200 results
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17ms
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Sources: EU EUDAMED, US FDA
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Status: Open, Classified
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Scoot Control R-net, Product Number P015-61. The Scoot Control is intended to support a wheelchair attendant in controlling or maneuvering a power chair
FDA Recall
Open, Classified
·mo-Vis BVBA Biebuyckstraat 15D Nevele Belgium·Product code KNN·November 28, 2023
ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS BOWED CANAL FILLING STEMS. Canal filling stem implants.
FDA Recall
Open, Classified
·Onkos Surgical, Inc.·Product code JDI·July 11, 2025
Segmental Stem, Cemented, Bowed, 152MM, 1 EACH. Model Numbers: CB-11152-03M, CB-13152-03M, CB-15152-03M, CB-17152-03M. Component of ELEOS LIMB SALVAGE SYSTEM
FDA Recall
Open, Classified
·Onkos Surgical, Inc.·Product code KRO·September 1, 2023
Rifton Equipment, TRAM. Model/Catalog Number: K310. The TRAM is a powered lift device for transferring clients in a seated position or assisting in a sit-to-stand transfer and gait training.
FDA Recall
Open, Classified
·Community Products, LLC·Product code FSA·December 18, 2025
Philips Respironics V60/V60 Plus Ventilator, PCBA Part Number: 453561544461 V60 Device Part Numbers 1053617 (US) and 1137276 (Philippines)
FDA Recall
Open, Classified
·Philips Respironics, Inc.·Product code MNT·August 25, 2023
Merlin@home Transmitter REF EX1100 The Merlin@home" (M@h) transmitter is intended to transfer stored data from the patient s implanted heart device to Merlin.net" Patient Care Network (PCN) to facilitate remote monitoring by using inductive (EX1100 Model) or RF telemetry (EX1150 Model) to read device data and transmitting to the Merlin.net PCN server.
FDA Recall
Open, Classified
·Abbott Medical·Product code NVZ·October 1, 2024
Newport s N-LHP-928(j) units if sold as a laser head/power supply set, and N5-LPL-944-080 and N6-LPL-944-080 if sold as a power supply alone.
FDA Recall
Open, Classified
·Product code RFN·March 27, 2024
Sapphire Infusion Pumps, Models: Multi-Therapy (REF 15031-000-0028), Epidural (REF 15032-000-0027) and SapphirePlus (REF 15038-000-0001)
FDA Recall
Open, Classified
·EITAN MEDICAL LTD 29, Yad Kharutsim Netanya Israel·Product code FRN·September 11, 2023
Merlin@home with the MerlinOnDemand capability Transmitter REF EX1150 Merlin@home with the MerlinOnDemand" (MoD) capability is a transmitter configured for multiple patient use. It can receive information from an implantable heart device in unpaired mode. With MoD capability, the transmitter will retrieve full follow-up data or retrieve data for display on the Merlin.net" Patient Care Network (PCN). The MoD capability enables clinicians to do the following: . support remote care patients in emergency rooms and heart failure clinics . triage patients for in clinic follow-ups . support patients in a clinical setting with Merlin.net PCN
FDA Recall
Open, Classified
·Abbott Medical·Product code NVZ·October 1, 2024
Power-PRO 2- A powered ambulance cot that consists of a platform, including a mattress, mounted on a wheeled, retractable X-frame that is designed to support and transport a maximum weight of 700 lb (318 kg). Model Number: 6507
FDA Recall
Open, Classified
·Stryker Medical Division of Stryker Corporation·Product code FPO·May 24, 2023
Moberg Component Neuromonitoring System (CNS Monitor)-Intended as a short-term neurological monitoring system that collects, displays, and stores multiple physiological measurements Model: CNS-350
FDA Recall
Open, Classified
·Moberg Research, Inc.·Product code OMA·February 20, 2023
BD EpiCenter Microbiology Data Management System, labeled as the following: 1. Computer System Epicenter F/G, Catalog Number: 441002. 2. COMPUTER OPTIPLEX EPICENTER SPARE, Catalog Number: 441421. 3. Generic NUC 2, Catalog Number: 445398. 4. Nuc 5i5 Os Image Bow 2.X, Catalog Number: 443971.
FDA Recall
Open, Classified
·Becton Dickinson & Co.·Product code JQP·September 23, 2025
Affected components are limited to the Monoprice charging cable (Product # 4867) and 24W iClever Boost Cube charging brick components for the SoundPOD Bluetooth Speaker accessory to the ProSlate Speech Generation Devices (including Proslate 13: B398PS130; Proslate 10: B398PS100; Proslate 8: B398PS080; Proslate 4: B398PS040)
FDA Recall
Open, Classified
·Forbes Rehab Services Inc·Product code ILQ·October 11, 2021
Segmental Stem, Canal Filling, Bowed 152MM, 1 EACH. Model Numbers: FB-11152-03M, FB-12152-03M, FB-13152-03M, FB-14152-03M, FB-15152-03M, FB-16152-03M, FB-17152-03M, FB-18152-03M, FB-19152-03M, FB-20152-03M, FB-21152-03M. Component of ELEOS LIMB SALVAGE SYSTEM
FDA Recall
Open, Classified
·Onkos Surgical, Inc.·Product code KRO·September 1, 2023
KLS Martin Battery Pack, REF: KLS BP 001, and KLS BP 040 (bulk case of 40), used in conjunction with the KLS Martin MaxDriver
FDA Recall
Open, Classified
·Pro-Dex Inc·Product code GEY·February 15, 2023
Rifton Equipment, Low Base TRAM. Model/Catalog Number: K320. The TRAM is a powered lift device for transferring clients in a seated position or assisting in a sit-to-stand transfer and gait training. The low base variant includes smaller casters and lower base frame so that the legs fit underneath beds.
FDA Recall
Open, Classified
·Community Products, LLC·Product code FSA·December 18, 2025
Autotome RX 20mm CUT WIRE Cannulating Sphincterotome, Material Number (UPN) M00545170. The device is used in selective cannulation of the bile duct.
FDA Recall
Open, Classified
·Boston Scientific Corporation·Product code KNS·June 12, 2024
(1) Ingenia Ambition X (Product Number 781356); (2) Ingenia Ambition S (Product Number 781359)
FDA Recall
Open, Classified
·Philips North America·Product code LNI·July 15, 2021
RibLoc U Plus 90 Instrument PRIMARY GUIDE ASSY, LOW PROFILE REF RBL2320 The RBL2320, Low Profile Primary Guide is an instrument used with a power system to compress the RibLoc plates onto the bone, determine the length of the screw to install, locate the position of the holes to drill, and provide proper orientation for the installation of the screws.
FDA Recall
Open, Classified
·Acumed LLC·Product code LXH·November 27, 2023
Model Number SM-40HF-B-D-C; 40KW CANON READY.005, Mobile X-ray system
FDA Recall
Open, Classified
·SEDECAL SA Pelaya, 9 Pol. Pol. Ind. Rio De Janeiro Algete Spain·Product code IZL·June 10, 2025