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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 76774

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

Open FDA event record

Event summary

Timeline bucket
March 16, 2017
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Windstone Medical Packaging, Inc.

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

18 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 18

Cataract Kit, part numbers CAT1467AM and CAT1538(B. Product packaged in a convenient manner for use in a general clinical procedure

Z-1783-2017
Recall number
Z-1783-2017
Initiated
March 16, 2017
Classification
Class II
Status
Terminated
Quantity
4,065 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile packaging of the eye pad to be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential for the sterile packaging of the eye pad to be compromised.

Code information

Lot numbers: 76819 76820 78070 78533 78534 78535 79189 79972 80673 80674 80696 81600 82230 83093 83094 83585 83899 84580 85193 86565 86956 87679 88237 88915 88917 89946 95370 95574 95575 96215 96720 97384 97669 99621 99816 99881 101220

Distribution pattern

Nationwide Distribution including CA, CO, FL, GA, IA, KY, MA, MN, MO, ND, NJ, NV, OH, SD, TX, UT, WI, and WY.

device · product 2 of 18

Cataract Kit - Dr. Slingsby, part number CMP1017(B. Product packaged in a convenient manner for use in a general clinical procedure

Z-1784-2017
Recall number
Z-1784-2017
Initiated
March 16, 2017
Classification
Class II
Status
Terminated
Quantity
990 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile packaging of the eye pad to be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential for the sterile packaging of the eye pad to be compromised.

Code information

Lot numbers: 77429 79999 81143 81960 84055 84556 85169 85550 86501 87632 87819 96056 96963 97873 98741 99416 99763 100278 101449

Distribution pattern

Nationwide Distribution including CA, CO, FL, GA, IA, KY, MA, MN, MO, ND, NJ, NV, OH, SD, TX, UT, WI, and WY.

device · product 3 of 18

Cataract Pack, part numbers 008886-1, AMS2806, PSS3442, PSS3442(A, WAL1155, and WAL1155(A. Product packaged in a convenient manner for use in a general clinical procedure

Z-1785-2017
Recall number
Z-1785-2017
Initiated
March 16, 2017
Classification
Class II
Status
Terminated
Quantity
7,508 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile packaging of the eye pad to be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential for the sterile packaging of the eye pad to be compromised.

Code information

Lot numbers: 63660 64459 65292 65897 65898 66764 66765 66770 67186 67187 67403 67867 67868 68184 68858 69648 69649 71075 71076 71077 71472 71950 71951 71952 72496 72497 72498 74246 74623 74985 75511 75512 75583 75904 76936 77245 77481 77591 78638 82162 82430 82583 82952 82954 82955 82956 82957 83400 83401 83855 83856 83857 83858 83904 84167 85095 85475 85944 86233 86234 86235 86593 86788 86925 87176 87552 87616 87721 88020 88234 88708 88709 89240 89643 89978 94699 95340 95341 95671 95873 96086 96372 96651 96847 96848 97636 97905 97985 98071 98228 98229 98585 98586 98587 98775 98826 98977 99442 99443 99587 99803 100091 100092 100155 100312 100313 100698 100699 101691 101692 101926 101927 102049 102139 102361

Distribution pattern

Nationwide Distribution including CA, CO, FL, GA, IA, KY, MA, MN, MO, ND, NJ, NV, OH, SD, TX, UT, WI, and WY.

device · product 4 of 18

Custom Tray, part numbers PSS1111 and PSS1111(A. Product packaged in a convenient manner for use in a general clinical procedure

Z-1786-2017
Recall number
Z-1786-2017
Initiated
March 16, 2017
Classification
Class II
Status
Terminated
Quantity
164 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile packaging of the eye pad to be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential for the sterile packaging of the eye pad to be compromised.

Code information

Lot numbers: 64496 70752 79598 79966 82199 84036 85170 86682 87625 88001 89215 96462 100885

Distribution pattern

Nationwide Distribution including CA, CO, FL, GA, IA, KY, MA, MN, MO, ND, NJ, NV, OH, SD, TX, UT, WI, and WY.

device · product 5 of 18

Dicken Eye Pack, part number CPA-3202-2. Product packaged in a convenient manner for use in a general clinical procedure

Z-1787-2017
Recall number
Z-1787-2017
Initiated
March 16, 2017
Classification
Class II
Status
Terminated
Quantity
172 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile packaging of the eye pad to be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential for the sterile packaging of the eye pad to be compromised.

Code information

Lot numbers: 66434 67357 67740 68573 72552 72934 73659 75891 82964 84240 84810 88958 96250 99637

Distribution pattern

Nationwide Distribution including CA, CO, FL, GA, IA, KY, MA, MN, MO, ND, NJ, NV, OH, SD, TX, UT, WI, and WY.

device · product 6 of 18

Dr. Wischmeier Pack, part numbers: AMS3509 and AMS3509(A Product packaged in a convenient manner for use in a general clinical procedure

Z-1788-2017
Recall number
Z-1788-2017
Initiated
March 16, 2017
Classification
Class II
Status
Terminated
Quantity
1,170 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile packaging of the eye pad to be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential for the sterile packaging of the eye pad to be compromised.

Code information

Lot numbers: 75870 78661 79154 81580 81800 83500 83594 83680 84118 84262 86073 86485 86887 87119 89180 95109 95422 95809 96760 97589 98512 99060 100410 101234

Distribution pattern

Nationwide Distribution including CA, CO, FL, GA, IA, KY, MA, MN, MO, ND, NJ, NV, OH, SD, TX, UT, WI, and WY.

device · product 7 of 18

ENT Pack, part number AMS2727 Product packaged in a convenient manner for use in a general clinical procedure

Z-1789-2017
Recall number
Z-1789-2017
Initiated
March 16, 2017
Classification
Class II
Status
Terminated
Quantity
16 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile packaging of the eye pad to be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential for the sterile packaging of the eye pad to be compromised.

Code information

Lot numbers: 72702 and 78567

Distribution pattern

Nationwide Distribution including CA, CO, FL, GA, IA, KY, MA, MN, MO, ND, NJ, NV, OH, SD, TX, UT, WI, and WY.

device · product 8 of 18

Eye Cataract Pack, part numbers AMS1359 and AMS1359-1 Product packaged in a convenient manner for use in a general clinical procedure

Z-1790-2017
Recall number
Z-1790-2017
Initiated
March 16, 2017
Classification
Class II
Status
Terminated
Quantity
1,520 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile packaging of the eye pad to be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential for the sterile packaging of the eye pad to be compromised.

Code information

Lot numbers: 62980 63106 63387 63825 63826 64186 64490 64584 65937 75122 75329 77010 77089 77480 77664 78265 78312 78499 79042 79211 79944 79945 80709 80994 82316 82537 82538 82931

Distribution pattern

Nationwide Distribution including CA, CO, FL, GA, IA, KY, MA, MN, MO, ND, NJ, NV, OH, SD, TX, UT, WI, and WY.

device · product 9 of 18

Eye Pack, part numbers WAL1085(B and WAL1085(C\ Product packaged in a convenient manner for use in a general clinical procedure

Z-1791-2017
Recall number
Z-1791-2017
Initiated
March 16, 2017
Classification
Class II
Status
Terminated
Quantity
1,330 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile packaging of the eye pad to be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential for the sterile packaging of the eye pad to be compromised.

Code information

Lot numbers: 62736 63388 63389 64189 64190 64586 65070 65171 65307 65714 65715 66342 66343 67079 67080 68165 68166 68234 68641 69264 69536 69545

Distribution pattern

Nationwide Distribution including CA, CO, FL, GA, IA, KY, MA, MN, MO, ND, NJ, NV, OH, SD, TX, UT, WI, and WY.

device · product 10 of 18

Lasik Tray, part number DDS1045-2 Product packaged in a convenient manner for use in a general clinical procedure

Z-1792-2017
Recall number
Z-1792-2017
Initiated
March 16, 2017
Classification
Class II
Status
Terminated
Quantity
260 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile packaging of the eye pad to be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential for the sterile packaging of the eye pad to be compromised.

Code information

Lot numbers: 100960 103358 79099 81317 82664 82900 85028 86965 88297 89067 89311 94809 95531 98618 99932

Distribution pattern

Nationwide Distribution including CA, CO, FL, GA, IA, KY, MA, MN, MO, ND, NJ, NV, OH, SD, TX, UT, WI, and WY.

device · product 11 of 18

Minor Operation Kit, part number AMS1530 Product packaged in a convenient manner for use in a general clinical procedure

Z-1793-2017
Recall number
Z-1793-2017
Initiated
March 16, 2017
Classification
Class II
Status
Terminated
Quantity
700 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile packaging of the eye pad to be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential for the sterile packaging of the eye pad to be compromised.

Code information

Lot numbers: 81885 84227 89474 98076 99390

Distribution pattern

Nationwide Distribution including CA, CO, FL, GA, IA, KY, MA, MN, MO, ND, NJ, NV, OH, SD, TX, UT, WI, and WY.

device · product 12 of 18

Ophthalmic Pack, Part number WAL1107(A and WAL1190 Product packaged in a convenient manner for use in a general clinical procedure

Z-1794-2017
Recall number
Z-1794-2017
Initiated
March 16, 2017
Classification
Class II
Status
Terminated
Quantity
169 packs

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile packaging of the eye pad to be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential for the sterile packaging of the eye pad to be compromised.

Code information

Lot numbers: 87223 88773 89837 95552 97215 97765 100154 100984 102837

Distribution pattern

Nationwide Distribution including CA, CO, FL, GA, IA, KY, MA, MN, MO, ND, NJ, NV, OH, SD, TX, UT, WI, and WY.

device · product 13 of 18

Ortho Basic Pack, part number AMS6459 Product packaged in a convenient manner for use in a general clinical procedure

Z-1795-2017
Recall number
Z-1795-2017
Initiated
March 16, 2017
Classification
Class II
Status
Terminated
Quantity
12 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile packaging of the eye pad to be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential for the sterile packaging of the eye pad to be compromised.

Code information

Lot number: 101180

Distribution pattern

Nationwide Distribution including CA, CO, FL, GA, IA, KY, MA, MN, MO, ND, NJ, NV, OH, SD, TX, UT, WI, and WY.

device · product 14 of 18

Plastic Pack, part numbers AMS1028, AMS1028(A, and WAL1189. Product packaged in a convenient manner for use in a general clinical procedure

Z-1796-2017
Recall number
Z-1796-2017
Initiated
March 16, 2017
Classification
Class II
Status
Terminated
Quantity
376 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile packaging of the eye pad to be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential for the sterile packaging of the eye pad to be compromised.

Code information

Lot numbers: 76028 76762 77415 77811 80676 81907 82972 83238 84514 86860 88156 89013 89567 94566 95941 97769 98479 99356 101279 102974

Distribution pattern

Nationwide Distribution including CA, CO, FL, GA, IA, KY, MA, MN, MO, ND, NJ, NV, OH, SD, TX, UT, WI, and WY.

device · product 15 of 18

PRK Tray, part number DDS1044 Product packaged in a convenient manner for use in a general clinical procedure

Z-1797-2017
Recall number
Z-1797-2017
Initiated
March 16, 2017
Classification
Class II
Status
Terminated
Quantity
20 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile packaging of the eye pad to be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential for the sterile packaging of the eye pad to be compromised.

Code information

Lot numbers: 78709 84777 103152

Distribution pattern

Nationwide Distribution including CA, CO, FL, GA, IA, KY, MA, MN, MO, ND, NJ, NV, OH, SD, TX, UT, WI, and WY.

device · product 16 of 18

Setup Pack, part number AMS3112(A Product packaged in a convenient manner for use in a general clinical procedure

Z-1798-2017
Recall number
Z-1798-2017
Initiated
March 16, 2017
Classification
Class II
Status
Terminated
Quantity
500 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile packaging of the eye pad to be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential for the sterile packaging of the eye pad to be compromised.

Code information

Lot numbers: 84197 85135 86063 87112 88181 89030 94937 95806 96599 97277 97705 99303 100020

Distribution pattern

Nationwide Distribution including CA, CO, FL, GA, IA, KY, MA, MN, MO, ND, NJ, NV, OH, SD, TX, UT, WI, and WY.

device · product 17 of 18

Vitrectomy Kit, part number CMP1016(A. Product packaged in a convenient manner for use in a general clinical procedure

Z-1799-2017
Recall number
Z-1799-2017
Initiated
March 16, 2017
Classification
Class II
Status
Terminated
Quantity
440 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile packaging of the eye pad to be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential for the sterile packaging of the eye pad to be compromised.

Code information

Lot numbers: 75908 78658 79157 79577 81959 83285 84916 85168 86500 87319 88343 88984 89749 96802 99415 102487

Distribution pattern

Nationwide Distribution including CA, CO, FL, GA, IA, KY, MA, MN, MO, ND, NJ, NV, OH, SD, TX, UT, WI, and WY.

device · product 18 of 18

Vitrectomy Pack, part number AMS4952 Product packaged in a convenient manner for use in a general clinical procedure

Z-1800-2017
Recall number
Z-1800-2017
Initiated
March 16, 2017
Classification
Class II
Status
Terminated
Quantity
100 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile packaging of the eye pad to be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential for the sterile packaging of the eye pad to be compromised.

Code information

Lot numbers: 84384 85615 96957 99402

Distribution pattern

Nationwide Distribution including CA, CO, FL, GA, IA, KY, MA, MN, MO, ND, NJ, NV, OH, SD, TX, UT, WI, and WY.

Field note

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