Browse Device Recalls
334 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 334 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 334 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jan 30, 2026 | HealthCast "Vital Sync" Remote Patient Monitoring System which consists of: ... | Due to complaints and investigations stating that alarms from the primary patient bedside monitor... | Class II | Covidien LLC |
| Aug 19, 2022 | Puritan Bennett 560 Ventilator, PB560, CFN 4096600 | Medtronic has confirmed six reports from customers outside the US where the ventilator became ino... | Class II | Covidien Llc |
| Jun 8, 2022 | Palindrome HSI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and ... | There is a potential leaking condition within the hub of specific chronic dialysis catheters, due... | Class I | Covidien Llc |
| 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 |
| 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 |
| Mar 23, 2021 | Covidien Tri-Staple 2.0 Reinforced Intelligent Reload 60 mm Medium/Thick-For ... | Potential for the pouch to contain an extra laminate layer, creating the potential for the device... | Class II | Covidien Llc |
| Feb 26, 2021 | BRAVO PH CAPS DELIVERY DEV5-PK, FGS-0312/FGS-0313 - Product Usage: intended t... | The capsule may fail to attach to the esophageal mucosa, which in turn may lead to the aspiration... | Class II | Covidien Llc |
| Feb 26, 2021 | CF Delivery Dev Caps Bravo x5, FGS-0635/FGS 0636 - Product Usage: intended to... | The capsule may fail to attach to the esophageal mucosa, which in turn may lead to the aspiration... | Class II | Covidien Llc |
| Jan 13, 2021 | Covidien Parietex hydrophilic anatomical mesh 15 cm x 10 cm polyester left - ... | incorrect device is contained in the package. The packaging label indicates that the device is fo... | Class II | Covidien Llc |
| Nov 23, 2020 | Covidien TA Auto Suture Vascular Stapler with DST Series Technology 30mm-V 3... | May contain a damaged internal component which could impede staple deployment and result in incom... | Class II | Covidien Llc |
| Nov 23, 2020 | Covidien TA Auto Suture Vascular Loading Unit with DST Series Technology 30 m... | May contain a damaged internal component which could impede staple deployment and result in incom... | Class II | Covidien Llc |
| Nov 16, 2020 | Capnostream 35 Portable Respiratory Monitor, Product numbers PM35MN02, PM35MN... | The firm has released software update V01.05.02.16 (also known as V1.5.2) in response to customer... | Class II | Covidien Llc |
| Oct 16, 2020 | Puritan Bennett 980 (PB980) Ventilator Series - Product Usage: for use on pat... | In-house lab observations and customer reports of overheating and/or thermal damage to the batter... | Class II | Covidien Llc |
| Jun 26, 2020 | Beacon EUS Access System Preloaded Access 90degree Needle sterile, single-us... | This voluntary recall is being conducted following three customer reports of the device cannula d... | Class II | Covidien Llc |
| Jun 26, 2020 | Beacon EUS Access System Preloaded Access 135degree Needle sterile, single-u... | This voluntary recall is being conducted following three customer reports of the device cannula d... | Class II | Covidien Llc |
| May 12, 2020 | Multifire VersaTrack Auto Suture Hernia Stapler, 4.8mm, Part No. 174023 - Pro... | The product is recalled due to a manufacturing assembly error that may cause the staples to fail ... | Class II | Covidien Llc |
| May 12, 2020 | Multifire Endo Hernia 0 12mm Stapler with 4.0mm Disposable Loading Unit , Par... | The product is recalled due to a manufacturing assembly error that may cause the staples to fail ... | Class II | Covidien Llc |
| May 12, 2020 | Multifire Endo Hernia 0 12mm Stapler with 4.8mm Disposable Loading Unit , Par... | The product is recalled due to a manufacturing assembly error that may cause the staples to fail ... | Class II | Covidien Llc |
| May 12, 2020 | Multifire VersaTrack Auto Suture Hernia Stapler, 4.0mm, Part No. 174021 - Pro... | The product is recalled due to a manufacturing assembly error that may cause the staples to fail ... | Class II | Covidien Llc |
| Apr 30, 2020 | Dover 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Tray 40... | Temperature sensing catheters failed to meet the established calibrated temperature sensing tole... | Class II | Covidien Llc |
| Apr 30, 2020 | Dover 100% Silicone Premium Urine Meter Tray 400mL, 16 Fr/Ch (5.3 mm), 5 mL F... | Temperature sensing catheters failed to meet the established calibrated temperature sensing tole... | Class II | Covidien Llc |
| Apr 30, 2020 | Dover 400 ml 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley T... | Temperature sensing catheters failed to meet the established calibrated temperature sensing tole... | Class II | Covidien 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.