Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Philips Medical Systems Nederland B.v.
Azurion 7 M20 System code: (1) 722224 (2) 722079 (3) 722234 (4) 722282 System Code: (1) 722078 (2) 722223 (3) 722233
Medical Devices·1,346 affected·Jan 13, 2025
CriticalFDA
Philips Medical Systems Nederland B.v.
Azurion 5 M12; Catalog numbers: (1) 722227, (2) 722231 (OUS ONLY).
Medical Devices·282 affected·Jan 13, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
AlluraXper FD20 OR Table System Code: (1) 722023 (2) 722035
Medical Devices·1 affected·Jan 13, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
AlluraXperFD20/15 System Code: (1) 722058
Medical Devices·69 affected·Jan 13, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Azurion 5 M12 System Code: (1) 722227 (2) 722231
Medical Devices·6 affected·Jan 13, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
AlluraXper FD10/10 System Code: (1) 722005 (2) 722011 (3) 722027
Medical Devices·146 affected·Jan 13, 2025
CriticalFDA
Philips Medical Systems Nederland B.v.
Allura Xper FD20 OR Table; Catalog numbers: (1) 722023, (2) 722035.
Medical Devices·2 affected·Jan 13, 2025
High RiskFDA
Integra Lifesciences Corp.
Brand Name: MediHoney¿ Gel Product Name: MediHoney¿ Wound & Burn Dressing Gel Model/Catalog Number: 31815 Software Version: N/A Produ...
Medical Devices·12,166 affected·Jan 10, 2025
CriticalFDA
Fresenius Kabi Usa, Llc
Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Indicated for use in a hospital and in outpatient care environments for the co...
Medical Devices·23 affected·Jan 10, 2025
High RiskFDA
Beckman Coulter Laboratory Systems (suzhou) Co., Ltd.
DxC 500 AU Clinical Chemistry Analyzer, REF: C63519, and C63520 with affected software.
Medical Devices·56 affected·Jan 10, 2025
High RiskFDA
Kung Shin Plastics Co. Ltd.
CircuitGuard Bacterial/Viral Filter with Elbow (Model/Catalogue number: SK200FPE / 7056)
Medical Devices·30,000 affected·Jan 9, 2025
High RiskFDA
Medline Industries, Lp - Northfield
Medline Convenience Kits for Various Procedures: 1) ADULT INTUBATION TRAY, Model Number DYNJAA254A; 2) ADULT MAIN DISP. INTUB PART A, M...
Medical Devices·70 affected·Jan 9, 2025
High RiskFDA
Kung Shin Plastics Co. Ltd.
CircuitGuard ThermoFlo Filter -Combined Heat and Moisture Exchanger, Bacterial Viral Filter w O2 Port and Elbow (Model/Catalogue number: ...
Medical Devices·50,000 affected·Jan 9, 2025
High RiskFDA
Stryker Corporation
stryker Precision Thin, Catalog Number REF 2296-003-155; Micro Oscillating and Sagittal Blades
Medical Devices·238 affected·Jan 8, 2025
High RiskFDA
Carefusion 303, Inc.
(1) Pyxis MedStation ES, Catalog No. 323; (2) Pyxis Anesthesia Station (PAS), Catalog No. 327; (3) Pyxis MedStation ES Tower, Catalog N...
Medical Devices·137,741 affected·Jan 8, 2025
High RiskFDA
Carefusion 303, Inc.
138913-01 BD PYXIS MEDBANK MINI CR-2HH-1FH-P 169-114 BD PYXIS MEDBANK MINI CR-2HH-1FH-P 138911-01 BD PYXIS MEDBANK MINI CR-4HH-P 169-115 ...
Medical Devices·6,075 affected·Jan 8, 2025
High RiskFDA
Carefusion 303, Inc.
139054-01 BD PYXIS MEDFLEX MN 1000 10HH-1FM 139055-01 BD PYXIS MEDFLEX MN 1000 12HH 139053-01 BD PYXIS MEDFLEX MN 1000 2HH-2FH-3FM 139041...
Medical Devices·0 affected·Jan 8, 2025
High RiskFDA
Zimmer, Inc.
NexGen LCCK Legacy Articular Surface with Locking Screw - Striped Yellow/E,F - Height 10 mm, Item Number 00-5994-032-10
Medical Devices·155 affected·Jan 6, 2025
High RiskFDA
Xtant Medical Holdings, Inc
Irix-A Integrated Lumbar Fusion System, Model Number X080-423011-08PC (Spacer Assy, 42 X 30 X 8¿, 11mm, PC (STERILE)) and Model Number X0...
Medical Devices·14 affected·Jan 3, 2025
High RiskFDA
Medline Industries, Lp - Northfield
Medline RR-LIVER TRNS ACCESSORY PEDS, DUNJ63397; medical procedure convenience kit
Medical Devices·36 affected·Jan 3, 2025
High RiskFDA
Us Endodontics, Llc
Brasseler ESR Rotary/Reciprocating Endodontic File Device SKU AP120213PK AP120253PK AP120313PK AP125213PK AP125253PK AP125313PK ...
Medical Devices·789,729 affected·Jan 2, 2025
High RiskFDA
Siemens Medical Solutions Usa, Inc
ARTIS One Angiographic X-Ray System
Medical Devices·1,140 affected·Jan 2, 2025
CriticalFDA
Medline Industries, Lp - Northfield
Medline General Surgery Tray kits: 1) ARTERIAL LINE TRAY, Item Number ART600; 2) A LINE TRAY, Item Number ART690
Medical Devices·58 affected·Dec 31, 2024
CriticalFDA
Roi Cps Llc
regard Item Number: 830106006, LD01114F - Newborn Kit containing the component Neo-Tee Resuscitator. Convenience kit to be used in Labor ...
Medical Devices·414 affected·Dec 26, 2024
High RiskFDA
Hollister Incorporated
AnchorFast SlimFit, Oral Endotracheal Tube Fastener, REF 9787,
Medical Devices·45 affected·Dec 23, 2024
High RiskFDA
Hollister Incorporated
AnchorFast, Oral Endotracheal Tube Fastener, REF 9799,
Medical Devices·30,527 affected·Dec 23, 2024
High RiskFDA
Oxoid Limited
Lev5, REF CT1587B, 50 Susceptibility discs Levofloxacin 5 ug, IVD, CE 2797
Medical Devices·1,406 affected·Dec 23, 2024
High RiskFDA
Accuray Incorporated
CyberKnife Treatment Delivery System, REF 0660000 The CyberKnife System may be labeled as CyberKnife M6TM or VSI TM Robotic Surgery Sy...
Medical Devices·212 affected·Dec 23, 2024
High RiskFDA
Hollister Incorporated
AnchorFast Guard Select, Oral Endotracheal Tube Fastener, REF 9700,
Medical Devices·701 affected·Dec 23, 2024
High RiskFDA
Baxter Healthcare Corporation
Baxter Continu-Flo Solution Set with Duo-Vent Spike, REF UC8519
Medical Devices·0 affected·Dec 20, 2024
High RiskFDA
Ethicon, Llc
ETHIBOND EXCEL Polyester Suture, REF: 6664H, X425H, X872H, EH7491H. Not sold in US
Medical Devices·48 affected·Dec 20, 2024
CriticalFDA
Max Mobility Llc
Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DC use in conjunction with the SmartDrive MX2+ Wheelchair Power Assis...
Medical Devices·0 affected·Dec 20, 2024
High RiskFDA
Baxter Healthcare Corporation
Baxter Solution Set with Duo-Vent Spike, REF 2R8404
Medical Devices·0 affected·Dec 20, 2024
High RiskFDA
Karl Storz Endoscopy
KARL STORZ - ENDOSKOPE, REF: 27010L, Uretero-Renoscope, 7 Fr., 43cm, NON STERILE, RxONLY, CE 0123
Medical Devices·1,510 affected·Dec 19, 2024
High RiskFDA
Intuitive Surgical, Inc.
8MM,HORIZON SMALL CLIP APPLIER,IS4000¿ REF 470401
Medical Devices·5,576 affected·Dec 19, 2024
High RiskFDA
Karl Storz Endoscopy
KARL STORZ - ENDOSKOPE, REF: 27003L, MICHEL Uretero-Renoscope, 9.5 Fr., 43cm, RxONLY, CE0123
Medical Devices·4 affected·Dec 19, 2024
High RiskFDA
Intuitive Surgical, Inc.
8MM,MEGA SUTURECUT ND,IS4000 REF 471309
Medical Devices·88,840 affected·Dec 19, 2024
High RiskFDA
Intuitive Surgical, Inc.
8MM, LARGE NEEDLE DRIVER, IS4000 REF 470006
Medical Devices·10,603 affected·Dec 19, 2024
High RiskFDA
Karl Storz Endoscopy
KARL STORZ - ENDOSKOPE, REF: 27030KA, Cysto-Urethroscope, NON STERILE, CE
Medical Devices·221 affected·Dec 19, 2024
High RiskFDA
New Medical Technologies Gmbh
Integra Miltex Cryosolutions Cartridges 4 Pack (23.5g N2O each), Model: C-CA-23, Item: 33517;
Medical Devices·3,352 affected·Dec 19, 2024
High RiskFDA
Intuitive Surgical, Inc.
8MM, MONOPOLAR CURVED SCISSORS, IS4000 REF 470179
Medical Devices·355,547 affected·Dec 19, 2024
High RiskFDA
Karl Storz Endoscopy
KARL STORZ - ENDOSKOPE, REF: 27001L, Uretero-Renoscope, 8 Fr., 6¿, 43 cm, NON STERILE, RxONLY, CE 0123
Medical Devices·59 affected·Dec 19, 2024
High RiskFDA
Intuitive Surgical, Inc.
8MM,ATRIAL RETRACTOR SHORT RIGHT,IS4000¿ REF 470246
Medical Devices·738 affected·Dec 19, 2024
High RiskFDA
Karl Storz Endoscopy
KARL STORZ - ENDOSKOPE, REF: 27001K, Ureteroscope, 9.5 Fr., 6¿, 34 cm, NON STERILE, RxONLY, CE 0123
Medical Devices·185 affected·Dec 19, 2024
High RiskFDA
Becton Dickinson & Co.
BD PCR Cartridges used with MAX System. Model Number: 437519
Medical Devices·516,435 affected·Dec 19, 2024
High RiskFDA
Karl Storz Endoscopy
KARL STORZ - ENDOSKOPE, REF: 27030KB, Pediatric Cysto-Urethroscope, NON STERILE, CE
Medical Devices·185 affected·Dec 19, 2024
High RiskFDA
Intuitive Surgical, Inc.
8MM,MEGA NEEDLE DRIVER,IS4000¿ REF 470194
Medical Devices·38,438 affected·Dec 19, 2024
High RiskFDA
Karl Storz Endoscopy
KARL STORZ - ENDOSKOPE, REF: 27002KP, Pediatric Uretero-Renoscope 7.3 Fr., NON STERILE, CE 0123
Medical Devices·39 affected·Dec 19, 2024