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Organogenesis Inc.

United StatesFDA applicant, unverified FDA FEI 1000148471

Organogenesis Inc. is a medical device manufacturer, with 52 devices listed in FDA GUDID, FDA 510(k) and FDA PMA (FDA Unclassified, Class II, Class III and Class I) and 7 FDA recalls as of 12 Nov 2026.

Devices
52
Registrations
FDA
FDA recalls
7

Registry facts

Counted by deviCERTS from registry records, 12 Nov 2026

Registries
  • FDA GUDID 39
  • FDA 510(k) 12
  • FDA PMA 1

A device listed in two registries counts in both.

Device classes
  • FDA Unclassified 39
  • FDA Class II 8
  • FDA Class III 4
  • FDA Class I 1
FDA recalls
Identifiers
  • FDA FEI 1000148471
  • DUNS 152165817

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA FEI, FDA recalls

Catalogue52

Newest first, rows 1-50 of 52

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Rows 1-50 of 52

Showing 1-50 of 52

Company details

FDA FEI number
1000148471
DUNS number
152165817
Address
150 DAN RD., CANTON, MA, 02021
Phone
1-888-432-5232

FDA recalls7

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

  • 2011

    • 21 Feb 2011 Z-1747-2011 Unclassified (pre-2012) Terminated Product sterility may be compromised Distribution: Nationwide. Submission number: P950032
    • 30 Jan 2011 Z-1746-2011 Unclassified (pre-2012) Terminated Product sterility compromised Distribution: nationwide. Submission number: P950032

  • 2010

    • 2 Aug 2010 Z-2589-2010 Unclassified (pre-2012) Terminated Product is contaminated with a yeast identified as Pseudozyma antarctica. Distribution: Nationwide Distribution -- AL, AZ, CA, CO, IL NC, PA, TN, and VA. Submission number: P950032

  • 2009

    • 27 Sep 2009 Z-0181-2010 Unclassified (pre-2012) Terminated Unit contaminated with Staphylococcus epidermidis Distribution: Nationwide Distribution Submission number: P950032

  • 2007

    • 26 Dec 2007 Z-0675-2008 Unclassified (pre-2012) Terminated Contamination: Apligraf units were reported to have contamination in the agarose nutrient medium of some units retained at Organogenesis. Preliminary tests show a gram negative rod (bacillus) organism. Distribution: Nationwide Distribution. Submission number: P950032

  • 2006

    • 29 Sep 2006 Z-0068-2007 Unclassified (pre-2012) Terminated Product pH out of specification Distribution: Nationwide Submission number: P950032

  • 2003

    • 2 May 2003 Z-0904-03 Unclassified (pre-2012) Terminated Did not meet finished device specifications for the DNA criteria. Distribution: To hospitals nationwide. Submission number: P000036

Frequently asked questions

How many devices does ORGANOGENESIS INC. have in the registry?

The registry currently lists 52 devices for ORGANOGENESIS INC.. Devices recorded under merged duplicate company entries are counted once.

Which registries list ORGANOGENESIS INC.'s devices?

Among its 50 most recently registered devices, ORGANOGENESIS INC. has devices listed in FDA 510(k) (11 devices) and FDA GUDID (39 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do ORGANOGENESIS INC.'s devices fall under?

Among its 50 most recently registered devices, the classes recorded for ORGANOGENESIS INC.'s devices are Class I, Class II and Class III. Each device page shows its own class and authorisation.

Are there FDA recall records for ORGANOGENESIS INC.?

FDA recall records list 7 recalls initiated by ORGANOGENESIS INC., the most recent initiated on 21 Feb 2011. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from ORGANOGENESIS INC. in the registry?

The most recently registered devices listed for ORGANOGENESIS INC. include PuraPly Antimicrobial Wound Matrix 515-026, PuraPly Antimicrobial Wound Matrix 515-028, PuraPly Antimicrobial Wound Matrix 515-030 and PuraPly Antimicrobial Wound Matrix 515-032.

Generated automatically from registry data and not verified by a human reviewer.