FDA Medical Device Recalls (openFDA)
Clorox Healthcare Holdings, LLC (dba HealthLink): PSS Select medical products***Biopsy Punches*** Disposable manual instrument for skin biopsy.
- Recall number
- Z-1655-2013
- Recalling firm
- Clorox Healthcare Holdings, LLC (dba HealthLink)
- Product
- PSS Select medical products***Biopsy Punches*** Disposable manual instrument for skin biopsy.
- Status
- Terminated
- Initiated
- 2013-03-18
- Posted
- 2013-07-02
- Terminated
- 2014-02-25
- Reason
- Due to lack of sterilization.
- 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
- 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.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K921822"]
- PMA numbers
- not on file
- Product code
- LRY
- Firm FEI
- 1000526105
- Firm city
- Jacksonville
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28