Medical Device Recalls
FDA recalls of medical devices including implants, diagnostic equipment, and surgical tools.
13,708 total recalls
The Pressio 2 ICP Monitoring System, Model Number PSO-4000; Intracranial Pressure Monitor
Sophysa
ARROW Pressure Injectable Arrowg+ard Blue Advance Two-Lumen Midline Kit, 5.5 Fr, 15 cm, .018 Inch dia., REF ASK-41552-JH
ARROW INTERNATIONAL Inc.
Philips Ingenuity CT Product Codes: Ingenuity CT Upgrades 728327, Ingenuity CT China 728324, Ingenuity Core 128 Elit
Philips North America Llc
NeuRx Diaphragm Pacing System (NeuRx DPS), Affected part numbers: Part # Part Name 20-0035 NeuRx
Synapse Biomedical Inc
MEGADYNE MEGA SOFT Universal Plus Patient Return Electrode. used during electrosurgery
Megadyne Medical Products, Inc.
Product Name: Ingenia 3.0T CX; Model Number: 781271;
Philips North America Llc
Compress Device Segmental Anchor Plug, 20 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previ
Biomet, Inc.
Precice Max REF: PM10.0-80B265 PRECICE MAX Antegrade Femur Piriformis Straight 10.0mm x 265mm PM10.0-80B280 PRECICE
NuVasive Specialized Orthopedics, Inc.
Remel Haemophilus Test Medium (Agar) (150mm), 10/pk, REF R04033; and Remel Haemophilus Test Medium (Agar)(100mm), 10/pk,
Remel, Inc
CYSTO-URETHRO-FIBERSCOPE REF 11272C1 CYSTOSCOPE, 15FR X 370MM, ADULT REF 11272C2 and Kit Number 11272CK2 CYSTO-UR
Karl Storz Endoscopy
Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100181045
TELEFLEX LLC
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus
B Braun Medical Inc
GE Vscan Extend, being sold as "Vscan Extend Dual Wi-Fi"
GE Healthcare, LLC
Aespire 100. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to
Datex-Ohmeda, Inc.
Brand Name: GMAX Product Name: SYR 10ML/LL Blue syringe Model/Catalog Number: TS2210B-M Product Description: NON-Ster
Jiangsu Shenli Medical Production Co., Ltd.
Syringes with Luer Slip Tips labeled as: 1) SOL-M 1ml Slip Tip Syringe w/o Needle, Model No. 180011, UPC 818392301013
Sol-Millennium Medical Inc.
WATCHDOG ACCESSORY KIT (20-PACK), UPN H74939343A021 (outer package), UPN H74939343A020 (inner package)
Boston Scientific Corporation
Medline convenience kits: WT LAVH PACK DYNJ46609F
Medline Industries, LP
SOMATOM Definition AS-Computed tomography system Model 8098027
Siemens Medical Solutions USA, Inc
a. METREX RESEARCH CORP CaviCide1 DISINFECTANT, CLNR CAVICIDE1 1GL (4/CS) METREX, Model Number: 13-5000. b. METREX
Mckesson Medical-Surgical Inc. Corporate Office
Cooper Surgical H/S ELLIPTOSPHERE CATH 5 FR Set-For administering contrast media during Hysterosalpingography or Hystero
CooperSurgical, Inc.
GRAPHENANO DENTAL G-CAM, Product Codes: a) 95 Multichroma 14LB2, REF GC00089; b) 95 Multichroma 24LA2, REF GC00112;
GRAPHENANO DENTAL SL
Vivid S6 ultrasound. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small O
GE Medical Systems, LLC
Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Mod
Alcon Research LLC
LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 14-Indicated for patients with Mobility-limiting diseases, frac
Waldemar Link GmbH & Co. KG (Mfg Site)
Aquilex Fluid Control System-Intended to provide fluid distension of the uterus during diagnostic and operative hysteros
WOM World Of Medicine AG
Stryker iBur 5.0mm Coarse Diamond Round, Distal Bend intended to cut bone in the following manner: drilling, reaming
Stryker Corporation
COOK MEDICAL Wayne Pneumothorax Set: Reference Part Number C-UTPT-1020-WAYNE-IMH, Order Number G56532; Reference Part
Cook Incorporated
BETTA LINK LG KNOTLESS IMPLANT KIT-Intended for use in soft tissue to bone fixation in the repair of the natural ligamen
T.A.G. MEDICAL PRODUCTS CORPORATION, LTD.
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K04
Merit Medical Systems, Inc.
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