Z-0039-2012

Thermo Scientific Microm: Rotary Microtome: REF HM355S-3 Used for slicing tissue blocks

Name: Z-0039-2012 Thermo Scientific Microm: Rotary Microtome: REF HM355S-3 Used for slicing tissue blocks
Creator: Richard-Allan Scientific Company
Published: 2011-08-12
License: https://open.fda.gov/license/

Richard-Allan Scientific LLC / initiated 2011-08-12 / Terminated / root cause: design

FDA source

Richard-Allan Scientific Company began a recall of Thermo Scientific Microm: Rotary Microtome: REF HM355S-3 Used for slicing tissue blocks on 2011-08-12. The reason FDA records is "The firm has received two complaints of finger lacerations in operators of this device". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0039-2012
Status: Terminated
Initiated: 2011-08-12
Posted: 2011-10-12
Terminated: 2013-07-25
Recalling firm: Richard-Allan Scientific LLC
Product: Thermo Scientific Microm: Rotary Microtome: REF HM355S-3 Used for slicing tissue blocks.
Product code: IDO Microtome, Rotary
Reason for recall: The firm has received two complaints of finger lacerations in operators of this device.
Root cause tag: design
FDA root cause: Device Design
Action: ThermoFisher Scientific sent "URGENT MEDICAL DEVICE CORRECTION, RE: Thermo Scientific HM355S-3 User Safety Advisory Notice" to all affected customers. The letter states the manufacturer identified a need to enhance the safety instructions and the description of the safety devices in the user manual. It mentions the HM3555S-3 User Manual has been modified to include more specific safe work practices and a new Quick -Reference Card summarizing the manual's safety enhancements and that the changes have been included on a CD that is enclosed with the letter. The firm requests confirmation of receipt of the new User Manual and Quick-Reference Card by October 31, 2011 to be sent by FAX to (269) 372-2674 For questions on this recall call the firms Technical Support representatives at 1-800-522-7270 08:00 AM- 4:30 PM.
Quantity in commerce: 786
Distribution: Worldwide Distribution: Nationwide distribution; including the country of Canada.
Product codes and lots: Model HM355S-3, Serial Nos: 34450, 34519, 34520, 34601, 34662, 34665, 34807, 34922, 35030, 35032, 35033, 35159, 35637, 35793, 35976, 35978, 35978, 38337, 38584, 38651, 39238, 39280, 39281, 39542, 39795, 40607, 41039, 45104, 45367, 45369, 45371, 45760, 45845, 47466, 47467, 47468, 47469, 47772, 47773, 47774, 47775, 47776, 48095, 48096, 48097, 48098, 48109, 48110, 48111, 48112, 48113, 48114, 48115, 48116, 48184, 48252, 48253, 48254, 48259, 48260, 48261, 48314, 48315, 48593, 48594, 48910, 48911, 48912, 48913, 48914, 48915, 48916, 48917, 48918, 48919, 48920, 48921, 48922, 48923, 48924, 48978, 48978, 49102, 49103, 49104, 49105, 49106, 49107, 49108, 49109, 49110, 49209, 49209, 49210, 49210, 49211, 49211, 49212, 49213, 49213, 49214, 49214, 49221, 49223, 49230, 49286, 49287, 49288, 49289, 49290, 49291, 49292, 49293, 49294, 49295, 49296, 49297, 49298, 49299, 49300, 49301, 49302, 49303, 49304, 49305, 49306, 49307, 49308, 49309, 49310, 49311, 49312, 49962, 49963, 49964, 49965, 49966, 49967, 49968, 49969, 49970, 49971, 49972, 49973, 49974, 49975, 49976, 49977, 49978, 49989, 49990, 49991, 49992, 49993, 49994, 49995, 50221, 50222, 50224, 50225, 50226, 50578, 50579, 50580, 50581, 50582, 50583, 50584, 50585, 50586, 50587, 50676, 50677, 50678, 50679, 50680, 50681, 50791, 50792, 50793, 50794 and 50911.

Product code IDO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)