Browse Device Recalls
3,428 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,428 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 3,428 FDA device recalls — Class I.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| May 30, 2025 | Hillrom Q-Link 13 component, Product Code 3156509, used with the following Mo... | The Q-link 13 could allow for an improper attachment (false latching) of the Quick-Release Hook u... | Class I | Baxter Healthcare Corporation |
| May 30, 2025 | Hillrom LikoScale component, Product Code 3156232, used with the following a... | The Q-link 13 could allow for an improper attachment (false latching) of the Quick-Release Hook u... | Class I | Baxter Healthcare Corporation |
| May 30, 2025 | Servo-n Ventilator System. Model Number: 6694800. | Potential for inaccurate measurement of the patient circuit compliance during the patient circuit... | Class I | Maquet Critical Care AB |
| May 30, 2025 | Servo-u Ventilator System. Model Number: 6688600. | Potential for inaccurate measurement of the patient circuit compliance during the patient circuit... | Class I | Maquet Critical Care AB |
| May 23, 2025 | MicroMyst Applicator, Box of 5. Consisting of a multilumen applicator and fil... | Lack of sterility assurance. | Class I | Integra LifeSciences Corp. (NeuroSciences) |
| May 22, 2025 | Extended Tip Applicator 8CM, Box of 1. | Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assur... | Class I | Integra LifeSciences Corp. (NeuroSciences) |
| May 22, 2025 | Extended Tip Applicator, 8CM, Box of 5. | Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assur... | Class I | Integra LifeSciences Corp. (NeuroSciences) |
| May 22, 2025 | Extended Tip Applicator, 15 CM, Box of 5. | Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assur... | Class I | Integra LifeSciences Corp. (NeuroSciences) |
| May 21, 2025 | Newport HT70 Ventilator, REF: HT70M-JP-NA, HT70M-CN-NA, HT70M-ES-EU, HT70M-PT... | Ventilator Printed Circuit Board Assembly may have two separate capacitors that may fail, which m... | Class I | Covidien |
| May 15, 2025 | Beacon Tip 5.0 Fr Angiographic catheters are designed to facilitate diagnosti... | Cook Medical identified that catheters supplied in the affected device lots may experience tip se... | Class I | Cook Incorporated |
| May 15, 2025 | Broselow Pediatric Emergency Rainbow Tape (distribution by AirLife); REF 7700... | The impacted tape was manufactured with incorrect information on the tape. Incorrect values are p... | Class I | SunMed Holdings, LLC |
| May 14, 2025 | Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannul... | due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the... | Class I | Edwards Lifesciences, LLC |
| May 14, 2025 | Brand Name: FEM-FLEXII Product Name: Femoral Arterial Cannula Model/Catalog... | due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the... | Class I | Edwards Lifesciences, LLC |
| May 14, 2025 | Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalo... | due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the... | Class I | Edwards Lifesciences, LLC |
| May 14, 2025 | Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalo... | due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the... | Class I | Edwards Lifesciences, LLC |
| May 14, 2025 | Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalo... | due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the... | Class I | Edwards Lifesciences, LLC |
| May 14, 2025 | Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannul... | due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the... | Class I | Edwards Lifesciences, LLC |
| May 12, 2025 | Dexcom G7 Glucose Receiver, SKUs (part number): STK-AT-011(MT26403-0), STK-... | Defective foam or an assembly error may cause the receiver speaker to lose contact with the print... | Class I | Dexcom, Inc. |
| May 12, 2025 | Dexcom G6 Glucose Receiver, SKUs (Part Number): STK-FM-001 (MT27408-1) & ST... | Defective foam or an assembly error may cause the receiver speaker to lose contact with the print... | Class I | Dexcom, Inc. |
| May 12, 2025 | Dexcom One Continuous Glucose Monitoring System, SKUs(Part Number): STK-DO-00... | Defective foam or an assembly error may cause the receiver speaker to lose contact with the print... | Class I | Dexcom, Inc. |
| May 12, 2025 | Dexcom One+ Continuous Glucose Monitoring System, SKU(Part Number): STK-D7-01... | Defective foam or an assembly error may cause the receiver speaker to lose contact with the print... | Class I | Dexcom, Inc. |
| May 12, 2025 | IVENIX INFUSION SYSTEM LVP Blood Products Administration Set, Dual-Inlet, Low... | Mis-assembly error of Blood Products Administrations Sets where the 200-micron drip chamber filte... | Class I | Fresenius Kabi USA, LLC |
| May 9, 2025 | BiPAP A30 Ventilators. Intended to provide noninvasive ventilation support in... | This device does not indicate for use in patients with respiratory failure. | Class I | Philips Respironics, Inc. |
| May 9, 2025 | BiPAP A40 Ventilator. Used to provide noninvasive ventilation support for the... | This device does not indicate for use in patients with respiratory failure. | Class I | Philips Respironics, Inc. |
| May 9, 2025 | BiPAP V30 Auto Ventilator. Intended to provide non-invasive ventilatory suppo... | This device does not indicate for use in patients with respiratory failure. | Class I | Philips Respironics, Inc. |
| May 7, 2025 | Z-800F Infusion System. Intended to provide intravenous infusion of parentera... | Unreleased software versions were installed on distributed devices without verification or valida... | Class I | Zyno Medical LLC |
| May 7, 2025 | Z-800W Infusion System. Intended to provide intravenous infusion of parentera... | Unreleased software versions were installed on distributed devices without verification or valida... | Class I | Zyno Medical LLC |
| May 7, 2025 | Z-800WF Infusion System. Intended to provide intravenous infusion of parenter... | Unreleased software versions were installed on distributed devices without verification or valida... | Class I | Zyno Medical LLC |
| May 7, 2025 | Z-800 Infusion System. Intended to provide intravenous infusion of parenteral... | Unreleased software versions were installed on distributed devices without verification or valida... | Class I | Zyno Medical LLC |
| May 1, 2025 | Adult Manual Resuscitator with Medium Adult Mask, Bag REservoir, Filter, Mano... | Affected lots were manufactured with B/V Filter incorrectly attached to the wrong port (patient p... | Class I | SunMed Holdings, LLC |
| Apr 24, 2025 | Baxter Novum IQ LVP INFUSION SYSTEM, REF 40700BAXUS | There is a potential for the Novum IQ LVP due to the potential for underinfusion following use of... | Class I | Baxter Healthcare Corporation |
| Apr 22, 2025 | Medline Kits containing Codman Disposable Perforator 14 mm: 1. CRANI ACC... | Affected kits contain recalled Integra Lifesciences Codman Disposable Perforators due to inadequa... | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 22, 2025 | Endopath Echelon Vascular White Reload for Advanced Placement Tip (35mm, 4 ro... | Firm has received an increase in reports regarding inadvertent instrument lockout during surgical... | Class I | Ethicon Endo-Surgery Inc |
| Apr 22, 2025 | Medline Kits containing Codman Disposable Perforator 14 mm: CRANIOTOMY, SK... | Affected kits contain recalled Integra Lifesciences Codman Disposable Perforators due to inadequa... | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 22, 2025 | Medline Kits containing Codman Disposable Perforator 14 mm: 1. CRANI ADD A... | Affected kits contain recalled Integra Lifesciences Codman Disposable Perforators due to inadequa... | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 17, 2025 | Bard Blakemore Esophageal-Nasogastric Tube (Adult) REF: 0092100 | Due to customer complaints, there is a potential for users to be unable to or find it difficult t... | Class I | C.R. Bard Inc |
| Apr 17, 2025 | Bard Minnesota Four Lumen Esophagogastric Tamponade Tube, REF:0092220 18 Fr. ... | Due to customer complaints, there is a potential for users to be unable to or find it difficult t... | Class I | C.R. Bard Inc |
| Apr 17, 2025 | Bard¿ Blakemore Esophageal-Nasogastric Tube (Child) REF: 0092110 | Due to customer complaints, there is a potential for users to be unable to or find it difficult t... | Class I | C.R. Bard Inc |
| Apr 17, 2025 | Bard¿ Blakemore Esophageal-Nasogastric Tube (Intermediate)REF: 0092300 | Due to customer complaints, there is a potential for users to be unable to or find it difficult t... | Class I | C.R. Bard Inc |
| Apr 17, 2025 | Bard¿ Single Intragastric Linton Balloon Tube, REF: 0092740 | Due to customer complaints, there is a potential for users to be unable to or find it difficult t... | Class I | C.R. Bard Inc |
| Apr 11, 2025 | MedicaLyte Liquid Bicarbonate Concentrate. Model Numbers: BC+201 (45X), BC+10... | Potential for the presence of visible foreign matter. | Class I | Nipro Renal Soultions USA, Corporation |
| Apr 11, 2025 | CODMAN Disposable Perforator, 14mm. Cranial perforator. | Inadequate weld that can potentially cause the product to disassemble. | Class I | Integra LifeSciences Corp. (NeuroSciences) |
| Apr 11, 2025 | iGo¿2 DC Car Adapter to be used with iGo¿2 Portable Oxygen Concentrator Syste... | Potential for DC Power Supply housing to become hot to the touch and deform the plastic housing. | Class I | Medical Depot Inc. |
| Apr 11, 2025 | CODMAN Craniotomy Kit, Disposable Perforator Cranio-blade Wire Pass Drill, 14... | Inadequate weld that can potentially cause the product to disassemble. | Class I | Integra LifeSciences Corp. (NeuroSciences) |
| Apr 11, 2025 | Centerline Biomedical IOPS Guidewire 2, REF ATW-2; Sensorized wire used to na... | Centerline Biomedical has determined that the coating on the guidewires for lot 2404-2005 may del... | Class I | Centerline Biomedical Inc |
| Apr 10, 2025 | Brand Name: AirLife Product Name: AirLife Infant Heated Wire Circuit Model/... | Adapters may disconnect during setup or while in use, potentially interrupting ventilation. Any d... | Class I | Vyaire Medical |
| Apr 10, 2025 | Brand Name: AirLife Product Name: AirLife Infant Heated Wire Circuit Model/... | Adapters may disconnect during setup or while in use, potentially interrupting ventilation. Any d... | Class I | Vyaire Medical |
| Apr 10, 2025 | CADD Solis HSPCA Pump | Pumps may experience Wireless Connection Modules intermittent connection alarms, which will inter... | Class I | Smiths Medical ASD, Inc. |
| Apr 10, 2025 | CADD-Solis Infusion Pump Models: 1) PUMP KIT, CADD-SOLIS, MDL 2110, V4.2, ... | There is a potential for thermal damage in CADD-Solis and CADD- Solis VIP infusion pumps. | Class I | Smiths Medical ASD, Inc. |
| Apr 10, 2025 | CADD Solis VIP Ambulatory Infusion Pump Models: 1) PUMP KIT, CADD-SOLIS VI... | There is a potential for thermal damage in CADD-Solis and CADD- Solis VIP infusion pumps. | Class I | Smiths Medical ASD, 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.