Browse Device Recalls
2,602 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,602 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 2,602 FDA device recalls in 2020.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jan 11, 2020 | AAMI 3 FABRNF SURG GOWN L 2 TOWELS, Item Code ASG9511 | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... | Class II | Cardinal Health |
| Jan 11, 2020 | AAMI 3 NONREINF SURG GOWN 3XL BNS, Item Code 9585N | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... | Class II | Cardinal Health |
| Jan 11, 2020 | AAMI 3 ROYALSILK SCRBNURGOWN BNS XL, Gown. Item Code 90380NC | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... | Class II | Cardinal Health |
| Jan 11, 2020 | AAMI 3 ROYALSILK SURGGOWN BNS L, Gown. Item Code 9518NC | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... | Class II | Cardinal Health |
| Jan 11, 2020 | AAMI 3 NON-REINF SURG GWN XL 2 TWL, Gown Item Code ASG9545 | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... | Class II | Cardinal Health |
| Jan 11, 2020 | AAMI 3 NONREINF SURGICAL GOWN 3XL, Item Code 9585 | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... | Class II | Cardinal Health |
| Jan 11, 2020 | GOWN SURG LG W/TOWEL ST BACK, Item Code 9515 | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... | Class II | Cardinal Health |
| Jan 11, 2020 | ROYALSILK XLARGE, Gown. Item Code 9548 | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... | Class II | Cardinal Health |
| Jan 11, 2020 | AAMI 3 FABREINF SCRUB SURG GWN L NS, Gown. Item Code 90970NA | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... | Class II | Cardinal Health |
| Jan 11, 2020 | ROYALSILK LARGE, Gown. Item Code 9518 | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... | Class II | Cardinal Health |
| Jan 11, 2020 | AAMI 3 NON-REINF SURGICAL GOWN XL, Item Code 9545 | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... | Class II | Cardinal Health |
| Jan 11, 2020 | ROYALSILK 3XLARGE/XLONG, Gown. Item Code 95998 | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... | Class II | Cardinal Health |
| Jan 11, 2020 | ROYALSILK 3XLARGE/XLONG NS, Gown Item Code 95998N | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... | Class II | Cardinal Health |
| Jan 11, 2020 | AAMI 3 FABRNF SCRUB SURG GWN XL NS, Gown. Item Code 91070NB | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... | Class II | Cardinal Health |
| Jan 11, 2020 | AAMI 3 NONREINF SURGICAL GOWN 4XL, Item Code 9599 | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... | Class II | Cardinal Health |
| Jan 11, 2020 | AAMI 3 NON-REINF SURG GOWN LG 2 TWL, Item Code ASG9515 | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... | Class II | Cardinal Health |
| Jan 11, 2020 | AAMI 3 FABRIC REINF SURG GOWN XL, Item Code 9541 | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... | Class II | Cardinal Health |
| Jan 11, 2020 | AAMI 3 ROYALSILK SURGGOWN BNS XL, Item Code 9548NC | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... | Class II | Cardinal Health |
| Jan 11, 2020 | AAMI 3 NONRNF SURG GWN 2XL XLNG BNS, Item Code 9575ELNA | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... | Class II | Cardinal Health |
| Jan 11, 2020 | AAMI 3 NONREIN SCRBNURGOWN BNS L, Item Code 90270NB | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... | Class II | Cardinal Health |
| Jan 10, 2020 | CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 3.8MM(P) X 6MM(H) Refe... | Resulting impression or scanned data produced from the Healing Abutment lots will result in an in... | Class II | Biomet 3i, LLC |
| Jan 10, 2020 | CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 6MM(P) X 3MM(H) Refere... | Resulting impression or scanned data produced from the Healing Abutment lots will result in an in... | Class II | Biomet 3i, LLC |
| Jan 10, 2020 | NUCLISENS¿ Lysis Buffer, IVD, REF 200292, 48X2 ML LYS Manufacturer bioMerie... | Following a customer complaint about colored eluates, leading to invalid results bioMerieux has c... | Class II | BIOMERIEUX - Grenoble |
| Jan 10, 2020 | CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 5MM(P) X 4MM(H) Refere... | Resulting impression or scanned data produced from the Healing Abutment lots will result in an in... | Class II | Biomet 3i, LLC |
| Jan 10, 2020 | CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 6MM(P) X 4MM(H) ... | Resulting impression or scanned data produced from the Healing Abutment lots will result in an in... | Class II | Biomet 3i, LLC |
| Jan 10, 2020 | CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 7.5MM(P) X 4MM(H) Reference... | Resulting impression or scanned data produced from the Healing Abutment lots will result in an in... | Class II | Biomet 3i, LLC |
| Jan 10, 2020 | Terumo Advanced Perfusion System 1 Roller Pump, 6 Inch, Catalog Number 816571... | These roller pumps were assembled with pump shafts that may fail at the location of the thread wh... | Class II | Terumo Cardiovascular Systems Corporation |
| Jan 10, 2020 | CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 5MM(P) X 3MM(H) Referen... | Resulting impression or scanned data produced from the Healing Abutment lots will result in an in... | Class II | Biomet 3i, LLC |
| Jan 10, 2020 | CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 6MM(P) X 4MM(H) Referen... | Resulting impression or scanned data produced from the Healing Abutment lots will result in an in... | Class II | Biomet 3i, LLC |
| Jan 10, 2020 | Terumo Advanced Perfusion Assembly Pump Guts, 6 Inch, Catalog Number 801798 -... | These roller pumps were assembled with pump shafts that may fail at the location of the thread wh... | Class II | Terumo Cardiovascular Systems Corporation |
| Jan 10, 2020 | CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 7.5MM(P) X 4MM(H) Refer... | Resulting impression or scanned data produced from the Healing Abutment lots will result in an in... | Class II | Biomet 3i, LLC |
| Jan 10, 2020 | CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 5MM(P) X 6MM(H) Referen... | Resulting impression or scanned data produced from the Healing Abutment lots will result in an in... | Class II | Biomet 3i, LLC |
| Jan 10, 2020 | CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 5.6MM(P) X 4MM(H) Referen... | Resulting impression or scanned data produced from the Healing Abutment lots will result in an in... | Class II | Biomet 3i, LLC |
| Jan 10, 2020 | Terumo Advanced Perfusion System 1 Roller Pump, 4 Inch, Catalog Number 816570... | These roller pumps were assembled with pump shafts that may fail at the location of the thread wh... | Class II | Terumo Cardiovascular Systems Corporation |
| Jan 10, 2020 | CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 4.1MM(P) X 3MM(H) Refe... | Resulting impression or scanned data produced from the Healing Abutment lots will result in an in... | Class II | Biomet 3i, LLC |
| Jan 10, 2020 | CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 5.6MM(P) X 3MM(H) Referen... | Resulting impression or scanned data produced from the Healing Abutment lots will result in an in... | Class II | Biomet 3i, LLC |
| Jan 10, 2020 | Terumo Advanced Perfusion Assembly Pump Guts, 4 Inch, Catalog Number 801805 -... | These roller pumps were assembled with pump shafts that may fail at the location of the thread wh... | Class II | Terumo Cardiovascular Systems Corporation |
| Jan 10, 2020 | CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 4.1MM(P) X 6MM(H) Refere... | Resulting impression or scanned data produced from the Healing Abutment lots will result in an in... | Class II | Biomet 3i, LLC |
| Jan 10, 2020 | CERTAIN¿ BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 3.8MM(P) X 4MM(H) Ref... | Resulting impression or scanned data produced from the Healing Abutment lots will result in an in... | Class II | Biomet 3i, LLC |
| Jan 10, 2020 | AIA-360 Automated Immunoassay Analyzer, Product Code 019945 | A display screen software issue on the analyzer causes the display to freeze when display screen ... | Class II | Tosoh Bioscience Inc |
| Jan 10, 2020 | CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 6MM(P) X 3MM(H) Referenc... | Resulting impression or scanned data produced from the Healing Abutment lots will result in an in... | Class II | Biomet 3i, LLC |
| Jan 10, 2020 | CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 6MM(P) X 4MM(H) ... | Resulting impression or scanned data produced from the Healing Abutment lots will result in an in... | Class II | Biomet 3i, LLC |
| Jan 10, 2020 | CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 5MM(P) X 6MM(H) Refere... | Resulting impression or scanned data produced from the Healing Abutment lots will result in an in... | Class II | Biomet 3i, LLC |
| Jan 10, 2020 | CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 5MM(P) X 4MM(H) Refer... | Resulting impression or scanned data produced from the Healing Abutment lots will result in an in... | Class II | Biomet 3i, LLC |
| Jan 10, 2020 | CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 3.8MM(P) X 3MM(H) Refere... | Resulting impression or scanned data produced from the Healing Abutment lots will result in an in... | Class II | Biomet 3i, LLC |
| Jan 10, 2020 | CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 6MM(P) X 6MM(H) Referen... | Resulting impression or scanned data produced from the Healing Abutment lots will result in an in... | Class II | Biomet 3i, LLC |
| Jan 10, 2020 | CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 4.1MM(P) X 4MM(H) Refe... | Resulting impression or scanned data produced from the Healing Abutment lots will result in an in... | Class II | Biomet 3i, LLC |
| Jan 10, 2020 | CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 6MM(P) X 6MM(H) Referen... | Resulting impression or scanned data produced from the Healing Abutment lots will result in an in... | Class II | Biomet 3i, LLC |
| Jan 10, 2020 | CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 5MM(P) X 3MM(H) Referenc... | Resulting impression or scanned data produced from the Healing Abutment lots will result in an in... | Class II | Biomet 3i, LLC |
| Jan 9, 2020 | Rusch Greenlite Single-Use Metal Laryngoscope Blade for Fiber Optic System | The products are being recalled due to reports of breakage broke at the point of a welded joint e... | Class II | TELEFLEX MEDICAL INC |
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.