Z-0897-2014Class II

25ga Mid-Field Endo Illuminator, Synergetics, length 7.5 ft, sterile / EO, 56.22.25P. Packed 12 units per...

Name: Z-0897-2014 25ga Mid-Field Endo Illuminator, Synergetics, length 7.5 ft, sterile / EO, 56.22.25P. Packed 12 units per...
Creator: Synergetics Inc
Published: 2013-12-09
License: https://open.fda.gov/license/

Synergetics Inc / initiated 2013-12-09 / Terminated / root cause: packaging

FDA source

Synergetics Inc began a recall of 25ga Mid-Field Endo Illuminator, Synergetics, length 7.5 ft, sterile / EO, 56.22.25P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO on 2013-12-09. FDA classified it as Class II and gives the reason as "Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0897-2014
Classification: Class II
Status: Terminated
Initiated: 2013-12-09
Posted: 2014-01-30
Terminated: 2015-03-25
Recalling firm: Synergetics Inc
Product: 25ga Mid-Field Endo Illuminator, Synergetics, length 7.5 ft, sterile / EO, 56.22.25P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
Product code: HQB Photocoagulator And Accessories
Reason for recall: Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.
Root cause tag: packaging
FDA root cause: Use error
Action: Domestic customers were sent recall notices by FedEx on December 9, 2013. Foreign customers were sent recall notices by e-mail between December 6 and December 13, 2013. The recall notice instructed customers to return the recalled product.
Quantity in commerce: 6 units
Distribution: Worldwide Distribution-USA (nationwide) and the countries of Argentina, Austria, Brazil, Canada, China, Egypt, France, Germany, Greece, Hong Kong, Italy, Japan, Mexico, Morocco, the Netherlands, Pakistan, South Korea, Spain, Sweden, Switzerland, and the United Kingdom.
Product codes and lots: Lot number: M276380

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0897-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0872-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-05	2014-01-30
Z-0873-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-05	2014-01-30
Z-0874-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-05	2014-01-30
Z-0875-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-05	2014-01-30
Z-0876-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-05	2014-01-30
Z-0877-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-05	2014-01-30
Z-0878-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-05	2014-01-30
Z-0879-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-05	2014-01-30
Z-0880-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-05	2014-01-30
Z-0881-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-05	2014-01-30
Z-0882-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-05	2014-01-30
Z-0883-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-05	2014-01-30
Z-0884-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-05	2014-01-30
Z-0885-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-05	2014-01-30
Z-0886-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-05	2014-01-30
Z-0887-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-05	2014-01-30
Z-0888-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-05	2014-01-30
Z-0889-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-05	2014-01-30
Z-0890-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-05	2014-01-30
Z-0891-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-05	2014-01-30
Z-0892-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-05	2014-01-30
Z-0893-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-05	2014-01-30
Z-0894-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-05	2014-01-30
Z-0895-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-05	2014-01-30
Z-0896-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-05	2014-01-30
Z-0897-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-05	2014-01-30
Z-0898-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-05	2014-01-30
Z-0899-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-05	2014-01-30

Product code HQB

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)