Browse Device Recalls
32 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 32 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 32 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 4, 2023 | VERIQUICK PREGNANCY TEST 1CT, SKU 901260 | Products were stored outside of labeled temperature requirements. | Class II | Family Dollar Stores, Llc. |
| Oct 4, 2023 | ORAL B MOUTH SORE RINSE 237ML, SKU 999087 | Products were stored outside of labeled temperature requirements. | Class II | Family Dollar Stores, Llc. |
| Oct 4, 2023 | FIXODENT ORG CREAM 2.4OZ, SKU 906018 FIXODENT ADH CREAM WITH SCOPE 2OZ, SKU ... | Products were stored outside of labeled temperature requirements. | Class II | Family Dollar Stores, Llc. |
| Oct 4, 2023 | AT HOME MARIJUANA TEST STRIP, SKU 900752 | Products were stored outside of labeled temperature requirements. | Class II | Family Dollar Stores, Llc. |
| Oct 4, 2023 | GOODSENSE DENTURE CLEANSER GRN TAB 40CT, SKU 906312 GOODSENSE DENTURE CLEAN ... | Products were stored outside of labeled temperature requirements. | Class II | Family Dollar Stores, Llc. |
| Oct 4, 2023 | CLEARBLUE SMART COUNTDOWN PRGNCY TST 1CT, SKU 900260 | Products were stored outside of labeled temperature requirements. | Class II | Family Dollar Stores, Llc. |
| Oct 4, 2023 | ARC TEETH WHITENING PEN 0.06 FL OZ, SKU 997950 | Products were stored outside of labeled temperature requirements. | Class II | Family Dollar Stores, Llc. |
| Oct 4, 2023 | FIRST RESPONSE 2 CT, SKU 902343 | Products were stored outside of labeled temperature requirements. | Class II | Family Dollar Stores, Llc. |
| Oct 4, 2023 | DENTEMP ONE STEP .077OZ, SKU 902139 | Products were stored outside of labeled temperature requirements. | Class II | Family Dollar Stores, Llc. |
| Oct 4, 2023 | MEDIC's CHOICE CONTACT LENS SOLUTION 12FLOZ, SKU 998935 | Products were stored outside of labeled temperature requirements. | Class II | Family Dollar Stores, Llc. |
| Jun 23, 2022 | NEW SKIN LIQUID BANDAGE CLEAR .3FL OZ, SKU 999417 | Affected product was not appropriately stored in temperature-controlled areas between April 30, 2... | Class II | Family Dollar Stores, Llc. |
| Jun 23, 2022 | SKYN ORIGINAL NON LATEX CONDOM 12CT, SKU 903409 LS SKYN NON LATEX LUBRICAT... | Affected product was not appropriately stored in temperature-controlled areas between April 30, 2... | Class II | Family Dollar Stores, Llc. |
| Jun 23, 2022 | AT HOME MARIJUANA TEST STRIP, SKU 900752 | Affected product was not appropriately stored in temperature-controlled areas between April 30, 2... | Class II | Family Dollar Stores, Llc. |
| Jun 23, 2022 | B L BIOTRU MULTI PURPOSE SOLUTION 4 FLOZ, SKU 999009 | Affected product was not appropriately stored in temperature-controlled areas between April 30, 2... | Class II | Family Dollar Stores, Llc. |
| Jun 23, 2022 | GS DENTURE CLEANSER GRN TAB 40CT, SKU 906312 GS DENTURE CLEAN OVRNT TAB 40CT... | Affected product was not appropriately stored in temperature-controlled areas between April 30, 2... | Class II | Family Dollar Stores, Llc. |
| Jun 23, 2022 | Veriquick Pregnancy Test 2CT, SKU 903756 | Affected product was not appropriately stored in temperature-controlled areas between April 30, 2... | Class II | Family Dollar Stores, Llc. |
| Jun 23, 2022 | LIFESTYLES ULTRA SENSITIVE CONDOMS 12CT, SKU 900265 | Affected product was not appropriately stored in temperature-controlled areas between April 30, 2... | Class II | Family Dollar Stores, Llc. |
| Jun 23, 2022 | FIXODENT ORG CREAM 2.4OZ, SKU 906018 FIXODENT ORG CREAM TRAVEL .75OZ, SKU 90... | Affected product was not appropriately stored in temperature-controlled areas between April 30, 2... | Class II | Family Dollar Stores, Llc. |
| Jun 23, 2022 | SIMPLY SALINE NASAL MIST 3.1 OZ, SKU 999801 | Affected product was not appropriately stored in temperature-controlled areas between April 30, 2... | Class II | Family Dollar Stores, Llc. |
| Jun 23, 2022 | CURAD FIRST AID KIT, SKU 999037 | Affected product was not appropriately stored in temperature-controlled areas between April 30, 2... | Class II | Family Dollar Stores, Llc. |
| Jun 23, 2022 | VERIQUICK PREGNANCY TEST 1CT, SKU 901260, 939504 | Affected product was not appropriately stored in temperature-controlled areas between April 30, 2... | Class II | Family Dollar Stores, Llc. |
| Jun 23, 2022 | POLIGRIP ADH CREAM FREE 2.4OZ, SKU 900334 POLIGRIP DENTURE ADHESIVE ORIGINAL... | Affected product was not appropriately stored in temperature-controlled areas between April 30, 2... | Class II | Family Dollar Stores, Llc. |
| Jun 23, 2022 | POLIDENT DENTURE CLEANSERS 84 CT, SKU 901634 POLIDENT DENTURE CLNS TAB 28CT,... | Affected product was not appropriately stored in temperature-controlled areas between April 30, 2... | Class II | Family Dollar Stores, Llc. |
| Jun 23, 2022 | TRVL KIT TOTHBRSH CAP PASTE IN POUCH 1CT, SKU 900737 | Affected product was not appropriately stored in temperature-controlled areas between April 30, 2... | Class II | Family Dollar Stores, Llc. |
| Jun 23, 2022 | GS SALINE SOLUTION 12FL OZ, SKU 902274 | Affected product was not appropriately stored in temperature-controlled areas between April 30, 2... | Class II | Family Dollar Stores, Llc. |
| Jun 23, 2022 | OPTI FREE REPLENISH MULTI PURPOSE 2 OZ | Affected product was not appropriately stored in temperature-controlled areas between April 30, 2... | Class II | Family Dollar Stores, Llc. |
| Jun 23, 2022 | DENTEMP ONE STEP .077OZ, SKU 902139 | Affected product was not appropriately stored in temperature-controlled areas between April 30, 2... | Class II | Family Dollar Stores, Llc. |
| Jun 23, 2022 | CLEARBLUE SMART COUNTDOWN PRGNCY TST 1CT, SKU-ID 900260 | Affected product was not appropriately stored in temperature-controlled areas between April 30, 2... | Class II | Family Dollar Stores, Llc. |
| Jun 23, 2022 | CLEAR EYES CONTCT LENS DRPS LBRCTNG .5FO, SKU 900531 | Affected product was not appropriately stored in temperature-controlled areas between April 30, 2... | Class II | Family Dollar Stores, Llc. |
| Jun 23, 2022 | CURAD STRNG WATRPRF STRIP 1IN 20CT, SKU | Affected product was not appropriately stored in temperature-controlled areas between April 30, 2... | Class II | Family Dollar Stores, Llc. |
| Jun 23, 2022 | FIRST RESPONSE 2 CT, SKU 902343 | Affected product was not appropriately stored in temperature-controlled areas between April 30, 2... | Class II | Family Dollar Stores, Llc. |
| Jun 23, 2022 | KY JELLY LUBRICANT 2 FL OZ, SKU 901443 | Affected product was not appropriately stored in temperature-controlled areas between April 30, 2... | Class II | Family Dollar Stores, 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.