Z-1655-2013Class II

PSS Select medical productsBiopsy Punches Disposable manual instrument for skin biopsy

Name: Z-1655-2013 PSS Select medical products***Biopsy Punches*** Disposable manual instrument for skin biopsy
Creator: Clorox Healthcare Holdings, LLC (dba HealthLink)
Published: 2013-03-18
License: https://open.fda.gov/license/

EDM 3, LLC / initiated 2013-03-18 / Terminated / root cause: packaging

FDA source

Clorox Healthcare Holdings, LLC (dba HealthLink) began a recall of PSS Select medical products***Biopsy Punches*** Disposable manual instrument for skin biopsy on 2013-03-18. FDA classified it as Class II and gives the reason as "Due to lack of sterilization". 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-1655-2013
Classification: Class II
Status: Terminated
Initiated: 2013-03-18
Posted: 2013-07-02
Terminated: 2014-02-25
Recalling firm: EDM 3, LLC
Product: PSS Select medical products***Biopsy Punches*** Disposable manual instrument for skin biopsy.
Product code: LRY Punch, Surgical
Reason for recall: Due to lack of sterilization.
Root cause tag: packaging
FDA root cause: Packaging change control
Action: On March 19, 2013, HealthLink sent their customers letters instructing them to do the following: 1) Screen their inventory and quarantine the product. 2) Notify all customers that received the affected products and ask them to return the lots to their firm. 3) Complete the attached form and return the lots to HealthLink Distribution center. For further assistance, customers were directed to call customer service at 1-800-638-2625.
Quantity in commerce: 1,032,700 units
Distribution: Worldwide Distribution-USA (nationwide) including Puerto Rico and the states of AZ, CA, CO, FL, GA, IA, IL, IN, MI, MO, MS, MT, NC, NJ, NY, OH, SC,TX ,VA ,WA, WI, and HI, and the countries of Canada, Mexico, and New Zealand.
Product codes and lots: 1103316, 1100626, 1100625, 1100624, 1100623, 1100622, 1100621, 1100620, 1100619, 1100618, 1100617, 1100616, 1100615, 1100318, 1100317, 1100316, 1034725, 1034724, 1033414, 1031515, 1028733, 1028732, 1028723, 1028722, 1028721, 1028720, 1028719, 1028718, 1028717, 1028716, 1028715, 1028721, 1028722, 1028723, 1028706, 1028707, 1023914, 1023913, 1023912, 1023910, 1023908, 1023907, 1023904, 1023903, 1023902, 1023901, 1023114, 1023111, 1023110, 1023107, 1023106, 1023110, 1023111, 1023112, 1023113, 1023114, 1023115, 1023116, 1023117, 1023118, 1023119, 1023120, 1023121, 1023122, 1019605, 1019606, 1019607, 1019608, 1019609, 1019610, 1019615, 1019616, 1019617, 1019618, 1019619, 1015217, 1015216, 1015215, 1013315, 1013219, 1001861, 1001860, 1001859, 1001858, 1001857, 1001856, 1001854, 1001852, 1001851, 1001850, 1001849, 1001848, 1001847, 1001846, 1001845, 1001843, 1001842, 1001841, 1000527, 1000526, 1000525, 1000518, 0935203, 0935202, 0935201, 0934418, 0931016, 0931015, 0931013, 0931012, 0931011, 0931009, 0931008, 0931007, 0931006, 0931005, 0931004, 0930216, 0930215, 0930214, 0930213, 0927931, 0927930, 0927929, 0927928, 0927927, 0927926, 0927924, 0927923, 0927922, 0927921, 0927920, 0927919, 0927128, 0927127, 0927126, 0927125, 0927124, 0927123, 0927122, 0927121, 0927120, 0926021, 0926020, 0926019, 0926018, 0926017, 0926016, 0926015, 0923116, 0923019, 0923018, 0923017, 0922516, 0922515, 0921533, 0921532, 0921529, 0921526, 0921525, 0921524, 0921523, 0921523, 0921522, 0921517, 0919724, 0919723, 0919722, 0919720, 0919719, 0919718, 0919715, 0919714, 0919713, 0919712, 0919711, 0917612, 0917321, 0917320, 0917319, 0917318, 0917316, 0916228, 0916227, 0916225, 0916223, 0916221, 0916219, 0914718, 0914717, 0914716, 0914715, 0913326, 0913324, 0913323, 0913322, 0913321, 0911413, 0911412, 0911410, 0911408, 0911403, 0911401, 0909922, 0909920, 0909918, 0909913, 0907901, 0907819, 0907720, 0907719, 0907618, 0905824, 0905821, 0905820, 0905819, 0905818, 0905815, 0905814, 0905813, 0905812, 0905807, 0905804, 0905802, 0904319, 0903522, 0901335, 0901333, 0901332, 0901329, 0901327, 0901325, 0901324, 0901323, 0901322, 0901321, 0901319, 0901318, 0834723, 0834721, 0834720, 0834719, 0834321, 0834318, 0834317, 0834316, 0832616, 0832615, 0832614, 0832213, 0832212, 0831918, 0831917, 0831916, 0831915, 0831714, 0831713, 0831017, 0831016, 0831015, 0830415, 0829817, 0829816, 0829815, 0829514, 0829513, 0828717, 0826812, 0826612, 0826314, 0825214, 0823812, 0823811, 0823214, 0823115, 0822618, 0822617, 0819320, 0819319, 0819318, 0819316, 0819315, 0815815, 0815813, 0815812, 0815811, 0815810, 0811616, 0811615, 0811614, 0807319, 0807315, 0807314, 0807115, 0806513, 0805919, 0805917, 0805121, 0805119, 0804519, 0803518, 0802418, 0801517, 0800320, 0800319, 0800318, 0800317, 0736517, 0735515, 0735117, 0734818, 0734817, 0734417, 0734117, 0732517, 0732317, 0729217, 0728817.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1655-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1654-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-10	2013-07-02
Z-1655-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-10	2013-07-02
Z-1656-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-10	2013-07-02

Product code LRY

K921822Class IFray Bio-PunchFray Products Corp. / cleared 1992-10-28

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)