Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Zimmer, Inc.
NexGen Option Stemmed Tibial Component Size 5, Item Number 00-5986-047-01
Medical Devices·2,460 affected·Dec 6, 2022
High RiskFDA
Zimmer, Inc.
NexGen Option Stemmed Tibial Component Size 4, Item Number 00-5986-037-02
Medical Devices·2,092 affected·Dec 6, 2022
High RiskFDA
Zimmer, Inc.
NexGen Option Stemmed Tibial Component Size 6, Item Number 00-5986-047-02
Medical Devices·1,366 affected·Dec 6, 2022
RecallFDA
Young Dental Manufacturing I, Llc
Denticator PICK-A-DENT, periodontal aid - intradental pick, REF 621714
Medical Devices·600 affected·Dec 5, 2022
High RiskFDA
Medtronic Neuromodulation
Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900C
Medical Devices·18 affected·Dec 3, 2022
High RiskFDA
Medtronic Neuromodulation
Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900E
Medical Devices·22 affected·Dec 3, 2022
High RiskFDA
Medtronic Neuromodulation
Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900B
Medical Devices·362 affected·Dec 3, 2022
High RiskFDA
Medtronic Neuromodulation
Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900D
Medical Devices·1,337 affected·Dec 3, 2022
High RiskFDA
Covidien, Lp
Surgilon Braided Nylon suture Product Description: 88861883-51 SURGILON* 2-0 BLK 75CM C16 88861915-71 SURGILON* 1 BLK 75CM GS11 88861...
Medical Devices·87,708 affected·Dec 2, 2022
High RiskFDA
Covidien, Lp
Dermalon Monofilament Nylon Suture: (1) 88861741-11 DERMALON* 6-0 BLU 45CM C1 (2) 88861747-11 DERMALON* 6-0 BLU 45CM C12 (3) 8886174...
Medical Devices·9,606 affected·Dec 2, 2022
High RiskFDA
Covidien, Lp
Custom Suture Pack Product Description: US1638 CUSTOM SUTURE PACK US1756 CUSTOM SUTURE PACK
Medical Devices·9,606 affected·Dec 2, 2022
High RiskFDA
Remington Medical, Inc.
Remington MEDICAL, Automatic Cutting Needle, 18ga (1.3mm) x 20cm, REF NAC-1820M (1)
Medical Devices·290 affected·Dec 2, 2022
High RiskFDA
Covidien, Lp
Ti-Cron Coated Braided Polyester Suture Product Description 88862775-31 TICRON* 4-0 BLU 75CM CV327DA 88862880-41 TICRON* 3-0 WHI 75CM ...
Medical Devices·40,152 affected·Dec 2, 2022
High RiskFDA
Covidien, Lp
Surgidac Uncoated Braided Polyester suture Product Description D-1764K SURGIDAC* 5-0 WHI 45CM SS24DA
Medical Devices·2,070 affected·Dec 2, 2022
High RiskFDA
Tomy International Inc.
Lamaze Chill Teether, Fluid-Filled Teething Ring, Model No. Y5288L
Medical Devices·55,000 affected·Dec 2, 2022
High RiskFDA
Covidien, Lp
Sofsilk Coated Braided Silk Suture Product Description CS-211 SOFSILK* 4-0 BLK 45CM CVF21 X36 CS211 CS-490 SOFSILK* 2-0 BLK 75...
Medical Devices·271,800 affected·Dec 2, 2022
High RiskFDA
Covidien, Lp
Monosof Monofilament Nylon sutures: Product Description CN-724 MONOSOF* 1 BLK 100CM GS25 X36 CN-791 MONOSOF* 2-0 BLK 100CM ...
Medical Devices·54,288 affected·Dec 2, 2022
High RiskFDA
Covidien, Lp
Surgipro II Monofilament Polypropylene Sutures Product Description Model Number VP-421X SURGIPRO*II 4-0 90CM V20 DA7P VP421X VP-435-X ...
Medical Devices·322,152 affected·Dec 2, 2022
High RiskFDA
Altimate Medical, Inc.
ActiveAid 922, Shower/Commode Chair
Medical Devices·1 affected·Nov 30, 2022
High RiskFDA
Beaver Visitec International, Inc.
Beaver EdgeAhead Stiletto/MVR Knife .90mm Straight (20G)-for ocular paracentesis incisions in cataract procedures. Part Number: 376630
Medical Devices·599 affected·Nov 30, 2022
High RiskFDA
Acumed Llc
Acutrak 2 Part Number/Part Description: 30-0021 25.0mm Acutrak 2¿ - 5.5 Screw 30-0021-S 25.0mm Acutrak 2¿ - 5.5 Screw 30-0023 30.0mm ...
Medical Devices·1,681,860 affected·Nov 29, 2022
High RiskFDA
Biomet, Inc.
OSS Modular Arthrodesis Nail, 7 Degree Collar Assembly with Locking Bolts-For use in the replacement of segmental defects of long bone, i...
Medical Devices·2 affected·Nov 29, 2022
High RiskFDA
Acumed Llc
Dual-Trak Clavicle Screws Part Number/Part Description: 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 40-0136-S 3.0mm x 80mm Dual-Trak...
Medical Devices·7,498 affected·Nov 29, 2022
RecallFDA
Abbott Laboratories
Alinity Reaction Vessels, REF: 06P1401, for use with Alinity i Systems; ARCHITECT Reaction Vessels
Medical Devices·70 affected·Nov 24, 2022
CriticalFDA
Emergent Protective Products Usa Inc
RSDL (Reactive Skin Decontamination Lotion) Kit, NSN 6505-21-912-5229. Used to remove and/or neutralize chemical warfare agents and T-2 ...
Medical Devices·4,000 affected·Nov 24, 2022
High RiskFDA
Baxter Healthcare Corporation
Revaclear 300 dialyzers. Indicated for treatment of chronic and acute renal failure by hemodialysis.
Medical Devices·14,053,824 affected·Nov 23, 2022
High RiskFDA
Baxter Healthcare Corporation
Revaclear 400 dialyzers. Indicated for treatment of chronic and acute renal failure by hemodialysis.
Medical Devices·6,338,280 affected·Nov 23, 2022
High RiskFDA
Siemens Medical Solutions Usa, Inc
Luminos Agile Max (VE10, VF10, VF11)
Medical Devices·704 affected·Nov 23, 2022
High RiskFDA
Siemens Medical Solutions Usa, Inc
Luminos dRF Max (VE10, VF10, VF11)
Medical Devices·704 affected·Nov 23, 2022
CriticalFDA
Philips North America Llc
Philips SmartPath to Ingenia Elition X MR System, Model Numbers 782118, 782132, 782144
Medical Devices·566 affected·Nov 22, 2022
CriticalFDA
Philips North America Llc
Philips MR 7700 System, Model Number 782120
Medical Devices·566 affected·Nov 22, 2022
High RiskFDA
Abbott Molecular, Inc.
Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-096
Medical Devices·3,896 affected·Nov 22, 2022
High RiskFDA
Becton Dickinson & Co.
BBL Chocolate II Agar- IVD for the isolation and cultivation of Neisseria species. Catalog (Ref) Number: 221267
Medical Devices·9,600 affected·Nov 21, 2022
High RiskFDA
Medtronic Minimed
Guardian iOS app (MMT-8200) and Guardian Android app (MMT-8201), part of the Guardian 4 system
Medical Devices·3,235 affected·Nov 21, 2022
High RiskFDA
Cardinal Health 200, Llc
Cardinal Health Presource Packs IV START TRAY I-Intended for IV access device CATALOG #: 01-5799A
Medical Devices·36 affected·Nov 18, 2022
High RiskFDA
Cardinal Health 200, Llc
Cardinal Health Presource Packs IV START KIT-Intended for IV Access CATALOG #: 01A4553E
Medical Devices·31,300 affected·Nov 18, 2022
CriticalFDA
Mobius Imaging, Llc
MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomography (CT) system, software version 2.1.1
Medical Devices·3 affected·Nov 18, 2022
High RiskFDA
Medline Industries, Lp - Northfield
Sterile Procedural Trays, labeled as the following: a. BREAST AUGMENTATION b. BREAST REDUCTION CDS c. CUH ABDOMINOPLASTY CDS d. AC...
Medical Devices·6,420 affected·Nov 17, 2022
High RiskFDA
Medline Industries, Lp - Northfield
UNIVERSAL CORE DR RUNNELS PACK. Sterile Procedural Tray
Medical Devices·20 affected·Nov 17, 2022
High RiskFDA
Medline Industries, Lp - Northfield
Sterile Procedural Trays, labeled as the following: AMBULATORY MINI PACK
Medical Devices·36 affected·Nov 17, 2022
High RiskFDA
Medline Industries, Lp - Northfield
Sterile Procedural Trays, labeled as the following: a. EAR CDS-LF b. SINUS CDS-1 c. ZALE FESS CDS d. ZALE OTOLOGY CDS e. ZALE HEAD & NEC...
Medical Devices·9,079 affected·Nov 17, 2022
High RiskFDA
Medline Industries, Lp - Northfield
Sterile Procedural Trays, labeled as the following: a. C-SECTION OR 30 CDS b. C-SECTION CDS c. C-SECTION CDS d. C-SECTION CDS e....
Medical Devices·11,886 affected·Nov 17, 2022
High RiskFDA
Ottlite Technologies, Inc.
OttLite Rechargeable UVC Disinfecting Wand
Medical Devices·7,376 affected·Nov 17, 2022
High RiskFDA
Medline Industries, Lp - Northfield
Sterile Procedural Trays, labeled as the following: a. CELEBRATION ROBOTIC CDS b. DAVINCI CDS UCC-LF c. ROBOTICS PACK-LF d. ROBOT...
Medical Devices·1,212 affected·Nov 17, 2022
High RiskFDA
Medline Industries, Lp - Northfield
Sterile Procedural Trays, labeled as the following: a. LAPAROTOMY CDS-LF b. LAPAROSCOPY CDS-LF c. BASIC LAPAROSCOPY CDS d. LAPAROSCOPY C...
Medical Devices·42,593 affected·Nov 17, 2022
High RiskFDA
Medline Industries, Lp - Northfield
LOCAL PACK. Sterile Procedural Tray.
Medical Devices·8 affected·Nov 17, 2022
High RiskFDA
Medline Industries, Lp - Northfield
Sterile Procedural Trays, labeled as the following: a. RHINOPLASTY PACK b. OSC OTOLOGY PACK-LF c. RHYZOTOMY
Medical Devices·86 affected·Nov 17, 2022
High RiskFDA
Medline Industries, Lp - Northfield
FEMORAL ARTERY PACK-LF. Sterile Procedural Tray
Medical Devices·15 affected·Nov 17, 2022