Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Olympus Corporation Of The Americas
Olympus Endoscope Suction Valve - MAJ-1443. Model Number: MAJ-1443.
Medical Devices·47,383 affected·Feb 12, 2026
High RiskFDA
Olympus Corporation Of The Americas
Olympus Endoscope Reprocessor OER-Pro. Model Number: N3058140.
Medical Devices·3,354 affected·Feb 12, 2026
High RiskFDA
Olympus Corporation Of The Americas
Olympus Endoscope Reprocessor OER-Elite. Model Number: N5789340.
Medical Devices·2,929 affected·Feb 12, 2026
High RiskFDA
Olympus Corporation Of The Americas
Olympus Endoscope Air/Water Valve - MAJ-1444. Model Number: MAJ-1444.
Medical Devices·89,579 affected·Feb 12, 2026
High RiskFDA
Burlington Medical, Llc
Burlington Medical, Wrap Aprons.
Medical Devices·5,198 affected·Feb 11, 2026
High RiskFDA
Burlington Medical, Llc
Burlington Medical, Leg Wraps.
Medical Devices·103 affected·Feb 11, 2026
High RiskFDA
Burlington Medical, Llc
Burlington Medical, Half Aprons.
Medical Devices·402 affected·Feb 11, 2026
High RiskFDA
Burlington Medical, Llc
Burlington Medical, Vest
Medical Devices·15,438 affected·Feb 11, 2026
High RiskFDA
Burlington Medical, Llc
Burlington Medical, Demi Half Aprons.
Medical Devices·29 affected·Feb 11, 2026
High RiskFDA
Carefusion 303, Inc.
BD Alaris" System with Guardrails" Suite MX with Point of Care Unit
Medical Devices·1,025,567 affected·Feb 11, 2026
High RiskFDA
Burlington Medical, Llc
Burlington Medical, Kilt Blockers.
Medical Devices·94 affected·Feb 11, 2026
High RiskFDA
Waldemar Link Gmbh & Co. Kg (mfg Site)
Embrace Drill Tower, Wedged (25mm); Item Number: 645-081/62;
Medical Devices·75 affected·Feb 11, 2026
High RiskFDA
Burlington Medical, Llc
Burlington Medical, Protective Sleeves.
Medical Devices·1,129 affected·Feb 11, 2026
High RiskFDA
Burlington Medical, Llc
Burlington Medical, Frontal Aprons
Medical Devices·14,323 affected·Feb 11, 2026
High RiskFDA
Burlington Medical, Llc
Burlington Medical, Blockers.
Medical Devices·51 affected·Feb 11, 2026
High RiskFDA
Orthalign, Inc
Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 1 -5 REF:402566 component Lantern Knee System
Medical Devices·7 affected·Feb 10, 2026
High RiskFDA
Orthalign, Inc
Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 6-7 REF:402567 component Lantern Knee System
Medical Devices·7 affected·Feb 10, 2026
High RiskFDA
Lemaitre Vascular, Inc.
Artegraft Vascular Graft; REF#: AG740;
Medical Devices·1 affected·Feb 10, 2026
High RiskFDA
Reflexion Medical, Inc.
RefleXion X1 Radiotherapy System Model RXM1000, Part #800-00006-00
Medical Devices·12 affected·Feb 9, 2026
High RiskFDA
Abbott Diagnostics Scarborough, Inc.
Product Name: ID NOW" Influenza A & B 2 Model/Catalog Number: 427-000 Software Version: Not Applicable Product Description: Influenza ...
Medical Devices·111,984 affected·Feb 9, 2026
High RiskFDA
International Life Sciences
Artelon FlexBand Dynamic Matrix Ref: 31057
Medical Devices·0 affected·Feb 6, 2026
High RiskFDA
Bd Kiestra Lab Automation
BD Kiestra" ReadA; Catalog No.: 446948.
Medical Devices·82 affected·Feb 6, 2026
RecallFDA
Datascope Corp.
Battery Charging Station; Model: 0998-00-0802;
Medical Devices·28 affected·Feb 6, 2026
High RiskFDA
Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha
Brand Name: Hitachi Proton Beam Therapy System Ref: PROBEAT-FR
Medical Devices·1 affected·Feb 6, 2026
High RiskFDA
International Life Sciences
Artelon FLEXBAND TWIST .12 Ref: TW012 3.85x17mm HEX Anchor (Qty 2) 5.0x17mm HEX Anchor (Qty 1) 0.5x12cm FLEXBAND (Qty 1)
Medical Devices·0 affected·Feb 6, 2026
High RiskFDA
International Life Sciences
Artelon FlexBand Plus Ref: 41054 & 41057
Medical Devices·0 affected·Feb 6, 2026
High RiskFDA
Exactech, Inc.
Brand Name: Equinoxe Ergo Product Name: Ergo Modular Impactor Handle Model/Catalog Number: 321-09-05
Medical Devices·120 affected·Feb 3, 2026
High RiskFDA
Ge Medical Systems, Llc
Imactis CT-Navigation System, stereotaxic accessory for Computer Tomography (CT), systems, Model Numbers E85101LA and E85101LP
Medical Devices·125 affected·Feb 3, 2026
High RiskFDA
Howmedica Osteonics Corp.
MICS3 Angled Sagittal Saw Attachment; Part Number: 210490
Medical Devices·1,098 affected·Feb 2, 2026
High RiskFDA
Beckman Coulter Mishima K.k.
CHEMISTRY ANALYZER AU5800, REF: B96697, B96698, B23279, B23280, B23281
Medical Devices·47 affected·Jan 30, 2026
High RiskFDA
Beckman Coulter Mishima K.k.
DxC 700 AU, REF: B86444, B86446
Medical Devices·142 affected·Jan 30, 2026
High RiskFDA
Ge Medical Systems, Llc
Centricity Universal Viewer Software Versions 6.0 through 6.0 Sp10.4.1, a device that displays medical images (including mammograms) and ...
Medical Devices·797 affected·Jan 30, 2026
High RiskFDA
Medtronic Minimed, Inc.
MiniMed" 780G - MMT-1884 MiniMed" 780G - MMT-1886 With Software 6.60 and 6.61
Medical Devices·26,851 affected·Jan 30, 2026
High RiskFDA
Ge Medical Systems, Llc
Centricity Universal Viewer Software Versions 5.0 SP6 through UV 5.0 SP7.1, a device that displays medical images (including mammograms) ...
Medical Devices·40 affected·Jan 30, 2026
High RiskFDA
Olympus Corporation Of The Americas
Olympus Single use Biopsy Valve. Model/Catalog Number: MAJ-210. 20 units per box. The MAJ-210 has been designed to be attached to the ...
Medical Devices·95,882 affected·Jan 29, 2026
High RiskFDA
Olympus Corporation Of The Americas
Olympus Single Use Biopsy Valve. Model/Catalog Number: MAJ-1218. 20 units per box. The MAJ-1218 has been designed to be attached to th...
Medical Devices·1,276 affected·Jan 29, 2026
High RiskFDA
Ultradent Products, Inc.
Jiffy Original Composite Polisher Cups (Coarse) 12pk, REF 7011.
Medical Devices·2,508 affected·Jan 28, 2026
CriticalFDA
Abiomed, Inc.
Impella RP Flex with SmartAssist. Product Code: 1000323.
Medical Devices·4,496 affected·Jan 27, 2026
CriticalFDA
Abiomed, Inc.
Impella RP with SmartAssist. Product Code: 0046-0035.
Medical Devices·291 affected·Jan 27, 2026
CriticalFDA
Abiomed, Inc.
Impella RP. Product Code: 0046-0011.
Medical Devices·179 affected·Jan 27, 2026
High RiskFDA
Becton Dickinson & Company
10mL Non-Sterile BD Luer-Lok Tip Syringe Only. Catalog Number: 301029. 850 bulk non-sterile units per case.
Medical Devices·204,000 affected·Jan 27, 2026
High RiskFDA
Philips Medical Systems Nederland B.v.
Azurion 7 M12 System Model Numbers: (1)722078, (2)722223, (3)722233; Software Version Number - All versions: R1.X, R2.X, R3.X
Medical Devices·1,979 affected·Jan 26, 2026
High RiskFDA
Philips Medical Systems Nederland B.v.
Azurion 7 M20 System Model Numbers: (1)722079, (2)722224, (3)722234, (4)722282(OUS only); Software Version Number - All versions: R1.X,...
Medical Devices·5,136 affected·Jan 26, 2026
High RiskFDA
Philips Medical Systems Nederland B.v.
Azurion 7 B12 System Model Numbers:(1) 722067, (2) 722225, (3) 722235; Software Version Number - All versions: R1.X, R2.X, R3.X
Medical Devices·655 affected·Jan 26, 2026
High RiskFDA
Philips Medical Systems Nederland B.v.
Azurion 5 M12 System Model Numbers: (1)722227, (2)722231; Software Version Number - All versions: R1.X, R2.X, R3.X
Medical Devices·326 affected·Jan 26, 2026
High RiskFDA
Philips Medical Systems Nederland B.v.
Azurion 3 M15 System Model Numbers: (1) 722064, (2) 722222, (3) 722230, (4)722280(OUS only); Software Version Number - All versions: R1...
Medical Devices·802 affected·Jan 26, 2026
High RiskFDA
Philips Medical Systems Nederland B.v.
Azurion 3 M12 System Model Numbers: (1) 722063, (2) 722221, (3) 722229; Software Version Number - All versions: R1.X, R2.X, R3.X
Medical Devices·291 affected·Jan 26, 2026
High RiskFDA
I.t.s. Gmbh
HCS - Headless Compression Screw System, Headless Compression Screw, Cannulated; Article Numbers: 31207-10, 31207-12, 31207-14, 31207-16,...
Medical Devices·623 affected·Jan 23, 2026