Medical Device Recalls
FDA recalls of medical devices including implants, diagnostic equipment, and surgical tools.
13,559 total recalls
PrestiBio URINALASYS TEST STRIP 10 PARAMETERS REF 900-10
Universal Meditech Inc.
Acorn 130 Stairlift, Brooks 130 Stairlift, Acorn 180 Stairlift, and Acorn Outdoor Stairlift
Acorn Stairlifts, Inc
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482S; use in Peritoneal Dialysis
Baxter Healthcare Corporation
DigitalDiagnost C90 (1) High Performance, (2) Flex/Value/Chest/ER; Model Number: (1) 712034, (2) 712035;
Philips Medical Systems DMC GmbH
vyaire Flexible Patient Circuit, 3100A, REF 29028-004, intended to be used with the 3100A High Frequency Oscillatory Ven
Vyaire Medical
Discrete photometric chemistry analyzer for clinical use.
Beckman Coulter, Inc.
Brand Name: I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix) with the below descriptions and corresponding art
I.T.S. GmbH
SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 230 ¿L; Prepared with Sodium Heparin Model/Catalog Number: 06 0009 P
ASP Global, LLC. dba Anatomy Supply Partners, LLC.
Maquet Lucea - Lucea10/40, Lucea50/100 OR Light Systems, Model Numbers and Catalog Numbers LCA 10 - ARD2LCA00040C, LCA 1
Getinge Usa Sales Inc
Halyard OPEN HEART PACK MAIN - Medical convenience kits Model Number: ESJH003-02
AVID Medical, Inc.
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.
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
InTouch 2131-intended to support a human patient in an acute care setting, Model Number: 2131000000, Part #1460000000¿¿
Stryker Medical Division of Stryker Corporation
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
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