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HAMILTON HEATER SHAKER, 115 VAC/ 230 VAC, 750 VA, Power Consumption 41V/ 100W (max.), Relative Hu...

FDA Device Recall #Z-1156-2021 — Class II — January 15, 2021

Recall Summary

Recall Number Z-1156-2021
Classification Class II — Moderate risk
Date Initiated January 15, 2021
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Hamilton Co
Location Reno, NV
Product Type Devices
Quantity 4729 units

Product Description

HAMILTON HEATER SHAKER, 115 VAC/ 230 VAC, 750 VA, Power Consumption 41V/ 100W (max.), Relative Humidity 15% - 85% no condensation. REF 19903400

Reason for Recall

There is a risk that the device can start a fire if flammable liquids contact and enter the device.

Distribution Pattern

US - AL, AR, AZ, CA, CO, CT, DC. DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA. MD, ME. MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI AND WY OUS - AUSTRALIA, AUSTRIA, BRAZIL , CANADA , CHILE, CHINA, , COLOMBIA , FINLAND , GERMANY , ITALY , JAPAN , JPN , KOREA, SOUTH, PARAGUAY , PERU , PHL , ROMANIA , ROU , SINGAPORE, SWITZERLAND , SWITZERLAND , THAILAND, TWN , UNITED KINGDOM, AND URUGUAY

Lot / Code Information

Various Part Numbers: Hamilton Company PART NUMBER/ DESCRIPTION 188318/ HHS2,2MM ORBIT,CUSTOMIZED; 188319/ HHS2,3MM ORBIT,CUSTOMIZED; 199000/ HHS 0.5 MTP FLAT BOTTOM; 199001/ HHS 2.0 MTP FLAT BOTTOM; 199002/ PLEASE USE PN: 199034; 199007/ HHS 2.0 NUNC DWP 96 2ML; 199008/ HHS 3.0 NUNC DWP 96 2ML; 199009/ HHS 1.5 MTP FLAT BOTTOM; 199011/ HHS,1.5MM,NUNC,96DWP,2ML; 199027/ HHS 1.5 MM SARSTEDT 48X1.5ML; 199033/ HHS2,2MM ORBIT,MTP FLT BOTTOM; 199034/ HHS2,3MM ORBIT,MTP FLT BOTTOM; 199037/ HHS 1.5MM NUNC DWP 96 2ML; 199038/ HHS2,2MM ORBIT,NUNC DWP96 2M; 199039/ HHS2,3MM ORBIT,NUNC DWP96 2M; 199085/ HHS 3.0 FLIPTUBE RACK; 199474/ HHS 3.0 BIO-RAD DWP FSD; 809018/ HHS 3.0 AUTOLYS; 0201710-001/ HHSADVWR40002-012DWP96CON2ML; 0202697-002/ HHS,RGT TRUGH HOLD FRAME,LID; 0203408-002/ HHS,199034; 188219APE/ HHS 3.0MM AMPLITUDE; 199033R/ HHS2,2MM ORBIT,MTP FLT BOT REF; 199034R/ HHS2,3MM ORBIT,MTP FLT BTM; 65608-01/ HHS2,3MM ORBIT, MPT; 65608-01R/ HHS2,3MM ORBIT, MPT,REFURB; 6601885-01/ KIT,HHS,3 MM ORBIT,ML PREP; 6601885-02/ KIT,HHS,2 MM ORBIT,ML PREP; 95379-01/ HHS2,3MM ORBIT,DWP96,EXACT SCI; Hamilton Bonaduz AG PART NUMBER DESCRIPTION 188319/ Hamilton Heater Shaker, flat bottom adapter (APE); 199033/ Hamilton Heater Shaker, flat bottom adapter; 199034/ Hamilton Heater Shaker, flat bottom adapter; 199037/ HHS 1.5 NUNC DWP 96 2ML; 199038/ HHS 2.0 NUNC DWP 96 2ML; 199039/ Hamilton Heater Shaker 3.0 Nunc DWP; 199068/ HHS 1.5 ROCHE; 199474/ HHS 3.0mm BIO-RAD FSD; 199525/ HHS 2.0 MTP V BOTTOM; 809018/ HHS 3.0 AUTOLYS; 816040/ HHS 1.5mm 2G; 816061/ HHS 1.5 NUNC DWP 96 2ML TIG; 819273/ HHS 3.0 V-BOTTOM; 10069018/ HHS 3.0 NUNC DWP 96 2ML TIG

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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