Medical Devices Recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
27,372 recalls · Page 208 of 548
FDA Devices Moderate Jul 29, 2020
Sysmex PS-10 Sample Preparation System Catalog number:BQ716341 - Product Usage: is a fully automated, user configurable, open system intended for us…
Sysmex America, Inc.
FDA Devices Moderate Jul 29, 2020
Ablation Galil Technology, IceFORCE 2.1 CX 90 Needle Cryoablation Needle, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intende…
Boston Scientific Corporation
FDA Devices Moderate Jul 29, 2020
LoFric Origo, Tiemann, 16in, FR14 urinary catheters
Wellspect HealthCare (Division of DENTSPLY IH AB)
FDA Devices Moderate Jul 29, 2020
MEVION S250 Proton Radiation Treatment System; intended to deliver proton radiation treatment to patients
Mevion Medical Systems, Inc.
FDA Devices Moderate Jul 29, 2020
Software 1898072 IPC upgrade v 2.7.3.0 - Product Usage: The IPC system is indicated for the incision/cutting removal, drilling and sawing of soft and…
Medtronic Xomed, Inc.
FDA Devices Moderate Jul 29, 2020
Safe-T PLUS Thora-Para 8 Fr Catheter Drainage Tray
Carefusion 2200 Inc
FDA Devices Moderate Jul 29, 2020
Thora-Para 5 Fr Catheter Drainage Tray
Carefusion 2200 Inc
FDA Devices Moderate Jul 29, 2020
Ablation Galil Technology, IceForce 2.1 CX 90 Cyroablation Needles, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for …
Boston Scientific Corporation
FDA Devices Moderate Jul 29, 2020
Ablation Galil Technology, IceFORCE 2.1 CX Prostate Kit Visual ICE System, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intend…
Boston Scientific Corporation
FDA Devices Moderate Jul 29, 2020
LoFric Origo, Nelaton, 16in, FR10 urinary catheters
Wellspect HealthCare (Division of DENTSPLY IH AB)
FDA Devices Moderate Jul 29, 2020
Safe-T-Centesis 6 Fr Catheter Drainage Tray w/o Lidocaine
Carefusion 2200 Inc
FDA Devices Moderate Jul 29, 2020
Nuvasive NVM5 EMG Module, REF 8020015, Rx ONLY, CE2797, Nonsterile, UDI: 00887517206633 - Product Usage: is intended for intraoperative neurophysiol…
NuVasive Inc
FDA Devices Moderate Jul 29, 2020
Safe-T-Centesis 8 Fr Catheter Drainage Tray
Carefusion 2200 Inc
FDA Devices Moderate Jul 29, 2020
Safe-T PLUS Thora-Para 5 Fr Non-Valved Catheter Drainage Tray
Carefusion 2200 Inc
FDA Devices Moderate Jul 29, 2020
Accurian RF Ablation, Cannula pk, Accurian, 100mm, 22G, 5mm, CS Product Number: AC0016 GTIN / UPN: 20763000153674 - Product Usage: (sterile, single-u…
Medtronic Sofamor Danek USA Inc
FDA Devices Low Jul 29, 2020
LivaNova USA Sterile Disposable Connector,1/2x1/2, 20 units per case
LivaNova USA Inc.
FDA Devices Moderate Jul 29, 2020
Accurian RF Ablation,Cannula pk, Accurian, 100mm, 22G, 10mm, SS Product Number: AC0019 GTIN / UPN: 20763000153667 - Product Usage: (sterile, single…
Medtronic Sofamor Danek USA Inc
FDA Devices Moderate Jul 29, 2020
Safe-T-Centesis PLUS 6 Fr Catheter Drainage Tray
Carefusion 2200 Inc
FDA Devices Moderate Jul 29, 2020
Thora-Para 8 Fr Catheter Drainage Tray w/o Lidocaine
Carefusion 2200 Inc
FDA Devices Moderate Jul 29, 2020
Safe-T-Centesis 6 Fr Catheter Drainage Tray
Carefusion 2200 Inc
FDA Devices Moderate Jul 29, 2020
Thora-Para 8 Fr Catheter Drainage Tray
Carefusion 2200 Inc
FDA Devices Moderate Jul 29, 2020
IntelliVue MX800 patient monitor, model no. 865240
Philips North America, LLC
FDA Devices Moderate Jul 29, 2020
Accurian RF Ablation, Cannula pk, Accurian, 100mm, 20G, 10mm, CS Product Number: AC0009 GTIN / UPN: 20763000153599 - Product Usage: (sterile, single-…
Medtronic Sofamor Danek USA Inc
FDA Devices Moderate Jul 29, 2020
Ablation Galil Technology, IcePearl 2.0 CX 90 Cryoablation Needle, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for c…
Boston Scientific Corporation
FDA Devices Moderate Jul 29, 2020
Accurian RF Ablation, Cannula pk, Accurian, 150mm, 18G, 10mm, CS Product Number: AC0007 GTIN / UPN: 20763000153568 - Product Usage: (sterile, single-…
Medtronic Sofamor Danek USA Inc
FDA Devices Moderate Jul 22, 2020
OSTEOVATION EX, 5CC, IMPACT FORMULA. Product Number: 390-0205, UDI: 813845020047 - Product Usage: Callos is indicated to fill bony voids or gaps of …
Skeletal Kinetics, Llc
FDA Devices Moderate Jul 22, 2020
EXACTECH OSSILIX MP FIL, 10CC. Product Number: 662-02-10, UDI: 813845021051 - Product Usage: Callos is indicated to fill bony voids or gaps of the s…
Skeletal Kinetics, Llc
FDA Devices Moderate Jul 22, 2020
CRANIOSCULPT FLOW, OUS, 10CC. Product Number: C-FLOW10CC-OUS, UDI: 813845020382 - Product Usage: Callos is indicated to fill bony voids or gaps of t…
Skeletal Kinetics, Llc
FDA Devices Moderate Jul 22, 2020
CRANIOSCULPT FLOW, CAN, 5CC. Product Number: C-FLOW5CC-CAN, UDI: 813845020344 - Product Usage: Callos is indicated to fill bony voids or gaps of the…
Skeletal Kinetics, Llc
FDA Devices Moderate Jul 22, 2020
OSTEOVATIONEX 5CC, INJECT FORMULA. Product Number: 390-0005, UDI: 813845020023 - Product Usage: Callos is indicated to fill bony voids or gaps of th…
Skeletal Kinetics, Llc
FDA Devices Moderate Jul 22, 2020
OSTEOVATION, 5CC, IMPACT FORMULA. Product Number: 390-2105, UDI: 813845020085 - Product Usage: Callos is indicated to fill bony voids or gaps of the…
Skeletal Kinetics, Llc
FDA Devices Moderate Jul 22, 2020
OSTEOVATION RMX 10CC. Product Number: 390-6002, UDI: 813845021099 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal sy…
Skeletal Kinetics, Llc
FDA Devices Critical Jul 22, 2020
BodyGuard Microset, REF: A120-161XPS
CME America, LLC
FDA Devices Moderate Jul 22, 2020
SKAFFOLD CMF IMPRESS (MP), 10CC. Product Number: CMMP-IM10, UDI: 813845020696 - Product Usage: Callos is indicated to fill bony voids or gaps of the…
Skeletal Kinetics, Llc
FDA Devices Critical Jul 22, 2020
BodyGuard Microset With Female Luer, REF: A120-160XPSN
CME America, LLC
FDA Devices Moderate Jul 22, 2020
MEDTRONIC BONE VOID FILLER, LARGE. Product Number: C07B, UDI: 813845020511 - Product Usage: Callos is indicated to fill bony voids or gaps of the sk…
Skeletal Kinetics, Llc
FDA Devices Moderate Jul 22, 2020
DRW-0739-02: Gen 2 Posterior Chairside Splint LRUL (lower right-upper left) - Product Usage: intended to provide assistance in both the planning (pre…
Neocis Inc.
FDA Devices Moderate Jul 22, 2020
EXACTECH OSSILIX FIL (MX), 10CC. Product Number: 660-02-10, UDI: 813845021013 - - Product Usage: Callos is indicated to fill bony voids or gaps of t…
Skeletal Kinetics, Llc
FDA Devices Critical Jul 22, 2020
BodyGuard Microset, REF: A120-160X2YB
CME America, LLC
FDA Devices Moderate Jul 22, 2020
ACUMED CALLOS INJECT 5CC. Product Number: 65-0005-S, UDI: 813845020238 - Product Usage: Callos is indicated to fill bony voids or gaps of the skelet…
Skeletal Kinetics, Llc
FDA Devices Critical Jul 22, 2020
BodyGuard BodySet, REF: A120-160SAS
CME America, LLC
FDA Devices Critical Jul 22, 2020
BodyGuard Microset, REF: A120-160XSFK
CME America, LLC
FDA Devices Moderate Jul 22, 2020
EXACTECH OSSILIX FIL (MX), 5CC. Product Number: 660-02-05, UDI: 813845021006 - Product Usage: Callos is indicated to fill bony voids or gaps of the …
Skeletal Kinetics, Llc
FDA Devices Moderate Jul 22, 2020
CRANIOSCULPT, CMF IMPACT, 3CC Product Number: C-CMF3CC, UDI: 813845020931 - Product Usage: Callos is indicated to fill bony voids or gaps of the ske…
Skeletal Kinetics, Llc
FDA Devices Critical Jul 22, 2020
CMExpress Microbore Sets, REF: A120-161C
CME America, LLC
FDA Devices Moderate Jul 22, 2020
SKAFFOLD FLOW, 10CC. Product Number: SKMX-FL10, UDI: 813845020900 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal sy…
Skeletal Kinetics, Llc
FDA Devices Moderate Jul 22, 2020
CRANIOSCULPT, CMF IMPACT, 10CC, Product Number: C-CMF10CC, UDI: 813845020955 - Product Usage: Callos is indicated to fill bony voids or gaps of the …
Skeletal Kinetics, Llc
FDA Devices Critical Jul 22, 2020
BodyGuard Microset w/ 0.2 mic filter and lower y-site with female luer, REF: A120-160CYFRV
CME America, LLC
FDA Devices Moderate Jul 22, 2020
CRANIOSCULPT FLOW, 3CC. Product Number: C-FLOW3CC, UDI: 813845020320 - - Product Usage: Callos is indicated to fill bony voids or gaps of the skelet…
Skeletal Kinetics, Llc
FDA Devices Critical Jul 22, 2020
BodyGuard set with Female Luer, REF: A120-003XSN
CME America, LLC