Browse Device Recalls
2,115 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,115 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 2,115 FDA device recalls in N/A.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 28, 2026 | Intellijoint Navigation System: Workstation G2 Configured, REF: 000-0241; Int... | A navigation system used to aid in selection and positioning of orthopedic implant system compone... | Class II | Intellijoint Surgical, Inc. |
| Aug 26, 2026 | HALYARD Laparoscopy Comprehensive Pack II REF: 49332 | Laparoscopy packs labeled as "latex free" were found to contain a latex urethral catheter | Class II | GRI Medical & Electronic Technology Co., Ltd. |
| Aug 19, 2026 | BD Alaris Pump Infusion Sets 10561554* 10885403232565 50885403232563 BD Alari... | Due to discrepancies in specific attributes in the performance data for infusion sets, which may ... | Class I | BD SWITZERLAND SARL |
| Aug 19, 2026 | NOxBOXi Nitric Oxide Delivery System. | Potential for oxygen tubing leaks due to failure of the tubing or tubing connection, which may le... | Class II | NOXBOX LTD |
| Aug 4, 2026 | Brand Name: VERIQA; Product Name: RT MonteCarlo 3D v3; Model/Catalog Number... | When a bolus is included in a treatment plan and sent for secondary dose calculation, the softwar... | Class II | PTW FREIBURG |
| Jul 31, 2026 | Percutaneous Insertion Kit (PIK), dilator set L, Model Numbers: 701054427 (US... | The packaging may not consistently maintain sterile barrier integrity. | Class II | Maquet Cardiopulmonary Gmbh |
| Jul 31, 2026 | SunMed Tracheal Tube, Size 2.5; Model Number: 1-7333-25 | The 6Fr suction catheter could not pass through the samples smoothly. | Class II | WELL LEAD MEDICAL CO. LTD |
| Jul 31, 2026 | Percutaneous Insertion Kit (PIK), Guidewire 150 cm, Model Numbers: 701053069 ... | The packaging may not consistently maintain sterile barrier integrity. | Class II | Maquet Cardiopulmonary Gmbh |
| Jul 31, 2026 | Percutaneous Insertion Kit (PIK), Guidewire 100 cm, Model Numbers: 701053068 ... | The packaging may not consistently maintain sterile barrier integrity. | Class II | Maquet Cardiopulmonary Gmbh |
| Jul 23, 2026 | Velys Enabling Tech Robotic-Assist Station REF: 451611001 | Software issue within robotic controller which may cause unintended movement of the robotic arm d... | Class II | Medos International Sarl |
| Jul 14, 2026 | Onli 17cm Hydrophilic Urethral Intermittent Catheter, labeled as: 1) 82081... | Hollister has identified that select lots of the catheters identified in the above table may exhi... | Class II | Hollister Ulc |
| Jul 6, 2026 | Pi-Cardia Inc. ShortCut REF: Z-A-20.003-US | Transfemoral catheter, positing arm may detached due to weld issue. | Class II | PI CARDIA LTD |
| Jul 1, 2026 | Stryker Hoffmann II Connecting Rod Micro 3 x 60mm. Catalog Number: 50796060. | Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization. | Class II | Stryker GmbH |
| Jul 1, 2026 | Stryker Hoffmann II Connecting Rod Micro 3 x 50mm. Catalog Number: 50796050. | Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization. | Class II | Stryker GmbH |
| Jul 1, 2026 | Stryker Hoffmann II Connecting Rod Micro 3 x 150mm. Catalog Number: 50796150. | Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization. | Class II | Stryker GmbH |
| Jul 1, 2026 | Stryker Hoffmann II Connecting Rod Micro 3 x 120mm. Catalog Number: 50796120. | Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization. | Class II | Stryker GmbH |
| Jul 1, 2026 | Stryker Hoffmann II Connecting Rod Micro 3 x 30mm. Catalog Number: 50796030. | Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization. | Class II | Stryker GmbH |
| Jul 1, 2026 | Stryker Hoffmann II Connecting Rod Micro 3 x 90mm. Catalog Number: 50796090. | Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization. | Class II | Stryker GmbH |
| Jul 1, 2026 | Stryker Hoffmann II Connecting Rod Micro 3 x 40mm. Catalog Number: 50796040. | Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization. | Class II | Stryker GmbH |
| Jun 30, 2026 | SnapshotGLO Wound Imaging Device, Model KB100, KB100AA. | The software controlling the wound imaging device's battery charging circuit was not designed to ... | Class II | KENT IMAGING, INC. |
| Jun 26, 2026 | Philips Incisive CT with software V4.5&V5.0, Product Code 728143 and Product ... | Potential of failing to trigger clinical scan during Bolus Tracking. | Class II | Philips Healthcare (Suzhou) Co., Ltd. |
| Jun 25, 2026 | Resmed Astral 100/150 Resmed Astral 100/50 is a ventilator system that pro... | Due to a Supercapacitor electrolyte leakage on Printed Circuit Board Assembly (PCBA) may damage t... | Class I | ResMed Ltd. |
| Jun 9, 2026 | Brand Name: Versius Surgical System US Product Name: Vesius Surgeon Console ... | Secure Boot was mistakenly not enabled at manufacturing time, which presents a potential cybersec... | Class II | CMR SURGICAL LIMITED |
| Jun 4, 2026 | MEDLINE 111 GRAVITY SET W/3 Needle Free Y-Sites REF DYNDTN0555 Catalog Numb... | Due to engineering sample labeled "Not for Human Use" being inadvertently shipped it the U.S. mar... | Class II | BD SWITZERLAND SARL |
| Jun 1, 2026 | Zeiss Intrabeam Spherical Applicator 1.5 cm REF:304534-6000-557 | Spherical applicators (radiation therapy accessory) failed to meet manufacturing specifications. | Class II | Carl Zeiss Meditec AG |
| May 29, 2026 | Breathing circuit set, coaxial: REF: 260127, 260128, 260167, 260168 used with... | Ventilator coaxial breathing circuit may have, expiratory valve sets with membranes sticking to v... | Class I | Hamilton Medical AG |
| May 22, 2026 | IntelliCuff, Portable automatic cuff pressure controller REF: 951001 | Due to reported complaints, the cuff device may alarm with a "Cuff System Leakage" error. As a re... | Class II | Hamilton Medical AG |
| May 20, 2026 | RayCare 2024A SP4. Oncology Information Systems. | Beam set delivery note issues in which there is potential data loss if the beam set delivery note... | Class II | RAYSEARCH LABORATORIES AB |
| May 20, 2026 | RayCare 2024A SP1. Oncology Information Systems. | Beam set delivery note issues in which there is potential data loss if the beam set delivery note... | Class II | RAYSEARCH LABORATORIES AB |
| May 19, 2026 | Depuy Synthes, ATTUNE Revision Hinge Knee Hinge Housing Components with the b... | The external sterile packaging was found adhered to the internal sterile packaging, potentially c... | Class II | DEPUY (IRELAND) |
| May 19, 2026 | Depuy Synthes, ATTUNE Revision Hinge Knee Hinge Insert Components with the be... | The external sterile packaging was found adhered to the internal sterile packaging, potentially c... | Class II | DEPUY (IRELAND) |
| May 18, 2026 | GSP Neonatal GALT Kit. Product Codes: 3303-001U, 3303-0010. in vitro diagnost... | Reduction in the on-board stability of the GSP GALT assay. This may increase the likelihood of ru... | Class II | WALLAC OY |
| May 8, 2026 | GE Healthcare AW Server 3.2 ext.6.5; Radiological Image Processing System | GE HealthCare has become aware of a context synchronization issue in AW Server 3.2 ext. 6.5. When... | Class II | GE Medical Systems SCS |
| May 7, 2026 | 3mensio Workstation (Vascular Fenestrated) software | User measurement value reported by diagnostic bioimaging software intended to measure/visualize c... | Class II | PIE Medical Imaging B.V. |
| May 4, 2026 | SD LTM 64 PLUS, EEG Amplifier/recorder, Model/Catalog Number: SD LTM 64 PLUS,... | Natus has become aware of two complaints related to the SD LTM 64 PLUS where the EEG traces acqui... | Class II | Micromed S.p.A. |
| Apr 30, 2026 | Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.125.NVG.U1; drills, burr... | Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). | Class II | SURGIFY MEDICAL OY |
| Apr 30, 2026 | Surgify Halo, 40 mm, Long, Model/Catalog Number: 40.125.NVG.U1; drills, burrs... | Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). | Class II | SURGIFY MEDICAL OY |
| Apr 30, 2026 | Surgify Halo, 4.0 mm, Short, Model/Catalog Number: 40.070.NVG.H1; drills, bur... | Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). | Class II | SURGIFY MEDICAL OY |
| Apr 30, 2026 | Surgify Halo, 5.4 mm, Short, Model/Catalog Number: 54.070.NVG.U1; drills, bur... | Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). | Class II | SURGIFY MEDICAL OY |
| Apr 30, 2026 | Surgify Halo, 3.0 mm, Extendable, Model/Catalog Number: 30.000.SEE.U2; drills... | Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). | Class II | SURGIFY MEDICAL OY |
| Apr 30, 2026 | Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.140.SHD.U1; drills, burr... | Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). | Class II | SURGIFY MEDICAL OY |
| Apr 30, 2026 | Surgify Halo, 5.4 mm, Medium, Model/Catalog Number: 54.085.SHD.U1; drills, bu... | Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). | Class II | SURGIFY MEDICAL OY |
| Apr 30, 2026 | Surgify Halo, 5.4 mm, Extendable, Model/Catalog Number: 54.000.SEE.H1; drills... | Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). | Class II | SURGIFY MEDICAL OY |
| Apr 30, 2026 | Surgify Halo, 3.0 mm, Short, Model/Catalog Number: 30.070.NVG.U2; drills, bur... | Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). | Class II | SURGIFY MEDICAL OY |
| Apr 30, 2026 | Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.125.NVG.H1; drills, burr... | Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). | Class II | SURGIFY MEDICAL OY |
| Apr 30, 2026 | Surgify Halo, 4.0 mm, Extendable, Model/Catalog Number: 40.000.SEE.U1; drills... | Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). | Class II | SURGIFY MEDICAL OY |
| Apr 30, 2026 | Surgify Halo, 3.0 mm, Long, Model/Catalog Number: 30.125.NVG.U2; drills, burr... | Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). | Class II | SURGIFY MEDICAL OY |
| Apr 30, 2026 | Surgify Halo, 5.4 mm, Short, Model/Catalog Number: 54.070.NVG.H1; drills, bur... | Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). | Class II | SURGIFY MEDICAL OY |
| Apr 30, 2026 | Surgify Halo, 5.4 mm, Extendable, Model/Catalog Number: 54.000.SEE.U1; drills... | Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). | Class II | SURGIFY MEDICAL OY |
| Apr 30, 2026 | Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.140.SHD.H1; drills, burr... | Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). | Class II | SURGIFY MEDICAL OY |
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.