Medical Devices Recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
27,372 recalls · Page 209 of 548
FDA Devices Moderate Jul 22, 2020
SKAFFOLD FLOW (MX) 5CC. Product Number: SKMX-FL05, UDI: 813845020894 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal…
Skeletal Kinetics, Llc
FDA Devices Critical Jul 22, 2020
BodyGuard Microset with Filter, REF: A120-160XSFE
CME America, LLC
FDA Devices Critical Jul 22, 2020
BodyGuard Microset with Filter and Manual Priming Valve, REF: A120-112XSFV
CME America, LLC
FDA Devices Moderate Jul 22, 2020
CRANIOSCULPT FLOW, CAN, 10CC, Product Number: C-FLOW10CC-CAN, UDI: 813845020375 - Product Usage: Callos is indicated to fill bony voids or gaps of t…
Skeletal Kinetics, Llc
FDA Devices Moderate Jul 22, 2020
OSTEOVATION IMPACT 10CC and OSTEOVATION, 10CC, IMPACT FORMULA, Product Number: 390-2110, UDI: 813845020092 - Product Usage: Callos is indicated to f…
Skeletal Kinetics, Llc
FDA Devices Moderate Jul 22, 2020
MOL3655 Simplexa VZV Swab Direct - Product Usage: is intended for use on the LIAISON MDX instrument for the qualitative detection of varicella-zoster…
DiaSorin Molecular LLC
FDA Devices Critical Jul 22, 2020
BodyGuard Microset, REF: A120-161XPSV
CME America, LLC
FDA Devices Moderate Jul 22, 2020
Trinias DAP Meter, a component of the Digital Anglo System Trinias contained within the DAR-9500f - Product Usage: It is intended to be used for inte…
Shimadzu Medical Systems
FDA Devices Moderate Jul 22, 2020
OSTEOVATION RMX 5CC. Product Number: 390-6001, UDI: 813845021082 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal sys…
Skeletal Kinetics, Llc
FDA Devices Moderate Jul 22, 2020
ACUMED CALLOS INJECT 10CC. Product Number: 65-0010-S, UDI: 813845020245 - Product Usage: Callos is indicated to fill bony voids or gaps of the skele…
Skeletal Kinetics, Llc
FDA Devices Critical Jul 22, 2020
BodyGuard Microset, REF: A120-161XYBS
CME America, LLC
FDA Devices Moderate Jul 22, 2020
ACUMED CALLOS INJECT 3CC. Product Number: 65-0003-S, UDI: 813845020221 - Product Usage: Callos is indicated to fill bony voids or gaps of the skele…
Skeletal Kinetics, Llc
FDA Devices Critical Jul 22, 2020
BodyGuard Microset, REF: A100-163XSL
CME America, LLC
FDA Devices Critical Jul 22, 2020
Standard BodySet with Needleless Connectors, REF: A120-125XS
CME America, LLC
FDA Devices Critical Jul 22, 2020
BodyGuard Microset with Male Luer Connectors, REF: A100-163XEBF
CME America, LLC
FDA Devices Moderate Jul 22, 2020
SKAFFOLD CMF IMPRESS (MP), 5CC. Product Number: CMMP-IM05, UDI: 813845020689 - Product Usage: Callos is indicated to fill bony voids or gaps of the …
Skeletal Kinetics, Llc
FDA Devices Moderate Jul 22, 2020
SKAFFOLD FLOW, 3CC and SKAFFOLD FLOW (MX) 3CC. Product Number: SKMX-FL03, UDI: 813845020887 - Product Usage: Callos is indicated to fill bony voids …
Skeletal Kinetics, Llc
FDA Devices Moderate Jul 22, 2020
OSTEOVATION, 10CC, INJECT FORMULA. Product Number: 390-2010, UDI: 813845020061 - Product Usage: Callos is indicated to fill bony voids or gaps of th…
Skeletal Kinetics, Llc
FDA Devices Moderate Jul 22, 2020
CRANIOSCULPT C, 5CC. Product Number: C-C5CC, UDI: 813845021112 - - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal sys…
Skeletal Kinetics, Llc
FDA Devices Moderate Jul 22, 2020
MOL2150 Simplexa HSV 1&2 Direct -CSF -Genital Swab -Cutaneous / Mucocutaneous Swabs Product Usage: is intended for use on the LIAISON MDX instrument …
DiaSorin Molecular LLC
FDA Devices Moderate Jul 22, 2020
OSTEOVATIONEX 2CC INJECT FORMULA. Product Number: 390-0002, UDI: 813845020009 - 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 Filter, REF: A100-164XESF
CME America, LLC
FDA Devices Moderate Jul 22, 2020
CRANIOSCULPT C, 3CC. Product Number: C-C3CC, UDI: 813845021105 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal syste…
Skeletal Kinetics, Llc
FDA Devices Critical Jul 22, 2020
BodyGuard Microset, REF: A100-163XE90S
CME America, LLC
FDA Devices Critical Jul 22, 2020
BodyGuard Microset, REF: A120-003XS2YV
CME America, LLC
FDA Devices Moderate Jul 22, 2020
CRANIOSCULPT C, 10CC. Product Number: C-C10CC, UDI: 813845021129 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal sys…
Skeletal Kinetics, Llc
FDA Devices Moderate Jul 22, 2020
CRANIOSCULPT FLOW, OUS, 5CC Product Number: C-FLOW5CC-OUS, UDI: 813845020351 - 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: A120-160XYBF
CME America, LLC
FDA Devices Critical Jul 22, 2020
BodyGuard Microset, REF: A120-112XSFK
CME America, LLC
FDA Devices Critical Jul 22, 2020
BodyGuard Microset, REF: A120-160XYSF
CME America, LLC
FDA Devices Moderate Jul 22, 2020
DRW-0739-01: Gen 2 Posterior Chairside Splint LLUR (lower left-upper right) - Product Usage: intended to provide assistance in both the planning (pre…
Neocis Inc.
FDA Devices Moderate Jul 22, 2020
MEDTRONIC BONE VOID FILLER, SMALL. Product Number: C07A, UDI: 813845020504 - Product Usage: Callos is indicated to fill bony voids or gaps of the sk…
Skeletal Kinetics, Llc
FDA Devices Critical Jul 22, 2020
BodyGuard Microset, REF: A100-163XESV
CME America, LLC
FDA Devices Critical Jul 22, 2020
BodyGuard Microset with Filter, REF: A100-163XESF
CME America, LLC
FDA Devices Critical Jul 22, 2020
CMExpress Microbore Set, REF: A120-160C
CME America, LLC
FDA Devices Critical Jul 22, 2020
CMExpress Microbore Set, REF: A120-160CRV
CME America, LLC
FDA Devices Critical Jul 22, 2020
BodyGuard Microset with Needleless Adaptor, REF: A120-003XSNY
CME America, LLC
FDA Devices Moderate Jul 22, 2020
CRANIOSCULPT, CMF IMPACT, 5CC, Product Number: C-CMF5CC, UDI: 813845020948 - Product Usage: Callos is indicated to fill bony voids or gaps of the sk…
Skeletal Kinetics, Llc
FDA Devices Critical Jul 22, 2020
BodyGuard Microset, REF: A120-160XPS
CME America, LLC
FDA Devices Moderate Jul 22, 2020
CRANIOSCULPT, FLOW 5CC. Product Number: C-FLOW5CC, UDI: 813845020337 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal…
Skeletal Kinetics, Llc
FDA Devices Moderate Jul 22, 2020
MagNA Pure 96 Instrument, clinical sample concentrator, Material number 06541089001 - Product Usage: This protocol is intended for pipetting samples…
Roche Molecular Systems, Inc.
FDA Devices Moderate Jul 15, 2020
3COR DISTRACTION SCREW, 12 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine.
TeDan Surgical Innovations LLC
FDA Devices Moderate Jul 15, 2020
CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L30, H7mm, Part #018.1907.
CTL Medical Corporation
FDA Devices Moderate Jul 15, 2020
OrthoPediatrics ACL Reconstruction System ShieldLoc 7mm implant component model number 10-1008-4070 - Product Usage: is intended for fixation of tend…
OrthoPediatrics Corp
FDA Devices Moderate Jul 15, 2020
Prodimed Combicath catheters for mini bronchoalveolar lavage (BAL)-COMBICATH PE 85 cm x 4.0 mm 58124 40US
Prodimed Plastimed Division
FDA Devices Moderate Jul 15, 2020
TOMTEC-ARENA TTA2;software version no. 2.20 and lower; Picture archiving and communications system. Software Versions and applicable UDI: TTA 1…
Tomtec Imaging Systems Gmbh
FDA Devices Moderate Jul 15, 2020
PHANTOM CS DISTRACTION SCREW, 12 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical sp…
TeDan Surgical Innovations LLC
FDA Devices Moderate Jul 15, 2020
Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and single use only. Catalog number ENF-80P-50 (8 fr. 50 cm ENFit En…
Kentec Medical, Inc
FDA Devices Moderate Jul 15, 2020
Blood gases (PCO2, PO2) and blood pH test system; ABL800 FLEX; Model Number 393-800; UDI (01)05700693938004. Model 393-800 is available in the follow…
Radiometer Medical ApS
FDA Devices Moderate Jul 15, 2020
Prodimed Combicath Paediatric catheters for blind protected distal bronchial sampling- COMBICATH 35 cm x 1.9 mm Product Code: 58 223 19US
Prodimed Plastimed Division