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 12, 2017 MesaLabs Conductivity Standard Solution, 14 mS/cm, 32 ounces (950 ml). Produ... Mesa Laboratories is recalling Conductivity/TDS Calibrator Solution due to failure to meet produc... Class II Mesa Laboratories, Inc.
May 12, 2017 Tubing Pack Convenience Kit, Product Code 65217 Product Usage: Intended f... Kit was labeled with the incorrect Expiration Date of April 30, 2019. Class II Terumo Cardiovascular Systems Corp
May 12, 2017 DePuy Mitek LATARJET EXPERIENCE Top Hat Tap Product Code: 288203 Product U... Combo Screw Driver (Product Code 288211) tip has the increased potential to break intra-operative... Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
May 12, 2017 DePuy Mitek LATARJET EXPERIENCE Coracoid Drill Product Code: 288201 Product... Combo Screw Driver (Product Code 288211) tip has the increased potential to break intra-operative... Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
May 12, 2017 DePuy Mitek LATARJET EXPERIENCE Extraction Driver Product Code: 288216 Pro... Combo Screw Driver (Product Code 288211) tip has the increased potential to break intra-operative... Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
May 11, 2017 Brivo MR355, Optima MR360 Product Usage: The Brivo MR355/Optima MR360 is ... Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potent... Class II GE Medical Systems, LLC
May 11, 2017 Signa PET/MR (K163619, K142098) Product Usage: The SIGNA PET/MR system co... Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potent... Class II GE Medical Systems, LLC
May 11, 2017 Discovery MR750 3.0T Product Usage: Intended use: The Discovery MR750 3.0... Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potent... Class II GE Medical Systems, LLC
May 11, 2017 Clear Flashback Needle 7cm x 18G AMC/4; Clear Flashback Needle 2.5 cm x 21G A... Argon Medical has received a complaint from one of their distributors of a potential packaging de... Class II Argon Medical Devices, Inc
May 11, 2017 SIGNA Creator, SIGNA ExplorerProduct Usage: 1.5T SIGNA Creator and 1.5T SIGN... Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potent... Class II GE Medical Systems, LLC
May 11, 2017 1.5T Signa HDx, 3.0T Signa HDx, 1.5T Signa HDxt, 3.0T Signa HDxt, Signa HDi, ... Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potent... Class II GE Medical Systems, LLC
May 11, 2017 1.5T Signa HDxt, 3.0T Signa HDxt, Signa HDi, Signa Vibrant Product Usage:... Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potent... Class II GE Medical Systems, LLC
May 11, 2017 Sheridan SHER-I-SLIP and SOFT-TIP Intubating Stylets are intubating stylets m... Product size listed on the labeling is incorrect. Class II Teleflex Medical
May 11, 2017 BD Phoenix PMIC-107, Catalog Number 448417, UDI #s (01)30382904484171, (10)70... BD has recently confirmed quality control failures, related to a manufacturing issue, for the ind... Class II Becton Dickinson & Co.
May 11, 2017 Normed General Instruments 503004541: Werber Countersink Cannulated for micr... the devices used a different raw material to produce two countersink products which has higher h... Class II Zimmer Gmbh
May 11, 2017 Optima MR450w 1.5T Product Usage: The Optima MR450w 1.5T system is a whol... Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potent... Class II GE Medical Systems, LLC
May 11, 2017 Optima MR750 3.0T Product Usage: The Optima MR450 1.5T system is a whole... Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potent... Class II GE Medical Systems, LLC
May 11, 2017 Optima MR450 1.5T Product Usage: 1 .5T Brivo MR355 and 1.5T Optima MR360 ... Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potent... Class II GE Medical Systems, LLC
May 11, 2017 Philips DigitalDiagnost 3.1.x X-Ray System During recent evaluations of the Philips DigitalDiagnost 3.1.x, we have identified a potential is... Class II Philips Electronics North America Corporation
May 10, 2017 Vitality Spinal Fixation System, Vitality T27 Final Drivers and Vitality Torq... Zimmer Biomet is conducting a medical device recall for Vitality T27 Final Drivers and Vitality T... Class II Zimmer Biomet Spine Inc.
May 10, 2017 Non-Rebreathing Mask, Reservoir Bag, Check Valve, Two Side Valves, with Tubin... Class II ConvaTec, Inc
May 10, 2017 Oxygen Masks, Elongated (Under Chin), Adult High Conc., Non-Rebreather, 7ft O... Class II ConvaTec, Inc
May 10, 2017 Rebreather Oxygen Mask, Adult 7 (2.1 m) Tubing, Product Code 3104MM, Product... Class II ConvaTec, Inc
May 10, 2017 Non-Rebreather Oxygen Mask, Pediatric with Tubing, Product Code 86-3226E, Pro... Class II ConvaTec, Inc
May 10, 2017 Oxygen Mask, Adult High Concentration Non-Rebreather 2.1 m (7) Oxygen Tubing,... Class II ConvaTec, Inc
May 10, 2017 Rebreathing Mask, Reservoir bag, with Tubing, Product Code 104MM Class II ConvaTec, Inc
May 10, 2017 Pediatric, High Conc. Non-Rebreather, 7 ft. (2.1 m) Oxygen Tubing w/FITS-ALL ... Class II ConvaTec, Inc
May 10, 2017 Non-Rebreather Mask w 7 (2.1 m) No-Crush Tubing, Adult, Product Code 9106-... Class II ConvaTec, Inc
May 10, 2017 Non-Rebreather, Oxygen Mask, Adult 7 (2.1 m) Tubing, Product Code 3108-E, Pro... Class II ConvaTec, Inc
May 10, 2017 Oxygen Mask, Elongated (Under the Chin) Pediatric, High Concentration Rebreat... Class II ConvaTec, Inc
May 10, 2017 Oxygen Masks, Elongated (under chin), Adult Med Conc., No Tubing, Product Cod... Reports of tubing detaching from oxygen masks either prior to use (in packaging) or during use we... Class II ConvaTec, Inc
May 10, 2017 Non-Rebreather Mask, Reservoir Bag, Check Valve, Two Side Valves, No Tubing, ... Class II ConvaTec, Inc
May 10, 2017 Oxygen Mask, Standard (Under the Lip) Infant, High Concentration Non-Rebreath... Class II ConvaTec, Inc
May 10, 2017 Oxygen Masks, Elongated (Under Chin) Adult High Conc., Non-Rebreather, 7ft O2... Class II ConvaTec, Inc
May 10, 2017 Non-Rebreathing Mask, Reservoir Bag, Check Valve, One Side Valve, with Tubing... Class II ConvaTec, Inc
May 10, 2017 Oxygen Mask, Elongated (Under the Chin) Pediatric, High Concentration Rebreat... Class II ConvaTec, Inc
May 10, 2017 Oxygen Masks, Elongated (Under Chin), Adult Med Concentration, No Tubing, FIT... Class II ConvaTec, Inc
May 10, 2017 Non-Rebreather Oxygen Mask, Adult High Concentration with 2.1 m (7) Oxygen Tu... Class II ConvaTec, Inc
May 10, 2017 Install CD, Spine tools, Plus and S7, Version 25. Model Number 9731958. Software issue related to the StealthStation S7 system and the Synergy Spine application Version ... Class II Medtronic Navigation, Inc.
May 9, 2017 Access System-Free T4 Assay, B01902E, Catalog No. 33880 The Access immunoassays are susceptible to biotin interference. Class II Beckman Coulter Inc.
May 9, 2017 Cobas connection module (CCM) - OUTPUT UNIT The module CCM enables a unidire... a gap between the conveyor belt and the rack tray table (plastic part) may cause vibration of the... Class II Roche Diagnostics Corporation
May 9, 2017 ARROWg+ard Blue CVC Kit The ARROWg+ard Blue CVCs are intended to permit veno... The Arrow CVC is indicated to provide short-term (<30 days) central venous access for treatment o... Class II Arrow International Inc
May 9, 2017 Covidien Endo Peanut 5mm Auto Suture Blunt Dissector Item Code: 173019 The ... Cotton tip of the device may disengage due to insufficient adhesive Class II Covidien LLC
May 9, 2017 Arrow Multi-Lumen CVC Kit The Arrow Two-Lumen Central Venous Access device p... The Arrow CVC is indicated to provide short-term (<30 days) central venous access for treatment o... Class II Arrow International Inc
May 9, 2017 Access Total T3, A34435H, Catalog No. 33830 The Access immunoassays are susceptible to biotin interference. Class II Beckman Coulter Inc.
May 9, 2017 Access Thyroglobulin, A34085G, Catalog No. 33860 The Access immunoassays are susceptible to biotin interference. Class II Beckman Coulter Inc.
May 9, 2017 Arrow MAC Two-Lumen Central Venous Access Kit Introducer Catheter The Arrow... Arrow International is recalling the affected product because the packaging may not be completely... Class II Arrow International Inc
May 9, 2017 1) ARROWg+ard Blue You-Blend Two-Lumen Hemodialysis Catheterization Kit for H... Arrow International is recalling the affected product because the packaging may not be completely... Class II Arrow International Inc
May 9, 2017 Cook Multi-Use Holmium Laser Fibers, Supplied sterilized by ethylene oxide ga... Correction to the product Instructions for Use because the current reprocessing instructions do n... Class II Cook Inc.
May 9, 2017 1) ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit 2) ARROWg+ard Blu... Arrow International is recalling the affected product because the packaging may not be completely... Class II Arrow International 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.