ClearanceBrief
Recall Z-0188-2027 ยท MDM Instrument, Manual, Surgical, General Use

Healthmark Industries Co., Inc.

Vinyl Instrument Guards, labeled as: 1) VENTED INSTRUMENT GUARD 1/16 X 3/4H - WHITE, Model Number 09-1-011; 2) WHITE VENTED INSTRUMENT GUARD 1/16 X 3/4, Model Number 09-1-011; 3) VENTED INSTRUMENT GUARD 5/64 X 3/4 - BLUE, Model Number 09-1-012; 4) BLUE VENTED INSTRUMENT GUARD 5/64 X 3/4, Model Number 09-1-012; 5) VENTED INSTRUMENT GUARD 7/64 X 3/4 - GREEN, Model Number 09-1-013; 6) GREEN VENTED IN

DateOct 15, 2026 (initiated Sep 7, 2026)
StatusOpen, Classified
ReasonLabeling not compliant with 21 CFR 801 and steam sterilization IFU has been updated.
Root causeLabeling design
ActionGetinge issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 9/10/2026 via telephone and email. The notice explained the issue, risk to health, and requested the consignee replace the IFU with the Aspen Surgical IFU enclosed in the letter. Those who further distributed the affected devices were directed to notify those receiving the devices. The firm supplied a link and QR code for responses. For questions contact Customer Service via email at HMCS@hmark.com or 800-521-6224.
Quantity12,835,920 units
DistributionWorldwide distribution - US Nationwide and the countries of JAPAN, AUSTRALIA, CANADA, PORTUGAL, FRANCE, POLAND, PUERTO RICO, SAUDI ARABIA, HONG KONG, BAHRAIN, QATAR, OMAN, ISRAEL, MEXICO, UNITED ARAB EMIRATES, SINGAPORE, BERMUDA, SOUTH KOREA, THAILAND, and UNITED KINGDOM.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.