Browse Device Recalls
675 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 675 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 675 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jun 8, 2022 | Palindrome Precision SI Chronic Catheter, Sterile, Single Use, Rx Only. For v... | There is a potential leaking condition within the hub of specific chronic dialysis catheters, due... | Class I | Covidien Llc |
| Jun 8, 2022 | Palindrome Precision H Chronic Catheter, Sterile, Single Use, Rx Only. For va... | There is a potential leaking condition within the hub of specific chronic dialysis catheters, due... | Class I | Covidien Llc |
| Jun 8, 2022 | Palindrome Chronic Catheter, Sterile, Single Use, Rx Only. For vascular acces... | There is a potential leaking condition within the hub of specific chronic dialysis catheters, due... | Class I | Covidien Llc |
| Jun 8, 2022 | Mahurkar Chronic Carbothane (Maxid) Catheter, Sterile, Single Use, Rx Only. F... | There is a potential leaking condition within the hub of specific chronic dialysis catheters, due... | Class I | Covidien Llc |
| Jun 8, 2022 | Palindrome SI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and c... | There is a potential leaking condition within the hub of specific chronic dialysis catheters, due... | Class I | Covidien Llc |
| Jun 8, 2022 | Palindrome H Chronic Catheter, Sterile, Single Use, Rx Only. For acute and ch... | There is a potential leaking condition within the hub of specific chronic dialysis catheters, due... | Class I | Covidien Llc |
| Jun 8, 2022 | Palindrome Precision HSI Chronic Catheter, Sterile, Single Use, Rx Only. For ... | There is a potential leaking condition within the hub of specific chronic dialysis catheters, due... | Class I | Covidien Llc |
| Jun 8, 2022 | Palindrome Precision Chronic Catheter, Sterile, Single Use, Rx Only. For vasc... | There is a potential leaking condition within the hub of specific chronic dialysis catheters, due... | Class I | Covidien Llc |
| Jun 7, 2022 | TruClear Hysteroscopic Tissue Removal System Control Unit- designed to meet t... | Electrical component failure within the control unit. The observed failure mode is a loss of func... | Class II | Covidien Llc |
| May 13, 2022 | EEA Autosuture Circular Stapler with DST Series Technology, 25mm. Model Numbe... | The affected staplers have the potential for the staple guide to not be securely attached to the ... | Class II | Covidien, LP |
| Mar 25, 2022 | Puritan Bennett 980 Series Ventilator | The audible alarm may not sound and/or the omni-directional LED visual alarm may not display duri... | Class I | Medtronic formerly Covidien |
| Dec 22, 2021 | SonarMed AirWave Monitor Kit (Monitor, Sensor Cable, Power Cord), Item Code A... | Prior to use on a patient, the device alarm speaker failed to annunciate on power up and the devi... | Class II | Covidien, LP |
| Dec 17, 2021 | Chameleon PTA Balloon Dilation Catheter 8 mm x 40 mm, Chameleon PTA Balloon C... | The firm has received six (6) complaint reports from customers indicating difficulty removing the... | Class II | Covidien Llc |
| Dec 6, 2021 | LigaSure Blunt Tip Laparoscopic Sealer/Divider, Nano-Coated, Product Number L... | Customers reported that the device jaws were difficult to open or would not open following applic... | Class II | Covidien Llc |
| Nov 12, 2021 | Covidien Sonicision Battery Charger-intended to charge the Sonicision Reusabl... | Intermittent risk of electric shock to users if an affected charger is used in conjunction with a... | Class II | Covidien Llc |
| Nov 4, 2021 | Puritan Bennett 980 Series Ventilator, 980X1PLDIPC | Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, w... | Class I | Covidien Llc |
| Nov 4, 2021 | Puritan Bennett 980 Series Ventilator, 980X3JADIJJ | Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, w... | Class I | Covidien Llc |
| Nov 4, 2021 | Puritan Bennett 980 Series Ventilator, 980U3ESDIUU | Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, w... | Class I | Covidien Llc |
| Nov 4, 2021 | Puritan Bennett 980 Series Ventilator,980X1ENAIQC | Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, w... | Class I | Covidien Llc |
| Nov 4, 2021 | Puritan Bennett 980 Series Ventilator, 980X1JADIJJ | Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, w... | Class I | Covidien Llc |
| Nov 4, 2021 | Puritan Bennett 980 Series Ventilator, 980A1ENNISB | Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, w... | Class I | Covidien Llc |
| Nov 4, 2021 | Puritan Bennett 980 Series Ventilator, 980X1ENDIUU | Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, w... | Class I | Covidien Llc |
| Nov 4, 2021 | Puritan Bennett 980 Series Ventilator, 980S1ENDICU | Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, w... | Class I | Covidien Llc |
| Nov 4, 2021 | Puritan Bennett 980 Series Ventilator, 980X1ENDIPC | Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, w... | Class I | Covidien Llc |
| Nov 4, 2021 | Puritan Bennett 980 Series Ventilator, 980A3ENNISB | Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, w... | Class I | Covidien Llc |
| Nov 4, 2021 | Puritan Bennett 980 Series Ventilator, 980S3ENDICU | Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, w... | Class I | Covidien Llc |
| Nov 4, 2021 | Puritan Bennett 980 Series Ventilator, 980X1ENNISB | Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, w... | Class I | Covidien Llc |
| Nov 4, 2021 | Puritan Bennett 980 Series Ventilator, 980X3ENDIUU | Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, w... | Class I | Covidien Llc |
| Nov 4, 2021 | Puritan Bennett 980 Series Ventilator, 980U1ENASAA | Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, w... | Class I | Covidien Llc |
| Nov 4, 2021 | Puritan Bennett 980 Series Ventilator, 980U1ESDIUC | Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, w... | Class I | Covidien Llc |
| Nov 4, 2021 | Puritan Bennett 980 Series Ventilator, 980X2ESDIEC | Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, w... | Class I | Covidien Llc |
| Sep 29, 2021 | Covidien Emprint Ablation Catheter with Thermosphere Technology Bronchoscopic... | The firm identified an error in the device temperature monitoring circuitry which is designed to ... | Class II | Covidien Llc |
| Jun 23, 2021 | Covidien Sonicision Reusable Generator-converts electrical power from the bat... | Potential for a manufacturing assembly error-may result in a non-functional audio indicator of de... | Class II | Covidien Llc |
| Jun 18, 2021 | Covidien HysteroLux Fluid Management System Control Unit, REF: 72205000 | When the display of inflow volume to the uterus reaches 32450 ml, the fluid management system con... | Class II | WOM World of Medicine AG |
| May 28, 2021 | Palindrome RT Repair Kit 15 FR TAL 28cm, Sterile, Item Code 8888541128 | This voluntary withdrawal is being conducted to implement point-of-use labeling on each device an... | Class II | Covidien, LP |
| May 28, 2021 | Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunnele... | This voluntary withdrawal is being conducted to implement point-of-use labeling on each device an... | Class II | Covidien, LP |
| May 28, 2021 | Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch... | This voluntary withdrawal is being conducted to implement point-of-use labeling on each device an... | Class II | Covidien, LP |
| May 28, 2021 | Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch... | This voluntary withdrawal is being conducted to implement point-of-use labeling on each device an... | Class II | Covidien, LP |
| May 28, 2021 | Palindrome RT Repair Kit 15 FR TAL 19cm, Sterile, Item Code 8888541119 | This voluntary withdrawal is being conducted to implement point-of-use labeling on each device an... | Class II | Covidien, LP |
| May 28, 2021 | Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch... | This voluntary withdrawal is being conducted to implement point-of-use labeling on each device an... | Class II | Covidien, LP |
| May 28, 2021 | Palindrome RT Repair Kit 15 FR TAL 23cm, Sterile, Item Code 8888541123 | This voluntary withdrawal is being conducted to implement point-of-use labeling on each device an... | Class II | Covidien, LP |
| May 28, 2021 | Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunnele... | This voluntary withdrawal is being conducted to implement point-of-use labeling on each device an... | Class II | Covidien, LP |
| May 28, 2021 | Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch... | This voluntary withdrawal is being conducted to implement point-of-use labeling on each device an... | Class II | Covidien, LP |
| May 28, 2021 | Palindrome RT Repair Kit 15 FR TAL 33cm, Sterile, Item Code 8888541133 | This voluntary withdrawal is being conducted to implement point-of-use labeling on each device an... | Class II | Covidien, LP |
| May 28, 2021 | Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch... | This voluntary withdrawal is being conducted to implement point-of-use labeling on each device an... | Class II | Covidien, LP |
| May 28, 2021 | Palindrome RT Repair Kit 15 FR TAL 44cm, Sterile, Item Code 8888541144 | This voluntary withdrawal is being conducted to implement point-of-use labeling on each device an... | Class II | Covidien, LP |
| May 28, 2021 | Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunnele... | This voluntary withdrawal is being conducted to implement point-of-use labeling on each device an... | Class II | Covidien, LP |
| May 28, 2021 | Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch... | This voluntary withdrawal is being conducted to implement point-of-use labeling on each device an... | Class II | Covidien, LP |
| May 28, 2021 | Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunnele... | This voluntary withdrawal is being conducted to implement point-of-use labeling on each device an... | Class II | Covidien, LP |
| May 28, 2021 | Palindrome RT Repair Kit 15 FR TAL 55cm, Sterile, Item Code 8888541155 | This voluntary withdrawal is being conducted to implement point-of-use labeling on each device an... | Class II | Covidien, LP |
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.