Browse Device Recalls
35,290 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 35,290 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 35,290 FDA device recalls, Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 9, 2024 | MEDLINE convenience kits labeled as: 1) LITHOTOMY/PELVISCOPY PACK, REF DYN... | 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) ZALE HEAD & NECK CDS, REF CDS983184... | Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuat... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 8, 2024 | Approach Hydro ST Micro Wire Guide; Catalog prefix HMW Reference Part Numb... | Affected device lots have labels that state the incorrect expiration dates. | Class II | Cook Incorporated |
| Oct 8, 2024 | Approach CTO Micro Wire Guide, Guide Wire, Catalog Prefix CMW; Reference P... | Affected device lots have labels that state the incorrect expiration dates. | Class II | Cook Incorporated |
| Oct 8, 2024 | MONOCRYL" (poliglecaprone 25) Suture REF Y936H MONOCRYL" Sutures are indic... | Due a component mix-up in manufacturing, the affected products may contain incorrect needle type/... | Class II | ETHICON, INC. |
| Oct 7, 2024 | Philips Zenition 50, Model Number: 718096 | Potential for the Mains Control Unit board fuse may blow out during system start-up or during a p... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Oct 7, 2024 | Philips Zenition 70, Model Number: 718133 | Potential for the Mains Control Unit board fuse may blow out during system start-up or during a p... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Oct 7, 2024 | DRG:HYBRiD-XL Insulin. Model/Catalog Number: HYE-5361 | The user of the assay may either face a failure message during re-calibration of the Hybrid.XL in... | Class II | DRG International, Inc. |
| Oct 5, 2024 | CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM CardioMEMSTM HF System Hosptial El... | As a result of a cloud data migration of Patient and Hospital Electronic Systems (PES and HES) re... | Class II | St. Jude Medical |
| Oct 5, 2024 | CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM CardioMEMSTM HF System Patient Ele... | As a result of a cloud data migration of Patient and Hospital Electronic Systems (PES and HES) re... | Class II | St. Jude Medical |
| Oct 4, 2024 | ARTHROSCOPY Convenience kit used for surgical procedures, SKU SYNJ910004C | Products within a Medline pack may be impacted by a packaging error in which an incomplete seal h... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 4, 2024 | CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-103. | Potential failure of affected units to recharge the battery of the oxygen concentrators. | Class II | Caire, Inc. |
| Oct 4, 2024 | Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4702 | Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigati... | Class II | Hobbs Medical, Inc. |
| Oct 4, 2024 | CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-1. | Potential failure of affected units to recharge the battery of the oxygen concentrators. | Class II | Caire, Inc. |
| Oct 4, 2024 | CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-101. | Potential failure of affected units to recharge the battery of the oxygen concentrators. | Class II | Caire, Inc. |
| Oct 4, 2024 | Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4720 | Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigati... | Class II | Hobbs Medical, Inc. |
| Oct 4, 2024 | Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4706 | Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigati... | Class II | Hobbs Medical, Inc. |
| Oct 4, 2024 | Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4721 | Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigati... | Class II | Hobbs Medical, Inc. |
| Oct 4, 2024 | CARROLLTON HIP FX Convenience kit used for surgical procedures, SKU SYNJ910003A | Products within a Medline pack may be impacted by a packaging error in which an incomplete seal h... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 4, 2024 | Stryker Neptune SafeAir Smoke Evacuation Pencil, Coated, 70mm Blade, Push But... | There is a potential for the product to activate without manual input when plugged into a power s... | Class II | Stryker Corporation |
| Oct 4, 2024 | Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4718 | Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigati... | Class II | Hobbs Medical, Inc. |
| Oct 4, 2024 | Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4716 | Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigati... | Class II | Hobbs Medical, Inc. |
| Oct 4, 2024 | Stryker Neptune SafeAir Smoke Evacuation Pencil Coated Push-Button, Bulk Non-... | There is a potential for the product to activate without manual input when plugged into a power s... | Class II | Stryker Corporation |
| Oct 4, 2024 | Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4704 | Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigati... | Class II | Hobbs Medical, Inc. |
| Oct 4, 2024 | Stryker Neptune SafeAir Rocker-Switch Smoke Evacuation Pencil, Coated, 70mm -... | There is a potential for the product to activate without manual input when plugged into a power s... | Class II | Stryker Corporation |
| Oct 4, 2024 | Stryker Neptune SafeAir Smoke Evacuation Pencil Non coated 70 mm Blade Push-B... | There is a potential for the product to activate without manual input when plugged into a power s... | Class II | Stryker Corporation |
| Oct 4, 2024 | Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4723 | Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigati... | Class II | Hobbs Medical, Inc. |
| Oct 4, 2024 | Stryker Neptune SafeAir Rocker-Switch Smoke Evacuation Pencil, Non-coated, 70... | There is a potential for the product to activate without manual input when plugged into a power s... | Class II | Stryker Corporation |
| Oct 4, 2024 | CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-2. | Potential failure of affected units to recharge the battery of the oxygen concentrators. | Class II | Caire, Inc. |
| Oct 4, 2024 | Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4722 | Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigati... | Class II | Hobbs Medical, Inc. |
| Oct 4, 2024 | Stryker Neptune SafeAir Smoke Evacuation Pencil Coated Rocker-Switch, Bulk No... | There is a potential for the product to activate without manual input when plugged into a power s... | Class II | Stryker Corporation |
| Oct 3, 2024 | MEERA CL mobile operating table - Designed for the placement and positioning ... | Error code "50037" occurs on the IR-Hand Control when a MEERA-table is controlled, and the table ... | Class II | Getinge Usa Sales Inc |
| Oct 3, 2024 | DeRoyal CHILDREN'S LAPTRACEPACK, 89-9362.06 | DeRoyal is recalling certain lots of surgical procedure pack products that contain a Stryker Safe... | Class II | DeRoyal Industries Inc |
| Oct 3, 2024 | DeRoyal CHILDREN'S ORTHOPEDIC TRACEPACK, 89-9349-06 | DeRoyal is recalling certain lots of surgical procedure pack products that contain a Stryker Safe... | Class II | DeRoyal Industries Inc |
| Oct 3, 2024 | MEERA CL mobile operating table - Designed for the placement and positioning ... | Error code "50037" occurs on the IR-Hand Control when a MEERA-table is controlled, and the table ... | Class II | Getinge Usa Sales Inc |
| Oct 3, 2024 | MEERA CL mobile operating table - Designed for the placement and positioning ... | Error code "50037" occurs on the IR-Hand Control when a MEERA-table is controlled, and the table ... | Class II | Getinge Usa Sales Inc |
| Oct 3, 2024 | MEERA CL mobile operating table - Designed for the placement and positioning ... | Error code "50037" occurs on the IR-Hand Control when a MEERA-table is controlled, and the table ... | Class II | Getinge Usa Sales Inc |
| Oct 3, 2024 | MEERA CL mobile operating table - Designed for the placement and positioning ... | Error code "50037" occurs on the IR-Hand Control when a MEERA-table is controlled, and the table ... | Class II | Getinge Usa Sales Inc |
| Oct 3, 2024 | MEERA CL mobile operating table - Designed for the placement and positioning ... | Error code "50037" occurs on the IR-Hand Control when a MEERA-table is controlled, and the table ... | Class II | Getinge Usa Sales Inc |
| Oct 3, 2024 | Medtronic DLP Aortic Root Cannula with Flow-Guard, REF 11012; for use in card... | There is the potential for a potential sterility breach for three lots of the DLP Aortic Root Can... | Class II | Medtronic Perfusion Systems |
| Oct 3, 2024 | DeRoyal C-SECTION TRACEPACK, REF 89-9338-06 | DeRoyal is recalling certain lots of surgical procedure pack products that contain a Stryker Safe... | Class II | DeRoyal Industries Inc |
| Oct 3, 2024 | MEERA CL mobile operating table - Designed for the placement and positioning ... | Error code "50037" occurs on the IR-Hand Control when a MEERA-table is controlled, and the table ... | Class II | Getinge Usa Sales Inc |
| Oct 3, 2024 | MEERA CL mobile operating table - Designed for the placement and positioning ... | Error code "50037" occurs on the IR-Hand Control when a MEERA-table is controlled, and the table ... | Class II | Getinge Usa Sales Inc |
| Oct 3, 2024 | DeRoyal CHILDREN'S GENERAL TRACEPACK, REF 89-9342-06 | DeRoyal is recalling certain lots of surgical procedure pack products that contain a Stryker Safe... | Class II | DeRoyal Industries Inc |
| Oct 3, 2024 | GE Healthcare Centricity Universal Viewer Zero Footprint, Model Numbers: 1... | GE HealthCare has become aware of an issue in Centricity Universal Viewer Zero Footprint Client (... | Class II | GE Healthcare |
| Oct 2, 2024 | RENASYS EDGE The RENASYS¿ EDGE pump is indicated for patients who would be... | Due to issues with battery depletion and inability to recharge if the batteries are not appropria... | Class II | Smith & Nephew Medical, Ltd. |
| Oct 2, 2024 | TEMA Elbow - Axle Small REF 1590.15.010 TEMA Elbow - Axle Large REF 1590.1... | Due to a potential difference in mechanical behavior between the implanted device and tool(s) use... | Class II | Limacorporate S.p.A |
| Oct 2, 2024 | smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 4 L... | Complaint received indicating that a package contained a LGN OX CONSTRAINED FEM 3 LT implant inst... | Class II | Smith & Nephew Inc |
| Oct 2, 2024 | smith&nephew LEGION OXINIUM POSTERIOR STABILIZED NONPOROUS FEMORAL COMPONENT,... | Complaint received indicating that a package contained a LEGION NARROW PS OXIN SZ 5N RIGHT implan... | Class II | Smith & Nephew Inc |
| Oct 2, 2024 | smith&nephew GENESIS II NONPOROUS POSTERIOR STABILIZED FEMORAL COMPONENT, SIZ... | Complaint received indicating that a package contained a LEGION NARROW PS OXIN SZ 5N RIGHT implan... | Class II | Smith & Nephew 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.