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…
Read the official notice →- Date
- 2021-12-29
- Country
- United States
- Brand
- Leica Microsystems
- Product
- Leica Microsystems M220 F12 Microscope Systems
- Classification
- Class II
- Units
- Worldwide distribution - US Nationwide distribution in the states of CA, DC,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- 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
- 2022-12-21
USLeica 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…
- 2022-10-05
- US
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…
Other drugs & medical recalls in the United States
- 2021-12-29
- US
Acclarent, Inc. recalls TruDi NAV Suction Instruments: 0-Degree, REF: TDNS000Z; 70-Degree, REF: TDNS070Z; and 90-Degree, REF: TDNS090Z
Suction Instruments were incorrectly calibrated so they may not meet the system accuracy specification for visual verification of device location in the patient anatomy. If the surgeon does not detect the accuracy…
FDA · DeviceAcclarent, Inc.US: AZ, MI, IA, LA, IL, VA, SC, NY, IN, OR, SD, TX, PA, NE, FL, CT, MN, NV,…Official notice → - US
Cook Inc. recalls Skinny Needle with Chiba Tip. RPN 090010, 090010-ET; GPN G14254, G15290. Rigid needle available with EchoTip to provide enhanced…
Specific lots may contain black debris on the exterior of the inner stylet and/or on the interior of the outer cannula. Local inflammatory reactions may occur if an affected product is used.
FDA · DeviceCook Inc.Worldwide distribution - US Nationwide distribution in the states of AL, CA,…Official notice → - US
Coloplast Manufacturing US, LLC recalls Torosa Saline-Filled Testicular Prosthesis (Size Small)
Product is mislabeled for size.
FDA · DeviceColoplast Manufacturing US, LLCWorldwide distribution - US Nationwide distribution and the country of Canada.Official notice → - US
ROi CPS LLC recalls regard Clinical Packaging Solutions Item Number 830096005, OB01054E - Newborn Kit, containing 2 25GA x .625IN needles.
The kit contains a non-sterile needle.
FDA · DeviceROi CPS LLCDistribution was made to Missouri. There was no foreign/military/government…Official notice → - US
Beaver Visitec International, Inc. recalls Malosa Core SMILE Pack 1-Medical Refractive Kit intended to be used to aid in cataract, corneal, or refractive surgery. Part…
Kit packaging may have small holes compromising product sterility
- US
MEDLINE INDUSTRIES, LP - Northfield recalls Stanbio TDM/B-Hydroxybutyrate Tri-Level Controls, Ref. No. 2460-605
Affected product was shipped from the warehouse at room temperature instead of the required refrigerated environment.
FDA · DeviceMEDLINE INDUSTRIES, LP - NorthfieldUS Nationwide distribution in the states of IL, OH, MS, and PA.Official notice →