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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 85436

4 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
March 17, 2020
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Applied Medical Resources Corp

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

4 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 4

Epix latis GRASPER, 5 mm x 35 cm, REF C4130, Qty: 10, Sterile R, CE, Rx ONLY, UDI: (01)00607915110147

Z-2158-2020
Recall number
Z-2158-2020
Initiated
March 17, 2020
Classification
Class II
Status
Terminated
Quantity
32,760 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There may be a slightly protruding rivet on the distal end of the laparoscopic grasper which has the potential for tissue to catch on it during use and lead to tissue damage.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There may be a slightly protruding rivet on the distal end of the laparoscopic grasper which has the potential for tissue to catch on it during use and lead to tissue damage.

Code information

Batch: 1364578/Expiration Date: July 28, 2022; Batch: 1366453/Expiration Date: August 13, 2022; Batch: 1371249/Expiration Date: October 3, 2022; Batch: 1373050/Expiration Date: October 23, 2022; Batch: 1373248/Expiration Date: November 4, 2022; Batch: 1373249/Expiration Date: November 11, 2022; Batch: 1373255/Expiration Date: November 18, 2022; Batch: 1373260/Expiration Date: November 19, 2022; Batch; 1373261/Expiration Date: November 24, 2022; Batch: 1373262/Expiration Date: December 2, 2022; Batch: 1373263/Expiration Date: December 5, 2022; Batch: 1377363/Expiration Date: December 11, 2022; Batch: 1377364/Expiration Date: December 17, 2022

Distribution pattern

US: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY OUS: Argentina, Australia, Austria, Belgium, Canada, Chile, Costa Rica, Denmark, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Latvia, Liechtenstein, Luxembourg, Netherlands, New Zealand, Peru, Portugal, Serbia, Singapore, South Africa, Spain, Thailand, United Kingdom

device · product 2 of 4

Epix latis GRASPER, 5mm x 45 cm, REF: C4140, Qty: 10, Sterile R, CE, Rx ONLY, UDI: (01)00607915110154

Z-2159-2020
Recall number
Z-2159-2020
Initiated
March 17, 2020
Classification
Class II
Status
Terminated
Quantity
4320 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There may be a slightly protruding rivet on the distal end of the laparoscopic grasper which has the potential for tissue to catch on it during use and lead to tissue damage.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There may be a slightly protruding rivet on the distal end of the laparoscopic grasper which has the potential for tissue to catch on it during use and lead to tissue damage.

Code information

Batch: 1366454/ Expiration Date: August 25, 2022; Batch: 1371261/Expiration Date: October 7, 2022; Batch: 1371262/Expiration Date: October 14, 2022; Batch: 1373051/Expiration Date: October 29, 2022; Batch: 1373256/Expiration Date: December 1, 2022; Batch: 1376369/Expiration Date: December 10, 2022

Distribution pattern

US: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY OUS: Argentina, Australia, Austria, Belgium, Canada, Chile, Costa Rica, Denmark, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Latvia, Liechtenstein, Luxembourg, Netherlands, New Zealand, Peru, Portugal, Serbia, Singapore, South Africa, Spain, Thailand, United Kingdom

device · product 3 of 4

DR. THAMES - LAP CHOLE, REF: K0880, UDI: (01)30607915139620

Z-2160-2020
Recall number
Z-2160-2020
Initiated
March 17, 2020
Classification
Class II
Status
Terminated
Quantity
21 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There may be a slightly protruding rivet on the distal end of the laparoscopic grasper which has the potential for tissue to catch on it during use and lead to tissue damage.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There may be a slightly protruding rivet on the distal end of the laparoscopic grasper which has the potential for tissue to catch on it during use and lead to tissue damage.

Code information

Batch: 1378830/Expiration Date: September 8, 2022; Batch: 1379253/Expiration Date: August 13, 2022; Batch: 1380094/Expiration Date: August 22, 2022; Batch: 1381695/Expiration Date: October 30, 2022

Distribution pattern

US: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY OUS: Argentina, Australia, Austria, Belgium, Canada, Chile, Costa Rica, Denmark, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Latvia, Liechtenstein, Luxembourg, Netherlands, New Zealand, Peru, Portugal, Serbia, Singapore, South Africa, Spain, Thailand, United Kingdom

device · product 4 of 4

Clip Applier Kit, REF: K2887, UDI: (01)30607915139132(17)220822(30)1(10)

Z-2161-2020
Recall number
Z-2161-2020
Initiated
March 17, 2020
Classification
Class II
Status
Terminated
Quantity
12 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There may be a slightly protruding rivet on the distal end of the laparoscopic grasper which has the potential for tissue to catch on it during use and lead to tissue damage.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There may be a slightly protruding rivet on the distal end of the laparoscopic grasper which has the potential for tissue to catch on it during use and lead to tissue damage.

Code information

Batch: 1380797, 1382197

Distribution pattern

US: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY OUS: Argentina, Australia, Austria, Belgium, Canada, Chile, Costa Rica, Denmark, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Latvia, Liechtenstein, Luxembourg, Netherlands, New Zealand, Peru, Portugal, Serbia, Singapore, South Africa, Spain, Thailand, United Kingdom