Browse recalls

Alert level: Class II

1826 indexed recall(s) · page 15 of 19 · All filters →

• 2024-03-06 · US FDA — Medical DevicesClass II
  Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314
• 2024-03-06 · US FDA — Medical DevicesClass II
  Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-
• 2024-03-06 · US FDA — Medical DevicesClass II
  Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 12o, LEFT, FOR CEMENTED USE ONLY, Mates with: a) 38, 41, 44, 47
• 2024-03-06 · US FDA — Medical DevicesClass II
  Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Num
• 2024-03-06 · US FDA — Medical DevicesClass II
  stryker Infinity Resection Adjustment Block, REF 33600030, ankle arthroplasty
• 2024-03-05 · US FDA — Medical DevicesClass II
  Neria Soft Infusion Set, Product Code 507302, intravascular administration set
• 2024-03-05 · US FDA — Medical DevicesClass II
  Hill-Rom PRO+ 36" MRS Surface, REF P7924A03, The pro+ mattress is intended for patient support and for the prevention an
• 2024-03-05 · US FDA — Medical DevicesClass II
  DxI 9000 Access Immunoassay Analyzer, REF C11137, vitro diagnostic device used for the quantitative, semi-quantitative,
• 2024-03-05 · US FDA — Medical DevicesClass II
  QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20, 20 Tests
• 2024-03-04 · US FDA — Medical DevicesClass II
  ARCHITECT Anti-HCV Reagent Kit, List Numbers: a) 1L79-25, b) 1L79-35
• 2024-03-01 · US FDA — Medical DevicesClass II
  Abbott Cholestech LDX Battery Kit, Model: 3LP656194-PCM-LD, PN: 55170
• 2024-03-01 · US FDA — Medical DevicesClass II
  25-LHP-928, HeNe Laser System, 25 mW
• 2024-03-01 · US FDA — Medical DevicesClass II
  N-LHP-928, HeNe Laser System, 35 mW
• 2024-03-01 · US FDA — Medical DevicesClass II
  25-LHP-828, HeNe Laser System, 35 mW
• 2024-03-01 · US FDA — Medical DevicesClass II
  Olympus Triangle Tip Electrosurgical Knives- to be used with Olympus endoscopes and electrosurgical units to cut tissue
• 2024-02-28 · US FDA — Medical DevicesClass II
  Baxter Supple Peri-Guard Repair Patch (legacy product codes): a) PC0404SNBIO, b) PC0608NSBIO, c) PC0814SNBIO, d)
• 2024-02-28 · US FDA — Medical DevicesClass II
  Baxter Peri-Guard Repair Patch (new product codes): a) PG0404, b) PG0608, c) PG0814, d) PG1016, e) PG1225
• 2024-02-28 · US FDA — Medical DevicesClass II
  Baxter Peri-Guard Repair Patch (legacy product codes): a) PC0404NBIO, b) PC0608NBIO, c) PC0814NBIO, d) PC1016NBI
• 2024-02-28 · US FDA — Medical DevicesClass II
  Baxter Supple Peri-Guard Repair Patch (new product codes): a) SPG0404, b) SPG0406, c) SPG0608, d) SPG0814, e)
• 2024-02-27 · US FDA — Medical DevicesClass II
  VITROS Performance Verifier I
• 2024-02-23 · US FDA — Medical DevicesClass II
  ACUSON Redwood 1.0 Diagnostic Ultrasound System, REF: 11503314, running software version VA10A to VA10G
• 2024-02-23 · US FDA — Medical DevicesClass II
  Agfa DX-D 100 system-Digital Radiography mobile X-ray System. A mobile X-Ray modality, consisting of X-Ray console, gene
• 2024-02-23 · US FDA — Medical DevicesClass II
  ACUSON Maple Diagnostic Ultrasound System, REF: 11711750, ACUSON Maple Select, REF: 11711779, running software version V
• 2024-02-22 · US FDA — Medical DevicesClass II
  Surgical Tools and Cardiovascular Specialty marketing brochures, Reference numbers: US-AS18-210002 Surgical Tools Broch
• 2024-02-22 · US FDA — Medical DevicesClass II
  Surgical Tools and Cardiovascular Specialty marketing brochures, Reference numbers: US-AS18-210002 Surgical Tools Broch
• 2024-02-22 · US FDA — Medical DevicesClass II
  Surgical Tools and Cardiovascular Specialty marketing brochures, Reference numbers: US-AS18-210002 Surgical Tools Broch
• 2024-02-21 · US FDA — Medical DevicesClass II
  SYRINGE,BULB,2OZ/60CC,GREEN, Part: 300055070, packaged inside Alcon Custom-Pak Surgical Procedure Packs, Products: 1801
• 2024-02-21 · US FDA — Medical DevicesClass II
  Situate Laparotomy Sponge, RF and X-ray Detectable, REF: L1818-04P01C-1
• 2024-02-20 · US FDA — Medical DevicesClass II
  EndoVive 20 Fr Safety PEG Push w/ENFit Kit (Box 2)-Indicated for enteral nutrition directly into the stomach in both ped
• 2024-02-20 · US FDA — Medical DevicesClass II
  EndoVive 20Fr Push Standard PEG Kit w/ENFit (Box 2)-Indicated for enteral nutrition directly into the stomach in both pe
• 2024-02-20 · US FDA — Medical DevicesClass II
  EndoVive 20Fr Push Safety PEG Kit w/ENFit (Box 2)-Indicated for enteral nutrition directly into the stomach in both pedi
• 2024-02-20 · US FDA — Medical DevicesClass II
  Cardiovascular Procedure Kits that include High Crack Check Valve PN 205307A Part Number: 6375 16010 62974 65246 6
• 2024-02-15 · US FDA — Medical DevicesClass II
  DIVA 24 Inch Widescreen LCD Touch Display - Used with the Philips PIC iX system central monitoring system. Model: RGD
• 2024-02-14 · US FDA — Medical DevicesClass II
  Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVT
• 2024-02-14 · US FDA — Medical DevicesClass II
  Covidien Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVT
• 2024-02-08 · US FDA — Medical DevicesClass II
  Software VERIQA (S070031), version 2.0 and 2.1- Software package for display, evaluation and digital processing of medic
• 2024-02-08 · US FDA — Medical DevicesClass II
  microStar Reader, Model Numbers: 10015-000 (marketed in EMEA as 100, 102, 110, and 201), 10016-000 (marketed in EMEA as
• 2024-02-07 · US FDA — Medical DevicesClass II
  TENSIVE Conductive Adhesive Gel, REF 016-401600
• 2024-02-07 · US FDA — Medical DevicesClass II
  natus neurology, Sleep Supplies Start Kit with Single Use Supplies for Embla EX Series Amplifiers, REF 024252
• 2024-02-07 · US FDA — Medical DevicesClass II
  Access Substrate, REF 81906, For use with the Access Immunoassay Systems
• 2024-02-06 · US FDA — Medical DevicesClass II
  Azurion 7 with a Certeray generator-To perform image guidance in diagnostic, interventional, and minimally invasive surg
• 2024-02-06 · US FDA — Medical DevicesClass II
  Azurion 3 with a Certeray generator -To perform image guidance in diagnostic, interventional, and minimally invasive sur
• 2024-01-30 · US FDA — FoodClass II
  The recalled Reser's Amish Macaroni Salad was packaged in a plastic clear container where the top lid is labeled as Rese
• 2024-01-30 · US FDA — Medical DevicesClass II
  MINI STICK MAX 5F X 10 CM STD .018 NI/TU ECHO 1.6" PG- Used for the percutaneous introduction of a guidewire into the v
• 2024-01-30 · US FDA — Medical DevicesClass II
  MINI STICK MAX 5F X 10 CM STD .018 SS/SS ECHO 1.6" PG- Used for the percutaneous introduction of a guidewire into the va
• 2024-01-30 · US FDA — Medical DevicesClass II
  MINI STICK MAX 4F X 10 CM STD .018 NI/TU ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the va
• 2024-01-30 · US FDA — Medical DevicesClass II
  MINI STICK MAX 5F X 10 CM STD .018 NI/TU ECHO 2.75" PG Catalog Number: 45-756
• 2024-01-30 · US FDA — Medical DevicesClass II
  MINI STICK MAX 4F X 10 CM STD .018 SS/PD ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the va
• 2024-01-30 · US FDA — Medical DevicesClass II
  MINI STICK MAX 4F X 10 CM STIFF .018 SS/PD ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the
• 2024-01-30 · US FDA — Medical DevicesClass II
  MINI STICK MAX 5F X 10 CM STIFF .018 NI/TU ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the
• 2024-01-30 · US FDA — Medical DevicesClass II
  MINI STICK MAX 5F X 10 CM STD .018 SS/SS NON-ECHO 2.75" PG- Used for the percutaneous introduction of a guidewire into
• 2024-01-30 · US FDA — Medical DevicesClass II
  MINI STICK MAX 4F X 10 CM STIFF .018 SS/SS ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the
• 2024-01-30 · US FDA — Medical DevicesClass II
  MINI STICK MAX 4F X 10CM STIFF .018 NI/TU ECHO 1.6" PG- Used for the percutaneous introduction of a guidewire into the v
• 2024-01-30 · US FDA — Medical DevicesClass II
  MINI STICK MAX 5F X 10 CM STD .018 SS/SS NON-ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into th
• 2024-01-29 · US FDA — Medical DevicesClass II
  MRI system: Vantage Elan, Model: MRT-2020
• 2024-01-29 · US FDA — Medical DevicesClass II
  Vantage Titan, Model: MRT-1504
• 2024-01-26 · US FDA — Medical DevicesClass II
  I.B.S 6.5-C Compression screw - diam 6.5mm lg 80mm,Part Number S65 ST180
• 2024-01-26 · US FDA — Medical DevicesClass II
  I.B.S 6.5-C Compression screw - diam 6.5mm lg 75mm,Part Number S65 ST175
• 2024-01-26 · US FDA — Medical DevicesClass II
  VITROS XT 7600 Integrated System, Catalog No. 6844461
• 2024-01-25 · US FDA — Medical DevicesClass II
  Ionolux, Catalog (REF) Numbers: a) 2115, b)2117, c) 2118, d) 2119, e) 2120, f) 2122; dental cement
• 2024-01-24 · US FDA — Medical DevicesClass II
  Atellica IM Erythropoietin (EPO) Assay (100 Test)
• 2024-01-19 · US FDA — Medical DevicesClass II
  GORE VIABIL Short Wire Biliary Endoprosthesis, Product labeled as (1) Catalog Number VSWVH1008, 10 mm x 8 cm; with ho
• 2024-01-16 · US FDA — Medical DevicesClass II
  InstaClear Lens Cleaner-indicated for use during routine diagnostic procedures and during endoscopic sinus surgery. Mod
• 2024-01-09 · US FDA — Medical DevicesClass II
  Steris Corporation Endo Cleaning Indicator VERIFY" RESITEST"
• 2024-01-08 · US FDA — Medical DevicesClass II
  BD BBL Sensi Disc Piperacillin/Tazobactam- 100/10 ug, used for semi-quantitative in vitro susceptibility testing. Catal
• 2024-01-08 · US FDA — Medical DevicesClass II
  BD BBL Sensi Disc Azithromycin -15 ¿g, Catalog Number 231682 used for semi-quantitative in vitro susceptibility testing.
• 2024-01-08 · US FDA — Medical DevicesClass II
  BD BBL Sensi Disc Rifampin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231541 and
• 2024-01-08 · US FDA — Medical DevicesClass II
  BD BBL Sensi Disc Cefpodoxime - 10 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231673
• 2024-01-08 · US FDA — Medical DevicesClass II
  Sensi Disc Amoxicillin with Clavulanic Acid 20/10 ¿g, Catalog No. 231628 and 231629.¿ These discs are used for semi-q
• 2024-01-08 · US FDA — Medical DevicesClass II
  BD BBL Sensi Disc Minocycline - 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 23125
• 2024-01-08 · US FDA — Medical DevicesClass II
  BD BBL Sensi Disc Cefaclor - 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231653
• 2024-01-08 · US FDA — Medical DevicesClass II
  BD BBL Sensi Disc Cefotaxime - 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231606
• 2024-01-08 · US FDA — Medical DevicesClass II
  BD BBL Sensi Disc Tetracycline 30 ug,used for semi-quantitative in vitro susceptibility testing. Catalog Number 230998 a
• 2024-01-08 · US FDA — Medical DevicesClass II
  BD BBL Sensi Disc Meropenem- 10 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231703 an
• 2024-01-08 · US FDA — Medical DevicesClass II
  BD BBL Sensi Disc Ceftaroline - 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 232231
• 2024-01-08 · US FDA — Medical DevicesClass II
  BD BBL Sensi Disc Cefepime - 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231696
• 2024-01-08 · US FDA — Medical DevicesClass II
  BD BBL Sensi Disc Imipenem- 10 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231644 and
• 2024-01-08 · US FDA — Medical DevicesClass II
  BD BBL Sensi Disc Moxifloxacin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231758
• 2024-01-08 · US FDA — Medical DevicesClass II
  BD BBL Sensi Disc Chloramphenicol- 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 230
• 2024-01-08 · US FDA — Medical DevicesClass II
  BD BBL Sensi Disc Ertapenem- 10 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 232174 an
• 2024-01-08 · US FDA — Medical DevicesClass II
  BD BBL Sensi Disc Ciprofloxacin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231657
• 2024-01-08 · US FDA — Medical DevicesClass II
  BD BBL Sensi Disc Aztreonam - 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Numbers 231640
• 2024-01-08 · US FDA — Medical DevicesClass II
  BD BBL Sensi Disc Levofloxacin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231705
• 2024-01-08 · US FDA — Medical DevicesClass II
  BD BBL Sensi Disc Augmentin - 3µg, Catalog Number 291270 used for semi-quantitative in vitro susceptibility testing.
• 2024-01-08 · US FDA — Medical DevicesClass II
  BD BBL Sensi Disc Sulfamethoxazole with Trimethoprim 23.75/1.25 ug, used for semi-quantitative in vitro susceptibility t
• 2024-01-08 · US FDA — Medical DevicesClass II
  BD BBL Sensi Disc Ceftazidime- 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231632
• 2024-01-08 · US FDA — Medical DevicesClass II
  BD BBL Sensi Disc Ofloxacin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231672
• 2024-01-08 · US FDA — Medical DevicesClass II
  BD BBL Sensi Disc Cefixime - 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231664
• 2024-01-04 · US FDA — Medical DevicesClass II
  Medline Contro-Bulb Syringe, REF DYND20125; bulb irrigation syringe
• 2024-01-03 · US FDA — Medical DevicesClass II
  Intera 1.5T Achieva Nova. Model (REF) Numbers 781172.
• 2024-01-03 · US FDA — Medical DevicesClass II
  The Sofia 2 Flu + SARS Antigen FIA employs immunofluorescence technology in a sandwich design that is used with Sofia 2
• 2024-01-03 · US FDA — Medical DevicesClass II
  SmartPath to dStream for XR and 3.0T. Model (REF) Numbers 781270, 782113, 782129.
• 2024-01-03 · US FDA — Medical DevicesClass II
  Ingenia 3.0T CX. Model (REF) Numbers 781271, 782105.
• 2024-01-03 · US FDA — Medical DevicesClass II
  Achieva 1.5T. Model (REF) Numbers 781196, 781343, 781296.
• 2024-01-03 · US FDA — Medical DevicesClass II
  Synapse Cardiology PACS V7.3.0, V7.2, V7.1, V7.0. A web-based application as the primary user interface for the proces
• 2024-01-03 · US FDA — Medical DevicesClass II
  Achieva XR. Model (REF) Numbers 781153, 781253.
• 2024-01-03 · US FDA — Medical DevicesClass II
  Synapse CV 6. with AR. A web-based application as the primary user interface for the processing of medical images.
• 2024-01-03 · US FDA — Medical DevicesClass II
  Achieva 1.5T Initial system. Model (REF) Numbers 781178.
• 2024-01-02 · US FDA — Medical DevicesClass II
  Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of the affected
• 2024-01-02 · US FDA — Medical DevicesClass II
  Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of affected

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