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Browse Device Recalls

10 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 10 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 10 FDA device recalls.

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DateProductReasonClassFirm
Oct 13, 2025 Phantom Fibula Nail, 2.8mm x 130mm, Right, Ti, Fibula Nail, REF: P36-128-130R-S Fibula nail system intended for use in fixation of fibular fractures and osteotomies, has out of ... Class II Paragon 28, Inc.
Dec 21, 2023 Phantom TTC Nail, 10.0 X 200mm, Right Medical devices distributed, prior to sterilization Class II Paragon 28, Inc.
Dec 21, 2023 Phantom TTC Nail, TTC Nail, 10.0 X 150mm, RIGHT , REF: P31-600-175L Medical devices distributed, prior to sterilization Class II Paragon 28, Inc.
Dec 21, 2023 Phantom TTC Nail, TTC Nail, 11.5 X 250mm, RIGHT, REF: P31-615-250R Medical devices distributed, prior to sterilization Class II Paragon 28, Inc.
Jul 13, 2022 Grappler Suture Anchor, Titanium, 3.0 x 10mm, Sterile Kit, REF: P44-110-3010-... Suture anchor may break upon insertion, which could lead to potential debris in patient, and dela... Class II Paragon 28, Inc.
May 26, 2022 HammerTube Implant, 2.75mm, 10¿ Cannulated (Sterile) Due to Titanium plasma coating not present implant. Class II Paragon 28, Inc.
May 18, 2022 Paragon 28, Inc. System: Baby Gorilla/Gorilla Plating System, Ref: P99-100-28... Incorrect labeling; There is potential that the drill packaging contains the incorrect part number. Class II Paragon 28, Inc.
Jul 30, 2021 Phantom Nail System, Drill, 4.6 x 300mm, Cannulated, 3/16" Sq. Connection ... A thin wall condition between the inner cannulation and the flutes of the drill which potentially... Class II Paragon 28, Inc.
Sep 28, 2018 P28, Titan 3-D Wedge, Evans, Large, 10 mm, sterile, REF P03-EVN-1010-S, Type:... It has been determined that the wedge implant kit is permanently mislabeled with the wrong size. ... Class II Paragon 28, Inc.
Dec 19, 2017 P28 JAWS Nitinol Staple System kits are designed for use in an osteotomy, art... Missing drill guide as stated in the package. Class II Paragon 28, 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.