Browse Device Recalls

2,549 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,549 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 2,549 FDA device recalls in IN.

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DateProductReasonClassFirm
Jun 12, 2017 DRILL BIT MINI QUICK CONNECT 1.0MM, REF 2312-20-200 & 2312-20-202, NON STERILE A raw material anomaly was discovered in four lots of raw material and has the potential to be on... Class II Zimmer Biomet, Inc.
Jun 12, 2017 Accu-Chek Performa II Meter - Product Usage: a. The Accu-Chek Aviva Plus Bloo... Meters may contain a damaged C29 capacitor resulting in issues with power allegation (short batte... Class II Roche Diabetes Care, Inc.
Jun 12, 2017 Accu-Chek Aviva II Meter - Product Usage: a. The Accu-Chek Aviva Plus Blood G... Meters may contain a damaged C29 capacitor resulting in issues with power allegation (short batte... Class II Roche Diabetes Care, Inc.
Jun 8, 2017 Accu-Chek Connect Diabetes Management App, Catalog number 07562462001 / GTIN ... Certain iOS and Android App versions contain a program error (bug) in the Bolus Advisor feature. ... Class II Roche Diabetes Care, Inc.
Jun 8, 2017 Accu-Chek Connect diabetes management software app, Catalog number 0756246200... Certain iOS and Android App versions contain a program error (bug) in the Bolus Advisor feature. ... Class II Roche Diabetes Care, Inc.
Jun 5, 2017 ECHO POR FMRL NC 9X125, model # 192009 Possibility that the patient label inside the product box was incorrectly labeled. The outer box... Class II Zimmer Biomet, Inc.
Jun 5, 2017 Lateral Troch Plate Full Crimp - 254mm, model # 350837 Possibility that the patient label inside the product box was incorrectly labeled. The outer box... Class II Zimmer Biomet, Inc.
Jun 5, 2017 CER BIOLOXD OPTION HD 32MM, model # 650-1056 Possibility that the patient label inside the product box was incorrectly labeled. The outer box... Class II Zimmer Biomet, Inc.
Jun 5, 2017 COMP PRIMARY STEM 8MM MINI, model # 113628 Possibility that the patient label inside the product box was incorrectly labeled. The outer box... Class II Zimmer Biomet, Inc.
Jun 5, 2017 Zimmer Natural Nail System Tear Drop Guide Wire 2.4 mm Diameter, 70 cm lengt... The design verification for the previous packaging configuration G928 does not cover the 70cm wir... Class II Zimmer Biomet, Inc.
Jun 5, 2017 RED SEXP DSTL FEM 19CM LT ASSY, model # CP111828 Possibility that the patient label inside the product box was incorrectly labeled. The outer box... Class II Zimmer Biomet, Inc.
Jun 5, 2017 OSS CEMENTED IM STEM 12X150, model # 150366 Possibility that the patient label inside the product box was incorrectly labeled. The outer box... Class II Zimmer Biomet, Inc.
Jun 5, 2017 Zimmer Natural Nail System Tear Drop Guide Wire 3.0 mm Diameter, 70 cm lengt... The design verification for the previous packaging configuration G928 does not cover the 70cm wir... Class II Zimmer Biomet, Inc.
Jun 5, 2017 COMP 12MM HUM FRAC STEM MACRO, model # 11-113562 Possibility that the patient label inside the product box was incorrectly labeled. The outer box... Class II Zimmer Biomet, Inc.
Jun 5, 2017 Lateral Troch Plate Full Crimp - 254mm, model # 350838 Possibility that the patient label inside the product box was incorrectly labeled. The outer box... Class II Zimmer Biomet, Inc.
Jun 5, 2017 Humeral Guide Wire Ball Tip 2.4 mm Diameter 70 cm Length, Item Number 47-2255... The design verification for the previous packaging configuration G928 does not cover the 70cm wir... Class II Zimmer Biomet, Inc.
Jun 5, 2017 M/DN Intramedullary Fixation Humeral Guide Wire - Bullet Tip 2.4 mm Diameter ... The design verification for the previous packaging configuration G928 does not cover the 70cm wir... Class II Zimmer Biomet, Inc.
Jun 5, 2017 M/DN Intramedullary Fixation Humeral Guide Wire - Smooth 2.4 mm Diameter 70 c... The design verification for the previous packaging configuration G928 does not cover the 70cm wir... Class II Zimmer Biomet, Inc.
Jun 5, 2017 CER OPTION TYPE 1 TPR SLEVE -6, model # 650-1064 Possibility that the patient label inside the product box was incorrectly labeled. The outer box... Class II Zimmer Biomet, Inc.
Jun 5, 2017 RED SEXP DSTL FEM 19CM RT ASSY, model # CP111817 Possibility that the patient label inside the product box was incorrectly labeled. The outer box... Class II Zimmer Biomet, Inc.
May 22, 2017 Drill Bit Quick-Connect 1.5 mm Diameter 85 mm Length, Item Number/EDI 0048060... 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 1.5 mm Diameter (.059 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 Natural Nail System Freehand Drill 4.3 mm Diameter 152.5 mm Length, It... 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 3.2 mm Diameter (.126 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 Periarticular Locking Plate System Locking Screw Tap Standard Quick-Co... 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 3.2 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 Drill 4.5 mm Diameter (.177 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 Straight Shank Drill Bit 4.0 mm Diameter, Item Number/EDI 00231804000, Nonste... 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 2.7 mm Diameter (.106 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 2.5 mm Diameter (.098 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 Quick-Connect Drill 2.5 mm Diameter 11 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 Quick-Connect Drill 3.5 mm Diameter 11 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 Zimmer Natural Nail System Calibrated Drill Long 4.3mm, Item Number/EDI 00249... 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 3.2 mm Diameter 130 mm Length, Item Number/EDI 0048051... 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 2.0 mm Diameter (.079 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 Straight Shank Drill Bits 4.0 mm Diameter, Item Number/EDI 00231804006, Nonst... 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 4.5 mm Diameter (.177 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 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.

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.