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.

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DateProductReasonClassFirm
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.