Category

Medical Devices Recalls

15,654 medical devices recalls on record from CPSC, FDA, and USDA.

15,654 recalls
CriticalFDA
Tenacore Llc
Alaris Infusion Pump 8100 Bezel (plastic piece only), Part: TIPA-8100-4410
Medical Devices·1,494 affected·Feb 25, 2021
RecallFDA
Microbiologics Inc
KWIK-STIK, Enterobacter cloacae subsp. cloacae derived from ATCC 13047, REF 0323P. Packaged 2 units per pack. IVD controls.
Medical Devices·47 affected·Feb 24, 2021
RecallFDA
Microbiologics Inc
KWIK-STIK, Candida parapsilosis derived from ATCC 22019, REF 0726P. Packaged 2 units per pack. IVD controls.
Medical Devices·65 affected·Feb 24, 2021
High RiskFDA
Arthrex, Inc.
Drill Bit, Cannulated, 5.0 mm - Product Usage: may be used in a variety of foot and ankle procedures.
Medical Devices·9 affected·Feb 24, 2021
High RiskFDA
Depuy Orthopaedics, Inc.
The ATTUNE¿ Rotating Platform (RP) Total Knee System - Product Usage: consists of multiple components intended to replace the femoral, ti...
Medical Devices·355 affected·Feb 22, 2021
High RiskFDA
Depuy Orthopaedics, Inc.
The LCS COMPLETE P.F.C.TM SIGMA RP Mobile Bearing Total Knee System - Product Usage: consists of three components intended to replace th...
Medical Devices·102 affected·Feb 22, 2021
High RiskFDA
Sirtex Medical Limited
SIROS D-Vial Prep Set, Product Code SIR-10200 - Product Usage: intended for single use.
Medical Devices·3,310 affected·Feb 22, 2021
High RiskFDA
Ortho-clinical Diagnostics, Inc.
VITROS Chemistry Products Calibrator Kit 4-(Calibrator values for TIBC only). Used to calibrate VITROS 250/350/5,1 FS/4600/XT 3400 Chemi...
Medical Devices·7,546 affected·Feb 18, 2021
High RiskFDA
Teleflex Medical Inc
RUSCH¿ POLARIS" Laryngoscope - Product Usage: intended to allow direct visualization of the laryngeal structure and is used during trache...
Medical Devices·157 affected·Feb 18, 2021
CriticalFDA
Smisson-cartledge Biomedical, Llc
ThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge Biomedical ThermaCor 1200 Rapid Thermal Infusion System, used for i...
Medical Devices·7,118 affected·Feb 18, 2021
CriticalFDA
Smisson-cartledge Biomedical, Llc
ThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge Biomedical ThermaCor 1200 Rapid Thermal Infusion System, used for i...
Medical Devices·11,768 affected·Feb 18, 2021
High RiskFDA
Fujifilm Medical Systems U.s.a., Inc.
¿TASWako Chip Cassette is part of the Wako ¿TASWako i30 kit
Medical Devices·496 affected·Feb 18, 2021
High RiskFDA
Vectornate Usa Inc
MedSchenker Smart Transport Medium (STM) System: CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL - MULTIPURPOSE CULTURE MEDIUM - Produc...
Medical Devices·130,000 affected·Feb 16, 2021
High RiskFDA
Clerio Vision
EXTREME H2O 59% (hioxifilcon A) spherical soft contact lens for daily wear - Product Usage: indicated for the correction of visual acuity...
Medical Devices·153 affected·Feb 16, 2021
High RiskFDA
Carestream Dental, Llc
Carestream Dental CS 3600 Single Use Normal Tips, Catalog Number 5941216 - Product Usage: used to record the topographic characteristics ...
Medical Devices·11,400 affected·Feb 15, 2021
High RiskFDA
Nuvasive Specialized Orthopedics Inc
PRECICE PLATE - Product Usage: intended for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-union...
Medical Devices·40 affected·Feb 12, 2021
High RiskFDA
Nuvasive Specialized Orthopedics Inc
PRECICE STRYDE - Product Usage: intended for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-unio...
Medical Devices·2,360 affected·Feb 12, 2021
High RiskFDA
Nuvasive Specialized Orthopedics Inc
Precice Bone Transport - Product Usage: intended for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, ...
Medical Devices·226 affected·Feb 12, 2021
High RiskFDA
Cardinal Health 200, Llc
JUDKINS PACK
Medical Devices·298 affected·Feb 11, 2021
High RiskFDA
Getinge Group Logistics America, Llc
Operating Table System
Medical Devices·4,288 affected·Feb 11, 2021
High RiskFDA
In2bones, Sas
In2Bones Shannon Percutaneous Burr - Product Usage: indicated for forefoot mini-invasive and percutaneous surgery.
Medical Devices·60 affected·Feb 9, 2021
High RiskFDA
Cardinal Health 200, Llc
McKesson PREVENT M NEEDLE (Magellan Technology) 25G X 5/8". A single lumen needle intended to inject fluids into, or withdraw fluids fr...
Medical Devices·108,000 affected·Feb 9, 2021
High RiskFDA
Cardinal Health 200, Llc
Magellan 3 mL Syringe with Hypodermic Safety Needle, 25 G x 5/8" (0.508 mm x 1.6 cm). A single lumen needle intended to inject fluids int...
Medical Devices·6,800 affected·Feb 9, 2021
High RiskFDA
Sharp Medical Products
SHARP MEDICAL PRODUCTS, LLC Reactor and Sleeve REF 100-36-01 Size: Adult
Medical Devices·129 affected·Feb 8, 2021
High RiskFDA
Meridian Bioscience Inc
The ImmunoCard Mycoplasma EIA detects the presence of IgM to M. pneumoniae in serum - Product Usage: intended to aid in the diagnosis of ...
Medical Devices·8 affected·Feb 8, 2021
High RiskFDA
Ge Healthcare, Llc
NM/CT 860 Nuclear Medicine / CT Scanners
Medical Devices·242 affected·Feb 7, 2021
High RiskFDA
Encore Medical, Lp
DJO EMPOWR KNEE Femoral Sizer
Medical Devices·16 affected·Feb 5, 2021
High RiskFDA
Canon Medical System, Usa, Inc.
System INFX-8000C
Medical Devices·272 affected·Feb 5, 2021
High RiskFDA
Canon Medical System, Usa, Inc.
System INFX-8000F
Medical Devices·272 affected·Feb 5, 2021
High RiskFDA
Somatex Medical Technologies Gmbh
Thread-like wire marker
Medical Devices·196 affected·Feb 3, 2021
High RiskFDA
Philips North America Llc
IntelliVue MX40 Patient Monitor, Model Number: 865350 (US) 865352 (OUS) Software version number B.06.59 - Product Usage: Intended for mon...
Medical Devices·3 affected·Feb 2, 2021
High RiskFDA
Thermo Fisher Scientific
Cascadion SM Clinical Analyzer, REF 99990000 SN Type: 9910
Medical Devices·19 affected·Feb 1, 2021
High RiskFDA
Stryker Communications
S-Series Equipment Management System; Model Number(s):0682400550; UDI: 07613327400502 Components that are affected within the S-Series F...
Medical Devices·1,393 affected·Jan 29, 2021
High RiskFDA
Baxter Healthcare Corporation
Prismaflex Control Unit - Product Usage: Used for Continuous Renal Replacement Therapy (CRRT).
Medical Devices·1,225 affected·Jan 28, 2021
High RiskFDA
Baxter Healthcare Corporation
Prismaflex Control Unit - Product Usage: Used for Continuous Renal Replacement Therapy (CRRT).
Medical Devices·1,650 affected·Jan 28, 2021
High RiskFDA
Baxter Healthcare Corporation
Preventative Maintenance Kits G5010007) and spare part kits (G5064801 and G5006203) - Product Usage: For Prismaflex Control Units, used f...
Medical Devices·35,175 affected·Jan 28, 2021
High RiskFDA
Johnson & Johnson Surgical Vision Inc
TECNIS Toric 1-Piece IOL, Model Number: ZCT150 +23.5D SE 1.50D CYL - Product Usage: intended to be placed in the capsular bag.
Medical Devices·27 affected·Jan 27, 2021
High RiskFDA
Biofire Diagnostics, Llc
Gram-Negative Bacteria And Associated Resistance Markers; Film Array Blood Culture Identification (BCID); Film Array BCID Panel - Produc...
Medical Devices·21,922 affected·Jan 26, 2021
High RiskFDA
Medline Industries Inc
RNA MEDICAL, QCHGB HEMOGLOBIN CONTROL, MULTI, REF QC HGB - Product Usage: monitoring the performance of Hemocue Hemoglobin Analyzers. It ...
Medical Devices·4 affected·Jan 25, 2021
High RiskFDA
Raysearch America Inc
Radiation therapy software, RayStation standalone software treatment planning system. Model numbers: 8B, 8B SP1, 8B SP2, 9A, 9B, 9B SP1, ...
Medical Devices·5 affected·Jan 22, 2021
High RiskFDA
G & H Wire Company
Band, Elastic, Orthodontic - Product Usage: Orthodontic elastics, also referred to as rubber bands, are small stretchy loops of rubber th...
Medical Devices·371 affected·Jan 21, 2021
High RiskFDA
Boston Scientific Corporation
Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy Snares. Outer box UPN, Inner Pouch UPN: M00561311 (Box...
Medical Devices·335,788 affected·Jan 19, 2021
High RiskFDA
Cardinal Health 200, Llc
Enteral Infusion Pump
Medical Devices·146,944,334 affected·Jan 19, 2021
High RiskFDA
Renovo, Inc.
Various reprocessed products: PROVISION, Reprocessed Smith and Nephew Arthroscopic Shavers, STERILE EO; PROVISION Reprocessed Depy Mi...
Medical Devices·81 affected·Jan 19, 2021
High RiskFDA
Boston Scientific Corporation
Captivator/Captiflex/Sensation Short Throw Single-Use Polypectomy Snares Outer box UPN, Inner pouch UPN: M00560311 (Box 5), M005603...
Medical Devices·335,788 affected·Jan 19, 2021
High RiskFDA
Rti Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
CervAlign Anterior Cervical Plate System-Cervalign, 3 Level, 48mm Material Number: 66-348 - Product Usage: intended for anterior cervical...
Medical Devices·0 affected·Jan 15, 2021
High RiskFDA
Rti Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
CervAlign Anterior Cervical Plate System-Cervalign, 3Level, 63mm Material Number: 66-363 - Product Usage: intended for anterior cervical ...
Medical Devices·0 affected·Jan 15, 2021
High RiskFDA
Rti Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 38mm Material Number: 66-238 - Product Usage: intended for anterior cervical ...
Medical Devices·0 affected·Jan 15, 2021