CLASS II Device recall · Reported 10 Jul 2013 · FDA Enforcement Report

HealthLinkBiopsy Punches Disposable manual instrument recalled

Clorox Healthcare Holdings, LLC ( is recalling HealthLink***Biopsy Punches*** Disposable manual instrument for skin biopsy, distributed nationwide in the US. The recall was initiated on 18 Mar 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes1232041; 1232030, 1232028, 1232024, 1232021, 1232020, 1232015, 1232013, 1232010, 1232009, 1231324, 1231323, 1226436, 1226435 1226432, 1226421, 1226416, 1226415, 1226416, 1226417, 1226418, 1226419, 1222318, 1222319, 1222320, 1222321, 1222322, 1217409, 1217404, 1213926, 1213924, 1213923, 1213921, 1213918, 1213917, 1213916, 1213910, 1213907, 1213906, 1213905, 1213115, 1208740, 1208739, 1208738, 1208737, 1208736, 1208735, 1208734, 1208733, 1208732, 1208731, 1208730, 1208729, 1205343, 1205342, 1205341, 1205340, 1205339, 1205338, 1205337, 1205336, 1205335, 1205334, 1205333, 1205332, 1205331, 1205330, 1205329, 1203217, 1201930, 1201929, 1201928, 1201927, 1201926, 1134639, 1134638, 1134637, 1134636, 1129331, 1129330, 1129328, 1129327, 1129324, 1125634, 1125633, 1125632, 1125631, 1125630, 1125629, 1125628, 1125627, 1125626, 1125625, 1125624, 1125623, 1123522, 1123521, 1123520, 1123519, 1123517, 1123512, 1122926, 1122925, 1122924, 1122923, 1122922, 1122720, 1121521, 1119218, 1116715, 1116020, 1116019, 1113222, 1113221, 1113220, 1113219, 1113218, 1111812, 1111811, 1111810, 1111809, 1111808, 1111025, 1111024, 1111023, 1111022, 1110130, 1109622, 1109621, 1109620, 1109617, 1109020, 1109019, 1106224, 1106223, 1106222, 1106221, 1106220, 1106219, 1105421, 1105420, 1105419, 1105418, 1105417, 1105416, 1105415, 1104213, 1104212, 1104211, 1103825, 1103824, 1103320, 1103319, 1103318, 1103317, 1102611, 1102610, 1101218, 1035518, 1034723, 1034722, 1034721, 1034720, 1034719, 1030620, 1030619, 1030618, 1030617, 1030616, 1030615, 1028731, 1028730, 1028729, 1028728, 1028727, 1028726, 1028725, 1028724, 1028716, 1028717, 1028718, 1028719, 1028720, 1027217, 1027216, 1023916, 1023915, 1023911, 1023909, 1023906, 1023905, 1023113, 1023112, 1023109, 1023108, 1023107, 1023108, 1023109, 1019602, 1019603, 1019604, 1019611, 1019612, 1019613, 1019614, 1015220, 1015219, 1015218, 1013316, 1013220, 1013218, 1009814, 1001855, 1001853, 1001844, 1001840, 1001839, 1001838, 1001837, 1001836, 1001835, 1001834, 1001833, 1001832, 1001831, 1001830, 1001829, 1001828, 1001827, 1001826, 1001825, 1001824, 1001823, 1000524, 1000523, 1000522, 1000521, 1000520, 1000519, 1000517, 0935206, 0935205, 0935204, 0934417, 0934416, 0934415, 0931612, 0931010, 0931003, 0931002, 0931001, 0927925, 0927130, 0927129, 0926022, 0923119, 0923118, 0923117, 0923115, 0923016, 0921531, 0921530, 0921528, 0921527, 0919721, 0919717, 0919716, 0919710, 0917317, 0916226, 0916224, 0916222, 0916220, 0916218, 0913330, 0913329, 0913328, 0913327, 0911411, 0911409, 0911407, 0911406, 0911405, 0911404, 0911402, 0909921, 0909919, 0909917, 0909916, 0909915, 0909914, 0909912, 0907718, 0907620, 0907619, 0905817, 0905816, 0905811, 0905810, 0905809, 0905808, 0905806, 0905805, 0905803, 0905801, 0903521, 0903520, 0903519, 0903517, 0901334, 0901331, 0901330, 0901328, 0901326, 0901320, 0901317, 0834724, 0834722, 0834718, 0834322, 0834320, 0834319, 0834315, 0832613, 0832215, 0832214, 0831715, 0831018, 0829515, 0828716, 0828715, 0828416, 0826813, 0826613, 0825216, 0825215, 0823114, 0822809, 0822616, 0819321, 0819317, 0815814, 0811613, 0809412, 0807318, 0807317, 0807316, 0807313, 0807312, 0807114, 0807113, 0806515, 0806514, 0805921, 0805918, 0805719, 0805718, 0805717, 0804518, 0804517, 0802419, 0801917, 0801518.

Quantity recalled1,044,600 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1654-2013
FDA event ID: 64888
Recalling firm: Clorox Healthcare Holdings, LLC (, Jacksonville, FL
Classification: Class II
Status: Terminated
Recall initiated: 18 Mar 2013
FDA classified: 2 Jul 2013
Reported: 10 Jul 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Other Medical Devices

Timeline

18 Mar 2013	Recall initiated by company
2 Jul 2013	Classified by FDA	+106 days
10 Jul 2013	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Due to lack of sterilization.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

HealthLink***BIOPSY PUNCHES*** Disposable manual instrument for skin biopsy.

Where it was distributed

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.

Nationwide Arizona California Colorado Florida Georgia Hawaii Iowa Illinois Indiana Michigan Missouri Mississippi Montana North Carolina New Jersey New York Ohio Puerto Rico South Carolina Texas

Questions about this recall

Why was it recalled?

Due to lack of sterilization.

Which lots are affected?

1232041; 1232030, 1232028, 1232024, 1232021, 1232020, 1232015, 1232013, 1232010, 1232009, 1231324, 1231323, 1226436, 1226435 1226432, 1226421, 1226416, 1226415, 1226416, 1226417, 1226418, 1226419, 1222318, 1222319, 1222320, 1222321, 1222322, 1217409, 1217404, 1213926, 1213924, 1213923, 1213921, 1213918, 1213917, 1213916, 1213910, 1213907, 1213906, 1213905, 1213115, 1208740, 1208739, 1208738, 1208737, 1208736, 1208735, 1208734, 1208733, 1208732, 1208731, 1208730, 1208729, 1205343, 1205342, 1205341, 1205340, 1205339, 1205338, 1205337, 1205336, 1205335, 1205334, 1205333, 1205332, 1205331, 1205330, 1205329, 1203217, 1201930, 1201929, 1201928, 1201927, 1201926, 1134639, 1134638, 1134637, 1134636, 1129331, 1129330, 1129328, 1129327, 1129324, 1125634, 1125633, 1125632, 1125631, 1125630, 1125629, 1125628, 1125627, 1125626, 1125625, 1125624, 1125623, 1123522, 1123521, 1123520, 1123519, 1123517, 1123512, 1122926, 1122925, 1122924, 1122923, 1122922, 1122720, 1121521, 1119218, 1116715, 1116020, 1116019, 1113222, 1113221, 1113220, 1113219, 1113218, 1111812, 1111811, 1111810, 1111809, 1111808, 1111025, 1111024, 1111023, 1111022, 1110130, 1109622, 1109621, 1109620, 1109617, 1109020, 1109019, 1106224, 1106223, 1106222, 1106221, 1106220, 1106219, 1105421, 1105420, 1105419, 1105418, 1105417, 1105416, 1105415, 1104213, 1104212, 1104211, 1103825, 1103824, 1103320, 1103319, 1103318, 1103317, 1102611, 1102610, 1101218, 1035518, 1034723, 1034722, 1034721, 1034720, 1034719, 1030620, 1030619, 1030618, 1030617, 1030616, 1030615, 1028731, 1028730, 1028729, 1028728, 1028727, 1028726, 1028725, 1028724, 1028716, 1028717, 1028718, 1028719, 1028720, 1027217, 1027216, 1023916, 1023915, 1023911, 1023909, 1023906, 1023905, 1023113, 1023112, 1023109, 1023108, 1023107, 1023108, 1023109, 1019602, 1019603, 1019604, 1019611, 1019612, 1019613, 1019614, 1015220, 1015219, 1015218, 1013316, 1013220, 1013218, 1009814, 1001855, 1001853, 1001844, 1001840, 1001839, 1001838, 1001837, 1001836, 1001835, 1001834, 1001833, 1001832, 1001831, 1001830, 1001829, 1001828, 1001827, 1001826, 1001825, 1001824, 1001823, 1000524, 1000523, 1000522, 1000521, 1000520, 1000519, 1000517, 0935206, 0935205, 0935204, 0934417, 0934416, 0934415, 0931612, 0931010, 0931003, 0931002, 0931001, 0927925, 0927130, 0927129, 0926022, 0923119, 0923118, 0923117, 0923115, 0923016, 0921531, 0921530, 0921528, 0921527, 0919721, 0919717, 0919716, 0919710, 0917317, 0916226, 0916224, 0916222, 0916220, 0916218, 0913330, 0913329, 0913328, 0913327, 0911411, 0911409, 0911407, 0911406, 0911405, 0911404, 0911402, 0909921, 0909919, 0909917, 0909916, 0909915, 0909914, 0909912, 0907718, 0907620, 0907619, 0905817, 0905816, 0905811, 0905810, 0905809, 0905808, 0905806, 0905805, 0905803, 0905801, 0903521, 0903520, 0903519, 0903517, 0901334, 0901331, 0901330, 0901328, 0901326, 0901320, 0901317, 0834724, 0834722, 0834718, 0834322, 0834320, 0834319, 0834315, 0832613, 0832215, 0832214, 0831715, 0831018, 0829515, 0828716, 0828715, 0828416, 0826813, 0826613, 0825216, 0825215, 0823114, 0822809, 0822616, 0819321, 0819317, 0815814, 0811613, 0809412, 0807318, 0807317, 0807316, 0807313, 0807312, 0807114, 0807113, 0806515, 0806514, 0805921, 0805918, 0805719, 0805718, 0805717, 0804518, 0804517, 0802419, 0801917, 0801518.

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

2 other products · FDA event 64888

This product is part of a recall event; the main page for the event is PSS Select medical products***Biopsy Punches*** Disposable recalled.

Reported	Class	Recall	Company	Reason	Where
10 Jul 2013	CLASS II	PSS Select medical products*Biopsy Punches* Disposable recalled	Clorox Healthcare Holdings, LLC (	Sterility	Nationwide
10 Jul 2013	CLASS II	Argent Surgical Systems*Biopsy Punches* Disposable recalled	Clorox Healthcare Holdings, LLC (	Sterility	Nationwide

More recalls from Clorox Healthcare Holdings, LLC (

All 3

Reported	Class	Recall	Company	Reason	Where
10 Jul 2013Device	CLASS II	Argent Surgical Systems*Biopsy Punches* Disposable recalled	Clorox Healthcare Holdings, LLC (	Sterility	Nationwide
10 Jul 2013Device	CLASS II	PSS Select medical products*Biopsy Punches* Disposable recalled	Clorox Healthcare Holdings, LLC (	Sterility	Nationwide

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