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 5, 2024 | CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM CardioMEMSTM HF System Patient Ele... | As a result of a cloud data migration of Patient and Hospital Electronic Systems (PES and HES) re... | Class II | St. Jude Medical |
| Oct 5, 2024 | CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM CardioMEMSTM HF System Hosptial El... | As a result of a cloud data migration of Patient and Hospital Electronic Systems (PES and HES) re... | Class II | St. Jude Medical |
| Oct 4, 2024 | CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-101. | Potential failure of affected units to recharge the battery of the oxygen concentrators. | Class II | Caire, Inc. |
| Oct 4, 2024 | CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-1. | Potential failure of affected units to recharge the battery of the oxygen concentrators. | Class II | Caire, Inc. |
| Oct 4, 2024 | CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-103. | Potential failure of affected units to recharge the battery of the oxygen concentrators. | Class II | Caire, Inc. |
| Oct 4, 2024 | CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-2. | Potential failure of affected units to recharge the battery of the oxygen concentrators. | Class II | Caire, Inc. |
| May 31, 2024 | MIC-KEY* Gastric-Jejunal Feeding Tube Kit, Endoscopic / Radiologic Placement,... | The IFU was missing some risk information requested by another country to be contained in the IFU... | Class II | Avanos Medical, Inc. |
| May 28, 2024 | CryoValve SG Pulmonary Human Heart Valve, SGPV00, Cryopreserved Decellularize... | Grafts were found to have been approved, released, shipped and implanted with an invalid test res... | Class II | Artivion, Inc |
| May 28, 2024 | (1) CryoPatch SG Pulmonary Human Cardiac Hemi-Artery - Artery Patch, SGPH00 C... | Grafts were found to have been approved, released, shipped and implanted with an invalid test res... | Class II | Artivion, Inc |
| May 9, 2024 | Bard Medical SureStep Foley Tray System, 16 Fr., Catalog #A319416AM; and Bard... | Some of the devices may function incorrectly resulting in no temperature display or erratic tempe... | Class II | C.R. Bard Inc |
| Apr 26, 2024 | CDC, Influenza A/H5 Subtyping Kit, Model/Catalog Number: FluIVD03-11 | The H5b component may fail to amplify, resulting in an inconclusive result. | Class II | Centers For Disease Control and Prevention |
| Apr 18, 2024 | Optum Nimbus II Plus, Model number AAA-00170; Ambulatory Infusion Pump | Nimbus II Plus, Infusion Pump Systems, manufactured by InfuTronix, are being removed the from the... | Class I | OptumHealth Care Solutions LLC |
| Apr 17, 2024 | Yamaha Surface Mounter YR series, YS series, i-Pulse series, Sigma series, S ... | Non-medical laser products which were determined to not be in compliance with 21 C.F.R. ¿ 1010.2 ... | Class II | YAMAHA MOTOR CORPORATION |
| Apr 17, 2024 | Optical Inspection System, YSi series, YRi series. Affected models: YSi-V, YS... | Non-medical laser products which were determined to not be in compliance with 21 C.F.R. ¿ 1010.2 ... | Class II | YAMAHA MOTOR CORPORATION |
| Mar 7, 2024 | INNOMED CUP REMOVAL STARTER INSTRUMENT, REF 520054, Hip cutter blade cup | 54 MM finisher blade was inadvertently affixed to the shaft of the CupX handle in lieu of the 54 ... | Class II | Innomed, Inc. |
| Mar 6, 2024 | CryoValve SG Cryopreserved Pulmonary Human Heart Valve | The blood cultures performed as part of the organ donation process were positive for Staphylococc... | Class II | Artivion, Inc |
| Mar 4, 2024 | NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descrip... | The expiration date was not printed on the outer shipping label, leading to expired syringes bein... | Class III | Avanos Medical, Inc. |
| Mar 4, 2024 | NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descrip... | The expiration date was not printed on the outer shipping label, leading to expired syringes bein... | Class III | Avanos Medical, Inc. |
| Mar 4, 2024 | NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descrip... | The expiration date was not printed on the outer shipping label, leading to expired syringes bein... | Class III | Avanos Medical, Inc. |
| Feb 21, 2024 | Thermalon Heating Pad, Item Number 24002 | Thermalon and MediBeads moist heat compresses from certain lots may have been exposed to excessiv... | Class II | Bruder Healthcare Company, LLC |
| Feb 21, 2024 | MediBeads King Pad, Item Numbers: 34120, 34120PM, 34125R | Thermalon and MediBeads moist heat compresses from certain lots may have been exposed to excessiv... | Class II | Bruder Healthcare Company, LLC |
| Feb 21, 2024 | Thermalon Eye Compress, Item Number 2434 | Thermalon and MediBeads moist heat compresses from certain lots may have been exposed to excessiv... | Class II | Bruder Healthcare Company, LLC |
| Feb 21, 2024 | MediBeads Neck Wrap, Item Number 34320 | Thermalon and MediBeads moist heat compresses from certain lots may have been exposed to excessiv... | Class II | Bruder Healthcare Company, LLC |
| Feb 21, 2024 | Thermalon Neck Wrap, Item Number 24322 | Thermalon and MediBeads moist heat compresses from certain lots may have been exposed to excessiv... | Class II | Bruder Healthcare Company, LLC |
| Feb 21, 2024 | Thermalon Sinus Compress, Item Number 24332 | Thermalon and MediBeads moist heat compresses from certain lots may have been exposed to excessiv... | Class II | Bruder Healthcare Company, LLC |
| Feb 21, 2024 | Thermalon Back Wrap, Item Number 24312 | Thermalon and MediBeads moist heat compresses from certain lots may have been exposed to excessiv... | Class II | Bruder Healthcare Company, LLC |
| Feb 21, 2024 | Thermalon Sinus Compress (French), Item Number 24332F | Thermalon and MediBeads moist heat compresses from certain lots may have been exposed to excessiv... | Class II | Bruder Healthcare Company, LLC |
| Feb 21, 2024 | Thermalon Stye Compress, Item Number 24352 | Thermalon and MediBeads moist heat compresses from certain lots may have been exposed to excessiv... | Class II | Bruder Healthcare Company, LLC |
| Jan 16, 2024 | MIC* Gastric-Jejunal Feeding Tube, Endoscopic/Radiologic Placement, GJ-Tube: ... | MIC* Gastric - Jejunal Feeding Tube Kits contain a sterile pre-filled syringe subsequently recall... | Class I | Avanos Medical, Inc. |
| Jan 16, 2024 | MIC* Gastric-Jejunal Feeding Tube with ENFit Connectors: a) MIC* Gastric... | MIC* Gastric - Jejunal Feeding Tube Kits contain a sterile pre-filled syringe subsequently recall... | Class I | Avanos Medical, Inc. |
| Jan 11, 2024 | Brasseler 8S RA SHP RD (Super-Sharp Round) H1S.21.023, REF 001156T0), carbide... | The device has a grip detail (right angle latch) out of specification causing the bur to not adeq... | Class II | Brasseler USA I Lp |
| Dec 20, 2023 | Bard¿ Nasogastric Sump Tube with ENFit, 12Fr., 48in Long, REF EN0042120 | BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes wi... | Class II | C.R. Bard Inc |
| Dec 20, 2023 | Bard¿ Nasogastric Sump Tube with ENFit, 16Fr., 48in Long, REF EN0042160 | BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes wi... | Class II | C.R. Bard Inc |
| Dec 20, 2023 | Bard¿ Nasogastric Sump Tube and PreVent¿ Filter and Lopez Valve¿ with ENFit, ... | BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes wi... | Class II | C.R. Bard Inc |
| Dec 20, 2023 | Bard¿ Nasogastric Sump Tube and PreVent¿ Anti-Reflux Filter and Lopez Valve¿ ... | BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes wi... | Class II | C.R. Bard Inc |
| Dec 20, 2023 | Bard¿ Suction Connector with ENFit, REF EN0066000 | BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes wi... | Class II | C.R. Bard Inc |
| Dec 20, 2023 | Bard Nasogastric Sump Tube with ENFit, 10Fr., 36in Long, REF EN0042100 | BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes wi... | Class II | C.R. Bard Inc |
| Dec 20, 2023 | Bard¿ PreVent¿ Anti-Reflux Filter with ENFit, REF EN0046000 | BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes wi... | Class II | C.R. Bard Inc |
| Dec 20, 2023 | Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit, 16Fr... | BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes wi... | Class II | C.R. Bard Inc |
| Dec 20, 2023 | Bard¿ Nasogastric Sump Tube and PreVent¿ Anti-Reflux Filter and Lopez Valve¿ ... | BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes wi... | Class II | C.R. Bard Inc |
| Dec 20, 2023 | Bard¿ Lopez Valve¿ with ENFit, REF EN0056000 | BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes wi... | Class II | C.R. Bard Inc |
| Dec 20, 2023 | Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit, 10Fr... | BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes wi... | Class II | C.R. Bard Inc |
| Dec 20, 2023 | Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit", 12F... | BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes wi... | Class II | C.R. Bard Inc |
| Dec 20, 2023 | Bard¿ Nasogastric Sump Tube and PreVent¿ Filter and Lopez Valve¿ with ENFit, ... | BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes wi... | Class II | C.R. Bard Inc |
| Dec 20, 2023 | Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit, 14Fr... | BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes wi... | Class II | C.R. Bard Inc |
| Dec 20, 2023 | Bard¿ Nasogastric Sump Tube with ENFit, 18Fr., 48in Long, REF EN0042180 | BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes wi... | Class II | C.R. Bard Inc |
| Dec 20, 2023 | Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit, 18Fr... | BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes wi... | Class II | C.R. Bard Inc |
| Dec 20, 2023 | Bard¿ Nasogastric Sump Tube with ENFit, 14Fr., 48in Long, REF EN0042140 | BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes wi... | Class II | C.R. Bard Inc |
| Nov 17, 2023 | VERO BIOTECH GENOSYL DS (Delivery System) Generation 3 Cassette, Model Number... | Cassette did not meet an 1n-process flow criterion. | Class II | Vero Biotech, LLC |
| Nov 15, 2023 | Sensica Urine Output System, Catalog Number SCCS1002 | BD (C.R. Bard) has received user complaints reporting that when the device was connected to WiFi/... | Class II | C.R. Bard 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.