Browse Device Recalls
2,831 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,831 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 2,831 FDA device recalls in 2025.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Feb 17, 2025 | Refill 36 Coated Super Tampons; Model Number: FG-TMP-MM-REF00360000; | Product lacks 510(k) clearance. | Class II | DAYE (ANNE'S DAY LTD) |
| Feb 17, 2025 | Microstream Instructions for Use and Part Number used with - Product Descript... | Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/I... | Class II | Oridion Medical 1987 Ltd. |
| Feb 17, 2025 | Refill 3 Month Heavy Flow Bundle; Model Number: FG-BNDL-PC-MM-REFHF; | Product lacks 510(k) clearance. | Class II | DAYE (ANNE'S DAY LTD) |
| Feb 17, 2025 | Refill 18 Coated Super and 18 Nude Super Tampons; Model Number: FG-TMP-MM-RE... | Product lacks 510(k) clearance. | Class II | DAYE (ANNE'S DAY LTD) |
| Feb 17, 2025 | Microstream Instructions for Use and Part Number used with - Product Descript... | Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/I... | Class II | Oridion Medical 1987 Ltd. |
| Feb 17, 2025 | Heavy Flow Bundle; Model Number: FG-BNDL-PC-REFHF; | Product lacks 510(k) clearance. | Class II | DAYE (ANNE'S DAY LTD) |
| Feb 17, 2025 | Initiation 3 Month Regular Flow Bundle; Model Number: FG-BNDL-PC-MM-IBRF; | Product lacks 510(k) clearance. | Class II | DAYE (ANNE'S DAY LTD) |
| Feb 17, 2025 | Trial Tampon Box; Model Number: FG-TMP-REF04050504; | Product lacks 510(k) clearance. | Class II | DAYE (ANNE'S DAY LTD) |
| Feb 17, 2025 | Initiation 36 Coated Super Tampons; Model Number: FG-TMP-MM-IB00360000; | Product lacks 510(k) clearance. | Class II | DAYE (ANNE'S DAY LTD) |
| Feb 17, 2025 | Initiation 3 Month All in One Bundle; Model Number: FG-BNDL-PC-MM-IBAIO; | Product lacks 510(k) clearance. | Class II | DAYE (ANNE'S DAY LTD) |
| Feb 17, 2025 | Microstream Instructions for Use and Part Number used with - Product Descript... | Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/I... | Class II | Oridion Medical 1987 Ltd. |
| Feb 17, 2025 | Microstream Instructions for Use and Part Number used with - Product Descript... | Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/I... | Class II | Oridion Medical 1987 Ltd. |
| Feb 17, 2025 | Initiation 3 Month Trial Tampon Box; Model Number: FG-TMP-MM-IB09090909; | Product lacks 510(k) clearance. | Class II | DAYE (ANNE'S DAY LTD) |
| Feb 17, 2025 | 9 Coated Super and 9 Nude Super Tampons; Model Number: FG-TMP-REF00090009; | Product lacks 510(k) clearance. | Class II | DAYE (ANNE'S DAY LTD) |
| Feb 17, 2025 | Initiation 36 Coated Regular Tampons; Model Number: FG-TMP-MM-IB36000000; | Product lacks 510(k) clearance. | Class II | DAYE (ANNE'S DAY LTD) |
| Feb 17, 2025 | Microstream Instructions for Use and Part Number used with - Product Descript... | Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/I... | Class II | Oridion Medical 1987 Ltd. |
| Feb 17, 2025 | 18 Coated Regular Tampons; Model Number: FG-TMP-REF18000000; | Product lacks 510(k) clearance. | Class II | DAYE (ANNE'S DAY LTD) |
| Feb 17, 2025 | Refill 3 Month Regular Flow Bundle; Model Number: FG-BNDL-PC-MM-REFRF; | Product lacks 510(k) clearance. | Class II | DAYE (ANNE'S DAY LTD) |
| Feb 17, 2025 | 9 Coated Super Tampons and 9 Nude Super Tampons; Model Number: FG-TMP-RET000... | Product lacks 510(k) clearance. | Class II | DAYE (ANNE'S DAY LTD) |
| Feb 17, 2025 | Refill 18 Coated Regular and 18 Nude Regular Tampons; Model Number: FG-TMP-M... | Product lacks 510(k) clearance. | Class II | DAYE (ANNE'S DAY LTD) |
| Feb 17, 2025 | Microstream Instructions for Use and Part Number used with - Product Descript... | Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/I... | Class II | Oridion Medical 1987 Ltd. |
| Feb 17, 2025 | Microstream Instructions for Use and Part Number used with - Product Descript... | Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/I... | Class II | Oridion Medical 1987 Ltd. |
| Feb 17, 2025 | Refill 3 Month All in One Bundle; Model Number: FG-BNDL-PC-MM-REFAIO; | Product lacks 510(k) clearance. | Class II | DAYE (ANNE'S DAY LTD) |
| Feb 17, 2025 | Microstream Instructions for Use and Part Number used with - Product Descript... | Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/I... | Class II | Oridion Medical 1987 Ltd. |
| Feb 17, 2025 | Microstream Instructions for Use and Part Number used with - Product Descript... | Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/I... | Class II | Oridion Medical 1987 Ltd. |
| Feb 15, 2025 | Aveir DR Leadless Pacemaker (LP) Ventricular Device REF LSP202V UDI-DI code... | Due to a manufacturing issue, leadless pacemakers may have been exposed to higher than normal tem... | Class II | Abbott Medical |
| Feb 14, 2025 | Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 12... | A problem was discovered during the scanning process of the outer carton label because of an inco... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Feb 14, 2025 | CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW8214 | Airway adapter does not meet specification and may break off when attaching a valve or tube. Devi... | Class II | Smiths Medical ASD, Inc. |
| Feb 14, 2025 | Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 13... | A problem was discovered during the scanning process of the outer carton label because of an inco... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Feb 14, 2025 | CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW1100 | Airway adapter does not meet specification and may break off when attaching a valve or tube. Devi... | Class II | Smiths Medical ASD, Inc. |
| Feb 14, 2025 | Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 1... | A problem was discovered during the scanning process of the outer carton label because of an inco... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Feb 13, 2025 | Proxima Drape labeled as FACE LIFT. Sterile surgical drape. | Potential breach in pouch packaging which could lead to loss of sterility. | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 13, 2025 | smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Ca... | The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate... | Class I | Smiths Medical ASD, Inc. |
| Feb 13, 2025 | smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Ca... | The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate... | Class I | Smiths Medical ASD, Inc. |
| Feb 13, 2025 | remel BLOOD AGAR MacCONKEY AGAR BIPLATE, REF R02049, QTY 100, for invitro dia... | Product may contain surface and subsurface contamination of Listeria monocytogenes which is typic... | Class II | Remel, Inc |
| Feb 13, 2025 | smiths medical ProPort Plastic Venous Access System, PolyFlow Catheter, 2.6 (... | The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate... | Class I | Smiths Medical ASD, Inc. |
| Feb 13, 2025 | Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: G5S-... | The potential for devices to fail their self-test as a result of prolonged exposure to extreme en... | Class II | ZOLL Medical Corporation |
| Feb 13, 2025 | Proxima Drape labeled as DRAPE C-SECTION W/ WINDOW; SHEET, DRAPE, SPLIT, ST,1... | Potential breach in pouch packaging which could lead to loss of sterility. | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 13, 2025 | Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) ... | The potential for devices to fail their self-test as a result of prolonged exposure to extreme en... | Class II | ZOLL Medical Corporation |
| Feb 13, 2025 | Proxima Drape labeled as ENT-PLASTICS PACK. Sterile surgical drape. | Potential breach in pouch packaging which could lead to loss of sterility. | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 13, 2025 | Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) ... | The potential for devices to fail their self-test as a result of prolonged exposure to extreme en... | Class II | ZOLL Medical Corporation |
| Feb 13, 2025 | Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: G5S-... | The potential for devices to fail their self-test as a result of prolonged exposure to extreme en... | Class II | ZOLL Medical Corporation |
| Feb 13, 2025 | Proxima Drape labeled as MINOR PACK and LAPAROSCOPY. Sterile surgical drape. | Potential breach in pouch packaging which could lead to loss of sterility. | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 13, 2025 | smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Ca... | The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate... | Class I | Smiths Medical ASD, Inc. |
| Feb 13, 2025 | smiths medical ProPort Low Profile Plastic Venous Access System, Silicone Cat... | The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate... | Class I | Smiths Medical ASD, Inc. |
| Feb 13, 2025 | smiths medical ProPort Plastic Venous Access System, Silicone Catheter, 2.87,... | The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate... | Class I | Smiths Medical ASD, Inc. |
| Feb 13, 2025 | smiths medical ProPort Plastic Venous Access System, Silicone Catheter, 2.8mm... | The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate... | Class I | Smiths Medical ASD, Inc. |
| Feb 13, 2025 | Portex Endotracheal Tube, Item Codes 100/105/025 100/105/030 100/105/035 100/... | Affected devices have a smaller diameter than expected and may potentially result in inadequate v... | Class I | Smiths Medical ASD, Inc. |
| Feb 13, 2025 | Proxima Drape labeled as HEAD AND NECK OSIS, WILLIS SHOULDER PACK, EXTREMITY ... | Potential breach in pouch packaging which could lead to loss of sterility. | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 13, 2025 | Proxima Drape labeled as UNIVERSAL DAVINCI ROBOTIC P. Sterile surgical drape. | Potential breach in pouch packaging which could lead to loss of sterility. | Class II | MEDLINE INDUSTRIES, LP - Northfield |
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.