Browse Device Recalls
3,276 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,276 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 3,276 FDA device recalls in 2024.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 | 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 | 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 | 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 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 | 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 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 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 | 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 | 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 | 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 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 | 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 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 | 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 | 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 2, 2024 | smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 3 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 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 |
| 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 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 | 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 | 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 | Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code... | The door on the Spectrum IQ Infusion pump may not be able to fully close. | Class II | Baxter Healthcare Corporation |
| Oct 1, 2024 | Merlin@home with the MerlinOnDemand capability Transmitter REF EX1150 Merl... | Due to heart transmitter not being able to upgrade to the current software version in the field a... | Class III | Abbott Medical |
| Oct 1, 2024 | McKesson Calcium Alginate Dressing MFR# 3562 Wound dressing indicated for ... | Due to defects on primary packaging pouch that compromise the device's ability to maintain a ster... | Class II | Advanced Medical Solutions Ltd. |
| Oct 1, 2024 | Merlin@home Transmitter REF EX1100 The Merlin@home" (M@h) transmitter is i... | Due to heart transmitter not being able to upgrade to the current software version in the field a... | Class III | Abbott Medical |
| Oct 1, 2024 | Hollister CalciCare Calcium Alginate Dressing REF 529937R calcium alginate... | Due to defects on primary packaging pouch that compromise the device's ability to maintain a ster... | Class II | Advanced Medical Solutions Ltd. |
| Oct 1, 2024 | MEDLINE MAXORB EXTRA ALGINATE WOUND DRESSING 4X4 SQUARE REF MSC7044EP MEDLIN... | Due to defects on primary packaging pouch that compromise the device's ability to maintain a ster... | Class II | Advanced Medical Solutions Ltd. |
| Sep 30, 2024 | The Access Cortisol assay is a paramagnetic particle, chemiluminescent immun... | The Access Cortisol assay protocol file (APF) applies an incorrect calibration curve acceptance p... | Class II | Beckman Coulter, Inc. |
| Sep 30, 2024 | Bard Marquee Disposable Core Biopsy Instrument Kit: BARD MARQUEE KIT 12G X 1... | Disposable biopsy instruments were potentially manufactured missing the backend notch retention f... | Class II | Bard Peripheral Vascular Inc |
| Sep 30, 2024 | Brand Name: Z-800 Infusion System Product Name: Z-800WF Model/Catalog Numbe... | For the Z-800WF pumps, the WiFi software was not compatible with the pump software that had been ... | Class III | Zyno Medical LLC |
| Sep 30, 2024 | IMMULITE 2000 PSA assay, Catalog Number L2KPTS2(D) (SMN 10706281) and Catalog... | The IMMULITE 2000 PSA assay for use on the IMMULITE 2000 and IMMULITE 2000 XPi analyzers did not ... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Sep 30, 2024 | Precice Max REF: PM10.0-80B265 PRECICE MAX Antegrade Femur Piriformis Straig... | Due to potential issues with design, manufacturing and documentation issues related to the valida... | Class II | NuVasive Specialized Orthopedics, Inc. |
| Sep 27, 2024 | 1) Flex Extenders, 5.2" x 15mm OD x 15mm ID REF S6411P 2) Flex Extender, 5... | Due to connector within the circuit flex extender not meeting specifications resulting in a low c... | Class II | Westmed, Inc. |
| Sep 27, 2024 | AVOXimeter 1000E, Product Number: AVOX1000E. The AVOXimeter 1000E is a batter... | Values used to calibrate whole blood oximeter instruments were observed to be higher than normal,... | Class II | Accriva Diagnostics, Inc. |
| Sep 26, 2024 | KING LTSD,SIZE 2,W/SUCTION PORT STERILE-Inserted into a patient s pharynx thr... | Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new in... | Class II | King Systems Corp. dba Ambu, Inc. |
| Sep 26, 2024 | KING LTSD,SIZE 2.5, W/SUCTION PORT STERILE-Inserted into a patient s pharynx ... | Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new in... | Class II | King Systems Corp. dba Ambu, Inc. |
| Sep 26, 2024 | KING LTSD,SIZE 0, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s ph... | Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new in... | Class II | King Systems Corp. dba Ambu, Inc. |
| Sep 26, 2024 | KING LTSD,SIZE 2, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s ph... | Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new in... | Class II | King Systems Corp. dba Ambu, Inc. |
| Sep 26, 2024 | Duraform Dural Graft Implant, Size 3x3 , Model Number 80-1477US Lot CT007694 | Out of specification endotoxin levels. | Class II | Integra LifeSciences Corp. |
| Sep 26, 2024 | KING LTSD,SIZE 1, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s ph... | Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new in... | Class II | King Systems Corp. dba Ambu, Inc. |
| Sep 26, 2024 | KING LTSD,SIZE 2.5, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s ... | Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new in... | Class II | King Systems Corp. dba Ambu, Inc. |
| Sep 26, 2024 | KING LTSD,SIZE 1,W/SUCTION PORT STERILE-Inserted into a patient s pharynx thr... | Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new in... | Class II | King Systems Corp. dba Ambu, Inc. |
| Sep 26, 2024 | AMBU / KING LTSD, SIZE 0,1 W/SUCTION PORT, STERILE- Inserted into a patient s... | Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new in... | Class II | King Systems Corp. dba Ambu, Inc. |
| Sep 25, 2024 | intelliPATH Universal HRP Detection Kit, REF: IPK5011G80, containing DAB Buff... | Kits containing the DAB chromogen buffer, intended for use in either manual or automated Immunohi... | Class II | Biocare Medical, LLC |
| Sep 25, 2024 | Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 9119... | Elekta has become aware that Disposable Biopsy Needles can contain some microscopic debris on the... | Class I | Elekta Instrument AB |
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.