Browse Device Recalls
35,653 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 35,653 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 35,653 FDA device recalls, Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 15, 2024 | OrganOx metra -Intended as a Normothermic Machine Perfusion system of donor t... | Battery movement led to damage of one of the battery cells causing it to short to the battery ret... | Class II | OrganOx Ltd |
| Oct 14, 2024 | Defibtech DDP-200P: Pediatric Defibrillation Pads 0 For use with AED Models: ... | Within the Irish Market, that a Field Safety Notice is being issued due to a select number of aut... | Class II | Defibtech, LLC |
| Oct 14, 2024 | Defibtech DDP-100 Adult Defibrillation Pads For use with AED Models: Lifeline... | Within the Irish Market, a Field Safety Notice is being issued due to a select number of authoriz... | Class II | Defibtech, LLC |
| Oct 14, 2024 | Defibtech DDP-2002: Pediatric Defibrillation Pads For use with AED Models: L... | Within the Irish Market, that a Field Safety Notice is being issued due to a select number of aut... | Class II | Defibtech, LLC |
| Oct 14, 2024 | Approach CTO Micro Wire Guide, RPN CMW-14-190-25G, GPN G50789 | Devices from the affected device lots have labels that state the incorrect expiration dates. | Class II | Cook Incorporated |
| Oct 14, 2024 | Defibtech DDP-2001: Adult Defibrillation Pads For use with AED Models: Lifel... | Within the Irish Market, that a Field Safety Notice is being issued due to a select number of aut... | Class II | Defibtech, LLC |
| Oct 11, 2024 | Hillrom Welch Allyn Vision Express Holter Analysis System; Electrocardiograph | There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If th... | Class II | Baxter Healthcare Corporation |
| Oct 11, 2024 | Hillrom Welch Allyn Q-Stress Cardiac Stress Testing System; cardiac stress test | There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If th... | Class II | Baxter Healthcare Corporation |
| Oct 11, 2024 | Hillrom Welch Allyn RScribe 12-Lead Electrocardiograph System; Electrocardiog... | There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If th... | Class II | Baxter Healthcare Corporation |
| Oct 11, 2024 | 4.5 x 180 mm REF 28208BKS Aggressive Cutter, sterile, 6x 3.5 x 70 mm REF 2... | Due to holes detected in the inner barrier system that may compromise the sterility of the affect... | Class II | Karl Storz Endoscopy |
| Oct 11, 2024 | VITROS Chemistry Products CRP Slides- In vitro diagnostic quantitatively meas... | May Generate Negatively Biased Results When Testing Samples with High Concentrations of CRP, show... | Class II | Ortho-Clinical Diagnostics, Inc. |
| Oct 11, 2024 | Hillrom Welch Allyn HScribe Holter System; ambulatory monitoring | There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If th... | Class II | Baxter Healthcare Corporation |
| Oct 11, 2024 | Hillrom Welch Allyn XScribe Cardiac Stress Testing System; Programmable Diagn... | There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If th... | Class II | Baxter Healthcare Corporation |
| Oct 11, 2024 | Hillrom Welch Allyn Diagnostic Cardiology Suite (formerly Connex Cardio); Dia... | There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If th... | Class II | Baxter Healthcare Corporation |
| Oct 10, 2024 | Vue PACS Diagnostic Viewer with Vue PACS client 12.1.5 to 12.2.8.454 software... | A software issue affecting Philips Vue PACS may cause incorrect ischemic map and table value calc... | Class II | Philips Medical Systems Technologies Ltd. |
| Oct 9, 2024 | MEDLINE convenience kits labeled as: 1) MAMMOPLASTY-LF, REF CDS983478L; 2)... | Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuat... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 9, 2024 | CORMIX 250 mL EMPTY EVA CONTAINER With 2 Ports, REF MS64045; An empty single-... | A limited number of IV bags have been found to leak during filling. | Class II | The Metrix Company |
| Oct 9, 2024 | SECURE 100 mL EMPTY EVA CONTAINER With 2 Ports (Bulk Packed), REF 66041; An e... | A limited number of IV bags have been found to leak during filling. | Class II | The Metrix Company |
| Oct 9, 2024 | SECURE 50 mL EMPTY EVA CONTAINER With 2 Ports (Bulk Packed) , REF 66043; An e... | A limited number of IV bags have been found to leak during filling. | Class II | The Metrix Company |
| Oct 9, 2024 | VYGON 250 mL EMPTY EVA CONTAINER With 2 Ports, REF CMS-9602; An empty single-... | A limited number of IV bags have been found to leak during filling. | Class II | The Metrix Company |
| Oct 9, 2024 | SECURE 500 mL EMPTY EVA CONTAINER With 2 Ports, REF 66050; An empty single-us... | A limited number of IV bags have been found to leak during filling. | Class II | The Metrix Company |
| Oct 9, 2024 | Imed Products Imed EVA BAG, 1000 mL, 2-PORTS, REF IM68055; An empty single-us... | A limited number of IV bags have been found to leak during filling. | Class II | The Metrix Company |
| Oct 9, 2024 | Autosampler, Models: SIL-20ACXR CL, SIL-20ACHT CL, SIL-30AC CL | There have been cases of failure of the main board due to condensation water drained from the Pel... | Class II | Shimadzu Corp. Analytical & Measuring Instrumen... |
| Oct 9, 2024 | MEDLINE convenience kits labeled as: 1) BREAST BIOPSY PACK-LF, REF DYNJ01... | Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuat... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 9, 2024 | MEDLINE convenience kits labeled as: 1) GENERAL ENDOSCOPY PACK, REF DYNJ44... | Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuat... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 9, 2024 | MEDLINE convenience kits labeled as: 1) ORTHO LAMINECTOMY-LF, REF CDS780112... | Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuat... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 9, 2024 | MEDLINE convenience kits labeled as: 2) ABDOMINAL LAPAROSCOPY, REF CDS76005... | Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuat... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 9, 2024 | SECURE 1000 mL EMPTY EVA CONTAINER With 2 Ports, REF 66055; An empty single-u... | A limited number of IV bags have been found to leak during filling. | Class II | The Metrix Company |
| Oct 9, 2024 | MEDLINE convenience kits labeled as: 1) BURN, REF CDS983465M; 2) BURN, R... | Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuat... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 9, 2024 | VYGON 100 mL EMPTY EVA CONTAINER With 2 Ports, REF CMS-9601; An empty single-... | A limited number of IV bags have been found to leak during filling. | Class II | The Metrix Company |
| Oct 9, 2024 | Imed Products Imed EVA BAG, 150 mL, 2-PORTS, REF IM38040; An empty single-use... | A limited number of IV bags have been found to leak during filling. | Class II | The Metrix Company |
| Oct 9, 2024 | MEDLINE convenience kits labeled as: 1) LAKELAND SINGLE BASIN PACK-LF, REF... | Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuat... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 9, 2024 | MEDLINE convenience kits labeled as: 1) GYN LAPAROSCOPY-LF, REF CDS760059I... | Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuat... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 9, 2024 | MEDLINE convenience kits labeled as: 1) CIRCUMCISION PACK, REF DYNJ16826O;... | Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuat... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 9, 2024 | MEDLINE convenience kits labeled as: 1) TRACH TOTE, REF DYNJ85691; 2) TR... | Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuat... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 9, 2024 | MEDLINE convenience kits labeled as: 1) TOT/ GYN LITHOTOMY CDS, REF CDS985... | Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuat... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 9, 2024 | CORMIX 150 mL EMPTY EVA CONTAINER With 2 Ports, REF MS64040; An empty single-... | A limited number of IV bags have been found to leak during filling. | Class II | The Metrix Company |
| Oct 9, 2024 | SECURE 50 mL EMPTY EVA CONTAINER With 2 Ports, REF 66042; An empty single-use... | A limited number of IV bags have been found to leak during filling. | Class II | The Metrix Company |
| Oct 9, 2024 | CORMIX 500 mL EMPTY EVA CONTAINER With 2 Ports, REF MS64050; An empty single-... | A limited number of IV bags have been found to leak during filling. | Class II | The Metrix Company |
| Oct 9, 2024 | MEDLINE convenience kits labeled as: 1) MINOR EYE TRAY #81, REF DYNJ27466S... | Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuat... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 9, 2024 | Autosampler, Models: SIL-40C XR CL, SIL-40C X3 CL | There have been cases of failure of the main board due to condensation water occurring in the gap... | Class II | Shimadzu Corp. Analytical & Measuring Instrumen... |
| Oct 9, 2024 | MEDLINE convenience kits labeled as: PORT INSERTION PACK, REF DYNJ81597 | Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuat... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 9, 2024 | MEDLINE medical convenience kits labeled as: 1) ACETABULAR PACK-LF, REF DY... | Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuat... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 9, 2024 | MEDLINE convenience kits labeled as: 1) ANGIO PACK #2, REFDYNJ39185D; 2)... | Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuat... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 9, 2024 | MEDLINE convenience kits labeled as: L&D MINOR PACK, REF DYNJ82672 | Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuat... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 9, 2024 | MEDLINE convenience kits labeled as: 1) C-SECTION OR 30 CDS, REF CDS820075V... | Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuat... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 9, 2024 | MEDLINE convenience kits labeled as: COLON WOUND CLOSURE PACK, REF DYNJ52141B | Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuat... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 9, 2024 | MEDLINE convenience kits labeled as: 1) MAJOR VASCULAR-LF, REF CDS840232L; ... | Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuat... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 9, 2024 | MEDLINE convenience kits labeled as: 1) BASIC NEURO PACK, REF CDS780202P; ... | Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuat... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 9, 2024 | SECURE 250 mL EMPTY EVA CONTAINER With 2 Ports, REF 66045; An empty single-us... | A limited number of IV bags have been found to leak during filling. | Class II | The Metrix Company |
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.