Browse Device Recalls
2,831 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,831 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 2,831 FDA device recalls in 2025.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 22, 2025 | ICU Medical Plum Solos, Item number 400011001; infusion pump | Internal testing found that Plum Duo pumps with software version 1.1.1 have a workflow that may r... | Class II | ICU Medical, Inc. |
| 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 | Brand Name: Catalyst+ Product Name: C4D software used in conjunction with ... | Software issue with scanning equipment that can results in the filed rotation not being applied c... | Class II | C-RAD POSITIONING AB |
| 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 | 3M Ranger Irrigation Fluid Warming Set, REF 24750 | Notice was issued to clarify flow rates related to the inlet fluid temperature. | Class II | 3M Company |
| 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 21, 2025 | Precision Sampling Set, REF: C20206 for use with the CoSense End-Tidal Carbon... | Sampling set nasal cannula used with End-Tidal Carbon Monoxide (ETCO) monitor may have residual c... | Class II | Capnia Inc |
| Apr 21, 2025 | LOWER EXTREMITY, Model: NCEX20I; LOWER EXTREMITY, Model: NCEX20J; TOTAL KN... | Test results for cast padding component included in procedure trays shows Ethylene Oxide/Ethylene... | Class II | American Contract Systems, Inc. |
| Apr 21, 2025 | BD Cathena Safety IV Catheter BD Multiguard Technology 18 GA x 1.25 IN, REF: ... | Due to a manufacturing defect IV catheter may have a hole in the septum, which may result in bloo... | Class II | Becton Dickinson Infusion Therapy Systems, Inc. |
| Apr 21, 2025 | BIB Balloon in Balloon Dilatation Catheter. Model Number: 420 | Balloon extension lumens are not printed correctly. Specifically, the inner balloon inflation hub... | Class II | Numed Inc |
| Apr 17, 2025 | WB XL Anatomic Healing Abutment XC. Endosseous Dental Implant Abutments. | Incorrect blister labelling. | Class II | Straumann USA LLC |
| 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 | Tornado Embolization Microcoil, intended for embolization of selective vessel... | Cook Medical identified that devices from the affected device lots may contain the incorrectly si... | Class II | Cook Incorporated |
| 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 | Check=Flo Performer Introducer, 14.0Fr, Reference Part Number(RPN) REF RCFW-... | Cook Medical identified that devices from the affected device lots may contain the incorrectly si... | Class II | Cook Incorporated |
| Apr 17, 2025 | Check=Flo Performer Introducer, 10.0Fr, Reference Part Number(RPN) REF RCFW-... | Cook Medical identified that devices from the affected device lots may contain the incorrectly si... | Class II | Cook Incorporated |
| 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 16, 2025 | Tempus Pro Patient Monitor, REFs: 00-1004-R (Tempus Pro non-printer, IBP, wi... | software issue that causes an error screen on a portable vital signs monitor when attaching video... | Class II | Remote Diagnostic Technologies Ltd. |
| Apr 16, 2025 | VERIGENE Gram Negative Blood Culture (BC-GN) Nucleic Acid Test, REF 20-006-02... | It was determined that the consumable issue may result in No Call - INT CTL 1 and/or False Negati... | Class II | Luminex Corporation |
| Apr 15, 2025 | ADVIA Centaur HCY Calibrator (2 Pack). Siemens Material Number: 10310376. | Certain lots of Atellica IM Homocysteine Calibrator and ADVIA Centaur HCY Calibrator do not meet ... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Apr 15, 2025 | Atellica IM Homocysteine Calibrator (2 Pack). Siemens Material Number: 10995498 | Certain lots of Atellica IM Homocysteine Calibrator and ADVIA Centaur HCY Calibrator do not meet ... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Apr 15, 2025 | Philips Tempus Pro Patient Monitor, REF: 00-1004-R, 00-1007-R, 00-1024-R, 00... | Patient Monitor software update to address issues:1)May freeze at startup with MPM Application er... | Class II | Remote Diagnostic Technologies Ltd. |
| Apr 14, 2025 | Plus Initial Drill, Article Number: 103.170; | The referred batch was produced without the laser engraving of 7 mm. | Class II | Straumann USA LLC |
| Apr 14, 2025 | Augmedics Perc Pin Adaptor, Model/Catalog Number AMCH07200, a component of th... | The perc pin adaptor AMCH07200 tightening knob was found to be inconvenient to the user and the t... | Class II | Augmedics Ltd. |
| Apr 14, 2025 | VITROS Chemistry Products CRP Slides. One sales unit contains 5 cartridges, o... | Product was incorrectly assigned GEN 88 instead of GEN 83 on product carton, foil wrapper, and ca... | Class II | Ortho-Clinical Diagnostics, Inc. |
| Apr 14, 2025 | Glidewell HT Implant Twist Drill ¿1.5 x 8 mm " SKU # 70-1071-SRG0266 UDI cod... | Due to packaging mix up. Package of finished devices were reported to have an incorrect finished... | Class II | Prismatik Dentalcraft, Inc. |
| Apr 13, 2025 | Microtek Patient Drape ECOLAB AP6MMN Patient Drape, 6mm Adapter Plug Kit R... | Due to non-sterile products being labeled as sterile | Class II | Microtek Medical, Inc. |
| Apr 11, 2025 | Pruitt Irrigation Occlusion Catheter. Catalog Numbers: 2102-09, E2102-09. | During internal product testing, it was observed that some packages to have incomplete seals (ste... | Class II | LeMaitre Vascular, 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 | TufTex Over-the-Wire Embolectomy Catheter. All Catalog numbers: 1651-34, 1651... | During internal product testing, it was observed that some packages to have incomplete seals (ste... | Class II | LeMaitre Vascular, Inc. |
| Apr 11, 2025 | Pruitt Occlusion Catheter. Catalog Numbers: 2103-36, 2103-46, 2103-56, E2103-... | During internal product testing, it was observed that some packages to have incomplete seals (ste... | Class II | LeMaitre Vascular, Inc. |
| 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 | CMS8000 Patient Monitor | Patient monitor has nine identified cybersecurity vulnerabilities. | Class II | Contec Medical Systems Co., Ltd. |
| Apr 10, 2025 | Blueprint Software, BPUE001. Intended for use by surgeons as a pre surgical ... | A software bug in Blueprint version 4.2.1 prevents users from accessing cases initiated in previo... | Class II | Tornier S.A.S. |
| 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. |
| Apr 10, 2025 | CADD-Solis VIP Ambulatory Infusion Pump; Model/Number: 21-2120-0100-02 ... | Affected pumps may trigger an erroneous (false) Upstream Occlusion Alarm under certain conditions... | Class I | Smiths Medical ASD, Inc. |
| Apr 10, 2025 | 3M Ranger Blood/Fluid Warming High Flow Set Catalog Numbers 24355, 24370 | Field action to clarify the flow rates and inlet fluid temperatures, along with location of the o... | Class I | 3M Company |
| Apr 10, 2025 | CADD-Solis HPCA Ambulatory Infusion Pump; Model/Number: 21-2111-0402-09-KYO... | Affected pumps may trigger an erroneous (false) Upstream Occlusion Alarm under certain conditions... | Class I | Smiths Medical ASD, Inc. |
| Apr 9, 2025 | Centurion Sterile Weitlaner Retractor, Reorder: 67315 | Three is the potential for the retractors to puncture through the sterile packaging. | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 9, 2025 | PiezoWave 2 Control Unit, Product Number 100506US, compact myofascial acousti... | The high voltage capacitor may fail early in the product life cycle after delivery of surge volta... | Class II | Richard Wolf GmbH |
| Apr 9, 2025 | FoundationOne Companion Diagnostic (F1CDx) | Four (4) total reports were sent to customers with clinically relevant variants requiring amendme... | Class II | Foundation Medicine, 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.