Medical Devices Recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
27,372 recalls · Page 130 of 548
FDA Devices Moderate Dec 28, 2022
Revaclear 400 dialyzers. Indicated for treatment of chronic and acute renal failure by hemodialysis.
Baxter Healthcare Corporation
FDA Devices Low Dec 28, 2022
Full Dose CE Simplex P Single Bone Cement - Indicated for the fixation of prostheses to living bone in orthopaedic Catalog Number: 6191-0-001
Howmedica Osteonics Corp.
FDA Devices Moderate Dec 28, 2022
HeartWare Model 1100
Heartware, Inc.
FDA Devices Moderate Dec 28, 2022
Vivid S6 ultrasound. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid…
GE Medical Systems, LLC
FDA Devices Moderate Dec 28, 2022
ConvaTec AQUACEL Foam Ag Adhesive, wound dressing advesive
ConvaTec, Inc
FDA Devices Moderate Dec 28, 2022
Vivid S5 N ultrasound. Not marketed in the US. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ…
GE Medical Systems, LLC
FDA Devices Moderate Dec 28, 2022
Corin BIOLOX DELTA MOD HEAD, 036mm EX LONG +8mm, REF 104.3615
Corin Ltd
FDA Devices Moderate Dec 28, 2022
HeartWare HVAD Pump Kit, REF 1104CA-CLIN
Heartware, Inc.
FDA Devices Moderate Dec 28, 2022
HeartWare Model 1101
Heartware, Inc.
FDA Devices Moderate Dec 28, 2022
DeVilbiss, 525 5-liter Oxygen Concentrator Models 525DS, 525DS-Q
DeVilbiss Healthcare LLC
FDA Devices Moderate Dec 28, 2022
Vivid S5 Ultrasound. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid…
GE Medical Systems, LLC
FDA Devices Moderate Dec 28, 2022
Vivid i ultrasound. Marketed under the following 510(k) numbers: K033139, K061525, K082374, K092140, K102388, K121062). Used in ultrasound imagin…
GE Medical Systems, LLC
FDA Devices Low Dec 28, 2022
Tobra Full Dose CE Antibiotic Simplex P- Indicated for the fixation of prostheses to living bone in orthopaedic Catalog Number:6197-1-001
Howmedica Osteonics Corp.
FDA Devices Moderate Dec 28, 2022
Lamaze Chill Teether, Fluid-Filled Teething Ring, Model No. Y5288L
Tomy International Inc.
FDA Devices Moderate Dec 28, 2022
Corin BIOLOX DELTA MOD HEAD,032mm, EX LONG +7mm, REF 104.3215
Corin Ltd
FDA Devices Moderate Dec 28, 2022
2008T and 2008TBluestar Hemodialysis Machines with CDX-Indicated for acute and chronic dialysis therapy in a healthcare facility Models: (1) 19071…
Fresenius Medical Care Holdings, Inc.
FDA Devices Moderate Dec 28, 2022
HeartWare HVAD Pump Kit, REF 1103
Heartware, Inc.
FDA Devices Moderate Dec 28, 2022
Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-096
Abbott Molecular, Inc.
FDA Devices Moderate Dec 28, 2022
B105P Patient Monitor (with E-module slot option), REF 6160000-001-XXXXXX,
GE Medical Systems, LLC
FDA Devices Moderate Dec 28, 2022
B125M Patient Monitor, REF 6160000-004-XXXXXX
GE Medical Systems, LLC
FDA Devices Moderate Dec 28, 2022
Centricity Universal Viewer 6.0. Used to display medical images (Including mammograms) and data from various imaging sources.
GE Medical Systems, LLC
FDA Devices Moderate Dec 28, 2022
HeartWare HVAD Pump Kit, REF 1104
Heartware, Inc.
FDA Devices Moderate Dec 28, 2022
Medical Action Industries Inc. Disposable Instrument Pack, Littauer Scissor, REF 56247, packaged 1/package, 20 packages/box, 12 boxes/case, sterile.
Medical Action Industries, Inc. 306
FDA Devices Moderate Dec 28, 2022
Medical Action INDUSTRIES INC. Port a Cath Kit REF 58647D, cardiac catheter introduction kit
Medical Action Industries, Inc. 306
FDA Devices Moderate Dec 28, 2022
Vivid q ultrasound. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid)…
GE Medical Systems, LLC
FDA Devices Moderate Dec 28, 2022
The product is a handheld ultraviolet-C germicidal wand and contains narrow-diameter, tubular lamps with a peak emission wavelength in the 254 nm ran…
PHONESOAP
FDA Devices Moderate Dec 21, 2022
HENRY SCHEIN, Vas Reversal Pack, Item No.888-2549,
Stradis Medical, LLC dba Stradis Healthcare
FDA Devices Moderate Dec 21, 2022
DeRoyal MYELOGRAM PACK, REF 89-9304.05
DeRoyal Industries Inc
FDA Devices Moderate Dec 21, 2022
DeRoyal LUMBAR/CERVICAL PACK, REF 89-9521.11
DeRoyal Industries Inc
FDA Devices Moderate Dec 21, 2022
STRADIS HEALTHCARE, Angioplasty, Item No.682-1937,
Stradis Medical, LLC dba Stradis Healthcare
FDA Devices Moderate Dec 21, 2022
DeRoyal VIT RD PACK 86ST, REF 89-7308.09
DeRoyal Industries Inc
FDA Devices Critical Dec 21, 2022
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT2 WAVE REFURBISHED, REF IAP-0535X (IPN000329), cardiac pump
ARROW INTERNATIONAL Inc.
FDA Devices Moderate Dec 21, 2022
STRADIS HEALTHCARE, Surg Pk, Item No.40714IES, oral surgery tray
Stradis Medical, LLC dba Stradis Healthcare
FDA Devices Critical Dec 21, 2022
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-05001 (IPN000333), cardiac pump
ARROW INTERNATIONAL Inc.
FDA Devices Critical Dec 21, 2022
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT 2 WAVE, REF IAP-0535 (IPN000329), cardiac pump
ARROW INTERNATIONAL Inc.
FDA Devices Moderate Dec 21, 2022
DeRoyal FOOT PACK, REF 89-9252.08
DeRoyal Industries Inc
FDA Devices Moderate Dec 21, 2022
DeRoyal PAIN TRAY, REF 89-10464.03
DeRoyal Industries Inc
FDA Devices Moderate Dec 21, 2022
HENRY SCHEIN, SINGLE SHOT EPIDURAL, Item No.570-3089
Stradis Medical, LLC dba Stradis Healthcare
FDA Devices Moderate Dec 21, 2022
DeRoyal SHOULDER KIT, REF 89-9497.08
DeRoyal Industries Inc
FDA Devices Moderate Dec 21, 2022
DeRoyal CANNULTED HIP PACK, REF 89-6977.10
DeRoyal Industries Inc
FDA Devices Moderate Dec 21, 2022
DeRoyal TRANS CANAL PACK, REF 89-7157.12
DeRoyal Industries Inc
FDA Devices Moderate Dec 21, 2022
DeRoyal FACIAL PACK PGYBK, REF 89-10007.03
DeRoyal Industries Inc
FDA Devices Moderate Dec 21, 2022
DeRoyal CATARACT PACK CSM, REF 89-6863
DeRoyal Industries Inc
FDA Devices Moderate Dec 21, 2022
STRADIS HEALTHCARE, VENOUS ACCESS PACK, Item No.682-1993R1,
Stradis Medical, LLC dba Stradis Healthcare
FDA Devices Moderate Dec 21, 2022
HENRY SCHEIN, SURGICAL PAIN TRAY, Item No.570-1482
Stradis Medical, LLC dba Stradis Healthcare
FDA Devices Moderate Dec 21, 2022
DeRoyal KIT HEART B PACK, REF 89-9042.07
DeRoyal Industries Inc
FDA Devices Moderate Dec 21, 2022
DeRoyal TRACECART POSTEROR LUMBAR FUSION TRACECART, REF 53-1961.02
DeRoyal Industries Inc
FDA Devices Moderate Dec 21, 2022
DeRoyal SHOULDER PACK, REF 89-9449.13
DeRoyal Industries Inc
FDA Devices Moderate Dec 21, 2022
HENRY SCHEIN, LOOP RECORDER PACK, Item No.570-2891
Stradis Medical, LLC dba Stradis Healthcare
FDA Devices Moderate Dec 21, 2022
DeRoyal MINOR ORAL / ENT PACK, REF 89-2576.15
DeRoyal Industries Inc