Browse Device Recalls

2,729 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,729 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 2,729 FDA device recalls in 2014.

Clear

Date	Product	Reason	Class	Firm
Oct 14, 2014	Brivo NM615, is an all-purpose, single detector integrated nuclear imaging sy...	GE is issuing this recall due to a potential safety issue related to a portion of the system fall...	Class II	GE Healthcare, LLC
Oct 14, 2014	Optima NM/CT 640, Models H3100YA, H3100YC. Product Usage: The GE Optima...	GE is issuing this recall due to a potential safety issue related to a portion of the system fall...	Class II	GE Healthcare, LLC
Oct 14, 2014	St. Jude Medical, Fixed Curve Response 6F Electrophysiology Catheter, CSL, Mo...	St. Jude Medical is performing a voluntary recall of batch 4671318, model number 401353 of the Re...	Class II	St Jude Medical
Oct 14, 2014	Trabecular Metal Tibial Impactor Replacement Pads. Product Usage: TM Tibi...	To provide clarifying instructions relating to the assembly/disassembly of the Trabecular Metal T...	Class II	Zimmer, Inc.
Oct 14, 2014	Discovery NM/CT 670 dual detector free-geometry integrated nuclear imaging sy...	GE is issuing this recall due to a potential safety issue related to a portion of the system fall...	Class II	GE Healthcare, LLC
Oct 14, 2014	Discovery NM 630, dual detector free-geometry integrated nuclear imaging syst...	GE is updating the Preventative Maintenance procedure and schedule, and added an additional Preve...	Class II	GE Healthcare, LLC
Oct 13, 2014	Medtronic Launcher Coronary Guide Catheter; MODEL: LA6JR40K	Two reports have been received on the 6F launcher Guide Catheter lot (Model Number LA6JR40K; lot ...	Class II	Medtronic Vascular
Oct 10, 2014	Gel-E Donut : 92025-A (Extra Small), 92025-B (Small), 92025-C (Medium) an...	Mold on gel filled Gel-E and Squishon products	Class I	Philips Medical Systems, Inc.
Oct 10, 2014	The 5085 is a general surgical table with high patient weight capacity, exten...	The 5085 and 5085SRT stainless steel column shrouds may become damaged as a result of misalignmen...	Class II	Steris Corporation
Oct 10, 2014	Siemens SimView NT and SimView NT with IDI simulation system components: ...	Siemens became aware of a very rare occurrence where an intended movement of the SimView NT simul...	Class II	Siemens Medical Solutions USA, Inc
Oct 10, 2014	Medstream 81" (206 cm) 20 drop Universal Administration Sets. Disposable I...	Several complaints regarding the IV sets leaking at the Y site.	Class II	US Infusion Inc dba Trucare Biomedix-USA
Oct 10, 2014	Transport Chair and Rollator in 1, Model HE21630011 Burgundy and HE21630011 B...	Silver Star Brands is recalling the Transport Chair and Rollator in One because they have receive...	Class II	Silver Star Brands
Oct 10, 2014	AMS 700 Series Inflatable Penile Prosthesis Accessory Kit (AMS 700 Line Acces...	AMS' supplier has issued a recall of certain lots of Lightning Bolt Keith needles supplied in AMS...	Class II	American Medical Systems, Inc.
Oct 9, 2014	BD Insyte Autoguard Catheter An active safety engineered peripheral IV cat...	BD Insyte Autoguard may have potential damage along the body of the catheter.	Class II	Becton Dickinson & Company
Oct 9, 2014	TITAN Operating Room Table Patient positioning during surgery, ranging fro...	Unintended movement of the operating table during surgical cases due to the use of damaged TITAN ...	Class II	Trumpf Medical Systems, Inc.
Oct 9, 2014	Elite XPL (Pulsed Light) Handpiece for the Cynosure Elite MPX Laser System	If the laser system is turned on and the user adjusts, installs or removes the XPL pulsed light h...	Class II	Cynosure, Inc.
Oct 9, 2014	Optetrak Asymmetric Hi-Flex Posterior Stabilized Cemented Femorals, size 3, C...	Mislabeled	Class II	Exactech, Inc.
Oct 9, 2014	ADVIA Centaur XP Immunoassay System (including refurbished) Professional u...	A slight crack of the tubing at the connecting fitting on the reservoir connector assembly may oc...	Class II	Siemens Healthcare Diagnostics, Inc.
Oct 9, 2014	Persona Stemmed 5 Degree Cemented Tibia Product Usage: This device is i...	Cleaning process validation failure.	Class II	Zimmer, Inc.
Oct 9, 2014	MX 16-slice CT Scanner System and MX 16-slice CT Scanner System Phase 11 can ...	"The orientation of images is displayed incorrectly. When operator chooses gantry on the ri...	Class II	Philips Medical Systems (Cleveland) Inc
Oct 9, 2014	ADVIA Centaur (including refurbished) Professional use in a laboratory for...	A slight crack of the tubing at the connecting fitting on the reservoir connector assembly may oc...	Class II	Siemens Healthcare Diagnostics, Inc.
Oct 8, 2014	Wound Management Tray Ill, Catalog number 900-540. Used by medical staff t...	Customed products are being recalled because of compromised sterility, not limited to potentially...	Class I	Customed, Inc
Oct 8, 2014	Cataract Pack, Catalog # 900-944 Used by medical staff to perform patient ...	Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie...	Class I	Customed, Inc
Oct 8, 2014	Liposuction Pack, catalog #900-2656 Used by medical staff to perform patie...	Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie...	Class I	Customed, Inc
Oct 8, 2014	C-Section Surgical Pack, Catalog # 900-921A Used by medical staff to perfo...	Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie...	Class I	Customed, Inc
Oct 8, 2014	Wound Management Tray Ryder Memorial, Catalog number 900-1456. Used by med...	Customed products are being recalled because of compromised sterility, not limited to potentially...	Class I	Customed, Inc
Oct 8, 2014	Extremity PACK, catalog #900-2615 Used by medical staff to perform patient...	Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie...	Class I	Customed, Inc
Oct 8, 2014	Laparotomy Surgical Pack, catalog #900-281A Used by medical staff to perfo...	Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie...	Class I	Customed, Inc
Oct 8, 2014	Laparoscopy Chole Pack, Catalog number 900-1688. Used by medical staff to ...	Customed products are being recalled because of compromised sterility, not limited to potentially...	Class I	Customed, Inc
Oct 8, 2014	Surgeon Reinforced Gown XL, Catalog number 900-521. Used by medical staff ...	Customed products are being recalled because of compromised sterility, not limited to potentially...	Class I	Customed, Inc
Oct 8, 2014	Major Laparotomy Pack, Catalog number 900-036. Used by medical staff to pe...	Customed products are being recalled because of compromised sterility, not limited to potentially...	Class I	Customed, Inc
Oct 8, 2014	Transforaminal Lumbar Interbody Fusion (TLIF) pack, Catalog # 900-2918 Use...	Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie...	Class I	Customed, Inc
Oct 8, 2014	Irrigation Tray With Bulb Syringe, Catalog number 900-020. Used by medical...	Customed products are being recalled because of compromised sterility, not limited to potentially...	Class I	Customed, Inc
Oct 8, 2014	Uretheral Catheter Tray, Catalog number 900-278. Used by medical staff to ...	Customed products are being recalled because of compromised sterility, not limited to potentially...	Class I	Customed, Inc
Oct 8, 2014	Cesarean Pack, Catalog number 900-1689. Used by medical staff to perform p...	Customed products are being recalled because of compromised sterility, not limited to potentially...	Class I	Customed, Inc
Oct 8, 2014	Umbilical Vessel Catheter Kit, Catalog number 900-1408. Used by medical st...	Customed products are being recalled because of compromised sterility, not limited to potentially...	Class I	Customed, Inc
Oct 8, 2014	Arthroscopy Surgical Pack, Catalog # 900-740A Used by medical staff to per...	Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie...	Class I	Customed, Inc
Oct 8, 2014	Bard¿ PerFix Light Plug The Bard¿ PerFix Light Plug is indicated for rei...	The patient record peel-off label product code and size did not match the other labeling and actu...	Class II	Davol, Inc., Subs. C. R. Bard, Inc.
Oct 8, 2014	Premium OB Pack, Catalog number 900-1297. Used by medical staff to perform...	Customed products are being recalled because of compromised sterility, not limited to potentially...	Class I	Customed, Inc
Oct 8, 2014	Open Heart Tray, Catalog number 900-1196C Used by medical staff to perfor...	Customed products are being recalled because of compromised sterility, not limited to potentially...	Class I	Customed, Inc
Oct 8, 2014	Laparoscopy Pack, Catalog number 900-1967. Used by medical staff to perfor...	Customed products are being recalled because of compromised sterility, not limited to potentially...	Class I	Customed, Inc
Oct 8, 2014	Femoral Pack, Catalog number 900-164. Used by medical staff to perform pat...	Customed products are being recalled because of compromised sterility, not limited to potentially...	Class I	Customed, Inc
Oct 8, 2014	Gown Surgical Non Reinforced XXL, Catalog number 900-2566. Used by medical...	Customed products are being recalled because of compromised sterility, not limited to potentially...	Class I	Customed, Inc
Oct 8, 2014	Total Hysterectomy, catalog #900-2415 Used by medical staff to perform pat...	Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie...	Class I	Customed, Inc
Oct 8, 2014	Cystoscopy Pack III, catalog #900-2482 Used by medical staff to perform pa...	Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie...	Class I	Customed, Inc
Oct 8, 2014	Fanfold Drape, Catalog number 900-633. Used by medical staff to perform pa...	Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie...	Class I	Customed, Inc
Oct 8, 2014	Femoral Angiography Pack, Catalog number 900-796. Used by medical staff to...	Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie...	Class I	Customed, Inc
Oct 8, 2014	Laparotomy Basic Pack, Catalog number 900-547 Used by medical staff to pe...	Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie...	Class I	Customed, Inc
Oct 8, 2014	Laparotomy Pack, Catalog number 900-149. Used by medical staff to perform ...	Customed products are being recalled because of compromised sterility, not limited to potentially...	Class I	Customed, Inc
Oct 8, 2014	Laparoscopy Pack, Catalog number 900-484 Used by medical staff to perform...	Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie...	Class I	Customed, 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.