Browse Device Recalls
29 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 29 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 29 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Feb 17, 2025 | Refill 18 Coated Regular and 18 Coated Super Tampons; Model Number: FG-TMP-M... | Product lacks 510(k) clearance. | Class II | DAYE (ANNE'S DAY LTD) |
| Feb 17, 2025 | 9 Coated Regular Tampons and 9 Nude Regular Tampons; Model Number: FG-TMP-RE... | Product lacks 510(k) clearance. | Class II | DAYE (ANNE'S DAY LTD) |
| Feb 17, 2025 | Initiation 18 Coated Super and 18 Nude Super Tampons; Model Number: FG-TMP-M... | Product lacks 510(k) clearance. | Class II | DAYE (ANNE'S DAY LTD) |
| Feb 17, 2025 | 9 Coated Regular and 9 Coated Super Tampons; Model Number: FG-TMP-REF09090000; | Product lacks 510(k) clearance. | Class II | DAYE (ANNE'S DAY LTD) |
| Feb 17, 2025 | All in One Bundle; Model Number: FG-BNDL-PC-REFAIO; | Product lacks 510(k) clearance. | Class II | DAYE (ANNE'S DAY LTD) |
| Feb 17, 2025 | Refill 3 Month Trial Tampon Box; Model Number: FG-TMP-MM-REF09090909; | Product lacks 510(k) clearance. | Class II | DAYE (ANNE'S DAY LTD) |
| Feb 17, 2025 | Refill 36 Coated Regular Tampons; Model Number: FG-TMP-MM-REF36000000; | Product lacks 510(k) clearance. | Class II | DAYE (ANNE'S DAY LTD) |
| Feb 17, 2025 | 9 Coated Regular and 9 Nude Regular Tampons; Model Number: FG-TMP-REF09000900; | Product lacks 510(k) clearance. | Class II | DAYE (ANNE'S DAY LTD) |
| Feb 17, 2025 | Regular Flow Bundle; Model Number: FG-BNDL-PC-REFRF; | Product lacks 510(k) clearance. | Class II | DAYE (ANNE'S DAY LTD) |
| Feb 17, 2025 | 18 Coated Super Tampons; Model Number: FG-TMP-REF00180000; | Product lacks 510(k) clearance. | Class II | DAYE (ANNE'S DAY LTD) |
| Feb 17, 2025 | Initiation 18 Coated Regular and 18 Nude Regular Tampons; Model Number: FG-T... | Product lacks 510(k) clearance. | Class II | DAYE (ANNE'S DAY LTD) |
| Feb 17, 2025 | Initiation 18 Coated Regular and 18 Coated Super Tampons; Model Number: FG-T... | Product lacks 510(k) clearance. | Class II | DAYE (ANNE'S DAY LTD) |
| Feb 17, 2025 | Initiation 3 Month Heavy Flow Bundle; Model Number: FG-BNDL-PC-MM-IBHF; | Product lacks 510(k) clearance. | Class II | DAYE (ANNE'S DAY LTD) |
| 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 | 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 | 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 | 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 | 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 | 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) |
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.