Browse Device Recalls
706 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 706 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 706 FDA device recalls in GA.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 18, 2019 | BRASSELER KM166-310-35 Twist Drill Quick Connect Diameter 3.5 mm, Total Lengt... | One lot of 3.5 mm twist drills were incorrectly laser etched as 2.5 mm the shaft of the device. | Class II | Brasseler USA I Lp |
| Oct 18, 2019 | Coated PGA Undyed Polyglycolic Acid Braided Absorbable Suture Sterile EO 18" ... | Failed to meet USP minimum average value for knot pull (tensile) strength. | Class II | CP Medical Inc |
| Oct 8, 2019 | CORFLO* Percutaneous Endoscopic Gastrostomy (PEG) Kit, Labeled as CORFLO* PEG... | The connector piece to the PEG tube does not pass over the guidewire. | Class II | Avanos Medical, Inc. |
| Oct 8, 2019 | CORFLO* Percutaneous Endoscopic Gastrostomy (PEG) Kit, Labeled as CORFLO* PEG... | The connector piece to the PEG tube does not pass over the guidewire. | Class II | Avanos Medical, Inc. |
| Sep 16, 2019 | SAROS Oxygen System Model 3000 | There is an electronics control issue that causes the unit to not power on with battery power only. | Class II | Caire, Inc. |
| Aug 23, 2019 | Monaco Radiation Treatment Planning System (RTP) System | Monaco is displaying the Anatomy and Beam shift direction incorrectly on the Monaco Scan and Setu... | Class II | Elekta, Inc. |
| Aug 21, 2019 | CanGaroo Envelopes labeled as the following: 1. CanGaroo Envelope (Large... | Possible suture brittleness or breakage along the Envelope seam before the expiration date of the... | Class II | AZIYO BIOLOGICS |
| Aug 21, 2019 | BioEnvelope, surgical mesh envelope. Labeled as the following: 1. BioEn... | Possible suture brittleness or breakage along the Envelope seam before the expiration date of the... | Class II | AZIYO BIOLOGICS |
| Aug 16, 2019 | Irrisept Wound Debridement and Cleansing System. 12 units per case. | Potential defect in the sterile pouch seal, which may result in a lack of sterility assurance. | Class II | IrriMAX Corporation |
| Jul 17, 2019 | Petfine Auto Injector, REF 3310VET | There is a possible assembly error on Autoject EI, lot number V14. This lot was packed into two ... | Class II | Owen Mumford USA, Inc. |
| Jul 17, 2019 | Autoject EI, REF AJ1310 | There is a possible assembly error on Autoject EI, lot number V14. This lot was packed into two ... | Class II | Owen Mumford USA, Inc. |
| Jun 24, 2019 | Elekta Unity, Image-Guided Radiation Therapy System Elekta Unity using Mag... | The QA software solution to perform the MR to MV alignment check, does not display the stored MR ... | Class II | Elekta, Inc. |
| Jun 19, 2019 | iGUIDE System with software build iGuide 2.2.0, 2.2.1, and 2.2.2 | Potential for iGUIDE to incorrectly monitor the 3D position. | Class II | Elekta, Inc. |
| May 23, 2019 | Various products which were contract sterilized. | The contract sterilizer did not have adequate packaging data to support the 2-year shelf life. | Class II | Anewmed Corporation |
| Apr 26, 2019 | ThermaCare HEATWRAPS, ADVANCED BACK PAIN THERAPY, SKU: a) F00573301020A b)... | There is the potential that a HeatWrap could include cells that have a higher cell temperature th... | Class II | PF Consumer Healthcare 1 LLC |
| Apr 26, 2019 | ThermaCare HEATWRAPS, ADVANCED BACK PAIN THERAPY, UPC 305733010037 - Product ... | There is the potential that a HeatWrap could include cells that have a higher cell temperature th... | Class II | PF Consumer Healthcare 1 LLC |
| Apr 1, 2019 | Dornier Diode Laser Fibers:Used with Dornier Medilas D Family Lasers Part Nu... | Pin hole package failures compromising sterility of product | Class II | Dornier Medtech America, Inc. |
| Mar 26, 2019 | EZ Derm Porcine Xenograft, labeled as the following: a. EZ Derm 3x4 (8x1... | Intermittent heat seal failures on the outer pouch of some EZ Derm products. | Class II | Molnlycke Health Care, Inc |
| Feb 8, 2019 | Monaco Radiation Treatment Planning (RTP) System | If Improve Target Dose was chosen as an optimization model in a previous treatment session, Mon... | Class II | Elekta, Inc. |
| Feb 6, 2019 | LW Scientific ZIP IQ Combo Centrifuge, ZIC-CMBO-2RT3 Rev B Product Usage: ... | The clear, plastic, polycarbonate hematocrit rotor may break apart during use and be ejected thro... | Class II | LW Scientific, Inc. |
| Feb 6, 2019 | LW Scientific ZIP IQ Combo Centrifuge, ZIC-CMBO-4RT3 Rev B Product Usage: ... | The clear, plastic, polycarbonate hematocrit rotor may break apart during use and be ejected thro... | Class II | LW Scientific, Inc. |
| Feb 6, 2019 | LW Scientific ZIP IQ PCV Centrifuge, ZIC-24HD-75T3 Rev C Product Usage: u... | The clear, plastic, polycarbonate hematocrit rotor may break apart during use and be ejected thro... | Class II | LW Scientific, Inc. |
| Feb 4, 2019 | Plain and Chromic Gut Absorbable Surgical Sutures, sterile. 12 sutures per bo... | Potential compromise of product sterility after routine monitoring for Endotoxins showed an out o... | Class II | CP Medical Inc |
| Jan 30, 2019 | OMNIPORE Surgical Implant Petite Paranasal - Right - Product Usage: OmniPore... | Product mislabeling. | Class II | Matrix Surgical Holdings, LLC |
| Jan 30, 2019 | OMNIPORE Surgical Implant Petite Paranasal - Left - Product Usage: OmniPore... | Product mislabeling. | Class II | Matrix Surgical Holdings, LLC |
| Jan 17, 2019 | On-X Aortic Heart Valve with Anatomic Sewing Ring Product Usage: The On-X... | On-X Valve was mislabeled with the incorrect serial number. | Class II | CryoLife, Inc. |
| Dec 13, 2018 | SureStep(TM) FOLEY TRAY SYSTEM, Preconnected Closed System Foley Tray, Produc... | potential for urine leakage around the vent on the vented sample port | Class II | Bard Medical Division |
| Dec 13, 2018 | MOSAIQ¿ Oncology Information System and Sequencer MOSAIQ is an oncology in... | There is a potential that Wedge IDs were not included in the DICOM RT PLAN sent from the TPS, whi... | Class II | Elekta, Inc. |
| Dec 6, 2018 | BARD SureStep Foley Tray System Bardex I.C. Complete Care Temperature Sensing... | Some SureStep" Foley Tray Systems with product catalog number A319418AM and lot number NGCT1929 c... | Class II | Bard Medical Division |
| Dec 4, 2018 | MOSAIQ Oncology Information System Version 2.64. MOSAIQ is an oncology i... | If a Setup field (CT, kV, MV or MVCT) is created by COPYING a treatment field or another setup fi... | Class II | Elekta, Inc. |
| 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 |
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.