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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 90710

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

Open FDA event record

Event summary

Timeline bucket
July 19, 2022
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Cook Incorporated

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

13 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 13

Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN)RFPC-35-180 ORDER NUMBER (GPN) G07937. For vascular catheter positioning and exchange in diagnostic and interventional procedures.

Z-1706-2022
Recall number
Z-1706-2022
Initiated
July 19, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Cook Incorporated
Quantity
496 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.

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

Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.

Code information

UDI-DI: (01)00827002079373- Lot Numbers: 14145420, 14145424, 14156909, 14156912, 14156916, 14164348, 14173577

Distribution pattern

Nationwide Foreign: AR AT AU BE BG CA CA CH CL CN CZ DE DK ES FR GB GR GU HU IL IT JO JP KR KW MX MY NC NL PE PL PR PT PY RU SE SI TR UY ZA

device · product 2 of 13

Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): RFSPC-35-180 ORDER NUMBER (GPN) G09608. For vascular catheter positioning and exchange in diagnostic and interventional procedures.

Z-1707-2022
Recall number
Z-1707-2022
Initiated
July 19, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Cook Incorporated
Quantity
2407 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.

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

Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.

Code information

UDI-DI: (01)00827002096080- Lot Numbers: 14071906, 14091204, 14134663, 14134667, 14134669, 14134670, 14134673, 14134676, 14143872, 14143873, 14160997, 14184102, NS14143735, NS14152903

Distribution pattern

Nationwide Foreign: AR AT AU BE BG CA CA CH CL CN CZ DE DK ES FR GB GR GU HU IL IT JO JP KR KW MX MY NC NL PE PL PR PT PY RU SE SI TR UY ZA

device · product 3 of 13

Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN):RLPC-35-180 ORDER NUMBER (GPN) G07516. For vascular catheter positioning and exchange in diagnostic and interventional procedures.

Z-1708-2022
Recall number
Z-1708-2022
Initiated
July 19, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Cook Incorporated
Quantity
1450 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.

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

Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.

Code information

UDI-DI: (01)00827002075160- Lot Numbers: 14103953, 14103956, 14143728, 14145412, 14145419, 14153927, 14156907, 14156908, 14156914, 14160996

Distribution pattern

Nationwide Foreign: AR AT AU BE BG CA CA CH CL CN CZ DE DK ES FR GB GR GU HU IL IT JO JP KR KW MX MY NC NL PE PL PR PT PY RU SE SI TR UY ZA

device · product 4 of 13

Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): RPC-35-180 ORDER NUMBER (GPN):G07518. For vascular catheter positioning and exchange in diagnostic and interventional procedures.

Z-1709-2022
Recall number
Z-1709-2022
Initiated
July 19, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Cook Incorporated
Quantity
1997 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.

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

Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.

Code information

UDI-DI: (01)00827002075184 Lot Numbers: 14063361, 14087089, 14087092, 14117033, 14120926, 14120928, 14151216, 14151218, 14153159, 14158614, 14159695, 14159696

Distribution pattern

Nationwide Foreign: AR AT AU BE BG CA CA CH CL CN CZ DE DK ES FR GB GR GU HU IL IT JO JP KR KW MX MY NC NL PE PL PR PT PY RU SE SI TR UY ZA

device · product 5 of 13

Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPW-35-150 ORDER NUMBER (GPN):G56149. For vascular catheter positioning and exchange in diagnostic and interventional procedures.

Z-1710-2022
Recall number
Z-1710-2022
Initiated
July 19, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Cook Incorporated
Quantity
585 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.

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

Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.

Code information

UDI-DI: (01)00827002561496- Lot Numbers: 14070921, 14108915, 14108916, 14129152, 14141997, 14170230

Distribution pattern

Nationwide Foreign: AR AT AU BE BG CA CA CH CL CN CZ DE DK ES FR GB GR GU HU IL IT JO JP KR KW MX MY NC NL PE PL PR PT PY RU SE SI TR UY ZA

device · product 6 of 13

Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWA-18-150 ORDER NUMBER (GPN):G56161. For vascular catheter positioning and exchange in diagnostic and interventional procedures.

Z-1711-2022
Recall number
Z-1711-2022
Initiated
July 19, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Cook Incorporated
Quantity
85 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.

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

Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.

Code information

UDI-DI: (01)00827002561618- Lot Numbers: 14095646, 14174879

Distribution pattern

Nationwide Foreign: AR AT AU BE BG CA CA CH CL CN CZ DE DK ES FR GB GR GU HU IL IT JO JP KR KW MX MY NC NL PE PL PR PT PY RU SE SI TR UY ZA

device · product 7 of 13

Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWA-18-80 ORDER NUMBER (GPN): G56162. For vascular catheter positioning and exchange in diagnostic and interventional procedures.

Z-1712-2022
Recall number
Z-1712-2022
Initiated
July 19, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Cook Incorporated
Quantity
35 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.

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

Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.

Code information

UDI-DI: (01)00827002561625- Lot Numbers: 14070920, 14174878

Distribution pattern

Nationwide Foreign: AR AT AU BE BG CA CA CH CL CN CZ DE DK ES FR GB GR GU HU IL IT JO JP KR KW MX MY NC NL PE PL PR PT PY RU SE SI TR UY ZA

device · product 8 of 13

Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWA-35-150 ORDER NUMBER (GPN): G56173. For vascular catheter positioning and exchange in diagnostic and interventional procedures.

Z-1713-2022
Recall number
Z-1713-2022
Initiated
July 19, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Cook Incorporated
Quantity
5400 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.

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

Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.

Code information

UDI-DI: (01)00827002561731- Lot Numbers: 14070910, 14070913, 14070914, 14070915, 14070916, 14070917, 14080810, 14104898, 14104899, 14104902, 14106628, 14106629, 14120473, 14120474, 14120475, 14122089, 14122091, 14122093, 14122095, 14122322, 14129155, 14129156, 14129157, 14129158, 14129161, 14129162, 14129163, 14131012, 14131013, 14131014, 14134680, 14134681, 14134683, 14134684, 14139356, 14142001, 14142004, 14142005, 14142007, 14147337, 14147338, 14147339, 14148371, 14160531, 14160533, 14160534, NS14095649, NS14122100, NS14122327, NS14129168, NS14131010, NS14131011, NS14131015, NS14133505, NS14142008, NS14147334, NS14147335, NS14147336, NS14147336X, NS14153793, NS14176970

Distribution pattern

Nationwide Foreign: AR AT AU BE BG CA CA CH CL CN CZ DE DK ES FR GB GR GU HU IL IT JO JP KR KW MX MY NC NL PE PL PR PT PY RU SE SI TR UY ZA

device · product 9 of 13

Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWA-35-80 ORDER NUMBER (GPN): G56172. For vascular catheter positioning and exchange in diagnostic and interventional procedures.

Z-1714-2022
Recall number
Z-1714-2022
Initiated
July 19, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Cook Incorporated
Quantity
75 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.

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

Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.

Code information

UDI-DI: (01)00827002561724- Lot Numbers: 14156569

Distribution pattern

Nationwide Foreign: AR AT AU BE BG CA CA CH CL CN CZ DE DK ES FR GB GR GU HU IL IT JO JP KR KW MX MY NC NL PE PL PR PT PY RU SE SI TR UY ZA

device · product 10 of 13

Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWAS-35-150 ORDER NUMBER (GPN): G56176. For vascular catheter positioning and exchange in diagnostic and interventional procedures.

Z-1715-2022
Recall number
Z-1715-2022
Initiated
July 19, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Cook Incorporated
Quantity
865 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.

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

Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.

Code information

UDI-DI: (01)00827002561762- Lot Numbers: 14112845, NS14062106, NS14080814, NS14089120, NS14118843, NS14139358, NS14142006, NS14144747, NS14148490, NS14149799, NS14153797, NS14172915

Distribution pattern

Nationwide Foreign: AR AT AU BE BG CA CA CH CL CN CZ DE DK ES FR GB GR GU HU IL IT JO JP KR KW MX MY NC NL PE PL PR PT PY RU SE SI TR UY ZA

device · product 11 of 13

Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWAS-35-80 ORDER NUMBER (GPN): G56175. For vascular catheter positioning and exchange in diagnostic and interventional procedures.

Z-1716-2022
Recall number
Z-1716-2022
Initiated
July 19, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Cook Incorporated
Quantity
189 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.

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

Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.

Code information

UDI-DI: (01)00827002561755- Lot Numbers: 14174876, 14174880, NS14104906, NS14173970, NS14173971

Distribution pattern

Nationwide Foreign: AR AT AU BE BG CA CA CH CL CN CZ DE DK ES FR GB GR GU HU IL IT JO JP KR KW MX MY NC NL PE PL PR PT PY RU SE SI TR UY ZA

device · product 12 of 13

Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWS-35-150 ORDER NUMBER (GPN): G56152. For vascular catheter positioning and exchange in diagnostic and interventional procedures.

Z-1717-2022
Recall number
Z-1717-2022
Initiated
July 19, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Cook Incorporated
Quantity
30 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.

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

Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.

Code information

UDI-DI: (01)00827002561526- Lot Numbers: 14118842

Distribution pattern

Nationwide Foreign: AR AT AU BE BG CA CA CH CL CN CZ DE DK ES FR GB GR GU HU IL IT JO JP KR KW MX MY NC NL PE PL PR PT PY RU SE SI TR UY ZA

device · product 13 of 13

Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWS-35-80 ORDER NUMBER (GPN): G56151. For vascular catheter positioning and exchange in diagnostic and interventional procedures.

Z-1718-2022
Recall number
Z-1718-2022
Initiated
July 19, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Cook Incorporated
Quantity
15 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.

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

Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.

Code information

UDI-DI: (01)00827002561519- Lot Numbers: 14156572

Distribution pattern

Nationwide Foreign: AR AT AU BE BG CA CA CH CL CN CZ DE DK ES FR GB GR GU HU IL IT JO JP KR KW MX MY NC NL PE PL PR PT PY RU SE SI TR UY ZA

Field note

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