Browse Device Recalls

16 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 16 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 16 FDA device recalls.

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DateProductReasonClassFirm
Aug 29, 2023 Coventus Flower Orthopedics Flex-Thread TM 3.2mm Cannulated Reamer-used to re... Device is breaking while in use, potential for patients to require a revision surgery. Class II Flower Orthopedics Corporation
Nov 2, 2021 Flex-Thread Inserter Shaft intended for Fibula intramedullary-intended to be... Mating incompatibility between the Inserter Shaft and the Inserter Draw Rod causing the inserter ... Class II Flower Orthopedics Corporation
Sep 3, 2021 Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201 Product kit missing CDG 200 (Cannulated Countersink for 3.0-4.5mm Screws) from EWK 201 (Flower E-... Class II Flower Orthopedics Corporation
Sep 1, 2021 Flower Drill Bit Kit 2.7mm- The Drill Bit Kit, 2.7mm (DBK 027) is intended to... Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure Class II Flower Orthopedics Corporation
Sep 1, 2021 Flower Drill Bit Kit 2.4 mm-intended to be used with solid 2.4mm screws and c... Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure Class II Flower Orthopedics Corporation
Sep 1, 2021 Flower Lag Screw Kit 2.7 mm-intended to be used with 2.7mm lag screws and can... Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure Class II Flower Orthopedics Corporation
Sep 1, 2021 Flower Drill Bit Kit 2.0 mm - intended to be used with solid 2.0mm screws and... Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure Class II Flower Orthopedics Corporation
Apr 15, 2021 T25 Cannulated Screwdrivers (CSD 025) packaged in Guide Wire Kits (GWK 300) -... Cannulated Screwdrivers may break at the driver tip along the shaft, near the handle extending su... Class II Flower Orthopedics Corporation
Jul 8, 2020 Calcaneus Plate, Extensile, Large, Left, Catalog Number CPF 103 - Product Usa... The contract manufacturer of the calcaneus plate inadvertently used the incorrect material to man... Class II Flower Orthopedics Corporation
Jul 8, 2020 Calcaneus Plate, Extensile, Medium, Right, Catalog Number CPF 202 - Product U... The contract manufacturer of the calcaneus plate inadvertently used the incorrect material to man... Class II Flower Orthopedics Corporation
Jul 8, 2020 Calcaneus Plate, Extensile, Small, Left, Catalog Number CPF 101 - Product Usa... The contract manufacturer of the calcaneus plate inadvertently used the incorrect material to man... Class II Flower Orthopedics Corporation
Jul 8, 2020 Calcaneus Plate, Extensile, Small, Right, Catalog Number CPF 201 - Product Us... The contract manufacturer of the calcaneus plate inadvertently used the incorrect material to man... Class II Flower Orthopedics Corporation
Jul 8, 2020 Calcaneus Plate, Extensile, Large, Right, Catalog Number CPF 203 - Product Us... The contract manufacturer of the calcaneus plate inadvertently used the incorrect material to man... Class II Flower Orthopedics Corporation
Jul 8, 2020 Calcaneus Plate, Extensile, Medium, Left, Catalog Number CPF 102 - Product Us... The contract manufacturer of the calcaneus plate inadvertently used the incorrect material to man... Class II Flower Orthopedics Corporation
Dec 22, 2016 Cannulated Drill bit 2.0mm and 2.6 mm; Used in conjunction with the Flower Bo... The product is being recalled due to incidence and reports of the product breaking during surgery. Class II Flower Orthopedics Corporation
Feb 16, 2015 Variable Angle Locking Peg, D:1.8mm x L:14.0mm; Variable Angle Locking Peg, D... Locking pegs were not locking during distal radius procedures. There has been one (1) report of r... Class II Flower Orthopedics Corporation

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.