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Recall Observatory FDA recall evidence

Core noun

Recalled products

The canonical enforcement rows. Everything else groups, enriches, or interprets these records.

Indexed record set

86,536 products

Page 79 of 3462

Product Firm Event Initiated
GEM Premier 5000 PAK; Part No. 00055360011. Instrumentation Laboratory Event 98349 January 20, 2026
GEM Premier 5000 PAK; Part No. 00055415004. Instrumentation Laboratory Event 98349 January 20, 2026
GEM Premier 5000; Part No. 00055430008. Instrumentation Laboratory Event 98349 January 20, 2026
GEM Premier 5000; Part No. 00055445010 & 00055445011. Instrumentation Laboratory Event 98349 January 20, 2026
GEM Premier 5000; Part No. 00055430011. Instrumentation Laboratory Event 98349 January 20, 2026
GEM Premier 5000; Part No. 00055445008. Instrumentation Laboratory Event 98349 January 20, 2026
GEM Premier 5000 PAK; Part No. 00055360008. Instrumentation Laboratory Event 98349 January 20, 2026
GEM Premier 5000; Part No: 00055415011. Instrumentation Laboratory Event 98349 January 20, 2026
cobas pro integrated solutions with cobas c 503 analytical units: cobas pro sample supply unit, material number 08464502001 cobas pro SSU, material number 09205632001 Affected Assays: (Product Name/ Catalog Number/ Application Code/ Application Short Name) 1. Cystatin C Gen.2 08105596190 20510 CYSC2 2. Ferritin Gen.4 08057648190 20571 FER4X 3. Lipoprotein (a) Gen.2 08106126190 20861 LPA2X 4. Lipoprotein (a) molarity 08106126160 20864 LPA2-X 5. Vancomycin Gen.3 08058849190 21211 VANC3O 6. Kappa Free Light Chains Partner Channel 08896640190 21421 KFLCX 7. Lambda Free Light Chains Partner Channel 08896631190 21430 LFLC 8. fCAL turbo Partner Channel 08910367190 21490 FCAL Roche Diagnostics Operations, Inc. Event 98347 January 20, 2026
GEM Premier 5000; Part No. 00055415008. Instrumentation Laboratory Event 98349 January 20, 2026
GEM Premier 5000; Model No. 00055430010. Instrumentation Laboratory Event 98349 January 20, 2026
GEM Premier 5000 PAK; Part No. 00055407510. Instrumentation Laboratory Event 98349 January 20, 2026
GEM Premier 5000 PAK; Part No. 00055407508. Instrumentation Laboratory Event 98349 January 20, 2026
GEM Premier 5000 PAK; Part No. 00055407511. Instrumentation Laboratory Event 98349 January 20, 2026
GEM Premier 5000 PAK; Part No. 00055407504. Instrumentation Laboratory Event 98349 January 20, 2026
Atellica CH Urine Albumin (UAlb). Material Number: 11537225 Siemens Healthcare Diagnostics, Inc. Event 98370 January 20, 2026
GEM Premier 5000; Part No. 00055415005. Instrumentation Laboratory Event 98349 January 20, 2026
GEM Premier 5000; Part No. 00055415010. Instrumentation Laboratory Event 98349 January 20, 2026
GEM Premier 5000 PAK; Part No. 00055360010. Instrumentation Laboratory Event 98349 January 20, 2026
GEM Premier 5000; Part No. 00055445004. Instrumentation Laboratory Event 98349 January 20, 2026
GEM Premier 5000 PAK, Part No. 00055360004. Instrumentation Laboratory Event 98349 January 20, 2026
Med-Nap Cleansing Towelettes (Benzalkonium Chloride 0.13%), 100 Towelettes, Manufactured by: Acme United Corporation, 1 Waterview Dr., Stelton, CT 06484, NDC 0924-0243-01. ACME UNITED CORPORATION Event 98291 January 20, 2026
First Aid Only BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 50 Wipes, NDC 0924-7116-03. ACME UNITED CORPORATION Event 98291 January 20, 2026
WP WipesPlus Hand Sanitizing Wipes (Benzalkonium Chloride 0.13%), 5x7, 100 CT, Progressive Products, 211 S. Ridge Street, Rye Brook, NY 10573. NDC 67151-727-01. ACME UNITED CORPORATION Event 98291 January 20, 2026
BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 5" x7", 1000 ea Bulk, Med-Nap, Brooksville, FL 34601, Made in USA, NDC 0924-0246-02. ACME UNITED CORPORATION Event 98291 January 20, 2026

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