Browse Device Recalls
35,290 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 35,290 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 35,290 FDA device recalls, Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jun 26, 2024 | DVOT SARS-Cov-2 &Influenza A+B Antigen Combo Test Kit, Model Number FAT01 | The "DVOT brand" rapid test kits have not obtained the necessary authorization to be sold in the ... | Class II | FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN)CO.,LTD |
| Jun 26, 2024 | CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24JP | Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medicat... | Class II | Smiths Medical ASD Inc. |
| Jun 26, 2024 | DVOT SARS-CoV-2 ANTIGEN TEST KIT, Model Number FCY-AGT-01 | The "DVOT brand" rapid test kits have not obtained the necessary authorization to be sold in the ... | Class II | FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN)CO.,LTD |
| Jun 26, 2024 | DVOT SARS-CoV-2 & RSV &MP &ADV & FIu A/B Antigen Combo Test Kit, Model Number... | The "DVOT brand" rapid test kits have not obtained the necessary authorization to be sold in the ... | Class II | FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN)CO.,LTD |
| Jun 26, 2024 | ENT RES 100 ML Non-Sterile W CLAMP, TUBING FLAG, & FEMALE LUER, Product Code... | Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medicat... | Class II | Smiths Medical ASD Inc. |
| Jun 26, 2024 | smiths medical CADD-Solis Li-ion Rechargeable Battery Packs AC adapter, Model... | The adapter input plug can become damaged or broken. If the input plug is damaged, the metal con... | Class II | Smiths Medical ASD, Inc. |
| Jun 26, 2024 | BD Insyte Autoguard BC, Shielded IV Catheter with Blood Control Technology, R... | Catheters may contain a hole in the catheter tubing, which could result in leakage during the ins... | Class II | Becton Dickinson Infusion Therapy Systems, Inc. |
| Jun 26, 2024 | CADD Medication Cassette Reservoir, 100mL, FS, YELLOW, Product Code 21-7300-24 | Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medicat... | Class II | Smiths Medical ASD Inc. |
| Jun 26, 2024 | CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24 | Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medicat... | Class II | Smiths Medical ASD Inc. |
| Jun 26, 2024 | CADD Medication Cassette Reservoir, 50mL, FS, Product Code 21-7301-24 | Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medicat... | Class II | Smiths Medical ASD Inc. |
| Jun 26, 2024 | CADD Medication Cassette Reservoir, 50mL, Product Code 21-7001-24 | Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medicat... | Class II | Smiths Medical ASD Inc. |
| Jun 26, 2024 | CADD Medication Cassette Reservoir, 50mL, FS, Product Code 21-7301-24JP | Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medicat... | Class II | Smiths Medical ASD Inc. |
| Jun 26, 2024 | ARTIS is a family of dedicated angiography systems developed for single and b... | A potential issue with ARTIS icono systems equipped with a small detector and a corresponding col... | Class II | Siemens AG/Siemens Healthcare GmbH |
| Jun 25, 2024 | HeartMate 3 System Controllers provided within the following HeartMate 3 Left... | Left ventricular assist system controller UI membrane/screen may lift along the edge of the contr... | Class II | Thoratec LLC |
| Jun 25, 2024 | 1. Tech Medical Services Inc. Detachable Endo Retrieval Pouch, REF TM2001, 3... | The tube may fall into the surgical site during the grasping process. | Class II | UNIMAX MEDICAL SYSTEMS INC |
| Jun 25, 2024 | Multiple Digital Analog Products labeled as: NobelBiocare Tri-Lobe-compatibl... | Due to a manufacturing issue, the product has a out of specification rotation of the digital anal... | Class II | Preat Corp |
| Jun 24, 2024 | BD PYXIS MEDBANK TWR MN CR-12HH-1FH, REF: 169-84 containing software version ... | Due to software issue, there is a potential when a restock label is printed for a medication stor... | Class II | CareFusion 303, Inc. |
| Jun 24, 2024 | BD PYXIS MEDBANK TWR MN CR-12HH-1FM-P, REF: 169-85 containing software versio... | Due to software issue, there is a potential when a restock label is printed for a medication stor... | Class II | CareFusion 303, Inc. |
| Jun 24, 2024 | BD PYXIS MEDBANK TWR MN CR-8HH-1FH-2FM-P, REF: 169-96 containing software ver... | Due to software issue, there is a potential when a restock label is printed for a medication stor... | Class II | CareFusion 303, Inc. |
| Jun 24, 2024 | BD PYXIS MEDBANK TWR MN CR-10HH-2FM-P, REF: 169-83 containing software versio... | Due to software issue, there is a potential when a restock label is printed for a medication stor... | Class II | CareFusion 303, Inc. |
| Jun 24, 2024 | BD PYXIS MEDBANK TWR MN CR-4HH-5FM-P, REF: 169-91 containing software version... | Due to software issue, there is a potential when a restock label is printed for a medication stor... | Class II | CareFusion 303, Inc. |
| Jun 24, 2024 | BD PYXIS MDBNK TWR MN CR-4HH-5FM-P RxNow, REF: 169-131 containing software ve... | Due to software issue, there is a potential when a restock label is printed for a medication stor... | Class II | CareFusion 303, Inc. |
| Jun 24, 2024 | BD PYXIS MEDBANK TWR MN CR-2HH-6FH, REF: 169-88 containing software version 3... | Due to software issue, there is a potential when a restock label is printed for a medication stor... | Class II | CareFusion 303, Inc. |
| Jun 24, 2024 | BD PYXIS MEDBANK TWR MN CR-4HH-1FH-4FM-P, REF: 169-90 containing software ver... | Due to software issue, there is a potential when a restock label is printed for a medication stor... | Class II | CareFusion 303, Inc. |
| Jun 24, 2024 | BD PYXIS MEDBANK MINI CR-2HH-1FH-P, REF: 169-114 containing software version ... | Due to software issue, there is a potential when a restock label is printed for a medication stor... | Class II | CareFusion 303, Inc. |
| Jun 24, 2024 | BD PYXIS MEDBANK TWR MN CR-6HH-1FH-3FM-P, REF: 169-92 containing software ver... | Due to software issue, there is a potential when a restock label is printed for a medication stor... | Class II | CareFusion 303, Inc. |
| Jun 24, 2024 | BD PYXIS MEDBANK TWR MN CR-8HH-3FH-P, REF: 169-98 containing software version... | Due to software issue, there is a potential when a restock label is printed for a medication stor... | Class II | CareFusion 303, Inc. |
| Jun 24, 2024 | BD PYXIS MEDBANK TWR MN CR-2HH-6FM, REF: 169-89 containing software version 3... | Due to software issue, there is a potential when a restock label is printed for a medication stor... | Class II | CareFusion 303, Inc. |
| Jun 24, 2024 | BD PYXIS MEDBANK MINI CR-4HH-P, REF: 169-115 containing software version 3.9.1.9 | Due to software issue, there is a potential when a restock label is printed for a medication stor... | Class II | CareFusion 303, Inc. |
| Jun 24, 2024 | BD PYXIS MEDBANK TWR MN CR-6HH-2FH-2FM-P, REF: 169-93 containing software ver... | Due to software issue, there is a potential when a restock label is printed for a medication stor... | Class II | CareFusion 303, Inc. |
| Jun 24, 2024 | BD PYXIS MEDBANK TWR MN CR-6HH-4FM-P, REF: 169-94 containing software version... | Due to software issue, there is a potential when a restock label is printed for a medication stor... | Class II | CareFusion 303, Inc. |
| Jun 24, 2024 | BD PYXIS MEDBANK TWR MN CR-10HH-2FH-P, REF: 169-82 containing software versio... | Due to software issue, there is a potential when a restock label is printed for a medication stor... | Class II | CareFusion 303, Inc. |
| Jun 24, 2024 | BD PYXIS MEDBANK TWR MN CR-14HH-P, REF: 169-86 containing software version 3.... | Due to software issue, there is a potential when a restock label is printed for a medication stor... | Class II | CareFusion 303, Inc. |
| Jun 24, 2024 | BD PYXIS MEDBANK TWR MN CR-8HH-2FH-1FM-P, REF: 169-97 containing software ver... | Due to software issue, there is a potential when a restock label is printed for a medication stor... | Class II | CareFusion 303, Inc. |
| Jun 24, 2024 | BD PYXIS MEDBANK TWR MN CR-8HH-3FM-P, REF: 169-99 containing software version... | Due to software issue, there is a potential when a restock label is printed for a medication stor... | Class II | CareFusion 303, Inc. |
| Jun 21, 2024 | ESG-410 Electrosurgical Generator- In conjunction with electrosurgical access... | Electrosurgical Generators ESG-410 does not power on upon use, may result in delays in initiating... | Class II | Olympus Corporation of the Americas |
| Jun 20, 2024 | Arial Call Station, Model Numbers CSK200-1069 and CSK200-1069MR, is a wireles... | This is a risk that alarms will not be received by the Arial Wireless Nurse Call System and prema... | Class II | Securitas Healthcare LLC |
| Jun 20, 2024 | Cepheid, Sample Collection Device, Part: 900-0370 | Specimen collection device may leak after the patient sample swabs have been inserted into the te... | Class II | Cepheid |
| Jun 20, 2024 | Verigene Gram Positive Blood Culture (BC-GP) Nucleic Acid Test | Potential for defective test cartridges which may result in false positive results for the Staphy... | Class II | Luminex Corporation |
| Jun 20, 2024 | Arial Call Station, Model Numbers CSK200 and CSK200MR, is a wireless, battery... | There is a risk that alarms will not be received by the Arial Wireless Emergency Call System and ... | Class II | Securitas Healthcare LLC |
| Jun 19, 2024 | UNITRAX Endoprosthesis Head Component - 42mm. Implantable component used in p... | Mislabeled: the size on the package label of the UNITRAX¿ Endoprosthesis Head Component potentia... | Class II | Howmedica Osteonics Corp. |
| Jun 19, 2024 | UNITRAX Endoprosthesis Head Component - 43mm. Implantable component used in p... | Mislabeled: the size on the package label of the UNITRAX¿ Endoprosthesis Head Component potentia... | Class II | Howmedica Osteonics Corp. |
| Jun 19, 2024 | BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, for... | If blood culture identification panel is used in conjunction with specific lots of culture media ... | Class II | BioFire Diagnostics, LLC |
| Jun 19, 2024 | UNITRAX Endoprosthesis Head Component - 38mm. Implantable component used in p... | Mislabeled: the size on the package label of the UNITRAX¿ Endoprosthesis Head Component potentia... | Class II | Howmedica Osteonics Corp. |
| Jun 18, 2024 | CRANIOTOMY PACK, Pack Number DYNJ46552O | A non-sterile Mastisol component, which was not labeled as being sterile or non-sterile, was plac... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Jun 18, 2024 | ANESTHESIA TURNOVER KIT, Pack Number DYNJAA0377A | A non-sterile Mastisol component, which was not labeled as being sterile or non-sterile, was plac... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Jun 18, 2024 | KIT PEDI CRANI LAMI, Pack Number DYNJ907372A | A non-sterile Mastisol component, which was not labeled as being sterile or non-sterile, was plac... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Jun 18, 2024 | ANESTHESIA TURNOVER KIT, Pack Number DYNJAA0377 | A non-sterile Mastisol component, which was not labeled as being sterile or non-sterile, was plac... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Jun 18, 2024 | FoundationOne Companion Diagnostic (F1CDx) | Two (2) reports were sent to customers with an incorrect negative claim on the claims page; the d... | Class II | Foundation Medicine, Inc. |
| Jun 18, 2024 | SOFT-VU KUMPE 5F X 65CM -Used for patients in need of angiographic diagnosis.... | Mislabeled. The shelf-box labeling (unit of sale) is accurate for the packaged devices, however t... | Class II | Angiodynamics, 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.