Browse Device Recalls

676 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 676 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 676 FDA device recalls in GA.

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Date	Product	Reason	Class	Firm
Jul 7, 2017	Mac Pin Non-Cannulated Screw, 6.5 x 60mm	Incorrect labeling for the lot of MAC Pins. Although the pins are laser as 460 mm in length, t...	Class II	Amendia, Inc
Jun 30, 2017	MOSAIQ Medical Charged-Particle Radiation Therapy System	The table shift in the vertical direction was inverted during the use of CMA (Couch Move Assistan...	Class II	Elekta, Inc.
Jun 21, 2017	MOSAIQ(R) Oncology Information System, Versions 2.50.05 and higher Product...	Retention of Outdated Information in an Order Set. In the Care Plan Library, double clicking to ...	Class II	Elekta, Inc.
Jun 19, 2017	iGUIDE Software 2.2 Product Usage: Control of accurate patient positioni...	Incorrect PEC values.	Class II	Elekta, Inc.
Jun 2, 2017	Arctic Sun ArcticGel Pads - Medium, Product Code 317-07	Label on product box contains the incorrect reference #317-09 while the shelf box label with barc...	Class III	C.R. Bard, Inc.
Jun 2, 2017	BARD DISPOZ-A-BAG Leg Bag with Flip-Flo Valve with Drain Extension, Extension...	Customer complaint of a cut in the side of the leg bag, indicating a potential breach of the prod...	Class II	C.R. Bard, Inc.
May 23, 2017	Leksell Gamma Knife Icon is a teletherapy device intended for stereotactic ir...	If the gantry module is replaced after original installation the configuration settings may be mi...	Class II	Elekta, Inc.
May 19, 2017	BioGlue Surgical Adhesive, Model/Catalog Number BG3510-5-J	The courtesy labels in 9 boxes of BioGlue were incorrectly labeled as lot 17MJX007 instead of lot...	Class II	CryoLife, Inc.
Apr 24, 2017	Brennen Skin Graft Mesher. Surgical instrument designed to expand skin gra...	Sterilization validation failure.	Class II	Molnlycke Health Care, Inc
Apr 6, 2017	01.4mm x 457mm (18in) K-Wire, Threaded Blunt, Ref 9080B-18T, Qty: 1 per pack...	Mislabeled guide wires - It was discovered that some Guide Wires labeled as stainless steel were ...	Class II	Amendia, Inc
Mar 31, 2017	Arctic Sun 5000 Temperature Management System, 100-120 V North America and 10...	Potential failure of the Arctic Sun 5000 Temperature Management System may occur when the continu...	Class II	C.R. Bard, Inc.
Mar 9, 2017	SURESTEP Tray, Bardex I.C. Complete Care Drainage Bag, 2000 ml Drainage Bag, ...	Misbranded: Product labeled, Not made with natural rubber latex, may in fact contain natural ru...	Class II	C.R. Bard, Inc.
Mar 2, 2017	Myelotec Video Guided Catheters, REF 2010 3.0 mm OD x 30 Cm Working Length, ...	Obstructed/blocked port from defective VGC Access Port Body component.	Class II	Myelotec, Inc.
Feb 2, 2017	PGCL [poly (glycolide-co-caprolactone)] Absorbable Suture, Manufacturer CP Me...	The tensile strength minimum as directed by USP <881> was not met over the length of the product'...	Class II	CP Medical Inc
Jan 25, 2017	OP7543 Design Y Mandible Onlay - Medium - Left and OP7544 Design Y Mandible O...	Mislabeling. The packaging labeled as left mandible contained a right mandible.	Class II	Matrix Surgical Holdings, LLC
Jan 10, 2017	Monaco RTP System. Used to make treatment plans for patients with prescrip...	Incorrect dose after editing beam number an wedge angle.	Class II	Elekta, Inc.
Jan 6, 2017	Color contact lenses labeled under the following brands: Diamond, Fierce, Amb...	Sterility and Misbranding: Lenses may not be sterile and may be labeled with erroneous lot number...	Class II	The See Clear Company
Dec 23, 2016	Oncentra External Beam Oncentra Brachy Product Usage: Oncentra is radiati...	Cross profile for Varian 60 degree wedge shows "horns."	Class II	Elekta, Inc.
Dec 21, 2016	Monaco RTP System Product Usage: Used to make treatment plans for patient...	Incorrect Enhanced Dynamic Wedge (EDW) or Virtual Wedge (VW) Calculations.	Class II	Elekta, Inc.
Dec 9, 2016	I-125 CE Marked QuickLink Cartridges; Sterile; Bard Brachysource Radioactive ...	Activity and quantity of seeds sent in shipments were incorrect.	Class II	C.R. Bard, Inc.
Dec 2, 2016	MOSAIQ Oncology Information System The product is used to manage workflow...	Edits to Particle field definition parameters may not be saved when the field definition window i...	Class II	Elekta, Inc.
Nov 22, 2016	Black Widow Plate 19mm Plate, Part Number TBP119; Black Widow Plate 23mm Plat...	There is a problem with the mating feature between the plate and screw which could cause the plat...	Class II	Amendia, Inc
Nov 22, 2016	Ceres-C Standalone Cervical Interbody The product is a stand-alone anterio...	Absent tantalum market pin.	Class II	Amendia, Inc
Nov 22, 2016	Savannah-T Straight Rod, 200mm, Part Number 10704-200; Savannah-T Straight Ro...	The rods are packaged in packages with unacceptable seals. In some cases, the integrity of the s...	Class II	Amendia, Inc
Nov 22, 2016	Optimus Fixed Awl	Complaints that the tip of the awl broke after impaction during surgery.	Class II	Amendia, Inc
Nov 22, 2016	Dual Stylet Needle, Part Number 812-11R-15 The guide wire is passed through ...	The rods are packaged in packages with unacceptable seals. In some cases, the integrity of the s...	Class II	Amendia, Inc
Nov 22, 2016	Zeus-P Lumbar Interbody Device	Labeling error where three boxes in inventory had conflicting patient and primary labels. Evaluat...	Class II	Amendia, Inc
Nov 22, 2016	Black Widow 6.6mm x 20mm Screw, Part Number TBS020; Black Widow 6.6mm x 25mm ...	There is a problem with the mating feature between the plate and screw which could cause the plat...	Class II	Amendia, Inc
Nov 22, 2016	K-Wire 1.4mm x 12in Non-Threaded, Part Number 9080-12U; K-Wire Threaded 1.4mm...	The rods are packaged in packages with unacceptable seals. In some cases, the integrity of the s...	Class II	Amendia, Inc
Nov 21, 2016	CryoPatch SG Pulmonary Hemi-Artery Patch	The device is recalled due to donor ineligibility of released human tissue. The firm received inf...	Class II	CryoLife, Inc.
Nov 17, 2016	Monaco TRP System The Monaco system is used to make treatment plans for pati...	Contours are not handled correctly if the CT dataset contains slices with DICOM Z coordinates of ...	Class II	Elekta, Inc.
Nov 10, 2016	Sterling Nitrile Sterile Powder Free Exam Gloves, S, Sterile.	Defects: Product may be discolored and brittle resulting in the inability of the user to don the ...	Class II	Halyard Health
Nov 9, 2016	Halyard C-Section Drape with Clear Screen and Full Incise (Non-Sterile), Prod...	Drapes within the affected lots may include a manufacturing variation that prevents convenient re...	Class II	Halyard Health, Inc
Nov 3, 2016	Monaco RTP System; Used to make treatment plans for patients with prescriptio...	Incorrect Dose when using the reset function.	Class II	Elekta, Inc.
Oct 13, 2016	Bard Inlay Optima¿ Multi-Length Ureteral Stent Coated Double Pigtail Ureteral...	Labeling: Statement was added to the Warnings/Precautions section requesting end users to conside...	Class II	C.R. Bard, Inc.
Oct 13, 2016	Bard Fluoro-4 Silicone Ureteral Stent, Bard¿ Fluoro-4", Silicone Ureteral Coi...	Labeling: Statement was added to the Warnings/Precautions section requesting end users to conside...	Class II	C.R. Bard, Inc.
Oct 13, 2016	BARD INLAY Ureteral Stent with Suture, Manufacturer: C.R. Bard, Inc., Covingt...	Labeling: Statement was added to the Warnings/Precautions section requesting end users to conside...	Class II	C.R. Bard, Inc.
Oct 13, 2016	Totalis, RIGID and Totalis"I Flex ENDO KIT, Manufacturer: C.R. Bard, Inc., Co...	Labeling: Statement was added to the Warnings/Precautions section requesting end users to conside...	Class II	C.R. Bard, Inc.
Oct 12, 2016	X-Force Nephrostomy Balloon Dilation Catheter Kit with Inflation Device, PTFE...	Contract manufacturer packaged an incorrect sheath with the product. Packaged 30Fr instead of 24Fr.	Class II	C.R. Bard, Inc.
Oct 12, 2016	C-Max" Cutting Loop Electrodes, Storz One-Stem, 24 Fr, .014in., .35 mm, Steri...	Defect; The contact part could possibly separate from the electrode affecting to functionality of...	Class II	C.R. Bard, Inc.
Oct 5, 2016	Magic3 Antibacterial Hydrophilic Intermittent Catheter, Male 14 Fr. (30/Box),...	Misbranding; the product labeled as an Antibacterial Hydrophilic Intermittent Catheter, is instea...	Class II	C.R. Bard, Inc.
Sep 29, 2016	Monaco RTP System The Monaco system is used to make treatment plans for pati...	When creating 3D plans using either MU or Dose weighting modes, if the user changes the Physician...	Class II	Elekta, Inc.
Aug 18, 2016	Monaco RTP System Used to make treatment plans for patients with prescript...	In a specific workflow where contours are edited (enlarged, moved, copied, etc.) and then the con...	Class II	Elekta, Inc.
Aug 18, 2016	HexaPOD evo RT System Product Usage: The intended use of the device is th...	Potentially unrecognized incorrect position of the treatment couch in 3D workflow, i.e. the HexaP...	Class II	Elekta, Inc.
Aug 9, 2016	MED 5223 - VacuFlow Safe, Multi-Sample Blood Collection Set With Luer Adapter...	The multi-sample needle retractable sheath may not fully retract over the needle during the chang...	Class II	Global Healthcare Inc
Aug 3, 2016	BARDIA¿ 60cc Piston Irrigation Syringe, Sterile, Rx Only, The BARD¿ Syringe i...	Package Defect: Products may be at risk for having a slit defect on the package and that may affe...	Class II	C.R. Bard, Inc.
Aug 3, 2016	BARD¿ Piston Syringe, 60cc, Rx Only, Sterile, The BARD¿ Syringe is available ...	Package Defect: Products may be at risk for having a slit defect on the package and that may affe...	Class II	C.R. Bard, Inc.
Aug 3, 2016	BARD¿ Irrigation, Syringe 70cc With Resectoscope Tip, Catheter Tip, Luer Adap...	Package Defect: Products may be at risk for having a slit defect on the package and that may affe...	Class II	C.R. Bard, Inc.
Aug 3, 2016	BARD¿ 70cc Piston Syringe with Catheter Tip, Luer Adapter and Cap, Rx Only, T...	Package Defect: Products may be at risk for having a slit defect on the package and that may affe...	Class II	C.R. Bard, Inc.
Jul 15, 2016	MOSAIQ Oncology Information System	It is possible that a change to an Order Set will not be saved in the current open Care Plan. Thi...	Class II	Elekta, 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.