Drugs & medicalClass II

Leica Microsystems, Inc. recalls Leica MICROSYSTEMS M530 OHX, Part Number 10448737, surgical microscope system

There is a potential issue resulting in the Power Supply potentially becoming overheated due to internal components overstressing. Consequently, due to the overstressing of the internal components, one specific…

Read the official notice →
Date
2022-12-21
Country
United States
Brand
Leica Microsystems
Product
Leica MICROSYSTEMS M530 OHX, Part Number 10448737, surgical microscope system
Classification
Class II
Units
US Nationwide
Category
Drugs & medical
Source
FDA · Device

Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer

What to do

  1. Check the product name, strength and lot number against the official notice.
  2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
  3. Ask the pharmacy or supplier about a replacement or refund.

General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.

More Leica Microsystems recalls

  1. 2022-10-05
  2. US
    Drugs & medicalClass II

    Leica Microsystems, Inc. recalls Leica Surgical Operating Microscopes, M530 OHX, Part Number 10448737

    During internal testing, Leica Microsystems has become aware of a component change on the photodiodes inside the M530 Optics Carrier which will result in an inaccurate adjustment of the illumination limits by the…

    FDA · DeviceLeica Microsystems, Inc.US Nationwide distribution.Official notice →
  3. 2021-12-29
  4. US
    Drugs & medicalClass II

    Leica Microsystems, Inc. recalls Leica Microsystems M220 F12 Microscope Systems

    In May 2021, Leica Microsystems received one (1) complaint pertaining to the M220 F12 Surgical Microscope system. There was no patient injury reported for this complaint. However, the identified defect carries some…

    FDA · DeviceLeica Microsystems, Inc.Worldwide distribution - US Nationwide distribution in the states of CA, DC,…Official notice →
All 3 Leica Microsystems recalls →

Other drugs & medical recalls in the United States

  1. 2022-12-21
  2. US
    Drugs & medicalClass II

    Ethicon, Inc. recalls PDS II (polydioxanone) Suture- VIOLET MONOFILAMENT 27IN 0 S/A CT-1 Product Code: Z340H For use in soft tissue approximation, including use…

    knot tensile strengths were observed to be significantly below the minimum knot tensile, will result in breakage prior to use or intra-operatively rather than premature post-operative breakage

    FDA · DeviceEthicon, Inc.International (OUS) only: Canada, Japan, Australia and New ZealandOfficial notice →
  3. US
    Drugs & medicalClass II

    Stryker Medical Division of Stryker Corporation recalls Power-PRO 2, Model No. 6507, Item No. 650705550001 (US); 650700000000 (International)

    Cot may experience unintended motion due to damaged cables. Potential risk of soft tissue injury to patients such as scrapes or bruises resulting from the cot lowering faster than expected.

    FDA · DeviceStryker Medical Division of Stryker CorporationWorldwide Distribution: US (Nationwide) and Foreign to countries of:…Official notice →
  4. US
    Drugs & medicalClass II

    Allison Medical, Inc. recalls CarePoint 60 mL Syringe Without Needle, REF: 04-7560

    Syringe without needle may have a green substance on the plunger. Substance found to be nontoxic but its effect on drug potency or interaction is unknown.

    FDA · DeviceAllison Medical, Inc.US: IA, LA, MS, FL, PR; OUS: BARBADOSOfficial notice →
  5. US
    Drugs & medicalClass II

    ConMed Corporation recalls Foot Controlled Electrosurgical Suction Coagulator, Electrosurgical Suction Coagulator 10FR, Catalog Number 130187

    Suction ports may potentially be occluded on the affected devices. If this occurs, the affected devices will not be able to perform the suction function during use, which could cause a delay in procedure and could…

    FDA · DeviceConMed CorporationDomestic distribution nationwide. Foreign distribution to Colombia, Ecuador,…Official notice →
  6. US
    Drugs & medicalClass II

    Becton Dickinson & Co. recalls BBL Chocolate II Agar- IVD for the isolation and cultivation of Neisseria species. Catalog (Ref) Number: 221267

    Boxes contain a reduced concentration of Nicotinamide Adenine Dinucleotide and does not provide enough of the blood factors necessary to support Haemophilus growth. The reduction could cause a false negative result for…

    FDA · DeviceBecton Dickinson & Co.Worldwide distribution - US Nationwide and the countries of Canada, India,…Official notice →
  7. US
    Drugs & medicalClass II

    Siemens Medical Solutions USA, Inc recalls ARTISTE, ONCOR and PRIMUS with syngo RT Therapist with software version 4.3.1 MR3. Material Number: 8162815 Intended Use:…

    When selecting the site fraction group for treatment, the User may select the wrong site for treatment, and potentially deliver the dose to wrong isocenter

    FDA · DeviceSiemens Medical Solutions USA, IncUS Nationwide distribution in the states of CA, IA, LA, NE, NV, OH, SC.Official notice →
See all drugs & medical recalls →