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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 79608

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

Open FDA event record

Event summary

Timeline bucket
February 12, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Boston Scientific Corporation

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

11 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 11

Capio SLIM Suture Capturing Device, Model #M0068318250. Intended for use in general suturing applications during open surgery to assist in the placement of suture material in tissues at the operative site.

Z-1616-2018
Recall number
Z-1616-2018
Initiated
February 12, 2018
Classification
Class II
Status
Terminated
Quantity
21,250

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for Capio sutures to break and /or detach.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for Capio sutures to break and /or detach.

Code information

UDI:08714729842224. Batch numbers: 17781206 19335463 20312941 17782808 19435078 20423794 17790316 19568158 20453711 17792469 19573475 20453712 17986321 19701151 20475301 17991696 19711511 20484084 18106407 19833973 20484085 18110253 19858683 20532136 18213570 19858950 20628943 18304052 19882066 20633409 18384108 19882067 20637817 18407974 19887279 20693087 18420687 19942844 20697608 18492494 19959781 20838671 18494737 19963492 20838674 18620481 19993297 20838675 18740238 20000796 20838676 18792184 20001160 20902944 18855259 20001161 20968694 18922488 20006757 21065530 18925301 20009446 21135395 19027722 20017944 21166978 19138109 20202691 21168424 19173080 20203473 21168425 19243603 20305797 21258657 19243604 20305799 21362103 19335462 20305920 21386335

Distribution pattern

Worldwide Distribution -- US, Brazil, Guatemala, Ecuador, Malaysia, Czech Republic, United Kingdom, Argentina, Honduras, Peru, Singapore, Denmark, Iceland, Chile, Nicaragua, Venezuela, Japan, Egypt, Israel, Canada, Panama, Taiwan, United Arab Emirates, Finland, Ireland, Mexico, Dominican Republic, Hong Kong, Austria, France, Italy, Costa Rica, Trinidad and Tobago, Australia, Bahrain, Georgia, Islamic Republic of Iran, El Salvador, Colombia, New Zealand, Belgium, Germany, Jordan, Norway, Russia, Pakistan, Slovakia, Portugal, South Africa, Oman, Saudi Arabia, Poland, Slovenia, Qatar, Spain, Kenya, Lebanon, Mauritius, Netherlands, Sweden, Turkey, Kuwait, Malta, Namibia, Romania, Switzerland, and Greece.

device · product 2 of 11

Capio SLIM Box 5, Model #M0068318261; Intended for use in general suturing applications during open surgery to assist in the placement of suture material in tissues at the operative site.

Z-1617-2018
Recall number
Z-1617-2018
Initiated
February 12, 2018
Classification
Class II
Status
Terminated
Quantity
60,538

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for Capio sutures to break and /or detach.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for Capio sutures to break and /or detach.

Code information

UDI:08714729842224. Batch numbers: 19083076 19490462 20703048 19138102 19575737 20703101 19138104 19579790 20706387 20552143 19583816 20779052 20552145 19588973 20786955 20552147 19604718 20838609 20552300 19715051 20838611 19138106 19720437 20838613 19138108 19730190 20838615 19334997 19760389 20838617 20552153 19818985 20838619 17685429 19825371 20838661 17689642 19868166 20838663 17774102 19868170 20838665 17777555 19873851 20838667 17792395 19873853 20838670 17899922 19945906 20902946 17906429 19950376 20908772 17907124 19965002 20908774 17907855 19998515 20908776 17915689 20000798 20908778 17919851 20001166 20923178 17920787 20005049 20933960 17985873 20061149 20933962 17990901 20061151 20968696 17995421 20061153 20971515 17997519 20061155 20978294 18001945 20078729 21058901 18005330 20079183 21135392 18024683 20179283 21149060 18036357 20179505 21153916 18104991 20183190 21153918 18111726 20183193 21238940 18115409 20189154 21240810 18120488 20196783 21244374 18212832 20260976 21244755 18217456 20275824 21246277 18221332 20300581 21246370 18222053 20300685 21277765 18295603 20300689 21278301 18299439 20300692 21347579 18388438 20305782 21347701 18394085 20331414 21358289 18396171 20331416 21360859 18399797 20331418 21366235 18410457 20355333 21386338 18414187 20359462 21386740 18498497 20359470 21402640 18500136 20360846 21408533 18513753 20367015 21408536 18517656 20416925 21412229 18518037 20417300 20633990 18626569 20417302 20633992 18642959 20417304 20637803 18645072 20436291 20637805 18648870 20440668 20638061 18673869 20440672 20701932 18737139 20440674 19334999 18795870 20440677 19335461 18849259 20440679 19418628 18852877 20473754 19418630 18915563 20473758 19437992 18921359 20484087 19482938 18929303 20488264 20554655 18938181 20532138 20580835 19027577 20532440 20582262 19027750 20533045 19243606 19027752 20533047 19243608 19027754 20533580 19079309 20533582

Distribution pattern

Worldwide Distribution -- US, Brazil, Guatemala, Ecuador, Malaysia, Czech Republic, United Kingdom, Argentina, Honduras, Peru, Singapore, Denmark, Iceland, Chile, Nicaragua, Venezuela, Japan, Egypt, Israel, Canada, Panama, Taiwan, United Arab Emirates, Finland, Ireland, Mexico, Dominican Republic, Hong Kong, Austria, France, Italy, Costa Rica, Trinidad and Tobago, Australia, Bahrain, Georgia, Islamic Republic of Iran, El Salvador, Colombia, New Zealand, Belgium, Germany, Jordan, Norway, Russia, Pakistan, Slovakia, Portugal, South Africa, Oman, Saudi Arabia, Poland, Slovenia, Qatar, Spain, Kenya, Lebanon, Mauritius, Netherlands, Sweden, Turkey, Kuwait, Malta, Namibia, Romania, Switzerland, and Greece.

device · product 3 of 11

Capio CL; Model #M0068311350. Indicated for the placement of suture in a variety of Transvaginal procedures.

Z-1618-2018
Recall number
Z-1618-2018
Initiated
February 12, 2018
Classification
Class II
Status
Terminated
Quantity
1,258

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for Capio sutures to break and /or detach.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for Capio sutures to break and /or detach.

Code information

UDI:08714729516545. Batch numbers: 18011270 18245411 19491588 18011271 18654941 19668541 18229999 18881759 19987267 20602764 19173286 20382965 20602764 20850569 21234964

Distribution pattern

Worldwide Distribution -- US, Brazil, Guatemala, Ecuador, Malaysia, Czech Republic, United Kingdom, Argentina, Honduras, Peru, Singapore, Denmark, Iceland, Chile, Nicaragua, Venezuela, Japan, Egypt, Israel, Canada, Panama, Taiwan, United Arab Emirates, Finland, Ireland, Mexico, Dominican Republic, Hong Kong, Austria, France, Italy, Costa Rica, Trinidad and Tobago, Australia, Bahrain, Georgia, Islamic Republic of Iran, El Salvador, Colombia, New Zealand, Belgium, Germany, Jordan, Norway, Russia, Pakistan, Slovakia, Portugal, South Africa, Oman, Saudi Arabia, Poland, Slovenia, Qatar, Spain, Kenya, Lebanon, Mauritius, Netherlands, Sweden, Turkey, Kuwait, Malta, Namibia, Romania, Switzerland, and Greece.

device · product 4 of 11

Capio Open Access Box 4 (Capio OPC); Model #M0068311251. Intended for use in general suturing applications during open or endoscopic surgery to assist in the placement of suture material in tissues at the operative site.

Z-1619-2018
Recall number
Z-1619-2018
Initiated
February 12, 2018
Classification
Class II
Status
Terminated
Quantity
21,051

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for Capio sutures to break and /or detach.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for Capio sutures to break and /or detach.

Code information

UDI:08714729257615. Batch numbers: 17736884 18743137 19980158 17743915 18744758 20088658 17746353 18831921 20146415 17748695 18952185 20151917 17758603 18956329 20225741 17763024 18960345 20225743 17791930 19046994 20341445 17970678 19046996 20341447 18129693 19046998 20560166 18134147 19173285 20639024 18135271 19225756 20706637 18229178 19329479 20711254 18281817 19437996 20713128 18286295 19442739 20822293 18357019 19560316 20833214 18362244 19646043 20834317 18430411 19646222 20838382 18488288 19659042 21069563 18605754 19824767 21081751 18606004 19835267 21258659 18611631 19856248 21362105 19975069 21362107

Distribution pattern

Worldwide Distribution -- US, Brazil, Guatemala, Ecuador, Malaysia, Czech Republic, United Kingdom, Argentina, Honduras, Peru, Singapore, Denmark, Iceland, Chile, Nicaragua, Venezuela, Japan, Egypt, Israel, Canada, Panama, Taiwan, United Arab Emirates, Finland, Ireland, Mexico, Dominican Republic, Hong Kong, Austria, France, Italy, Costa Rica, Trinidad and Tobago, Australia, Bahrain, Georgia, Islamic Republic of Iran, El Salvador, Colombia, New Zealand, Belgium, Germany, Jordan, Norway, Russia, Pakistan, Slovakia, Portugal, South Africa, Oman, Saudi Arabia, Poland, Slovenia, Qatar, Spain, Kenya, Lebanon, Mauritius, Netherlands, Sweden, Turkey, Kuwait, Malta, Namibia, Romania, Switzerland, and Greece.

device · product 5 of 11

Capio Standard Box 4 (Capio PC); Model #M0068312321. Intended for use in general suturing applications during open or endoscopic surgery to assist in the placement of suture material in tissues at the operative site.

Z-1620-2018
Recall number
Z-1620-2018
Initiated
February 12, 2018
Classification
Class II
Status
Terminated
Quantity
4,144

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for Capio sutures to break and /or detach.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for Capio sutures to break and /or detach.

Code information

UDI:08714729257622 Batch numbers: 17817547 19050231 20639026 17925410 19225758 20717524 18139200 19335465 21081753 18363737 19437994 21258781 18615714 19698427 21386211 18826587 19983956 20341449 18955689 20341449

Distribution pattern

Worldwide Distribution -- US, Brazil, Guatemala, Ecuador, Malaysia, Czech Republic, United Kingdom, Argentina, Honduras, Peru, Singapore, Denmark, Iceland, Chile, Nicaragua, Venezuela, Japan, Egypt, Israel, Canada, Panama, Taiwan, United Arab Emirates, Finland, Ireland, Mexico, Dominican Republic, Hong Kong, Austria, France, Italy, Costa Rica, Trinidad and Tobago, Australia, Bahrain, Georgia, Islamic Republic of Iran, El Salvador, Colombia, New Zealand, Belgium, Germany, Jordan, Norway, Russia, Pakistan, Slovakia, Portugal, South Africa, Oman, Saudi Arabia, Poland, Slovenia, Qatar, Spain, Kenya, Lebanon, Mauritius, Netherlands, Sweden, Turkey, Kuwait, Malta, Namibia, Romania, Switzerland, and Greece.

device · product 6 of 11

Capio RP; Model #M0068321010. Intended for use in general suturing applications during open surgery to assist in the placement of suture material in tissues at the operative site.

Z-1621-2018
Recall number
Z-1621-2018
Initiated
February 12, 2018
Classification
Class II
Status
Terminated
Quantity
2,567

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for Capio sutures to break and /or detach.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for Capio sutures to break and /or detach.

Code information

UDI:08714729470212 Batch numbers: 17813516 18653139 19987270 18014753 18886132 20278129 18015797 19173287 20604455 18015964 19335466 20844362 18234939 19491590 21178815 18237323 19693866 21227473 21386746

Distribution pattern

Worldwide Distribution -- US, Brazil, Guatemala, Ecuador, Malaysia, Czech Republic, United Kingdom, Argentina, Honduras, Peru, Singapore, Denmark, Iceland, Chile, Nicaragua, Venezuela, Japan, Egypt, Israel, Canada, Panama, Taiwan, United Arab Emirates, Finland, Ireland, Mexico, Dominican Republic, Hong Kong, Austria, France, Italy, Costa Rica, Trinidad and Tobago, Australia, Bahrain, Georgia, Islamic Republic of Iran, El Salvador, Colombia, New Zealand, Belgium, Germany, Jordan, Norway, Russia, Pakistan, Slovakia, Portugal, South Africa, Oman, Saudi Arabia, Poland, Slovenia, Qatar, Spain, Kenya, Lebanon, Mauritius, Netherlands, Sweden, Turkey, Kuwait, Malta, Namibia, Romania, Switzerland, and Greece.

device · product 7 of 11

Uphold LITE w/ Capio SLIM; Model #M0068318170. Indicated for tissue reinforcement in women with pelvic organ prolapse.

Z-1622-2018
Recall number
Z-1622-2018
Initiated
February 12, 2018
Classification
Class II
Status
Terminated
Quantity
24,126

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for Capio sutures to break and /or detach.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for Capio sutures to break and /or detach.

Code information

UDI:08714729839200 Batch numbers: 27019 56827 21250249 27898 56829 21271669 28713 57715 21336724 28974 57716 21377535 29299 58081 21402115 30503 58083 21432026 31359 58944 21447170 31516 58945 21496403 32828 60407 ML00002769 32829 60409 ML00002810 33791 61098 ML00002857 33792 61420 ML00002913 34053 61421 ML00002964 36070 61422 ML00002999 37918 61425 ML00003034 39009 61426 ML00003091 39700 62156 ML00003142

Distribution pattern

Worldwide Distribution -- US, Brazil, Guatemala, Ecuador, Malaysia, Czech Republic, United Kingdom, Argentina, Honduras, Peru, Singapore, Denmark, Iceland, Chile, Nicaragua, Venezuela, Japan, Egypt, Israel, Canada, Panama, Taiwan, United Arab Emirates, Finland, Ireland, Mexico, Dominican Republic, Hong Kong, Austria, France, Italy, Costa Rica, Trinidad and Tobago, Australia, Bahrain, Georgia, Islamic Republic of Iran, El Salvador, Colombia, New Zealand, Belgium, Germany, Jordan, Norway, Russia, Pakistan, Slovakia, Portugal, South Africa, Oman, Saudi Arabia, Poland, Slovenia, Qatar, Spain, Kenya, Lebanon, Mauritius, Netherlands, Sweden, Turkey, Kuwait, Malta, Namibia, Romania, Switzerland, and Greece.

device · product 8 of 11

Posterior LITE w/ Capio SLIM; Model #M0068318150. Indicated for tissue reinforcement in women with pelvic organ prolapse.

Z-1623-2018
Recall number
Z-1623-2018
Initiated
February 12, 2018
Classification
Class II
Status
Terminated
Quantity
1,541

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for Capio sutures to break and /or detach.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for Capio sutures to break and /or detach.

Code information

GTIN: 08714729854548 Batch numbers: 36893 20721161 20867461 39699 20750829 20884690 47724 20750830 20884691 49915 20750831 20884692 49916 20774546 21021770 52597 20803727 21250250 56828 20803728 21320277 58771 20803729 21351865 60410 20807399 21359456 60770 20807700 ML00003061 62154 20807701 ML00003213 62509 20830041 ML00003329 20720887 20830060 ML00003360 20720888 20830202 20720889 20865779

Distribution pattern

Worldwide Distribution -- US, Brazil, Guatemala, Ecuador, Malaysia, Czech Republic, United Kingdom, Argentina, Honduras, Peru, Singapore, Denmark, Iceland, Chile, Nicaragua, Venezuela, Japan, Egypt, Israel, Canada, Panama, Taiwan, United Arab Emirates, Finland, Ireland, Mexico, Dominican Republic, Hong Kong, Austria, France, Italy, Costa Rica, Trinidad and Tobago, Australia, Bahrain, Georgia, Islamic Republic of Iran, El Salvador, Colombia, New Zealand, Belgium, Germany, Jordan, Norway, Russia, Pakistan, Slovakia, Portugal, South Africa, Oman, Saudi Arabia, Poland, Slovenia, Qatar, Spain, Kenya, Lebanon, Mauritius, Netherlands, Sweden, Turkey, Kuwait, Malta, Namibia, Romania, Switzerland, and Greece.

device · product 9 of 11

PFR Kit- Pinnacle, Anterior Apical; Model #M0068317100. Indicated for tissue reinforcement in women with pelvic organ prolapse.

Z-1624-2018
Recall number
Z-1624-2018
Initiated
February 12, 2018
Classification
Class II
Status
Terminated
Quantity
34

App-derived interpretation

No assignment exists because the official recall reason is blank.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Unavailable

Code information

GTIN: 08714729773047 Batch numbers: ML00002841

Distribution pattern

Worldwide Distribution -- US, Brazil, Guatemala, Ecuador, Malaysia, Czech Republic, United Kingdom, Argentina, Honduras, Peru, Singapore, Denmark, Iceland, Chile, Nicaragua, Venezuela, Japan, Egypt, Israel, Canada, Panama, Taiwan, United Arab Emirates, Finland, Ireland, Mexico, Dominican Republic, Hong Kong, Austria, France, Italy, Costa Rica, Trinidad and Tobago, Australia, Bahrain, Georgia, Islamic Republic of Iran, El Salvador, Colombia, New Zealand, Belgium, Germany, Jordan, Norway, Russia, Pakistan, Slovakia, Portugal, South Africa, Oman, Saudi Arabia, Poland, Slovenia, Qatar, Spain, Kenya, Lebanon, Mauritius, Netherlands, Sweden, Turkey, Kuwait, Malta, Namibia, Romania, Switzerland, and Greece.

device · product 10 of 11

PFR Kit- Pinnacle, Posterior; Model #M0068317100. Indicated for tissue reinforcement in women with pelvic organ prolapse.

Z-1625-2018
Recall number
Z-1625-2018
Initiated
February 12, 2018
Classification
Class II
Status
Terminated
Quantity
24

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for Capio sutures to break and /or detach.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for Capio sutures to break and /or detach.

Code information

GTIN: 08714729784449. Batch number: ML00002919

Distribution pattern

Worldwide Distribution -- US, Brazil, Guatemala, Ecuador, Malaysia, Czech Republic, United Kingdom, Argentina, Honduras, Peru, Singapore, Denmark, Iceland, Chile, Nicaragua, Venezuela, Japan, Egypt, Israel, Canada, Panama, Taiwan, United Arab Emirates, Finland, Ireland, Mexico, Dominican Republic, Hong Kong, Austria, France, Italy, Costa Rica, Trinidad and Tobago, Australia, Bahrain, Georgia, Islamic Republic of Iran, El Salvador, Colombia, New Zealand, Belgium, Germany, Jordan, Norway, Russia, Pakistan, Slovakia, Portugal, South Africa, Oman, Saudi Arabia, Poland, Slovenia, Qatar, Spain, Kenya, Lebanon, Mauritius, Netherlands, Sweden, Turkey, Kuwait, Malta, Namibia, Romania, Switzerland, and Greece.

device · product 11 of 11

Uphold Vaginal Support System; Model #M0068317080. Indicated for tissue reinforcement in women with pelvic organ prolapse.

Z-1626-2018
Recall number
Z-1626-2018
Initiated
February 12, 2018
Classification
Class II
Status
Terminated
Quantity
1,002

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for Capio sutures to break and /or detach.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for Capio sutures to break and /or detach.

Code information

GTIN: 08714729773955. Batch numbers: ML00002892 ML00003166 ML00003060 ML00003291 ML00003119 ML00003435 ML00003516

Distribution pattern

Worldwide Distribution -- US, Brazil, Guatemala, Ecuador, Malaysia, Czech Republic, United Kingdom, Argentina, Honduras, Peru, Singapore, Denmark, Iceland, Chile, Nicaragua, Venezuela, Japan, Egypt, Israel, Canada, Panama, Taiwan, United Arab Emirates, Finland, Ireland, Mexico, Dominican Republic, Hong Kong, Austria, France, Italy, Costa Rica, Trinidad and Tobago, Australia, Bahrain, Georgia, Islamic Republic of Iran, El Salvador, Colombia, New Zealand, Belgium, Germany, Jordan, Norway, Russia, Pakistan, Slovakia, Portugal, South Africa, Oman, Saudi Arabia, Poland, Slovenia, Qatar, Spain, Kenya, Lebanon, Mauritius, Netherlands, Sweden, Turkey, Kuwait, Malta, Namibia, Romania, Switzerland, and Greece.

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