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Browse Device Recalls

1,125 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,125 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 1,125 FDA device recalls.

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DateProductReasonClassFirm
May 22, 2017 Drill Bit Quick-Connect 3.5 mm Diameter 110 mm Length, Item Number/EDI 004806... Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw m... Class II Zimmer Biomet, Inc.
May 22, 2017 Drill Bit Quick-Connect 2.7 mm Diameter 100 mm Length, Item Number/EDI 004806... Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw m... Class II Zimmer Biomet, Inc.
May 22, 2017 ECT Internal Fracture Fixation Drill Bits 1.5 mm Diameter (.059 Inch), Item N... Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw m... Class II Zimmer Biomet, Inc.
May 22, 2017 Zimmer Natural Nail System Calibrated Drill Short 4.9 mm, Item Number/EDI 002... Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw m... Class II Zimmer Biomet, Inc.
May 22, 2017 ECT Internal Fracture Fixation Quick-Connect Drill 4.0 mm Diameter 20cm Lengt... Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw m... Class II Zimmer Biomet, Inc.
May 22, 2017 NCB Periprosthetic Plate System Drill Bit With Quick-Coupling 3.5 mm Diameter... Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw m... Class II Zimmer Biomet, Inc.
May 22, 2017 Drill Bit Quick-Connect 3.2 mm Diameter 195 mm Length, Item Number/EDI 004806... Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw m... Class II Zimmer Biomet, Inc.
May 22, 2017 ECT Internal Fracture Fixation Drill 3.2 mm Diameter (.126 Inch), Item Number... Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw m... Class II Zimmer Biomet, Inc.
May 22, 2017 ECT Internal Fracture Fixation Drill 1.1 mm Diameter (.043 Inch), Item Number... Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw m... Class II Zimmer Biomet, Inc.
May 22, 2017 Zimmer Trabecular Metal Reverse Shoulder System Instrumentation, Drill 2.5 mm... Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw m... Class II Zimmer Biomet, Inc.
May 22, 2017 M/DN Intramedullary Fixation Femoral Drill Large 5.0 mm Item Number/EDI 00225... Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw m... Class II Zimmer Biomet, Inc.
May 22, 2017 ECT Internal Fracture Fixation Quick-Connect Drill 2.0 mm Diameter 12.5 cm Le... Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw m... Class II Zimmer Biomet, Inc.
May 22, 2017 Drill bit Quick-Connect 3-Fluted 2.5 mm Diameter 180 mm Length, Item Number/E... Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw m... Class II Zimmer Biomet, Inc.
May 22, 2017 NCB Periprosthetic Plate System Drill Bit With Quick-Coupling 4.5 mm Diameter... Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw m... Class II Zimmer Biomet, Inc.
May 22, 2017 M/DN Intramedullary Fixation Distal Drill 3.2 mm Diameter Pilot Tip, Item Num... Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw m... Class II Zimmer Biomet, Inc.
May 22, 2017 Drill Bit Quick-Connect 2.5 mm Diameter 110 mm Length, Item Number/EDI 004806... Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw m... Class II Zimmer Biomet, Inc.
May 22, 2017 ECT Internal Fracture Fixation Drill Bits 1.1 mm Diameter, Item Number/EDI 00... Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw m... Class II Zimmer Biomet, Inc.
May 22, 2017 Drill Bit Quick-Connect 4.5 mm Diameter 145 mm Length, Item Number/EDI 004806... Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw m... Class II Zimmer Biomet, Inc.
May 22, 2017 Herbert Cannulated Bone Screw System, Cannulated Main Drill 3.1 mm Diameter, ... Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw m... Class II Zimmer Biomet, Inc.
May 22, 2017 Zimmer Periarticular Locking Plate System Cannulated Drill Standard Quick-Con... Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw m... Class II Zimmer Biomet, Inc.
May 22, 2017 ECT Internal Fracture Fixation Drill 3.5 mm Diameter (.138 Inch), Item Number... Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw m... Class II Zimmer Biomet, Inc.
May 22, 2017 Zimmer Periarticular Locking Plate System Drill Standard 2.7 mm Diameter, It... Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw m... Class II Zimmer Biomet, Inc.
May 22, 2017 Drill Bit Quick-Connect 3.2 mm Diameter 145 mm Length, Item Number/EDI 004806... Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw m... Class II Zimmer Biomet, Inc.
May 22, 2017 Drill Bit Quick-Connect 2.0 mm Diameter 100 mm Length, Item Number/EDI 004806... Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw m... Class II Zimmer Biomet, Inc.
May 22, 2017 ECT Internal Fracture Fixation Quick-Connect Drill 2.5 mm Diameter 12.5 cm Le... Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw m... Class II Zimmer Biomet, Inc.
May 22, 2017 M/DN Intramedullary Fixation Femoral Drill 3.7 mm Diameter Replaces 2255-08-3... Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw m... Class II Zimmer Biomet, Inc.
May 22, 2017 Drill Bit Jacobs Chuck 1.5 mm Diameter 70 mm Length, Item Number/EDI 0048050... Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw m... Class II Zimmer Biomet, Inc.
May 22, 2017 Zimmer Periarticular Locking Plate System, Locking Screw Tap Standard Quick-C... Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw m... Class II Zimmer Biomet, Inc.
May 22, 2017 ECT Internal Fixation Drill Bits 2.5 mm Diameter (0.98 Inch), Item Number/EDI... Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw m... Class II Zimmer Biomet, Inc.
May 22, 2017 Drill Bit Quick-Connect 3-Fluted 4.5 mm Diameter 195 mm Length, Item Number/... Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw m... Class II Zimmer Biomet, Inc.
May 22, 2017 M/DN, Intramedullary Fixation Distal Drill Pilot Tip 3.7 mm Diameter Item Num... Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw m... Class II Zimmer Biomet, Inc.
May 22, 2017 ECT Internal Fracture Fixation Long Drill, 6.4 mm (1/4 Inch) Diameter 20.3 cm... Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw m... Class II Zimmer Biomet, Inc.
May 22, 2017 ECT Internal Fracture Fixation Drill Bits 3.5 mm Diameter (.138 Inch), Item N... Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw m... Class II Zimmer Biomet, Inc.
May 22, 2017 ECT Internal Fracture Fixation Quick-Connect Drill, 1.5 mm Diameter, 85mm Len... Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw m... Class II Zimmer Biomet, Inc.
May 22, 2017 ECT Internal Fracture Fixation Drill Bits 2.7 mm Diameter (.106 Inch), Item N... Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw m... Class II Zimmer Biomet, Inc.
May 22, 2017 Drill Bit Quick-Connect 1.1 mm Diameter 60 mm Length, Item Number/EDI 004806... Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw m... Class II Zimmer Biomet, Inc.
May 22, 2017 Zimmer Periarticular Locking Plate System Drill Standard 2.0 mm Diameter, Ite... Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw m... Class II Zimmer Biomet, Inc.
May 22, 2017 ECT Internal Fracture Fixation Quick-Connect Drill 2.7 mm Diameter 10 cm Leng... Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw m... Class II Zimmer Biomet, Inc.
May 22, 2017 ECT Internal Fracture Fixation Drill Bits 2.0 mm Diameter (.079 Inch) , Item ... Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw m... Class II Zimmer Biomet, Inc.
May 22, 2017 Long Drill 1/4 inch (6.4 mm) Diameter 8 inch (20.3 cm) Length, Item Number/ED... Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw m... Class II Zimmer Biomet, Inc.
May 22, 2017 Drill Bit Jacobs Chuck 2.0 mm Diameter 85 mm Length, Item Number/EDI 00480508... Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw m... Class II Zimmer Biomet, Inc.
May 22, 2017 ECT Internal Fracture Fixation Quick-Connect Drill 2.0 mm Diameter 10 cm Leng... Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw m... Class II Zimmer Biomet, Inc.
May 22, 2017 Drill Bit Quick-Connect Calibrated 3-Fluted 2.5 mm Diameter 230 mm Length, It... Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw m... Class II Zimmer Biomet, Inc.
May 8, 2017 Reusable instruments in the Knee, Hip, Trauma, and Extremities segments. Durability characteristics of reusable instruments were not established Class II Zimmer Biomet, Inc.
May 1, 2017 ROSA Spine 1.0.2 Stereotaxic instrument Computer-assisted surgical device. ... Robot arm being sent to the wrong position Class II Zimmer Biomet, Inc.
May 1, 2017 ROSA Brain 3.0 Stereotaxic instrument Computer-assisted surgical device. I... Robot arm being sent to the wrong position Class II Zimmer Biomet, Inc.
Apr 28, 2017 R-F IM NAIL 10MMDX48CM LG, 11MMDX42CM, 11MMDX44CM, 11MMDX46CM LG, 11MMDX48C... Zimmer Biomet is initiating a field action for sterile-packaged implants packaged in a single pac... Class II Zimmer Biomet, Inc.
Apr 28, 2017 4.5 BROAD SCP PLT 26-H STER Zimmer Biomet is initiating a field action for sterile-packaged implants packaged in a single pac... Class II Zimmer Biomet, Inc.
Apr 28, 2017 TIBIAL I/M NAIL 15MMDX26CM, TIBIAL I/M NAIL 15MMDX28CM TIBIAL I/M NAIL 15MMD... Zimmer Biomet is initiating a field action for sterile-packaged implants packaged in a single pac... Class II Zimmer Biomet, Inc.
Apr 28, 2017 NexGen Offset Stem Extension, sizes 14mm and 17mm For use in total arthr... Zimmer Biomet is conducting a lot-specific medical device field action for two lots of the NexGen... Class II Zimmer Biomet, 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.