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Browse Device Recalls

12 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 12 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 12 FDA device recalls.

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DateProductReasonClassFirm
Nov 13, 2017 Piranha Screw 4.0 x 12mm, used in Piranha Surgical Plate System The Piranh... Potential incorrect marking and color identification of Piranha screw. Some screws marked as 12 ... Class II Amendia, Inc dba Spinal Elements
Jul 7, 2017 Ceres Self-Drilling Variable Screw 4.0 x 12mm The Ceres screws are self-dr... Incorrect direct marking and color identification for the affected lot of Ceres Self-Drilling Var... Class II Amendia, Inc
Jul 7, 2017 Mac Pin Non-Cannulated Screw, 6.5 x 60mm Incorrect labeling for the lot of MAC Pins. Although the pins are laser as 460 mm in length, t... Class II Amendia, Inc
Apr 6, 2017 01.4mm x 457mm (18in) K-Wire, Threaded Blunt, Ref 9080B-18T, Qty: 1 per pack... Mislabeled guide wires - It was discovered that some Guide Wires labeled as stainless steel were ... Class II Amendia, Inc
Nov 22, 2016 Black Widow Plate 19mm Plate, Part Number TBP119; Black Widow Plate 23mm Plat... There is a problem with the mating feature between the plate and screw which could cause the plat... Class II Amendia, Inc
Nov 22, 2016 Ceres-C Standalone Cervical Interbody The product is a stand-alone anterio... Absent tantalum market pin. Class II Amendia, Inc
Nov 22, 2016 Savannah-T Straight Rod, 200mm, Part Number 10704-200; Savannah-T Straight Ro... The rods are packaged in packages with unacceptable seals. In some cases, the integrity of the s... Class II Amendia, Inc
Nov 22, 2016 Optimus Fixed Awl Complaints that the tip of the awl broke after impaction during surgery. Class II Amendia, Inc
Nov 22, 2016 Dual Stylet Needle, Part Number 812-11R-15 The guide wire is passed through ... The rods are packaged in packages with unacceptable seals. In some cases, the integrity of the s... Class II Amendia, Inc
Nov 22, 2016 Zeus-P Lumbar Interbody Device Labeling error where three boxes in inventory had conflicting patient and primary labels. Evaluat... Class II Amendia, Inc
Nov 22, 2016 Black Widow 6.6mm x 20mm Screw, Part Number TBS020; Black Widow 6.6mm x 25mm ... There is a problem with the mating feature between the plate and screw which could cause the plat... Class II Amendia, Inc
Nov 22, 2016 K-Wire 1.4mm x 12in Non-Threaded, Part Number 9080-12U; K-Wire Threaded 1.4mm... The rods are packaged in packages with unacceptable seals. In some cases, the integrity of the s... Class II Amendia, 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.