Browse Device Recalls

3,313 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,313 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 3,313 FDA device recalls in 2017.

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DateProductReasonClassFirm
May 22, 2017 Boston Scientific Zurpaz(TM) MEDIUM CURL, SYMMETRIC CURVE, Steerable Sheath, ... Lack of sterility assurance. Class II Creganna Medical Devices
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.
May 22, 2017 Exactech 1.5" Novation Calcar Planer Guide Tip To assist the surgeon in th... The firm determined that the labeling (surgical technique) should be updated to clarify the prope... Class II Exactech, 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 3M Ranger(TM) Pressure Infusor, Model 145, SKU 70200792979 The 3M Ranger P... It was discovered that one Ranger Pressure lnfusor Model 145, SN: 100873, produced a left chamber... Class II 3M Company - Health Care Business
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 Boston Scientific Zurpaz(TM) MEDIUM CURL, ASYMMETRIC CURVE, Steerable Sheath,... Lack of sterility assurance. Class II Creganna Medical Devices
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 SST TWIST DRILL, STANDARD, 1.6mm Dia. x 127mm, REF 8054-010, STERILE This ... One lot was found to contain both the correct twist drill (1.6mm) as well as an incorrect twist d... Class II MicroAire Surgical Instruments, LLC
May 22, 2017 MULTIGENT Creatinine (Enzymatic), Catalog Numbers 8L24-31 and 8L24-41; IVD. ... Reagent 1 component may result in Quality Control values shifting out of acceptable range, which ... Class II Sentinel CH SPA
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 Hemofiltration Standard Pack including BC 60 Plus-T 8036. Part Number: 70106... 55 kits were distributed after their expiration date of September 2015. Class II Maquet
May 22, 2017 The Olympic Pasteurmatic 3000 and Olympic Pasteurmatic 3500 are intended for ... Olympic Pasteurmatic 3000/3500 Systems are recalled because they do not fully meet todays regulat... Class II Natus Medical Incorporated
May 22, 2017 Syngo.plaza, Picture Archiving and Communications System(PACS), Model 1086317... Siemens is releasing a non-medical software application LTA Incomplete Archive Check Tool V1.0. ... Class II Siemens Medical Solutions USA, 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 PROMETRA II Programmable Infusion Pump, Implantable Infusion Pump, Catalog Nu... Flowonix Medical received a report of a patient implanted with the Prometra II Programmable Pump ... Class II Flowonix Medical, 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 Coulter PrepPlus, Part Number 286600, Product Usage: The COULTER PrepPlu... When samples are prepared using the PrepPlus or PrepPlus 2 sample preparation systems and then ru... Class II Beckman Coulter 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 DIASTAT(R) ANA (anti-Nuclear antibody) EURO DIAGNOSTICA, The DIASTAT(R) anti-... FANA200 kit lot TS 3577 was re-worked due to shortened shelf-life. The alert sticker on the kit b... Class III Euro Diagnostica AB

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.