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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
Aug 7, 2017 Affixus Hip Fracture Nail, RH 130 DEG 9MM X 380MM During the rework process for the April 17, 2017, field action, it was detected that the set scre... Class II Zimmer Biomet, Inc.
Aug 7, 2017 Affixus Hip Fracture Nail, LH 125 DEG 11MM X 440MM During the rework process for the April 17, 2017, field action, it was detected that the set scre... Class II Zimmer Biomet, Inc.
Aug 7, 2017 Affixus Hip Fracture Nail, RH 125 DEG 9MM X 400MM During the rework process for the April 17, 2017, field action, it was detected that the set scre... Class II Zimmer Biomet, Inc.
Aug 7, 2017 Affixus Hip Fracture Nail, LH 130 DEG 11MM X 460MM During the rework process for the April 17, 2017, field action, it was detected that the set scre... Class II Zimmer Biomet, Inc.
Aug 7, 2017 Affixus Hip Fracture Nail, LH 130 DEG 13MM X 460MM During the rework process for the April 17, 2017, field action, it was detected that the set scre... Class II Zimmer Biomet, Inc.
Aug 7, 2017 Affixus Hip Fracture Nail, RH 125 DEG 9MM X 260MM During the rework process for the April 17, 2017, field action, it was detected that the set scre... Class II Zimmer Biomet, Inc.
Aug 7, 2017 Affixus Hip Fracture Nail, RH 130 DEG 11MM X 380MM During the rework process for the April 17, 2017, field action, it was detected that the set scre... Class II Zimmer Biomet, Inc.
Aug 7, 2017 Affixus Hip Fracture Nail, LH 130 DEG 9MM X 300MM During the rework process for the April 17, 2017, field action, it was detected that the set scre... Class II Zimmer Biomet, Inc.
Aug 7, 2017 Affixus Hip Fracture Nail, RH 130 DEG 9MM X 260MM During the rework process for the April 17, 2017, field action, it was detected that the set scre... Class II Zimmer Biomet, Inc.
Aug 7, 2017 Persona Cemented Tibial SZ PLT Size H Left, Item Number 42539908301 For u... There is a potential for intermittent cracks in the raw material batch used to produce the affect... Class II Zimmer Biomet, Inc.
Aug 7, 2017 Affixus Hip Fracture Nail, RH 125 DEG 11MM X 460MM During the rework process for the April 17, 2017, field action, it was detected that the set scre... Class II Zimmer Biomet, Inc.
Aug 7, 2017 Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 30cm, Mat... The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna dise... Class II Covidien LLC
Aug 7, 2017 Affixus Hip Fracture Nail, 130 DEG 11MM X 180MM During the rework process for the April 17, 2017, field action, it was detected that the set scre... Class II Zimmer Biomet, Inc.
Aug 7, 2017 MicroVention Terumo Traxcess 7 Mini Guidewire with Hydrophilic Coating, Ref G... There is a potential for the hydrophilic coating on the guidewire to delaminate from the guidewire. Class II Microvention, Inc.
Aug 7, 2017 Total Hip Application (THA) Product Usage: The Robotic Arm Interactive O... Software discrepancy of not showing all the EE constants, when the screen is filled. Class II Mako Surgical Corporation
Aug 7, 2017 Affixus Hip Fracture Nail, LH 125 DEG 9MM X 440MM During the rework process for the April 17, 2017, field action, it was detected that the set scre... Class II Zimmer Biomet, Inc.
Aug 7, 2017 Affixus Hip Fracture Nail, LH 125 DEG 9MM X 380MM During the rework process for the April 17, 2017, field action, it was detected that the set scre... Class II Zimmer Biomet, Inc.
Aug 7, 2017 Affixus Hip Fracture Nail, RH 130 DEG 11MM X 360MM During the rework process for the April 17, 2017, field action, it was detected that the set scre... Class II Zimmer Biomet, Inc.
Aug 7, 2017 Affixus Hip Fracture Nail, RH 130 DEG 13MM X 440MM During the rework process for the April 17, 2017, field action, it was detected that the set scre... Class II Zimmer Biomet, Inc.
Aug 7, 2017 Affixus Hip Fracture Nail, RH 125 DEG 9MM X 460MM During the rework process for the April 17, 2017, field action, it was detected that the set scre... Class II Zimmer Biomet, Inc.
Aug 7, 2017 Affixus Hip Fracture Nail, 130 DEG 9MM X 180MM During the rework process for the April 17, 2017, field action, it was detected that the set scre... Class II Zimmer Biomet, Inc.
Aug 7, 2017 Affixus Hip Fracture Nail, RH 130 DEG 9MM X 320MM During the rework process for the April 17, 2017, field action, it was detected that the set scre... Class II Zimmer Biomet, Inc.
Aug 7, 2017 Affixus Hip Fracture Nail, RH 130 DEG 9MM X 340MM During the rework process for the April 17, 2017, field action, it was detected that the set scre... Class II Zimmer Biomet, Inc.
Aug 7, 2017 Affixus Hip Fracture Nail, LH 130 DEG 9MM X 400MM During the rework process for the April 17, 2017, field action, it was detected that the set scre... Class II Zimmer Biomet, Inc.
Aug 7, 2017 Makoplasty Partial Knee Application (PKA) Product Usage: The Robotic Arm ... Software discrepancy of not showing all the EE constants, when the screen is filled. Class II Mako Surgical Corporation
Aug 7, 2017 Persona Stemmed Tibial Provisional Size H Right, Item Number 42532108302 ... There is a potential for intermittent cracks in the raw material batch used to produce the affect... Class II Zimmer Biomet, Inc.
Aug 7, 2017 Affixus Hip Fracture Nail, RH 125 DEG 9MM X 320MM During the rework process for the April 17, 2017, field action, it was detected that the set scre... Class II Zimmer Biomet, Inc.
Aug 7, 2017 Affixus Hip Fracture Nail, LH 130 DEG 11MM X 400MM During the rework process for the April 17, 2017, field action, it was detected that the set scre... Class II Zimmer Biomet, Inc.
Aug 7, 2017 Spectranetics Bridge Occlusion Balloon catheter, Sheath Compatibility 12F, Gu... Possible inability to pass the guidewire through the Bridge device, therefore, resulting in a pot... Class I Spectranetics Corporation
Aug 7, 2017 Affixus Hip Fracture Nail, LH 130 DEG 11MM X 340MM During the rework process for the April 17, 2017, field action, it was detected that the set scre... Class II Zimmer Biomet, Inc.
Aug 7, 2017 Affixus Hip Fracture Nail, RH 125 DEG 11MM X 440MM During the rework process for the April 17, 2017, field action, it was detected that the set scre... Class II Zimmer Biomet, Inc.
Aug 7, 2017 Affixus Hip Fracture Nail, RH 130 DEG 11MM X 440MM During the rework process for the April 17, 2017, field action, it was detected that the set scre... Class II Zimmer Biomet, Inc.
Aug 7, 2017 Merge Unity software, formerly known as DR Systems Unity PACS software. The ... The software is not identifying the patient as having atypical hyperplasia, resulting in an incor... Class II Merge Healthcare, Inc.
Aug 7, 2017 Affixus Hip Fracture Nail, LH 125 DEG 11MM X 360MM During the rework process for the April 17, 2017, field action, it was detected that the set scre... Class II Zimmer Biomet, Inc.
Aug 7, 2017 Affixus Hip Fracture Nail, 125 DEG 11MM X 180MM During the rework process for the April 17, 2017, field action, it was detected that the set scre... Class II Zimmer Biomet, Inc.
Aug 4, 2017 Aspire HD (for FDR-1000AWS) The Fujifilm Digital Mammography System, Aspir... FUJIFILM Medical Systems U.S.A., Inc. (FMSU) identified a potential failure with our Mammography ... Class II Fujifilm Medical Systems U.S.A., Inc.
Aug 4, 2017 Aspire HD Plus, Aspire HD-s (for FDR-2000AWS) The Fujifilm Digital Mammog... FUJIFILM Medical Systems U.S.A., Inc. (FMSU) identified a potential failure with our Mammography ... Class II Fujifilm Medical Systems U.S.A., Inc.
Aug 4, 2017 ASPIRE Cristalle (for FDR-3000AWS) The Fujifilm Digital Mammography Syste... FUJIFILM Medical Systems U.S.A., Inc. (FMSU) identified a potential failure with our Mammography ... Class II Fujifilm Medical Systems U.S.A., Inc.
Aug 4, 2017 MODIFIED/SPECIAL INSTRUMENT, TURON GLENOID REAMER, REAM AND RUN, Catalog Numb... It was reported that the models used to manufacture S-200956/958 had the wrong dimension used to ... Class II Encore Medical, Lp
Aug 4, 2017 Ultradent Products, Inc. Paper Points, Size 30 PN #1555, 200 per container, ... The barcode label was placed underneath the sterile barrier and the product was re-wrapped. Class II Ultradent Products, Inc.
Aug 4, 2017 Ultradent Products, Inc. Paper Points, Size 45 PN #1558, 200 per container, ... The barcode label was placed underneath the sterile barrier and the product was re-wrapped. Class II Ultradent Products, Inc.
Aug 4, 2017 Ultradent Products, Inc. Paper Points, Size 20 PN #1560, 200 per container, ... The barcode label was placed underneath the sterile barrier and the product was re-wrapped. Class II Ultradent Products, Inc.
Aug 4, 2017 Ultradent Products, Inc. Paper Points, Size 25 PN #1554, 200 per container, ... The barcode label was placed underneath the sterile barrier and the product was re-wrapped. Class II Ultradent Products, Inc.
Aug 4, 2017 Fuji Computed Radiography Mammography Suite, FCRMS (for CR-IR363AWS) The ... FUJIFILM Medical Systems U.S.A., Inc. (FMSU) identified a potential failure with our Mammography ... Class II Fujifilm Medical Systems U.S.A., Inc.
Aug 4, 2017 Ultradent Products, Inc. Paper Points, Size 50 PN #1559, 200 per container, ... The barcode label was placed underneath the sterile barrier and the product was re-wrapped. Class II Ultradent Products, Inc.
Aug 4, 2017 OneStep CPR Complete, Adult Multi Function Electrodes, Part Numbers: 8900 021... A portion of one lot of ZOLL OneStep Complete Electrodes for adults will cause the defibrillator ... Class II ZOLL Medical Corporation
Aug 3, 2017 Gyrus ACMI Round Cutting Burrs - to be used with the Diego Elite system "Chattering" when cutting burrs are used in bone. Class II Gyrus ACMI, Inc.
Aug 3, 2017 Heliomolar Refill 20x0.25g 210/A3, Product code 541503AN, Catalog number 541503 Complaints were filed claiming the material consistency was too soft and too sticky in comparison... Class III Ivoclar Vivadent, Inc.
Aug 3, 2017 Power Processor 1K Stockyard. The Power Processor performs all pre-analyti... Beckman Coulter has identified that due to a PLC software nonconformity the 1K Stockyard can ini... Class II Beckman Coulter Inc.
Aug 3, 2017 Heliomolar Refill 20x0.25g 110T, Product code 550559AN, Catalog number 550559 Complaints were filed claiming the material consistency was too soft and too sticky in comparison... Class III Ivoclar Vivadent, 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.