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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 77661

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

Open FDA event record

Event summary

Timeline bucket
June 07, 2017
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Terumo Medical 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

17 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 17

Glidesheath Slender Hydrophilic Coated Introducer Sheath, 5FR - 10CM (0.021), REF/Product Code RM*CS5F10NA, STERILE, Rx ONLY

Z-0214-2018
Recall number
Z-0214-2018
Initiated
June 07, 2017
Classification
Class II
Status
Terminated
Recalling firm
Terumo Medical Corp
Quantity
N/A

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
incomplete seal
Sterility assurance reason.sterility_assurance · v1.0.0
breach of the sterile barrier

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

An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units). This breach of the sterile barrier may compromise the sterility of the sheath.

Code information

Lot 161104

Distribution pattern

Nationwide and Canada

device · product 2 of 17

Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 10CM (0.021), REF/Product Code RM*CS6F10NA, STERILE, Rx ONLY

Z-0215-2018
Recall number
Z-0215-2018
Initiated
June 07, 2017
Classification
Class II
Status
Terminated
Recalling firm
Terumo Medical Corp
Quantity
N/A

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
incomplete seal
Sterility assurance reason.sterility_assurance · v1.0.0
breach of the sterile barrier

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

An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units). This breach of the sterile barrier may compromise the sterility of the sheath.

Code information

Lots 161116, 170113

Distribution pattern

Nationwide and Canada

device · product 3 of 17

Glidesheath Slender Hydrophilic Coated Introducer Sheath, 7FR - 10CM (0.021), REF/Product Code RM*CS7F10NA, STERILE, Rx ONLY

Z-0216-2018
Recall number
Z-0216-2018
Initiated
June 07, 2017
Classification
Class II
Status
Terminated
Recalling firm
Terumo Medical Corp
Quantity
N/A

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
incomplete seal
Sterility assurance reason.sterility_assurance · v1.0.0
breach of the sterile barrier

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

An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units). This breach of the sterile barrier may compromise the sterility of the sheath.

Code information

Lot 161111

Distribution pattern

Nationwide and Canada

device · product 4 of 17

Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 5FR - 10CM (0.021), REF/Product Code RM*ES5F10HAU, STERILE, Rx ONLY

Z-0217-2018
Recall number
Z-0217-2018
Initiated
June 07, 2017
Classification
Class II
Status
Terminated
Recalling firm
Terumo Medical Corp
Quantity
N/A

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
incomplete seal
Sterility assurance reason.sterility_assurance · v1.0.0
breach of the sterile barrier

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

An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units). This breach of the sterile barrier may compromise the sterility of the sheath.

Code information

Lot s161118, 161206, 170119

Distribution pattern

Nationwide and Canada

device · product 5 of 17

Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 5FR - 16CM (0.021), REF/Product Code RM*ES5F16HAU, STERILE, Rx ONLY

Z-0218-2018
Recall number
Z-0218-2018
Initiated
June 07, 2017
Classification
Class II
Status
Terminated
Recalling firm
Terumo Medical Corp
Quantity
N/A

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
incomplete seal
Sterility assurance reason.sterility_assurance · v1.0.0
breach of the sterile barrier

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

An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units). This breach of the sterile barrier may compromise the sterility of the sheath.

Code information

Lot 170316

Distribution pattern

Nationwide and Canada

device · product 6 of 17

Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 5FR - 10CM (0.025), REF/Product Code RM*ES5J10HAT, STERILE, Rx ONLY

Z-0219-2018
Recall number
Z-0219-2018
Initiated
June 07, 2017
Classification
Class II
Status
Terminated
Recalling firm
Terumo Medical Corp
Quantity
N/A

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
incomplete seal
Sterility assurance reason.sterility_assurance · v1.0.0
breach of the sterile barrier

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

An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units). This breach of the sterile barrier may compromise the sterility of the sheath.

Code information

Lot 161110, 161214, 170119

Distribution pattern

Nationwide and Canada

device · product 7 of 17

Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 6FR - 10CM (0.021), REF/Product Code RM*ES6F10HAU, STERILE, Rx ONLY

Z-0220-2018
Recall number
Z-0220-2018
Initiated
June 07, 2017
Classification
Class II
Status
Terminated
Recalling firm
Terumo Medical Corp
Quantity
N/A

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
incomplete seal
Sterility assurance reason.sterility_assurance · v1.0.0
breach of the sterile barrier

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

An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units). This breach of the sterile barrier may compromise the sterility of the sheath.

Code information

Lot s161019, 161102, 161103, 161118, 161201, 161202, 161205, 161215, 161216, 170109, 170110, 170111, 170202, 17023

Distribution pattern

Nationwide and Canada

device · product 8 of 17

Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 6FR - 16CM (0.021), REF/Product Code RM*ES6F16HAU, STERILE, Rx ONLY

Z-0221-2018
Recall number
Z-0221-2018
Initiated
June 07, 2017
Classification
Class II
Status
Terminated
Recalling firm
Terumo Medical Corp
Quantity
N/A

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
incomplete seal
Sterility assurance reason.sterility_assurance · v1.0.0
breach of the sterile barrier

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

An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units). This breach of the sterile barrier may compromise the sterility of the sheath.

Code information

Lot s 161209, 170118, 170215, 170317

Distribution pattern

Nationwide and Canada

device · product 9 of 17

Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 6FR - 10CM (0.025), REF/Product Code RM*ES6J10HAT, STERILE, Rx ONLY

Z-0222-2018
Recall number
Z-0222-2018
Initiated
June 07, 2017
Classification
Class II
Status
Terminated
Recalling firm
Terumo Medical Corp
Quantity
N/A

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
incomplete seal
Sterility assurance reason.sterility_assurance · v1.0.0
breach of the sterile barrier

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

An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units). This breach of the sterile barrier may compromise the sterility of the sheath.

Code information

Lot s 161018, 161116, 161117, 161213, 161214, 170118, 170119

Distribution pattern

Nationwide and Canada

device · product 10 of 17

Glidesheath Slender Hydrophilic Coated Introducer Sheath, 5FR - 10CM (0.021), REF/Product Code RM*RS5F10PA, STERILE, Rx ONLY

Z-0223-2018
Recall number
Z-0223-2018
Initiated
June 07, 2017
Classification
Class II
Status
Terminated
Recalling firm
Terumo Medical Corp
Quantity
N/A

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
incomplete seal
Sterility assurance reason.sterility_assurance · v1.0.0
breach of the sterile barrier

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

An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units). This breach of the sterile barrier may compromise the sterility of the sheath.

Code information

Lot s 161019, 161115, 161212, 170112

Distribution pattern

Nationwide and Canada

device · product 11 of 17

Glidesheath Slender Hydrophilic Coated Introducer Sheath, 5FR - 16CM (0.021), REF/Product Code RM*RS5F16PA, STERILE, Rx ONLY

Z-0224-2018
Recall number
Z-0224-2018
Initiated
June 07, 2017
Classification
Class II
Status
Terminated
Recalling firm
Terumo Medical Corp
Quantity
N/A

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
incomplete seal
Sterility assurance reason.sterility_assurance · v1.0.0
breach of the sterile barrier

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

An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units). This breach of the sterile barrier may compromise the sterility of the sheath.

Code information

Lot s 161107, 170209, 170307, 170406

Distribution pattern

Nationwide and Canada

device · product 12 of 17

Glidesheath Slender Hydrophilic Coated Introducer Sheath, 5FR - 10CM (0.025), REF/Product Code RM*RS5J10PA, STERILE, Rx ONLY

Z-0225-2018
Recall number
Z-0225-2018
Initiated
June 07, 2017
Classification
Class II
Status
Terminated
Recalling firm
Terumo Medical Corp
Quantity
N/A

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
incomplete seal
Sterility assurance reason.sterility_assurance · v1.0.0
breach of the sterile barrier

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

An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units). This breach of the sterile barrier may compromise the sterility of the sheath.

Code information

Lot 170113

Distribution pattern

Nationwide and Canada

device · product 13 of 17

Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 10CM (0.021), REF/Product Code RM*RS6F10PA, STERILE, Rx ONLY

Z-0226-2018
Recall number
Z-0226-2018
Initiated
June 07, 2017
Classification
Class II
Status
Terminated
Recalling firm
Terumo Medical Corp
Quantity
N/A

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
incomplete seal
Sterility assurance reason.sterility_assurance · v1.0.0
breach of the sterile barrier

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

An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units). This breach of the sterile barrier may compromise the sterility of the sheath.

Code information

Lot s 161020, 161021, 161024, 161025, 161027, 161028, 161031, 161101, 161104, 101107, 101108, 161109, 161109, 161110, 161111, 161114, 161121, 161122, 161122, 161123, 161124, 161125, 161128, 161129, 161130, 161206, 161207, 161208, 161209, 161212, 161219, 161220, 161221, 161222, 1612223, 161226, 161227, 161228, 170109, 170112, 170113, 170116, 170117, 170120, 170123, 170124, 170125, 170126, 170127, 170130, 170131, 170201

Distribution pattern

Nationwide and Canada

device · product 14 of 17

Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 16CM (0.021), REF/Product Code RM*RS6F16PA, STERILE, Rx ONLY

Z-0227-2018
Recall number
Z-0227-2018
Initiated
June 07, 2017
Classification
Class II
Status
Terminated
Recalling firm
Terumo Medical Corp
Quantity
N/A

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
incomplete seal
Sterility assurance reason.sterility_assurance · v1.0.0
breach of the sterile barrier

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

An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units). This breach of the sterile barrier may compromise the sterility of the sheath.

Code information

Lot s 161116, 161213, 170117, 170213, 170308

Distribution pattern

Nationwide and Canada

device · product 15 of 17

Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 10CM (0.025), REF/Product Code RM*RS6J10PA, STERILE, Rx ONLY

Z-0228-2018
Recall number
Z-0228-2018
Initiated
June 07, 2017
Classification
Class II
Status
Terminated
Recalling firm
Terumo Medical Corp
Quantity
N/A

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
incomplete seal
Sterility assurance reason.sterility_assurance · v1.0.0
breach of the sterile barrier

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

An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units). This breach of the sterile barrier may compromise the sterility of the sheath.

Code information

Lot s 161115, 161130, 161207, 170116

Distribution pattern

Nationwide and Canada

device · product 16 of 17

Glidesheath Slender Hydrophilic Coated Introducer Sheath, 7FR - 10CM (0.021), REF/Product Code RM*RS7F10PA, STERILE, Rx ONLY

Z-0229-2018
Recall number
Z-0229-2018
Initiated
June 07, 2017
Classification
Class II
Status
Terminated
Recalling firm
Terumo Medical Corp
Quantity
N/A

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
incomplete seal
Sterility assurance reason.sterility_assurance · v1.0.0
breach of the sterile barrier

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

An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units). This breach of the sterile barrier may compromise the sterility of the sheath.

Code information

Lot s 161109, 161216, 170118, 170126

Distribution pattern

Nationwide and Canada

device · product 17 of 17

Glidesheath Slender Hydrophilic Coated Introducer Sheath, 7FR - 16CM (0.021), REF/Product Code RM*RS7F16PA, STERILE, Rx ONLY

Z-0230-2018
Recall number
Z-0230-2018
Initiated
June 07, 2017
Classification
Class II
Status
Terminated
Recalling firm
Terumo Medical Corp
Quantity
N/A

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
incomplete seal
Sterility assurance reason.sterility_assurance · v1.0.0
breach of the sterile barrier

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

An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units). This breach of the sterile barrier may compromise the sterility of the sheath.

Code information

Lot s 161019, 161108, 161215, 170112, 170213, 170314

Distribution pattern

Nationwide and Canada