CooperSurgical, Inc. recalls Box as labeled: Regard, Carter-Thomason CloseSure System XL, REF 733776, Quantity 1 Box of 3 Systems. Kit as labeled: Regard,…
Incorrect component descriptions within the "Contents" section on the Tyvek lid for individual kit trays.
Read the official notice →- Date
- 2024-02-14
- Country
- United States
- Brand
- CooperSurgical
- Product
- Box as labeled: Regard, Carter-Thomason CloseSure System XL, REF 733776, Quantity 1 Box of 3 Systems. Kit as labeled: Regard,…
- Classification
- Class II
- Units
- US Nationwide distribution in the state of MO.
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 CooperSurgical recalls
- 2024-10-02
USCooperSurgical, Inc. recalls Origio Sperm Wash Medium Pack of Five 60ml bottles - Intended for washing of spermatozoa. Part Number: 84055060D
Low concentration of sodium pyruvate in the wash could compromise gamete development
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CooperSurgical, Inc. recalls Stainless Steel Sims Uterine Sound, Part Number 64-601
During the manufacturing process the devices were laser-marked with the incorrect part number.
FDA · DeviceCooperSurgical, Inc.Worldwide distribution - US Nationwide and the countries of Armenia, Bahrain,…Official notice → - 2024-02-21
- US
CooperSurgical, Inc. recalls global Medium, Model Numbers LGGG-020 (20mL bottle), LGGG-050 (50mL bottle), LGGG-100 (100mL bottle). Intended use: Culture of human…
The firm has become aware of a sudden increase in complaints for three associated lots. Performance issues may lead to impaired embryo development prior to the blastocyst stage.
FDA · DeviceCooperSurgical, Inc.Worldwide - US Nationwide including in the states of AL, AZ, CA, CO, FL, GA,…Official notice → - 2023-12-13
- US
CooperSurgical, Inc. recalls Cooper Surgical H/S ELLIPTOSPHERE CATH 5 Fr -For administering contrast media during Hysterosalpingography or Hysterosonography procedures…
Incorrect bonding material used for assembly of the catheter, may fail, resulting in detachment of component parts, broken components, or leakage. This breakage may result in delay of procedure
FDA · DeviceCooperSurgical, Inc.Nationwide Foreign: BELGIUM CANADA MALAYSIA NETHERLANDS SPAIN SWEDEN SWITZERLANDOfficial notice → - 2023-04-12
- US
CooperSurgical, Inc. recalls Global Total LP single step medium, 60mL, bicarbonate-buffered media for D1-5 embryo culture and transfer, Reference Number H5GT-060
It has come to CooperSurgical's attention that the affected Product may contain a medium other than the Global Total LP single step medium which does not contain the protein source required for embryo culture and…
FDA · DeviceCooperSurgical, Inc.Worldwide - US Nationwide distribution in the states of NY, UT and the…Official notice → - 2023-02-08
- US
CooperSurgical, Inc. recalls BIOPSY MEDIUM 10ML, Reference Number 10620010 A, used for blastomere biopsy of cleavage stage embryos for Pre-implantation Genetic…
The affected product may contain a medium other than the Biopsy Medium. There is a risk that use of the Product from this lot could cause degradation of the embryo.
FDA · DeviceCooperSurgical, Inc.Global Distribution including countries of: Bahrain, Belgium, Bulgaria, Egypt,…Official notice →
Other drugs & medical recalls in the United States
- 2024-02-14
- US
Randox Laboratories Ltd. recalls RX Series Copper (Cu) Assay Ref. Number CU2340
Randox Laboratories have released an update to the Carryover Avoidance Technical Bulletin to detail that Copper, should not be run directly after Total Protein, on the RX series instruments testing order. If copper…
FDA · DeviceRandox Laboratories Ltd.US Nationwide distribution in the states of SC and OK.Official notice → - US
Getinge Usa Sales Inc recalls Flow-c Anesthesia System, model 6887700
Potential cybersecurity vulnerability that could lead to a Denial of Service (DoS) attack, tampering, or remote code execution via remote login to the Flow Anesthesia System, any of which could lead to a hazardous…
FDA · DeviceGetinge Usa Sales IncWorldwide - US Nationwide distribution in the states of AL, AR, AZ, CA, CO,…Official notice → - US
Covidien LP recalls AbsorbaTack Absorbable Fixation Device 30 Violet Absorbable Tacks 5 mm- -intended for fixation of prosthetic material to soft tissue in…
Packaging of the device may cause a low seal strength in the side seal of the foil pouch potentially resulting in a sterile/moisture barrier breach, compromising the product sterility
FDA · DeviceCovidien LPUS Nationwide distribution in the states of CA, CO, FL, IL, TX.Official notice → - US
Steris Corporation recalls Dual Articulating Headrest, Pad Ret P/N P141210805, REF BF754
Dual-articulating head rest may not stay in place or may fail to lock into position during a patient procedure which could result in an injury to the patient or a procedural delay.
FDA · DeviceSteris CorporationWorldwide - US Nationwide distribution in the states of AZ, CA, FL, IL, IN,…Official notice → - US
Beckman Coulter, Inc. recalls DxI 9000 Access Immunoassay Analyzer running software version 1.16 or prior,
There are potential performance issues found in the DxI 9000 Access Immunoassay Analyzer, including: 1) Access Ultrasensitive Insulin users who configure SI units (pmol/L) applies an incorrect conversion factor; 2)…
FDA · DeviceBeckman Coulter, Inc.Worldwide distribution - US Nationwide and the countries of Australia,…Official notice → - US
Beckman Coulter, Inc. recalls Access Ultrasensitive Insulin only used on the DxI 9000 Access Immunoassay Analyzer, Catalog Number 33410
There is an issue with the Access Ultrasensitive Insulin assay protocol file (APF) for use with the DxI 9000 Access Immunoassay Analyzer (APF 182 test definition version 6.7 and below). The Access Ultrasensitive…
FDA · DeviceBeckman Coulter, Inc.Worldwide distribution - US Nationwide and the countries of Australia,…Official notice →