DeRoyal Industries Inc recalls DeRoyal CATARACT PACK CSM, REF 89-6863
DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.
Read the official notice →- Date
- 2022-12-21
- Country
- United States
- Brand
- DeRoyal Industries
- Product
- DeRoyal CATARACT PACK CSM, REF 89-6863
- Classification
- Class II
- Units
- US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 DeRoyal Industries recalls
- 2023-01-18
USDeRoyal Industries Inc recalls DeRoyal ORGAN RECOVERY PACK PGYBK, a) REF 89-9004.09 and b) 89-9004.10
DeRoyal is recalling certain lots of surgical procedure pack products that contain a Medtronic Non-Absorbable Suture. The recall is due to Medtronic determining a manufacturing error in the packaging of the…
FDA · DeviceDeRoyal Industries IncUS Nationwide distribution in the states of IL, MO.Official notice →- 2023-01-11
- US
DeRoyal Industries Inc recalls DeRoyal Tonsillectomy Tray, REF 89-10698.01
DeRoyal is recalling certain lots of surgical procedure pack products that contain a ConMed Foot Controlled Electrosurgical Suction Coagulator. The recall is due to ConMed receiving reports that the suction ports may…
- 2022-12-21
- US
DeRoyal Industries Inc recalls DeRoyal MYELOGRAM PACK, REF 89-9304.05
XXX
FDA · DeviceDeRoyal Industries IncUS: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts,…Official notice → - 2022-09-07
- US
DeRoyal Industries Inc recalls DeRoyal Sterile Custom Kits containing ICU Medical MicroClave Clear Connectors
Procedure packs contained a recalled product.
FDA · DeviceDeRoyal Industries IncUS Nationwide distribution in the states of OH and TN.Official notice → - 2022-08-31
- US
DeRoyal Industries Inc recalls DeRoyal limb holders: (1) DeRoyal Limb Holder, Wrist, Fixed, Quick Release, REF M8124; (2) DeRoyal Limb Holder, Ankle, Fixed, Quick…
The webbing strap was laced improperly through the teeth of the buckle allowing the webbing strap to slide and was, therefore, not secure.
FDA · DeviceDeRoyal Industries IncUS Nationwide distribution in the states of FL, IN, NV, RI, TN, TX, and WV.Official notice → - 2022-04-13
- US
DeRoyal Industries Inc recalls DeRoyal Ultra/Mammo Tray, containing Prevantics antiseptic (chlorhexidine gluconate and isopropyl alcohol) swab, for preparation of the…
A kit component, the PDI Prevantics Swab was recalled due to uncertain validation of test methods used to manufacture the products.
FDA · DeviceDeRoyal Industries IncUS distribution to Florida, New Jersey, and TennesseeOfficial notice →
Other drugs & medical recalls in the United States
- 2022-12-21
- US
Elekta, Inc. recalls Oncentra Brachy radiation therapy planning system software.
A reconstruction error may occur when using the Catheter Bending functionality in Applicator Modeling or Implant Modeling
FDA · DeviceElekta, Inc.Distribution US nationwide, including Puerto Rico. There was no…Official notice → - US
Siemens Healthcare Diagnostics, Inc. recalls IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests Japan Siemens Material Number (SMN): 10711939 For the…
Potential for falsely elevated specific IgE mold allergen reactivity with quality control material and patient samples, may result in false reactive result
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide distribution. US Nationwide, Argentina¿¿¿¿¿¿ Australia¿¿¿¿¿¿…Official notice → - US
DeRoyal Industries Inc recalls DeRoyal MYELOGRAM PACK, REF 89-9304.05
XXX
FDA · DeviceDeRoyal Industries IncUS: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts,…Official notice → - US
NuVasive Specialized Orthopedics, Inc. recalls NUVASIVE MAGEC MAGEC 2 Rod. The MAGEC System is used to brace the spine during growth to minimize the progression of…
During accelerated shelf-life extension studies it was noted that the final packaging was experiencing a potential of failure of the sterile packaging barrier which could result in a hazardous situation where the…
FDA · DeviceNuVasive Specialized Orthopedics, Inc.Distribution US nationwide including Puerto Rico; Chile, Israel, Jordan, New…Official notice → - US
Stradis Medical, LLC dba Stradis Healthcare recalls HENRY SCHEIN, Vas Reversal Pack, Item No.888-2549,
Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
FDA · DeviceStradis Medical, LLC dba Stradis HealthcareUS nationwide distribution, and Canada.Official notice → - US
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 →