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
Oct 24, 2018	NEOCONNECT, Enteral Extension with ENFit connector, REF EXT-60NC The NeoM...	The sterile pouch label states the expiration date is 2016-11-19, but the correct expiration date...	Class III	Neomed Inc
Oct 9, 2018	Theragenics Applicator Needle (18g x 20cm) The device is comprised four ba...	Some of the pouches containing Brachytherapy Applicator Needles (18g x 20cm) were not sealed	Class II	Theragenics Corporation
Sep 6, 2018	CryoPatch SG Pulmonary Hemi-Artery, 1 graft	The conduit length and branch length of a SG Pulmonary Hemi-Artery were switched on the product l...	Class II	CryoLife, Inc.
Aug 3, 2018	MOSAIQ Oncology Information System	Order Status Remains Approved When Should Indicate Complete.	Class II	Elekta, Inc.
Jul 16, 2018	Valeris Medical Apollo Medial Suture Anchor, Catalog Number MSA-4515, 4.5 x 1...	The product was mislabeled as containing the incorrect type of suture.	Class II	Valeris Medical, LLC
Jun 14, 2018	CardioMEMS HF System Hospital and Patient Electronics Units: (a) Patient Ele...	Abbott is advising customers that a small number of CardioMEMS(R) Hospital Electronics Systems (M...	Class II	Abbott Laboratories, Inc.
Jun 13, 2018	Arctic Sun Temperature Management System, Model 5000. The Arctic Sun¿ 500...	An improper wiring connection on the chiller assembly may result in overheating of the connection...	Class II	Bard Medical Division
Jun 4, 2018	BioGlue Spreader Tip, 12mm, Sterile, RX Only. Product Usage: BioGlue is i...	The CryoLife L6318 (Label, BioGlue 12mm Spreader Tip, Indicator Label 2 1/8" x 1 1/4") was incorr...	Class II	CryoLife, Inc.
Jun 4, 2018	NeoMed Enteral Feeding Tubes with Enteral Only Connectors, French sizes 4.0Fr...	Potential for the tethered plug on the hub of the NeoMed Enteral Feeding Tubes with Enteral Only ...	Class II	Neomed Inc
May 16, 2018	HexaPOD evo RT Couch Top (also known as HexaPOD evo Module), a component of t...	Upon completion of a 6D workflow, the HexaPOD evo Module may be in a tilted state if it is moved ...	Class II	Elekta, Inc.
May 14, 2018	Cryopatch SG Pulmonary Human Cardiac Branch, Catalog Number SGP020	Devices, which met FDA and AATB eligibility criteria, were distributed. Final autopsy and toxico...	Class II	CryoLife, Inc.
May 14, 2018	Cryovalve(R) SG Pulmonary Human Heart Valve, Catalog Number SGPVVOO	Devices, which met FDA and AATB eligibility criteria, were distributed. Final autopsy and toxico...	Class II	CryoLife, Inc.
Apr 16, 2018	AMENDIA Omega Lumbar Interbody Fusion Device, Part Number 72-00-2-092812-11 ...	Omega LIF interbody implants labeled as having 11 degrees of lordosis was assembled using compone...	Class II	Spinal Elements
Mar 21, 2018	Bard Midstream Urine Collector with Rigid Funnel and Iodophor Prep Pads. Pro...	Medline notified BMD that the Aplicare Povidone Iodine (PVP-I) Prep Pads were not meeting the iod...	Class II	Bard Medical Division
Feb 27, 2018	Bard(R) Premature Infant Feeding Tube, ENFit(TM), REF EN0036400 Product U...	BMD has identified that the product code/lot number combination identified above may have ineffec...	Class II	C.R. Bard, Inc.
Feb 27, 2018	Bard(R) Infant Feeding Tube, ENFit(TM), REF EN0036410 Product Usage: BAR...	BMD has identified that the product code/lot number combination identified above may have ineffec...	Class II	C.R. Bard, Inc.
Feb 27, 2018	Bard(R) Adult/Pediatric Feeding Tube, ENFit(TM), REF EN0036420 Product Us...	BMD has identified that the product code/lot number combination identified above may have ineffec...	Class II	C.R. Bard, Inc.
Feb 27, 2018	Bard(R) Premature Infant Feeding tube, ENFit(TM), REF EN0036430 Product U...	BMD has identified that the product code/lot number combination identified above may have ineffec...	Class II	C.R. Bard, Inc.
Feb 7, 2018	Halyard Closed Suction System for Adults, Double Swivel Elbow (DSE). Used to ...	Certain Flex Connectors supplied with Halyard Closed Suction Kits with Flex Connector may become ...	Class II	Halyard Health, Inc
Feb 7, 2018	Halyard Closed Suction System for Adults, Multi-Access¿Port¿Closed¿Suction¿Sy...	Certain Flex Connectors supplied with Halyard Closed Suction Kits with Flex Connector may become ...	Class II	Halyard Health, Inc
Feb 7, 2018	Halyard Closed Suction System for Adults, Turbo- cleaning¿Closed¿Suction¿Syst...	Certain Flex Connectors supplied with Halyard Closed Suction Kits with Flex Connector may become ...	Class II	Halyard Health, Inc
Jan 22, 2018	Apollo XT Suture Anchor, 5.5 x 15 Product Usage: Apollo XT Suture Anchors...	The label on Apollo XT 5.5mm Suture Anchor (part # XTS-5515; lots 2358, 2362, and 2363) indicated...	Class II	Valeris Medical, LLC
Dec 13, 2017	CORTRAK* 2 Nasogastric/Nasointestinal (NG/NI) Feeding Tubes with Electromagne...	The transmitting stylet within CORTRAK* 2 nasogastric/Nasointestinal (NG/NI) Feeding Tubes with A...	Class II	Halyard Health, Inc
Dec 13, 2017	Bardex Lubricath 3-Way 75cc Continuous Irrigation Foley Catheter (Creevy), 22...	Foley Catheter with Incorrect Retainer Cap Print	Class II	C.R. Bard, Inc.
Dec 1, 2017	ELEKTA Digital Accelerator under the following brand names: Elekta Synergy, S...	There is a potential for an uncontrolled extension of iViewGT / XVI detector arms.	Class II	Elekta, Inc.
Nov 13, 2017	Piranha Screw 4.0 x 12mm, used in Piranha Surgical Plate System The Piranh...	Potential incorrect marking and color identification of Piranha screw. Some screws marked as 12 ...	Class II	Amendia, Inc dba Spinal Elements
Nov 10, 2017	BARD(R) CRITICORE(R) MONITOR, Model: 000002N Series The CritiCore(R) Autom...	BMD has identified that some lots of CritiCore(R) monitors may experience failures involving urin...	Class II	C.R. Bard, Inc.
Nov 10, 2017	CritiCore Automated Urine Output and Temperature Monitor	Issues identified with the monitor including urine output measurement errors, temperature measure...	Class II	C.R. Bard, Inc.
Nov 8, 2017	Medivance(R) ARCTIC SUN(R) ARCTICGEL(TM) Pads: Description, Catalog Number ...	Specific lots of ArcticGel Pads have potential issues which may result in the insufficient adhesi...	Class II	Bard Medical Division
Nov 6, 2017	Unifine Pentips 5mm x 31G pen needles, packaged in 30 ct pen needles. Pro...	Device may potentially be compromised by water in end user packaging. Exposure to liquid may comp...	Class II	Owen Mumford USA, Inc.
Nov 6, 2017	Unifine Pentips 5mm x 31G pen needles, packaged in 100 ct pen needles. Pro...	Device may potentially be compromised by water in end user packaging. Exposure to liquid may comp...	Class II	Owen Mumford USA, Inc.
Oct 16, 2017	Medivance ArcticGel Small Pad Kit - a box containing a single foil pouch, whi...	Hydrogel peeling from the pads.	Class II	C.R. Bard, Inc.
Oct 6, 2017	Halyard Closed Suction System for Adults, 14 F, T-Piece, MDI, Wet Pak. 12 via...	Received recall notification from Smiths Medical that lots of 15ml Saline Vials may be susceptibl...	Class II	Halyard Health, Inc
Oct 6, 2017	Halyard Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE, Wet Pak. ...	Received recall notification from Smiths Medical that lots of 15ml Saline Vials may be susceptibl...	Class II	Halyard Health, Inc
Oct 6, 2017	Halyard Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE, MDI, Wet ...	Received recall notification from Smiths Medical that lots of 15ml Saline Vials may be susceptibl...	Class II	Halyard Health, Inc
Oct 6, 2017	NOVAPLUS* Endotracheal WET PAK* Closed Suction System for Adults with BALLARD...	Received recall notification from Smiths Medical that lots of 15ml Saline Vials may be susceptibl...	Class II	Halyard Health, Inc
Oct 6, 2017	Halyard Closed Suction System for Adults, 14 F, Elbow, Directional Tip, Wet P...	Received recall notification from Smiths Medical that lots of 15ml Saline Vials may be susceptibl...	Class II	Halyard Health, Inc
Oct 6, 2017	Halyard Turbo-Cleaning Closed Suction System for Adults, 14 F, T-Piece, Wet P...	Received recall notification from Smiths Medical that lots of 15ml Saline Vials may be susceptibl...	Class II	Halyard Health, Inc
Oct 6, 2017	Halyard Closed Suction System for Adults with BALLARD Technology WET PAK. 12 ...	Received recall notification from Smiths Medical that lots of 15ml Saline Vials may be susceptibl...	Class II	Halyard Health, Inc
Oct 6, 2017	Halyard Closed Suction System for Adults, 14 F, DSE, Wet Pak. 12 or 6 vials p...	Received recall notification from Smiths Medical that lots of 15ml Saline Vials may be susceptibl...	Class II	Halyard Health, Inc
Oct 6, 2017	Halyard Closed Suction System for Adults, 14 F, T-Piece, Wet Pak. 12 or 6 via...	Received recall notification from Smiths Medical that lots of 15ml Saline Vials may be susceptibl...	Class II	Halyard Health, Inc
Sep 29, 2017	BARD UROS AUTOMATED URINE OUPTUT AND TEMPERATURE MONITOR, MODEL BK10001M ...	The possibility exists that use of the Uros Automated Urine Output and Temperature Monitor may le...	Class II	C.R. Bard, Inc.
Sep 14, 2017	Magic 3 Intermittent Catheters- 12 Male - 30 catheters per box, each catheter...	Several instances of a catheter caught in the sterile barrier seal and in some instances cut cath...	Class II	C.R. Bard, Inc.
Sep 14, 2017	Personal Intermittent Catheters- 16" and 10" lengths - 30 catheters per box, ...	Several instances of a catheter caught in the sterile barrier seal and in some instances cut cath...	Class II	C.R. Bard, Inc.
Sep 14, 2017	HydroSil Gripper Intermittent Catheters- 10" lengths - 30 catheters per box,...	Several instances of a catheter caught in the sterile barrier seal and in some instances cut cath...	Class II	C.R. Bard, Inc.
Jul 28, 2017	Bard Magic 3 Antibacterial Hydrophilic Intermittent Catheter Female, 14 FR (3...	Specific lots labeled as an Antibacterial Hydrophilic Intermittent Catheter may lack the hydrophi...	Class II	C.R. Bard, Inc.
Jul 26, 2017	7x10" Small Utility Positioner with Cover	Products may not meet specifications due to possible presence of metal shavings.	Class II	Molnlycke Health Care, Inc
Jul 26, 2017	9x15" Medium Utility Positioner with Cover	Products may not meet specifications due to possible presence of metal shavings.	Class II	Molnlycke Health Care, Inc
Jul 17, 2017	Covidien Vistec" X-Ray Detectable Sponges, 7317 Vistec" X-Ray Detectable Spon...	Medtronic is voluntarily recalling two production lots of its Covidien Vistec" x-ray detectable s...	Class II	Covidien LP
Jul 7, 2017	Ceres Self-Drilling Variable Screw 4.0 x 12mm The Ceres screws are self-dr...	Incorrect direct marking and color identification for the affected lot of Ceres Self-Drilling Var...	Class II	Amendia, 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.