Hearth Record

HAMILTON HEATER SHAKER, 115 VAC/ 230 VAC, 750 VA, Power Consumption 41V/ 100W (max.), Relative Humidity 15% -…

Medical device recall Z-1156-2021. Published in FDA’s Enforcement Report on Mar 10, 2021.

FDA’s own record, on accessdata.fda.gov

No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.

The short answer

Published in FDA’s Enforcement Report on Mar 10, 2021. Copied from openFDA on Oct 20, 2026.

Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.

How serious is it, by FDA’s class?

Class II, the middle of FDA’s three classes.

“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”

openFDA, in plain words, its enforcement report fields.

“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”

FDA’s rule, 21 CFR 7.3(m)(2), eCFR.

Source:

What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.

What’s wrong with it?

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

Source:

FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.

Which ones are recalled?

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

4729 units, in FDA’s words.

Source:

FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.

Codes to check against yours

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/…

Every code shown here, 1,644 characters

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

Source:

Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.

Where did it go?

FDA’s words for the “general area of initial distribution”: where the firm first shipped it.

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

The states and territories these words name

44 states and territories.

Every one of them
  • Alabama
  • Arkansas
  • Arizona
  • California
  • Colorado
  • Connecticut
  • District of Columbia
  • Delaware
  • Florida
  • Georgia
  • Hawaii
  • Iowa
  • Idaho
  • Illinois
  • Indiana
  • Kansas
  • Kentucky
  • Louisiana
  • Massachusetts
  • Maryland
  • Maine
  • Michigan
  • Minnesota
  • Missouri
  • Mississippi
  • Montana
  • North Carolina
  • New Hampshire
  • New Jersey
  • New Mexico
  • Nevada
  • New York
  • Ohio
  • Oklahoma
  • Oregon
  • Pennsylvania
  • South Carolina
  • Tennessee
  • Texas
  • Utah
  • Virginia
  • Washington
  • Wisconsin
  • Wyoming

The words say it went outside the United States too.

Source:

FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.

Is it still going on?

Ongoing, in FDA’s file.

“A recall which is currently in progress.”

openFDA, on “On-Going”, its enforcement report fields.

Source:

What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.

  • The firm began the recall on Jan 15, 2021.
  • FDA classified it on Feb 27, 2021.
  • FDA’s Enforcement Report published it on Mar 10, 2021.
Source:

FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.

Who is recalling it?

  • Hamilton Co, of Reno, NV.
  • Who began it, in FDA’s words: Voluntary: Firm initiated.
  • How the firm first told its customers: E-Mail.
Source:

FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.

What this record can’t tell you

  • Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
  • Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
  • How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
  • Whether anyone was hurt or fell ill: the report doesn’t say.
  • How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
  • A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Source:

Hearth Record wrote these lines; the quotations are FDA’s.

Sources

  • U.S. Food and Drug Administration, Device recall enforcement reports.

    Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.

Source:

Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.

How to read a record

Four things every record does, shown on an example record made up for this guide.

An example record, made up for this guide

An example nursing home

Made up for this guide: no real place is shown

Not fully inspected in over two years (CMS flag)

11 health citations at the latest inspection cycle

The state average is 14.3.

Source:

CMS, State and US Averages and Health Deficiencies. Released Oct 28, 2026. Updated monthly.

From the homeNone yet. Replies and paid listings aren’t open, and when they open they will sit here, below the record.

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Every fact names its source.

Who published it, when, and how often it changes sit beside each fact, with a link to the agency’s own file.

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