Browse Device Recalls

3,010 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,010 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 3,010 FDA device recalls in 2019.

Date	Product	Reason	Class	Firm
Dec 20, 2019	LIFEPAK 15 MONITOR/DEFIBRILLATOR that was either manufactured with or receive...	Monitor/Defibrillator may not deliver a shock after the "Shock" button on the keypad is pressed a...	Class II	Physio-Control, Inc.
Dec 20, 2019	(1) Arrow¿ STIM CPNB TUOHY NDL: 18G x 14CM (5-1/2") AB-18140-N (2) Arrow¿ S...	Product lidstock contains the incorrect expiration date for the product	Class II	Arrow International Inc
Dec 20, 2019	Arrow EPIDURAL CATHETERIZATION KIT CK-02220	Product lidstock contains the incorrect expiration date for the product	Class II	Arrow International Inc
Dec 20, 2019	Arrow FlexTip Plus(R) Epidural Catheterization Kit ASK-05500-CAN	Product lidstock contains the incorrect expiration date for the product	Class II	Arrow International Inc
Dec 20, 2019	Arrow EPIDURAL CATHETERIZATION COMPONENT EC-05000	Product lidstock contains the incorrect expiration date for the product	Class II	Arrow International Inc
Dec 20, 2019	Arrow EPIDURAL CATHETERIZATION KIT YC-02220	Product lidstock contains the incorrect expiration date for the product	Class II	Arrow International Inc
Dec 20, 2019	Arrow FlexTip Plus(R) Epidural Catheterization Kit ASK-17019-MSC	Product lidstock contains the incorrect expiration date for the product	Class II	Arrow International Inc
Dec 20, 2019	LIFEPAK 15 MONITOR/DEFIBRILLATOR service kits	Monitor/Defibrillator may not deliver a shock after the "Shock" button on the keypad is pressed a...	Class II	Physio-Control, Inc.
Dec 20, 2019	Arrow PSI Kit for use with 7 - 7.5 Fr. Catheters ASK-09801-UPM	Product lidstock contains the incorrect expiration date for the product	Class II	Arrow International Inc
Dec 20, 2019	Arrow Central Venous Catheterization Kit ASK-04200-UPM	Product lidstock contains the incorrect expiration date for the product	Class II	Arrow International Inc
Dec 20, 2019	Arrow FlexTip Plus(R) Epidural Catheterization Kit ASK-05400-CA1	Product lidstock contains the incorrect expiration date for the product	Class II	Arrow International Inc
Dec 20, 2019	PICC Set- PR-35052-HPHNM	Product lidstock contains the incorrect expiration date for the product	Class II	Arrow International Inc
Dec 20, 2019	Siemens ARTIS pheno, Model # 10849000. Interventional Fluoroscopic X-Ray Sys...	The potential exists for system movement to be permanently blocked by an activation of the collis...	Class II	Siemens Medical Solutions USA, Inc
Dec 20, 2019	Arrow FlexTip Plus(R) Combined Spinal Epidural Catheterization Kit ASK-05560-WH	Product lidstock contains the incorrect expiration date for the product	Class II	Arrow International Inc
Dec 20, 2019	Arrow StimuCath(R) Continuous Nerve Block Kit ASK-05060-CHO1	Product lidstock contains the incorrect expiration date for the product	Class II	Arrow International Inc
Dec 19, 2019	LEGION PS High Flex XLPE size 5-6 9mm Articular Insert	LEGION PS High Flex XLPE Articular Insert was packaged with an incorrect part	Class II	Smith & Nephew, Inc.
Dec 19, 2019	STAINLESS STEEL REPROCESSING TRAY, 2D CAMERA HEAD, IS4000, Model No. 400499-...	Small but detectable holes in the sterilization wrap used with the firm's 8 mm endoscope steriliz...	Class II	Intuitive Surgical, Inc.
Dec 19, 2019	ASI 2.0 Calcar Trimmer Shaft for Use with Zimmer Rasp Mode Number: 110032332...	Potential issue associated with the instrument -end of the shaft could fail to effectively mate w...	Class II	Zimmer Biomet, Inc.
Dec 19, 2019	CombiDiagnost PCF, Software v. 1.0.5, Product Code 709030 - Product Usage: Xr...	When using the Table Up/Down button, the system may experience Error 80, which locks the geometry...	Class II	Philips Medical Systems Gmbh, DMC
Dec 19, 2019	RayStation stand-alone software treatment planning system. Models 4.0, 4.3, 4...	Three issues found: i) The Map ROI options in the ROI list in the Structure Definition module ma...	Class II	RAYSEARCH LABORATORIES AB
Dec 19, 2019	CombiDiagnost GCF, Software v. 1.0.5, Product Code 709030 - Product Usage: Xr...	When using the Table Up/Down button, the system may experience Error 80, which locks the geometry...	Class II	Philips Medical Systems Gmbh, DMC
Dec 19, 2019	RX Daytona Plus (with ISE/without ISE); Models Nos. RX4040 (w/ISE) and RX4041...	Software version UI2550642107 for the RX Daytona + instrument released to correct the following i...	Class II	Randox Laboratories, Limited
Dec 19, 2019	STAINLESS STEEL REPROCESSING TRAY, 8MM ENDOSCOPE, IS4000, Model No. 400498-02...	Small but detectable holes in the sterilization wrap used with the firm's 8 mm endoscope steriliz...	Class II	Intuitive Surgical, Inc.
Dec 18, 2019	Polysorb Braided Absorbable Suture 1 36 VIOLET GS-21, Item Code CL925 - Produ...	There is a potential for packaging integrity issues impacting the humidity or sterility barrier o...	Class II	Covidien LLC
Dec 18, 2019	ADVIA Chemistry Enzymatic Creatinine (ECRE_2) reagent, SMN 10335869	There is a potential for falsely depressed creatinine results for patients on phenindione therapy...	Class II	Siemens Healthcare Diagnostics, Inc.
Dec 18, 2019	Polysorb Braided Absorbable Suture 1 36 VIOLET GS-24, Item Code CL915 - Produ...	There is a potential for packaging integrity issues impacting the humidity or sterility barrier o...	Class II	Covidien LLC
Dec 18, 2019	Polysorb Braided Absorbable Suture UD 4/0 18 P-13, Item Code SL5690 - Product...	There is a potential for packaging integrity issues impacting the humidity or sterility barrier o...	Class II	Covidien LLC
Dec 18, 2019	Polysorb Braided Absorbable Suture UD 3/0 30 P-14, Item Code SL5679 - Product...	There is a potential for packaging integrity issues impacting the humidity or sterility barrier o...	Class II	Covidien LLC
Dec 18, 2019	Polysorb Braided Absorbable Suture 0 VIOLET 30" V-20, Item Code GL124 - Produ...	There is a potential for packaging integrity issues impacting the humidity or sterility barrier o...	Class II	Covidien LLC
Dec 18, 2019	Elekta Unity, Image-Guided Radiation Therapy System	There have been reports of excessive heating in the MRL Gradient Connection Module.	Class II	Elekta, Inc.
Dec 18, 2019	Polysorb Braided Absorbable Suture 2-0 UNDYED 36" GS-21, Item Code CL953 - Pr...	There is a potential for packaging integrity issues impacting the humidity or sterility barrier o...	Class II	Covidien LLC
Dec 18, 2019	Dimension Enzymatic Creatinine (EZCR) reagent, SMN 10471520	There is a potential for falsely depressed creatinine results for patients on phenindione therapy...	Class II	Siemens Healthcare Diagnostics, Inc.
Dec 18, 2019	Polysorb Braided Absorbable Suture 2-0 VIOLET 36" GS-21, Item Code CL923 - Pr...	There is a potential for packaging integrity issues impacting the humidity or sterility barrier o...	Class II	Covidien LLC
Dec 18, 2019	Polysorb Braided Absorbable Suture 2-0 VIOLET 30" V-20, Item Code GL123 - Pro...	There is a potential for packaging integrity issues impacting the humidity or sterility barrier o...	Class II	Covidien LLC
Dec 18, 2019	Polysorb Braided Absorbable Suture 2/0 UNDYED 30" V-30 (75CM), Item Code GL22...	There is a potential for packaging integrity issues impacting the humidity or sterility barrier o...	Class II	Covidien LLC
Dec 18, 2019	Polysorb Braided Absorbable Suture 13-0 VIOLET 30" GS-23, Item Code CL892 - P...	There is a potential for packaging integrity issues impacting the humidity or sterility barrier o...	Class II	Covidien LLC
Dec 18, 2019	Polysorb Braided Absorbable Suture 2/0 30"VIOLET GU-46, Item Code UL878 - Pro...	There is a potential for packaging integrity issues impacting the humidity or sterility barrier o...	Class II	Covidien LLC
Dec 18, 2019	Polysorb Braided Absorbable Suture 0 30" VIOLET GU-46, Item Code UL877 - Prod...	There is a potential for packaging integrity issues impacting the humidity or sterility barrier o...	Class II	Covidien LLC
Dec 18, 2019	Polysorb Braided Absorbable Suture 0 36 VIOLET GS-24, Item Code CL914 - Produ...	There is a potential for packaging integrity issues impacting the humidity or sterility barrier o...	Class II	Covidien LLC
Dec 18, 2019	Polysorb Braided Absorbable Suture 3/0 VIOLET 30" CV-24 (75CM), Item Code CL4...	There is a potential for packaging integrity issues impacting the humidity or sterility barrier o...	Class II	Covidien LLC
Dec 18, 2019	Polysorb Braided Absorbable Suture 4/0 30 VIOLET CVF23, Item Code UL203 - Pro...	There is a potential for packaging integrity issues impacting the humidity or sterility barrier o...	Class II	Covidien LLC
Dec 18, 2019	Polysorb Braided Absorbable Suture 6/0 12"" VL SS-24 D/A, Item Code L1742K - ...	There is a potential for packaging integrity issues impacting the humidity or sterility barrier o...	Class II	Covidien LLC
Dec 18, 2019	Polysorb Braided Absorbable Suture 1 30 VIOLET GS-22, Item Code CL885 - Produ...	There is a potential for packaging integrity issues impacting the humidity or sterility barrier o...	Class II	Covidien LLC
Dec 18, 2019	Polysorb Braided Absorbable Suture 2-0 UNDYED 30" V-20, Item Code GL323 - Pro...	There is a potential for packaging integrity issues impacting the humidity or sterility barrier o...	Class II	Covidien LLC
Dec 18, 2019	Atellica CH Enzymatic Creatinine (ECRE_2) reagent, SMN 11097533	There is a potential for falsely depressed creatinine results for patients on phenindione therapy...	Class II	Siemens Healthcare Diagnostics, Inc.
Dec 18, 2019	Polysorb Braided Absorbable Suture 3/0 30 VIOLET GS-11, Item Code CL815 - Pro...	There is a potential for packaging integrity issues impacting the humidity or sterility barrier o...	Class II	Covidien LLC
Dec 18, 2019	Polysorb Braided Absorbable Suture 2/0 30 VIOLET GS-21, Item Code CL811 - Pro...	There is a potential for packaging integrity issues impacting the humidity or sterility barrier o...	Class II	Covidien LLC
Dec 18, 2019	Biosyn Monofilament Absorbable Suture 6/0 30" VIOLET CV-23, Item Code UM201	There is a potential for packaging integrity issues impacting the humidity or sterility barrier o...	Class II	Covidien LLC
Dec 18, 2019	Polysorb Braided Absorbable Suture 3/0 30" UNDYED V-20, Item Code GLS322 - Pr...	There is a potential for packaging integrity issues impacting the humidity or sterility barrier o...	Class II	Covidien LLC
Dec 18, 2019	Polysorb Braided Absorbable Suture 4/0 30 VIO SC-2 124K, Item Code SL654 - Pr...	There is a potential for packaging integrity issues impacting the humidity or sterility barrier o...	Class II	Covidien LLC

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.