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.

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DateProductReasonClassFirm
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.