Browse Device Recalls
47 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 47 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 47 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Feb 17, 2025 | Microstream Instructions for Use and Part Number used with - Product Descript... | Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/I... | Class II | Oridion Medical 1987 Ltd. |
| Feb 17, 2025 | Microstream Instructions for Use and Part Number used with - Product Descript... | Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/I... | Class II | Oridion Medical 1987 Ltd. |
| Feb 17, 2025 | Microstream Instructions for Use and Part Number used with - Product Descript... | Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/I... | Class II | Oridion Medical 1987 Ltd. |
| Feb 17, 2025 | Microstream Instructions for Use and Part Number used with - Product Descript... | Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/I... | Class II | Oridion Medical 1987 Ltd. |
| Feb 17, 2025 | Microstream Instructions for Use and Part Number used with - Product Descript... | Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/I... | Class II | Oridion Medical 1987 Ltd. |
| Feb 17, 2025 | Microstream Instructions for Use and Part Number used with - Product Descript... | Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/I... | Class II | Oridion Medical 1987 Ltd. |
| Feb 17, 2025 | Microstream Instructions for Use and Part Number used with - Product Descript... | Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/I... | Class II | Oridion Medical 1987 Ltd. |
| Feb 17, 2025 | Microstream Instructions for Use and Part Number used with - Product Descript... | Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/I... | Class II | Oridion Medical 1987 Ltd. |
| Feb 17, 2025 | Microstream Instructions for Use and Part Number used with - Product Descript... | Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/I... | Class II | Oridion Medical 1987 Ltd. |
| Feb 17, 2025 | Microstream Instructions for Use and Part Number used with - Product Descript... | Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/I... | Class II | Oridion Medical 1987 Ltd. |
| Jul 31, 2018 | CAPNOSTREAM 20 (US) N, Part Number CS08651 | The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the fac... | Class II | Oridion Medical 1987 Ltd. |
| Jul 31, 2018 | CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-02 | The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the fac... | Class II | Oridion Medical 1987 Ltd. |
| Jul 31, 2018 | Capnostream20 (US) M W/PRINTER, Part Number CS08659 | The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the fac... | Class II | Oridion Medical 1987 Ltd. |
| Jul 31, 2018 | Capnostream20 (INTL) M W/PRINTER, CS08660 | The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the fac... | Class II | Oridion Medical 1987 Ltd. |
| Jul 31, 2018 | Capnostream20 M W/PRINTER CYVITAL, CS08796 | The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the fac... | Class II | Oridion Medical 1987 Ltd. |
| Jul 31, 2018 | CAPNOSTREAM 20P (INTL) N - ROHS, Part Number CS08652-02 | The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the fac... | Class II | Oridion Medical 1987 Ltd. |
| Jul 31, 2018 | CAPNOSTREAM 20P (COV-INTL) N W/PRINTER ROHS, CS051COV | The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the fac... | Class II | Oridion Medical 1987 Ltd. |
| Jul 31, 2018 | CAPNOSTREAM 20P (US) N, Part Number CS08651-01 | The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the fac... | Class II | Oridion Medical 1987 Ltd. |
| Jul 31, 2018 | Capnostream20 N W/PRINTER CYVITAL, CS08798 | The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the fac... | Class II | Oridion Medical 1987 Ltd. |
| Jul 31, 2018 | Capnostream20 (US) N REFURBISHED, Part Number CS78651 | The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the fac... | Class II | Oridion Medical 1987 Ltd. |
| Jul 31, 2018 | CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-03 | The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the fac... | Class II | Oridion Medical 1987 Ltd. |
| Jul 31, 2018 | CAPNOSTREAM 20P (US) N W/PRINTER - ROHS, Part Number CS08657-02 | The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the fac... | Class II | Oridion Medical 1987 Ltd. |
| Jul 31, 2018 | CAPNOSTREAM 20P (INTL) N W/PRINTER - ROHS, CS08658-02 | The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the fac... | Class II | Oridion Medical 1987 Ltd. |
| Jul 31, 2018 | CAPNOSTREAM 20P (US) N W/PRINTER - ROHS, Part Number CS08657-03 | The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the fac... | Class II | Oridion Medical 1987 Ltd. |
| Jul 31, 2018 | Capnostream20 (US) M W/PRINTER TO MASIMO, Part Number CS08751 | The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the fac... | Class II | Oridion Medical 1987 Ltd. |
| Jul 31, 2018 | Capnostream20 (INTL) N W/PRINTER REFURBISHED, CS78658 | The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the fac... | Class II | Oridion Medical 1987 Ltd. |
| Jul 31, 2018 | Capnostream20 (INTL) M REFURBISHED, CS78654 | The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the fac... | Class II | Oridion Medical 1987 Ltd. |
| Jul 31, 2018 | Capnostream20 (US) M TO MASIMO, Part Number CS08750 | The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the fac... | Class II | Oridion Medical 1987 Ltd. |
| Jul 31, 2018 | Capnostream20 (US)M REFURBISHED, Part Number CS78653 | The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the fac... | Class II | Oridion Medical 1987 Ltd. |
| Jul 31, 2018 | CAPNOSTREAM 20P (INTL) N, Part Number CS08652-01 | The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the fac... | Class II | Oridion Medical 1987 Ltd. |
| Jul 31, 2018 | Capnostream20 N CYVITAL, CS08799 | The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the fac... | Class II | Oridion Medical 1987 Ltd. |
| Jul 31, 2018 | Capnostream20 (US) M W/PRINTER REFURBISHED, Part Number CS78659 | The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the fac... | Class II | Oridion Medical 1987 Ltd. |
| Jul 31, 2018 | Capnostream20 (INTL) M W/PRINTER REFURBISHED, CS78660 | The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the fac... | Class II | Oridion Medical 1987 Ltd. |
| Jul 31, 2018 | CAPNOSTREAM 20P (INTL) N W/PRINTER - ROHS, CS051COV-03 | The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the fac... | Class II | Oridion Medical 1987 Ltd. |
| Jul 31, 2018 | CAPNOSTREAM 20 (US) N W/PRINTER, Part Number CS08657 | The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the fac... | Class II | Oridion Medical 1987 Ltd. |
| Jul 31, 2018 | Capnostream20 (US) M, Part Number CS08653 | The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the fac... | Class II | Oridion Medical 1987 Ltd. |
| Jul 31, 2018 | CAPNOSTREAM 20P (INTL) N W/PRINTER, Part Number CS08658-01 | The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the fac... | Class II | Oridion Medical 1987 Ltd. |
| Jul 31, 2018 | CAPNOSTREAM 20 (INTL) N, Part Number CS08652 | The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the fac... | Class II | Oridion Medical 1987 Ltd. |
| Jul 31, 2018 | CAPNOSTREAM 20P (INTL) N - ROHS, Part Number CS08652-03 | The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the fac... | Class II | Oridion Medical 1987 Ltd. |
| Jul 31, 2018 | Capnostream20 M NICU (CPM), CS08654RN | The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the fac... | Class II | Oridion Medical 1987 Ltd. |
| Jul 31, 2018 | Capnostream20 (INTL) N REFURBISHED, CS78652 | The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the fac... | Class II | Oridion Medical 1987 Ltd. |
| Jul 31, 2018 | Capnostream20 (INTL) M, CS08654 | The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the fac... | Class II | Oridion Medical 1987 Ltd. |
| Jul 31, 2018 | CAPNOSTREAM 20 (INTL) N W/PRINTER, Part Number CS08658 | The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the fac... | Class II | Oridion Medical 1987 Ltd. |
| Jul 31, 2018 | Capnostream20 (US) N W/PRINTER REFURBISHED, Part Number CS78657 | The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the fac... | Class II | Oridion Medical 1987 Ltd. |
| Jul 31, 2018 | CAPNOSTREAM 20P (US) N W/PRINTER, Part Number CS08657-01 | The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the fac... | Class II | Oridion Medical 1987 Ltd. |
| Jul 31, 2018 | CAPNOSTREAM 20P (INTL) N W/PRINTER - ROHS, CS08658-03 | The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the fac... | Class II | Oridion Medical 1987 Ltd. |
| Jul 31, 2018 | Capnostream20 M ADULT ICU (CPM), CS08654RA | The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the fac... | Class II | Oridion Medical 1987 Ltd. |
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.