Adaptive VS07... There may be voids located in the seal of Tyvek pouches associated with identified catalog number... Class II Vortex Surgical Inc.
Dec 16, 2025 25GA Subretinal Injection Cannula VS0220.25 There may be voids located in the seal of Tyvek pouches associated with identified catalog number... Class II Vortex Surgical Inc.
Dec 16, 2025 Tecfen Retractable Membrane Polisher, QTPR1267-23 There may be voids located in the seal of Tyvek pouches associated with identified catalog number... Class II Vortex Surgical Inc.
Dec 16, 2025 Vortex Surgical 25GA I.D.D. Internal Delivery Device, VS0250.25 There may be voids located in the seal of Tyvek pouches associated with identified catalog number... Class II Vortex Surgical Inc.
Dec 16, 2025 Oertli 1. 23G Laser Probe OS4 Flex-Tip VK401113 2. 23G Laser Probe OS4 I... There may be voids located in the seal of Tyvek pouches associated with identified catalog number... Class II Vortex Surgical Inc.
Dec 16, 2025 Vortex Surgical 25GA Backflush, VS0270.25; 25GA Backflush Retractable, VS02... There may be voids located in the seal of Tyvek pouches associated with identified catalog number... Class II Vortex Surgical Inc.
Dec 16, 2025 Vortex Surgical I2 Injection Kit, VS0500 There may be voids located in the seal of Tyvek pouches associated with identified catalog number... Class II Vortex Surgical Inc.
Dec 16, 2025 Vortex Surgical TID Pharos Illuminated Depressor, VS0801B XXX Class II Vortex Surgical Inc.
Dec 16, 2025 Vortex Surgical 1. 23GA Laser Probe Curved Cat No. VS0120.23 2. 25GA L... There may be voids located in the seal of Tyvek pouches associated with identified catalog number... Class II Vortex Surgical Inc.
Dec 16, 2025 Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA C... There may be voids located in the seal of Tyvek pouches associated with identified catalog number... Class II Vortex Surgical Inc.
Nov 19, 2025 Vortex Surgical 25ga Illuminated Flex-Tip Laser Probe, Catalog Number VS0135.25; Reason for the voluntary recall is some products in this lot are not passing through a 25ga cannu... Class II Vortex Surgical Inc.
Dec 18, 2023 Vortex Surgical ACTU8 FORCEPS, 25 GA, ADAPTIVE, REF VS0740.25 Reason for the voluntary recall is residue was identified on the two forceps tips of a customer i... Class II Vortex Surgical 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.