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Browse Device Recalls

19 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 19 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 19 FDA device recalls.

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DateProductReasonClassFirm
Dec 23, 2020 2 X Sterile Human Home Artificial Insemination Semen Kit (Human), SKU 1432985... Device was distributed without a proper marketing authorization. This event is an expansion of RE... Class II Tenderneeds Fertility LLC
Dec 23, 2020 Pro Series Fertility Device (SKU 644042788139) Device was distributed without a proper marketing authorization. Class II Tenderneeds Fertility LLC
Dec 23, 2020 Professional Artificial Intrauterine Insemination Kit (SKU 636391205986) Device was distributed without a proper marketing authorization. Class II Tenderneeds Fertility LLC
Dec 23, 2020 Deluxe At Home Artificial Insemination Kit (SKU 636391205832) Device was distributed without a proper marketing authorization. Class II Tenderneeds Fertility LLC
Dec 23, 2020 TenderNeeds Fertility PRO IUI Human Artificial Home Insemination Kits, SKU 13... Device was distributed without a proper marketing authorization. This event is an expansion of RE... Class II Tenderneeds Fertility LLC
Dec 23, 2020 2 Complete ICI Human At Home Donor Artificial Insemination Kits Tenderneeds, ... Device was distributed without a proper marketing authorization. This event is an expansion of RE... Class II Tenderneeds Fertility LLC
Dec 23, 2020 Professional At Home Artificial Intrauterine Insemination Set (SKU 644042787811) Device was distributed without a proper marketing authorization. Class II Tenderneeds Fertility LLC
Dec 23, 2020 Home Artificial Insemination Kit Human IUI ICI Pregnancy & Ovulation Tests, S... Device was distributed without a proper marketing authorization. This event is an expansion of RE... Class II Tenderneeds Fertility LLC
Dec 23, 2020 At Home Artificial Intrauterine Insemination Flex Set (SKU 636391205870) Device was distributed without a proper marketing authorization. Class II Tenderneeds Fertility LLC
Dec 23, 2020 Professional Clinical Artificial Intrauterine Insemination Kit (SKU 636391205... Device was distributed without a proper marketing authorization. Class II Tenderneeds Fertility LLC
Dec 23, 2020 At Home Artificial Intrauterine Insemination Kit (SKU 636391205825, 636391205... Device was distributed without a proper marketing authorization. Class II Tenderneeds Fertility LLC
Dec 23, 2020 Deluxe At-Home Human Artificial Intracervical (ICI) Insemination Kit with Pre... Device was distributed without a proper marketing authorization. This event is an expansion of RE... Class II Tenderneeds Fertility LLC
Dec 23, 2020 Premium At Home Pro Series Insemination Kit (SKU 644042787927) Device was distributed without a proper marketing authorization. Class II Tenderneeds Fertility LLC
Dec 23, 2020 Deluxe At Home Pro Series Insemination Kit (SKU 644042787958) Device was distributed without a proper marketing authorization. Class II Tenderneeds Fertility LLC
Dec 23, 2020 Premium Human Artificial Intrauterine Insemination (IUI) Kit & Metal Speculum... Device was distributed without a proper marketing authorization. This event is an expansion of RE... Class II Tenderneeds Fertility LLC
Dec 23, 2020 Flex IUI Set with LED Lighted Speculum and Test kit, SKU fls1001 Device was distributed without a proper marketing authorization. This event is an expansion of RE... Class II Tenderneeds Fertility LLC
Dec 23, 2020 Ultimate Fertility At Home Insemination Kit with Sperm Wash Medium, SKU ULTFKSW Device was distributed without a proper marketing authorization. This event is an expansion of RE... Class II Tenderneeds Fertility LLC
Dec 23, 2020 At Home Semi-Flex/Rigid Insemination Device (SKU 644042787903) Device was distributed without a proper marketing authorization. Class II Tenderneeds Fertility LLC
Dec 23, 2020 Deluxe IntraCervical Insemination (ICI) Kit (3), SKU 382903096046 Device was distributed without a proper marketing authorization. This event is an expansion of RE... Class II Tenderneeds Fertility LLC

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.