Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Onkos Surgical, Inc.
a. Segmental Stem, Cemented, Straight, 100MM, 1 EACH; Model Numbers: CS-09100-03M, CS-10100-03M. b. Segmental Stem, Cemented, Straight...
Medical Devices·147 affected·Sep 1, 2023
High RiskFDA
American Contract Systems, Inc.
Robotics Pack, REF SJVO56B
Medical Devices·112 affected·Sep 1, 2023
High RiskFDA
Onkos Surgical, Inc.
Ethos Collar Stem, Cemented, Fluted, 100MM, 1 EACH. Model Numbers: HC-09100-03M, HC-10100-03M, HC-11120-03M, HC-13120-03M, HC-15120-03M, ...
Medical Devices·233 affected·Sep 1, 2023
High RiskFDA
Onkos Surgical, Inc.
Segmental Stem, Canal Filling, Straight, 120MM, 1 EACH. Model Numbers: FS-11120-03M, FS-12120-03M, FS-13120-03M, FS-14120-03M, FS-15120-0...
Medical Devices·120 affected·Sep 1, 2023
High RiskFDA
American Contract Systems, Inc.
Vasc. Open CVOR SJH, REF SJVO56B
Medical Devices·84 affected·Sep 1, 2023
High RiskFDA
American Contract Systems, Inc.
CVS PCSU SJH, REF SJCV48J
Medical Devices·36 affected·Sep 1, 2023
High RiskFDA
American Contract Systems, Inc.
Robotics Pack, REF SSRO22D
Medical Devices·56 affected·Sep 1, 2023
High RiskFDA
Siemens Medical Solutions Usa, Inc
(1) Over-ear headphones used with the MAGNETOM Amira MAGNETOM Free.Star MAGNETOM Sempra, MAGNETOM Free.Max, MAGNETOM Mica MAGNETOM Spectr...
Medical Devices·3,470 affected·Sep 1, 2023
High RiskFDA
American Contract Systems, Inc.
Sub Q Recorder Pack, REF BPRC87A
Medical Devices·96 affected·Sep 1, 2023
High RiskFDA
Pulmonx, Corp.
Zephyr Endobronchial Valve (EBV) 5.5-LP, REF: EBV-TS-5.5-LP
Medical Devices·144 affected·Aug 31, 2023
High RiskFDA
Philips North America Llc
EarlyVue VS30 Vitals Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo Rainbow RRa) simultaneously, Product C...
Medical Devices·13 affected·Aug 31, 2023
High RiskFDA
Access Vascular, Inc
HydroPICC 5Fr Dual Lumen, 80cm guidewire - Basic Kit, Product Model Number 80002002
Medical Devices·58 affected·Aug 31, 2023
High RiskFDA
Access Vascular, Inc
HydroPICC 5Fr Dual Lumen Maximal Barrier Kit, Product Model Number 80002004
Medical Devices·58 affected·Aug 31, 2023
High RiskFDA
Smith & Nephew Inc
smith&nephew LEGION OXINUM POSTERIOR STABILIZED NONPOROUS FERMOAL COMPONENT, SIZE 5N, LEFT, NARROW, REF 71421265; knee joint
Medical Devices·8 affected·Aug 31, 2023
CriticalFDA
Stryker Medical Division Of Stryker Corporation
ProCuity bed series, model number 3009, item number: 3009PX-LE-400.
Medical Devices·0 affected·Aug 30, 2023
High RiskFDA
Ab Sciex, Llc
Citrine Triple Quad Mass Spectrometer, Part Number 5063684
Medical Devices·14 affected·Aug 30, 2023
High RiskFDA
Ab Sciex, Llc
4500MD Triple Quad Mass Spectrometer, Part Number 5032522
Medical Devices·38 affected·Aug 30, 2023
High RiskFDA
Royalvibe Health Ltd.
CellQuicken Analyzer (Smart-Watch and Software), RoyalVibe Ultrasound Generator, Brainvibe, Envirovibe Water Restructuring Pad, Royal...
Medical Devices·564 affected·Aug 30, 2023
CriticalFDA
Stryker Medical Division Of Stryker Corporation
ProCuity bed series, model number 3009, item number: 3009PX-L-100.
Medical Devices·0 affected·Aug 30, 2023
CriticalFDA
Stryker Medical Division Of Stryker Corporation
ProCuity bed series, model number 3009, item number: 3009PX-ZM-450.
Medical Devices·0 affected·Aug 30, 2023
CriticalFDA
Stryker Medical Division Of Stryker Corporation
ProCurity bed series, model number 3009, item number: 3009PX-ZMX-600.
Medical Devices·0 affected·Aug 30, 2023
CriticalFDA
Stryker Medical Division Of Stryker Corporation
ProCuity bed series, model number 3009, item number: 3009PX-LEX-400.
Medical Devices·0 affected·Aug 30, 2023
CriticalFDA
Stryker Medical Division Of Stryker Corporation
ProCurity bed series, model number 3009, item number: 3009PX-ZX-450.
Medical Devices·0 affected·Aug 30, 2023
High RiskFDA
Coopersurgical, Inc.
Box as labeled: Regard, Carter-Thomason CloseSure System XL, REF 733776, Quantity 1 Box of 3 Systems. Kit as labeled: Regard, Carter-Tho...
Medical Devices·127 affected·Aug 29, 2023
High RiskFDA
Arjohuntleigh Polska Sp. Z.o.o.
Arjo medical beds, Models Enterprise 5000X, Enterprise 8000X, Enterprise 9000X and Citadel, assembled with IndiGo Drive Assistance module...
Medical Devices·83 affected·Aug 29, 2023
High RiskFDA
Arjohuntleigh Polska Sp. Z.o.o.
Arjo medical beds, Models Enterprise 5000X, Enterprise 8000X, Enterprise 9000X and Citadel, assembled with IndiGo Drive Assistance module...
Medical Devices·846 affected·Aug 29, 2023
High RiskFDA
Techno-path Manufacturing Ltd.
Multichem P, Part Code 08P90-10
Medical Devices·2,964 affected·Aug 25, 2023
High RiskFDA
Immunostics, Inc.
Detector H. Pylori, Catalog Number IHP-30
Medical Devices·10 affected·Aug 25, 2023
High RiskFDA
Techno-path Manufacturing Ltd.
Multichem S Plus, Part Codes: a) 08P88-10, b) 08P88-11, c) 08P88-12
Medical Devices·117,155 affected·Aug 25, 2023
High RiskFDA
Remote Diagnostic Technologies Ltd.
Philips Tempus Pro Patient Monitor, REF: 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R, 00-1004, and 00-1007, when Used With Tempus Pro Vide...
Medical Devices·3,524 affected·Aug 24, 2023
High RiskFDA
Microvention Inc.
AZUR CX 35 Peripheral Coil System Detachable 13mm x 24 CM, REF: 45-751324
Medical Devices·14 affected·Aug 24, 2023
High RiskFDA
Stryker Corporation
Cinchlock SS Knotless Anchor Inserter, Part Number CAT02462
Medical Devices·96 affected·Aug 23, 2023
High RiskFDA
3m Company - Health Care Business
3M Attest Super Rapid Readout Biological Indicator, REF 1492V; used to qualify or monitor dynamic-air-removal steam sterilization cycles
Medical Devices·79,500 affected·Aug 22, 2023
High RiskFDA
Apellis Pharmaceuticals, Inc.
Apellis Injection Kit 29g Injection Needle -single use intended to inject fluids into, or withdraw fluids from, parts of the body below t...
Medical Devices·61,943 affected·Aug 22, 2023
High RiskFDA
Smiths Medical Asd Inc.
Smiths Medical Portex Bivona Pediatric Tracheostomy Tube, Cuffless, Model 60P045, Sterile.
Medical Devices·0 affected·Aug 22, 2023
High RiskFDA
3m Company - Health Care Business
3M Attest Super Rapid 5 Steam-Plus Steam Challenge Pack, REF 41482VF; designed to qualify and monitor dynamic-air removal steam steriliza...
Medical Devices·77,280 affected·Aug 22, 2023
High RiskFDA
3m Company - Health Care Business
3M Attest Super Rapid Readout Steam Challenge Pack, REF 1496V; designed to qualify and monitor dynamic-air removal steam sterilization pr...
Medical Devices·33,504 affected·Aug 22, 2023
High RiskFDA
Covidien
Puritan Bennett Cuff Pressure Manager, REF: 180-03
Medical Devices·408 affected·Aug 22, 2023
High RiskFDA
Carefusion 303, Inc.
BD Pyxis MedBank MedPass Software, REF: 139088-01
Medical Devices·37 affected·Aug 18, 2023
High RiskFDA
Alcon Research, Llc
Constellation Vision System, REF: 8065751150
Medical Devices·3 affected·Aug 18, 2023
High RiskFDA
Carl Zeiss Suzhou Co., Ltd.
OPMI LUMERA 300, REF 6137
Medical Devices·8 affected·Aug 18, 2023
High RiskFDA
Philips North America Llc
Patient Information Center iX with Software Version Number 4.x in the following: (1) Patient Information Center iX Product Number: 866...
Medical Devices·960 affected·Aug 17, 2023
High RiskFDA
Impedimed Limited
SOZO Bilateral Arm L-Dex Software
Medical Devices·354 affected·Aug 17, 2023
High RiskFDA
Cardinal Health 200, Llc
Procedure pack: Presource PBDS Cat. PLMHCSBHF, Hermann Hospital MHHS, Kit, C Section B MHHS, Sterile.
Medical Devices·13,351 affected·Aug 16, 2023
High RiskFDA
Cardinal Health 200, Llc
Procedure pack: Presource PBDS, Cat. PEMHEEESR, Southeast Hospital MHHS, Kit, ENT, SE, Sterile.
Medical Devices·13,351 affected·Aug 16, 2023
High RiskFDA
Smiths Medical Asd Inc.
Medfusion Syringe Pump, Model 3500-500, v3, v4, v5, and v6
Medical Devices·20,815 affected·Aug 16, 2023
High RiskFDA
Smiths Medical Asd Inc.
Medfusion Syringe Pump, Model 3500-0600-XX: a) 0600-00; b) 0600-01; c) 0600-50; d) 0600-51; e) 0600-82; f) 0600-249; softw...
Medical Devices·20,383 affected·Aug 16, 2023
High RiskFDA
Smiths Medical Asd Inc.
Medfusion Syringe Pump, Model 4000-XXXX-XX: a) 0100-50, b) 0100-249, c) 0101-50, d) 0101-51, e) 0101-78, f) 0101-249, g) 010...
Medical Devices·67,507 affected·Aug 16, 2023