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 INSTRUMENT GUARD 7/64 X 3/4, Model Number 09-1-013; 7) VENTED INSTRUMENT GUARD 1/8 X 1 - RED, Model Number 09-1-014; 8) RED VENTED INSTRUMENT GUARD 1/8 X 1, Model Number 09-1-014; 9) VENTED INSTRUMENT GUARD 3/16 X 1 - YELLOW, Model Number 09-1-015; 10) YELLOW VENTED INSTRUMENT GUARD 3/16 X 1, Model Number 09-1-015; 11) VENTED INSTRUMENT GUARD 13/32 X 3/4 - MAROON, Model Number 09-1-016; 12) MAROON VENTED INSTRUMENT GUARD 13/32 X 3/4, Model Number 09-1-016; 13) MAROON VENTED INSTRU GUARD 13/32 X 3/4, Model Number 09-1-016; 14) VENTED INSTRUMENT GUARD 1/16 X 3/8 X 1 - ORANGE, Model Number 09-1-017; 15) ORANGE VENTED INSTRUMENT GUARD 1/16 X 3/8 X 1, Model Number 09-1-017; 16) OR VENTED INSTRU GUARD 1/16 X 3/8 X 1, Model Number 09-1-017; 17) VENTED INSTRUMENT GUARD 5/64 X 5/8 X 1 - BROWN, Model Number 09-1-018; 18) BROWN VENTED INSTRUMENT GUARD 5/64 X 5/8 X 1, Model Number 09-1-018; 19) BROWN VENTED INSTRU GUARD 5/64 X 5/8 X 1, Model Number 09-1-018; 20) VENTED INSTRUMENT GUARD 1/8 X 1 X 1 - BLACK, Model Number 09-1-019; 21) BLACK VENTED INSTRUMENT GUARD 1/8 X 1 X 1, Model Number 09-1-019; 22) BLACK VENTED INSTRU GUARD 1/8 X 1 X 1, Model Number 09-1-019; 23) OPAQUE ASSORTED VENTED INSTRUMENT GUARDS, Model Number 09-1-020; 24) OPAQUE COLOR - ASSORTED VENTED INSTRUMENT GUARDS, Model Number 09-1-020; 25) VENTED INSTRUMENT GUARD 1/16 X 3/4 - TRANSPARENT BLUE, Model Number 09-2-011;

Class II

Recalling firm: Healthmark Industries Co., Inc.
Reason for recall: Labeling not compliant with 21 CFR 801 and steam sterilization IFU has been updated.
Affected products (lot / model / serial): Model Number 09-1-011, UDI DI 00840113213610, Lot Number 46313; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 48704; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 52563; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 54316; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 56859; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 62805; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 66222; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 68451; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 70818; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 76638; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 77955; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 85979; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 88504; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 091011; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 92954; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 93535; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 95456; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 96593; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 99366; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 103829; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 107222; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 112086; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 116183; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 125652; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 130885; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 141843; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 145497; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 149058; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 154671; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 161613; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 166797; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 168628; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 175315; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 181731; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 187198; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 188727; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 197096; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 201659; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 201659; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 202330; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 205350; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 205390; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 212318; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 212526; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 218245; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 221829; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 222154; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 223718; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 229372; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 231155; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 235520; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 236774; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 240155; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 242716; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 246432; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 247558; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 249963; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 251383; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 255148; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 258946; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 2
Units affected: 12,835,920 units
Distribution pattern: Worldwide 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.
Firm location: Fraser, MI, United States
Recall type: Voluntary: Firm initiated
How the firm notified customers: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Product type: Devices
Status: Ongoing
Recall number: Z-0188-2027
Recall initiated: September 7, 2026
FDA classification date: October 15, 2026
FDA report date: October 21, 2026
FDA event ID: 99943
Last updated on HTM Vibe: October 27, 2026

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