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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 81108

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

Open FDA event record

Event summary

Timeline bucket
June 08, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Stryker Neurovascular

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

8 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 8

Synchro2, 0.014 in x 200cm, SOFT Guidewire with Hydrophilic Coating, UPN Product No. M00326010 REF 2601, STERILE: EO - Product Usage: product is intended for general intravascular use, including neurovascular and peripheral vasculatures.

Z-0225-2020
Recall number
Z-0225-2020
Initiated
June 08, 2018
Classification
Class II
Status
Terminated
Recalling firm
Stryker Neurovascular
Quantity
13503

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.036mm) for the Guidewire Outer Diameter dimension. The inches dimension (0.014in) on the label is correct. The correct values are 0.014in (0.36mm). 0.036mm represents a typographical error.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.036mm) for the Guidewire Outer Diameter dimension. The inches dimension (0.014in) on the label is correct. The correct values are 0.014in (0.36mm). 0.036mm represents a typographical error.

Code information

UPN: M00326010 Lot Numbers/UDI:0000000558 /(01)04546540688729(17)201031(10)0000000558; 0000000560/ (01)04546540688729(17)201031(10)0000000560; 0000000671/ (01)04546540688729(17)201031(10)0000000671; 0000000672/ (01)04546540688729(17)201031(10)0000000672; 0000000980/ (01)04546540688729(17)201031(10)0000000980; 0000000987/ (01)04546540688729(17)201031(10)0000000987; 0000001013/ (01)04546540688729(17)201031(10)0000001013; 0000001014/ (01)04546540688729(17)201031(10)0000001014; 0000001275/ (01)04546540688729(17)201031(10)0000001275; 0000001274/ (01)04546540688729(17)201031(10)0000001274; 0000001276/ (01)04546540688729(17)201031(10)0000001276; 0000001287/ (01)04546540688729(17)201031(10)0000001287; 0000001285/ (01)04546540688729(17)201031(10)0000001285; 0000001492/ (01)04546540688729(17)201031(10)0000001492; 0000001286/ (01)04546540688729(17)201031(10)0000001286; 0000001493/ (01)04546540688729(17)201031(10)0000001493; 0000001909/ (01)04546540688729(17)201130(10)0000001909; 0000001910/ (01)04546540688729(17)201130(10)0000001910; 0000002053/ (01)04546540688729(17)201130(10)0000002053; 0000002054/ (01)04546540688729(17)201130(10)0000002054; 0000002425/ (01)04546540688729(17)201231(10)0000002425; 0000002639/ (01)04546540688729(17)201231(10)0000002639; 0000002638/ (01)04546540688729(17)201231(10)0000002638; B47912/ (01)04546540688729(17)200930(10)B47912; 0000002764/ (01)04546540688729(17)201231(10)0000002764; 0000002765/ (01)04546540688729(17)201231(10)0000002765; 0000003120/ (01)04546540688729(17)201231(10)0000003120; 0000003463/ (01)04546540688729(17)210131(10)0000003463; 0000003458/ (01)04546540688729(17)210131(10)0000003458; 0000003462/ (01)04546540688729(17)210131(10)0000003462; 0000003593/ (01)04546540688729(17)210109(10)0000003593; 0000003946/ (01)04546540688729(17)210131(10)0000003946; 0000003461/ (01)04546540688729(17)210131(10)0000003461; 0000003460/ (01)04546540688729(17)210131(10)0000003460; 0000003947/ (01)04546540688729(17)210131(10)0000003947; 0000003948/ (01)04546540688729(17)210131(10)0000003948; 0000003679/ (01)04546540688729(17)210111(10)0000003679; 0000004122/ (01)04546540688729(17)210131(10)0000004122; 0000004123/ (01)04546540688729(17)210131(10)0000004123; 0000004356/ (01)04546540688729(17)210131(10)0000004356; 0000004357/ (01)04546540688729(17)210131(10)0000004357; 0000004359/ (01)04546540688729(17)210131(10)0000004359; 0000004360/ (01)04546540688729(17)210131(10)0000004360; 0000004358/ (01)04546540688729(17)210131(10)0000004358; 0000004639/ (01)04546540688729(17)210228(10)0000004639; 0000004642/ (01)04546540688729(17)210228(10)0000004642; 0000004640/ (01)04546540688729(17)210228(10)0000004640; 0000004905/ (01)04546540688729(17)210228(10)0000004905; 0000004998/ (01)04546540688729(17)210214(10)0000004998; 0000005342/ (01)04546540688729(17)210228(10)0000005342; 0000005270/ (01)04546540688729(17)210222(10)0000005270; 0000005534/ (01)04546540688729(17)210331(10)0000005534; 0000005536/ (01)04546540688729(17)210331(10)0000005536; 0000005535/ (01)04546540688729(17)210331(10)0000005535; 0000005537/ (01)04546540688729(17)210331(10)0000005537; 0000005850/ (01)04546540688729(17)210331(10)0000005850; 0000005851/ (01)04546540688729(17)210331(10)0000005851; 0000006312/ (01)04546540688729(17)210331(10)0000006312; 0000006431/ (01)04546540688729(17)210321(10)0000006431; 0000006465/ (01)04546540688729(17)210322(10)0000006465; 0000006477/ (01)04546540688729(17)210331(10)0000006477; 0000006478/ (01)04546540688729(17)210331(10)0000006478; 0000006925/ (01)04546540688729(17)210402(10)0000006925; 0000006616/ (01)04546540688729(17)210331(10)0000006616; 0000006950/ (01)04546540688729(17)210404(10)0000006950; 0000006997/ (01)04546540688729(17)210430(10)0000006997; 0000007313/ (01)04546540688729(17)210430(10)0000007313; 0000007314/ (01)04546540688729(17)210430(10)0000007314; 0000007417/ (01)04546540688729(17)210430(10)0000007417; 0000007422/ (01)04546540688729(17)210430(10)0000007422;

Distribution pattern

Worldwide distributions- U.S. Nationwide including the states of AL, AZ, AR, CA, CO, CT, DC, DE, FL, GA, GU, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY. Countries of Austria, Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Hong Kong, Hungary, India, Indonesia, Iran, Israel, Italy, Japan, Jordan, Lithuania, Mexico, Netherlands, Norway, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, UAE, and UK.

device · product 2 of 8

Synchro2, 0.014in x 200cm, SOFT PRE-SHAPED Guidewire with Hydrophilic Coating, UPN Product No. M00326110, REF 2611, STERILE: EO - Product Usage: product is intended for general intravascular use, including neurovascular and peripheral vasculatures.

Z-0226-2020
Recall number
Z-0226-2020
Initiated
June 08, 2018
Classification
Class II
Status
Terminated
Recalling firm
Stryker Neurovascular
Quantity
3720

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.036mm) for the Guidewire Outer Diameter dimension. The inches dimension (0.014in) on the label is correct. The correct values are 0.014in (0.36mm). 0.036mm represents a typographical error.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.036mm) for the Guidewire Outer Diameter dimension. The inches dimension (0.014in) on the label is correct. The correct values are 0.014in (0.36mm). 0.036mm represents a typographical error.

Code information

UPN: M00326110 Lot Numbers/UDI: 0000000562/ (01)04546540688736(17)201031(10)0000000562; 0000001015/ (01)04546540688736(17)201031(10)0000001015; 0000001277/ (01)04546540688736(17)201031(10)0000001277; 0000001288/ (01)04546540688736(17)201031(10)0000001288; 0000001494/ (01)04546540688736(17)201031(10)0000001494; 0000000981/ (01)04546540688736(17)201031(10)0000000981; 0000002055/ (01)04546540688736(17)201130(10)0000002055; 0000002239/ (01)04546540688736(17)201130(10)0000002239; 0000002973/ (01)04546540688736(17)201231(10)0000002973; 0000003130/ (01)04546540688736(17)201231(10)0000003130; 0000003131/ (01)04546540688736(17)201231(10)0000003131; 0000003464/ (01)04546540688736(17)210131(10)0000003464; 0000003949/ (01)04546540688736(17)210131(10)0000003949; 0000003680/ (01)04546540688736(17)200112(10)0000003680; 0000004124/ (01)04546540688736(17)210131(10)0000004124; 0000005456/ (01)04546540688736(17)200227(10)0000005456; 0000005986/ (01)04546540688736(17)210331(10)0000005986; 0000006197/ (01)04546540688736(17)210331(10)0000006197; 0000006198/ (01)04546540688736(17)210331(10)0000006198; 0000006313/ (01)04546540688736(17)210331(10)0000006313; 0000006479/ (01)04546540688736(17)210331(10)0000006479; 0000006968/ (01)04546540688736(17)210407(10)0000006968; 0000007088/ (01)04546540688736(17)210430(10)0000007088; 0000007635/ (01)04546540688736(17)210421(10)0000007635; 0000007423/ (01)04546540688736(17)210430(10)0000007423; 0000007636/ (01)04546540688736(17)210421(10)0000007636; 0000007851/ (01)04546540688736(17)210425(10)0000007851.

Distribution pattern

Worldwide distributions- U.S. Nationwide including the states of AL, AZ, AR, CA, CO, CT, DC, DE, FL, GA, GU, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY. Countries of Austria, Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Hong Kong, Hungary, India, Indonesia, Iran, Israel, Italy, Japan, Jordan, Lithuania, Mexico, Netherlands, Norway, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, UAE, and UK.

device · product 3 of 8

Synchro2, 0.014in x 300cm SOFT Guidewire with Hydrophilic Coating , UPN Product No. M00326310, REF 2631, STERILE:EO - Product Usage: product is intended for general intravascular use, including neurovascular and peripheral vasculatures.

Z-0227-2020
Recall number
Z-0227-2020
Initiated
June 08, 2018
Classification
Class II
Status
Terminated
Recalling firm
Stryker Neurovascular
Quantity
831

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

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Unavailable

Code information

UPN: M00326310 Lot Numbers/UDI: 0000000563/ (01)04546540688743(17)201031(10)0000000563; 0000000986/ (01)04546540688743(17)201031(10)0000000986; 0000001646/ (01)04546540688743(17)201130(10)0000001646; 0000002238/ (01)04546540688743(17)201130(10)0000002238; 0000002426/ (01)04546540688743(17)201231(10)0000002426; 0000002640/ (01)04546540688743(17)201231(10)0000002640; 0000003465/ (01)04546540688743(17)210131(10)0000003465; 0000004906/ (01)04546540688743(17)210228(10)0000004906; 0000005147/ (01)04546540688743(17)210228(10)0000005147; 0000005343/ (01)04546540688743(17)210228(10)0000005343; 0000007637/ (01)04546540688743(17)210421(10)0000007637;

Distribution pattern

Worldwide distributions- U.S. Nationwide including the states of AL, AZ, AR, CA, CO, CT, DC, DE, FL, GA, GU, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY. Countries of Austria, Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Hong Kong, Hungary, India, Indonesia, Iran, Israel, Italy, Japan, Jordan, Lithuania, Mexico, Netherlands, Norway, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, UAE, and UK.

device · product 4 of 8

Synchro2, 0.014in. x 300cm, SOFT PRE-SHAPED Guidewire with Hydrophilic Coating, UPN Product No. M00326320, REF 2632, STERILE:EO - Product Usage: product is intended for general intravascular use, including neurovascular and peripheral vasculatures.

Z-0228-2020
Recall number
Z-0228-2020
Initiated
June 08, 2018
Classification
Class II
Status
Terminated
Recalling firm
Stryker Neurovascular
Quantity
107

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.036mm) for the Guidewire Outer Diameter dimension. The inches dimension (0.014in) on the label is correct. The correct values are 0.014in (0.36mm). 0.036mm represents a typographical error.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.036mm) for the Guidewire Outer Diameter dimension. The inches dimension (0.014in) on the label is correct. The correct values are 0.014in (0.36mm). 0.036mm represents a typographical error.

Code information

UPN: M00326320 Lot Numbers/UDI:0000001911/ (01)04546540688750(17)201130(10)0000001911; 0000002062/ (01)04546540688750(17)201130(10)0000002062.

Distribution pattern

Worldwide distributions- U.S. Nationwide including the states of AL, AZ, AR, CA, CO, CT, DC, DE, FL, GA, GU, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY. Countries of Austria, Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Hong Kong, Hungary, India, Indonesia, Iran, Israel, Italy, Japan, Jordan, Lithuania, Mexico, Netherlands, Norway, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, UAE, and UK.

device · product 5 of 8

Synchro2, 0.014in x 200cm STANDARD Guidewire with Hydrophilic Coating, UPN Product No. M00326410, REF 2641, STERILE: EO - Product Usage: product is intended for general intravascular use, including neurovascular and peripheral vasculatures.

Z-0229-2020
Recall number
Z-0229-2020
Initiated
June 08, 2018
Classification
Class II
Status
Terminated
Recalling firm
Stryker Neurovascular
Quantity
21971

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.036mm) for the Guidewire Outer Diameter dimension. The inches dimension (0.014in) on the label is correct. The correct values are 0.014in (0.36mm). 0.036mm represents a typographical error.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.036mm) for the Guidewire Outer Diameter dimension. The inches dimension (0.014in) on the label is correct. The correct values are 0.014in (0.36mm). 0.036mm represents a typographical error.

Code information

UPN: M00326410 Lot Numbers/UDI:0000000564/ (01)04546540688767(17)201031(10) 0000000564; 0000000565/ (01)04546540688767(17)201031(10)0000000565; 0000000566/(01)04546540688767(17)201031(10)0000000566; 0000000673/ (01)04546540688767(17)201031(10)0000000673; 0000000674/ (01)04546540688767(17)201031(10)0000000674; 0000000675/ (01)04546540688767(17)201031(10)0000000675; 0000000983/ (01)04546540688767(17)201031(10)0000000983; 0000000982/ (01)04546540688767(17)201031(10)0000000982; 0000001016/ (01)04546540688767(17)201031(10)0000001016; 0000001017/ (01)04546540688767(17)201031(10)0000001017; 0000001018/ (01)04546540688767(17)201031(10)0000001018; 0000001280/ (01)04546540688767(17)201031(10)0000001280; 0000001279/ (01)04546540688767(17)201031(10)0000001279; 0000001278/ (01)04546540688767(17)201031(10)0000001278; 0000001289/ (01)04546540688767(17)201031(10)0000001289; 0000001290/ (01)04546540688767(17)201031(10)0000001290; 0000001291/ (01)04546540688767(17)201031(10)0000001291; 0000001495/ (01)04546540688767(17)201031(10)0000001495; 0000001497/ (01)04546540688767(17)201031(10)0000001497; 0000001496/ (01)04546540688767(17)201031(10)0000001496; 0000001640/ (01)04546540688767(17)201130(10)0000001640; 0000001641/ (01)04546540688767(17)201130(10)0000001641; 0000001642/ (01)04546540688767(17)201130(10)0000001642; 0000000989/ (01)04546540688767(17)201031(10)0000000989; 0000001912/ (01)04546540688767(17)201130(10)0000001912; 0000001913/ (01)04546540688767(17)201130(10)0000001913; 0000001914/ (01)04546540688767(17)201130(10)0000001914; 0000001643/ (01)04546540688767(17)201130(10)0000001643; 0000002056/ (01)04546540688767(17)201130(10)0000002056; 0000002057/ (01)04546540688767(17)201130(10)0000002057; 0000002058/ (01)04546540688767(17)201130(10)0000002058; 0000002236/ (01)04546540688767(17)201130(10)0000002236; 0000002235/ (01)04546540688767(17)201130(10)0000002235; 0000002233/ (01)04546540688767(17)201130(10)0000002233; 0000002234/ (01)04546540688767(17)201130(10)0000002234; 0000002427/ (01)04546540688767(17)201231(10)0000002427; 0000002428/ (01)04546540688767(17)201231(10)0000002428; 0000002429/ (01)04546540688767(17)201231(10)0000002429; 0000002430/ (01)04546540688767(17)201231(10)0000002430; 0000002642/ (01)04546540688767(17)201231(10)0000002642; 0000002641/ (01)04546540688767(17)201231(10)0000002641; 0000002643/ (01)04546540688767(17)201231(10)0000002643; 0000002644/ (01)04546540688767(17)201231(10)0000002644; 0000002766/ (01)04546540688767(17)201231(10)0000002766; 0000002767/ (01)04546540688767(17)201231(10)0000002767; 0000002768/ (01)04546540688767(17)201231(10)0000002768; 0000002974/ (01)04546540688767(17)201231(10)0000002974; 0000002975/ (01)04546540688767(17)201231(10)0000002975; 0000002976/ (01)04546540688767(17)201231(10)0000002976; 0000003768/ (01)04546540688767(17)210131(10)0000003768; 0000003767/ (01)04546540688767(17)210131(10)0000003767; 0000003769/ (01)04546540688767(17)210131(10)0000003769; 0000003770/ (01)04546540688767(17)210131(10)0000003770; 0000003950/ (01)04546540688767(17)210131(10)0000003950; 0000004126/ (01)04546540688767(17)210131(10)0000004126; 0000004125/ (01)04546540688767(17)210131(10)0000004125; 0000004111/ (01)04546540688767(17)200124(10)0000004111; 0000004321/ (01)04546540688767(17)200130(10)0000004321; 0000004597/ (01)04546540688767(17)200205(10)0000004597; 0000004899/ (01)04546540688767(17)210228(10)0000004899; 0000004900/ (01)04546540688767(17)210228(10)0000004900; 0000004901/ (01)04546540688767(17)210228(10)0000004901; 0000005142/ (01)04546540688767(17)210228(10)0000005142; 0000005144/ (01)04546540688767(17)210228(10)0000005144; 0000005145/ (01)04546540688767(17)210228(10)0000005145; 0000005146/ (01)04546540688767(17)210228(10)0000005146; 0000005148/ (01)04546540688767(17)210228(10)0000005148; 0000005344/ (01)04546540688767(17)210228(10)0000005344; 0000005346/ (01)04546540688767(17)210228(10)0000005346; 0000005345/ (01)04546540688767(17)210228(10)0000005345; 0000005347/ (01)04546540688767(17)210228(10)0000005347; 0000005348/ (01)04546540688767(17)210228(10)0000005348; 0000005532/ (01)04546540688767(17)210331(10)0000005532; 0000005533/ (01)04546540688767(17)210331(10)0000005533; 0000005531/ (01)04546540688767(17)200301(10)0000005531; 0000005687/ (01)04546540688767(17)200305(10)0000005687; 0000005828/ (01)04546540688767(17)200307(10)0000005828; 0000004902/ (01)04546540688767(17)210228(10)0000004902; 0000004903/ (01)04546540688767(17)210228(10)0000004903; 0000005852/ (01)04546540688767(17)210331(10)0000005852; 0000005853/ (01)04546540688767(17)210331(10)0000005853; 0000005987/ (01)04546540688767(17)210331(10)0000005987; 0000005988/ (01)04546540688767(17)210331(10)0000005988; 0000005989/ (01)04546540688767(17)210331(10)0000005989; 0000006199/ (01)04546540688767(17)210331(10)0000006199; 0000006200/ (01)04546540688767(17)210331(10)0000006200; 0000006316/ (01)04546540688767(17)210331(10)0000006316; 0000006315/ (01)04546540688767(17)210331(10)0000006315; 0000006314/ (01)04546540688767(17)210331(10)0000006314; 0000006601/ (01)04546540688767(17)210325(10)0000006601; 0000006672/ (01)04546540688767(17)210326(10)0000006672; 0000006482/ (01)04546540688767(17)210331(10)0000006482; 0000006480/ (01)04546540688767(17)210331(10)0000006480; 0000006481/ (01)04546540688767(17)210331(10)0000006481; 0000006827/ (01)04546540688767(17)210401(10)0000006827; 0000006619/ (01)04546540688767(17)210331(10)0000006619; 0000006618/ (01)04546540688767(17)210331(10)0000006618; 0000006620/ (01)04546540688767(17)210331(10)0000006620; 0000007032/ (01)04546540688767(17)210407(10)0000007032; 0000007001/ (01)04546540688767(17)210430(10)0000007001; 0000006999/ (01)04546540688767(17)210430(10)0000006999; 0000007000/ (01)04546540688767(17)210430(10)0000007000; 0000007174/ (01)04546540688767(17)210410(10)0000007174; 0000007082/ (01)04546540688767(17)210408(10)0000007082; 0000007089/ (01)04546540688767(17)210430(10)0000007089; 0000007090/ (01)04546540688767(17)210430(10)0000007090; 0000007091/ (01)04546540688767(17)210430(10)0000007091; 0000007092/ (01)04546540688767(17)210410(10)0000007092; 0000007315/ (01)04546540688767(17)210430(10)0000007315; 0000007317/ (01)04546540688767(17)210430(10)0000007317; 0000007316/ (01)04546540688767(17)210430(10)0000007316; 0000007426/ (01)04546540688767(17)210430(10)0000007426; 0000007425/ (01)04546540688767(17)210430(10)0000007425; 0000007741/ (01)04546540688767(17)210422(10)0000007741; 0000007771/ (01)04546540688767(17)210423(10)0000007771; 0000007772/ (01)04546540688767(17)210423(10)0000007772; 0000009017.

Distribution pattern

Worldwide distributions- U.S. Nationwide including the states of AL, AZ, AR, CA, CO, CT, DC, DE, FL, GA, GU, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY. Countries of Austria, Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Hong Kong, Hungary, India, Indonesia, Iran, Israel, Italy, Japan, Jordan, Lithuania, Mexico, Netherlands, Norway, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, UAE, and UK.

device · product 6 of 8

Synchro2, 0.014in. x 200cm STANDARD PRE-SHAPED Guidewire with Hydrophilic Coating UPN Product No. M00326420, REF 2642, STERILE: EO - Product Usage: product is intended for general intravascular use, including neurovascular and peripheral vasculatures.

Z-0230-2020
Recall number
Z-0230-2020
Initiated
June 08, 2018
Classification
Class II
Status
Terminated
Recalling firm
Stryker Neurovascular
Quantity
6269

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.036mm) for the Guidewire Outer Diameter dimension. The inches dimension (0.014in) on the label is correct. The correct values are 0.014in (0.36mm). 0.036mm represents a typographical error.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.036mm) for the Guidewire Outer Diameter dimension. The inches dimension (0.014in) on the label is correct. The correct values are 0.014in (0.36mm). 0.036mm represents a typographical error.

Code information

UPN: M00326420 Lot Numbers/UDI: 0000000676/ (01)04546540688774(17)201031(10)0000000676; 0000000984/ (01)04546540688774(17)201031(10)0000000984; 0000001019/ (01)04546540688774(17)201031(10)0000001019; 0000001281/ (01)04546540688774(17)201031(10)0000001281; 0000001292/ (01)04546540688774(17)201031(10)0000001292; 0000001498/ (01)04546540688774(17)201031(10)0000001498; 0000001644/ (01)04546540688774(17)201130(10)0000001644; 0000001915/ (01)04546540688774(17)201130(10)0000001915; 0000002059/ (01)04546540688774(17)201130(10)0000002059; 0000002232/ (01)04546540688774(17)201130(10)0000002232; 0000002769/ (01)04546540688774(17)201231(10)0000002769; 0000002977/ (01)04546540688774(17)201231(10)0000002977; 0000002978/ (01)04546540688774(17)201231(10)0000002978; 0000003121/ (01)04546540688774(17)201231(10)0000003121; 0000003122/ (01)04546540688774(17)201231(10)0000003122; 0000003466/ (01)04546540688774(17)210131(10)0000003466; 0000003773/ (01)04546540688774(17)210131(10)0000003773; 0000003952/ (01)04546540688774(17)210131(10)0000003952; 0000004127/ (01)04546540688774(17)210131(10)0000004127; 0000004361/ (01)04546540688774(17)210131(10)0000004361; 0000004644/ (01)04546540688774(17)210228(10)0000004644; 0000004643/ (01)04546540688774(17)210228(10)0000004643; 0000004702/ (01)04546540688774(17)200208(10)0000004702; 0000005894/ (01)04546540688774(17)200310(10)0000005894; 0000005991/ (01)04546540688774(17)210331(10)0000005991; 0000005990/ (01)04546540688774(17)210331(10)0000005990; 0000006201/ (01)04546540688774(17)210331(10)0000006201; 0000006202/ (01)04546540688774(17)210331(10)0000006202; 0000006317/ (01)04546540688774(17)210331(10)0000006317; 0000007002/ (01)04546540688774(17)210430(10)0000007002; 0000007236/ (01)04546540688774(17)210411(10)0000007236; 0000007093/ (01)04546540688774(17)210430(10)0000007093; 0000007319/ (01)04546540688774(17)210430(10)0000007319; 0000007318/ (01)04546540688774(17)210430(10)0000007318; 0000007427/ (01)04546540688774(17)210430(10)0000007427; 0000007773/ (01)04546540688774(17)210423(10)0000007773; 0000007907/ #N/A;

Distribution pattern

Worldwide distributions- U.S. Nationwide including the states of AL, AZ, AR, CA, CO, CT, DC, DE, FL, GA, GU, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY. Countries of Austria, Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Hong Kong, Hungary, India, Indonesia, Iran, Israel, Italy, Japan, Jordan, Lithuania, Mexico, Netherlands, Norway, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, UAE, and UK.

device · product 7 of 8

Synchro2, 0.014in x 300cm STANDARD Guidewire with Hydrophilic Coating UPN Product No. M00326510, REF 2651, STERILE:EO - Product Usage: product is intended for general intravascular use, including neurovascular and peripheral vasculatures.

Z-0231-2020
Recall number
Z-0231-2020
Initiated
June 08, 2018
Classification
Class II
Status
Terminated
Recalling firm
Stryker Neurovascular
Quantity
2421

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.036mm) for the Guidewire Outer Diameter dimension. The inches dimension (0.014in) on the label is correct. The correct values are 0.014in (0.36mm). 0.036mm represents a typographical error.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.036mm) for the Guidewire Outer Diameter dimension. The inches dimension (0.014in) on the label is correct. The correct values are 0.014in (0.36mm). 0.036mm represents a typographical error.

Code information

UPN: M00326510 Lot Numbers/UDI:0000000985/ (01)04546540688781(17)201031(10)0000000985; 0000001020/ (01)04546540688781(17)201031(10)0000001020; 0000001499/ (01)04546540688781(17)201031(10)0000001499; 0000001916/ (01)04546540688781(17)201130(10)0000001916; 0000001645/ (01)04546540688781(17)201130(10)0000001645; 0000002060/ (01)04546540688781(17)201130(10)0000002060; 0000002061/ (01)04546540688781(17)201130(10)0000002061; 0000002979/ (01)04546540688781(17)201231(10)0000002979; 0000003123/ (01)04546540688781(17)201231(10)0000003123; 0000003771/ (01)04546540688781(17)210131(10)0000003771; 0000003772/ (01)04546540688781(17)210131(10)0000003772; 0000003953/ (01)04546540688781(17)210131(10)0000003953; 0000004128/ (01)04546540688781(17)210131(10)0000004128; 0000004362/ (01)04546540688781(17)210131(10)0000004362; 0000005992/ (01)04546540688781(17)210331(10)0000005992; 0000006203/ (01)04546540688781(17)210331(10)0000006203; 0000006318/ (01)04546540688781(17)210331(10)0000006318; 0000006483/ (01)04546540688781(17)210331(10)0000006483; 0000006621/ (01)04546540688781(17)210331(10)0000006621; 0000006828/ (01)04546540688781(17)210401(10)0000006828; 0000006622/ (01)04546540688781(17)210331(10)0000006622; 0000007003/ (01)04546540688781(17)210430(10)0000007003; 0000007094/ (01)04546540688781(17)210430(10)0000007094; 0000007249/ (01)04546540688781(17)210411(10)0000007249; 0000007428/ (01)04546540688781(17)210430(10)0000007428;

Distribution pattern

Worldwide distributions- U.S. Nationwide including the states of AL, AZ, AR, CA, CO, CT, DC, DE, FL, GA, GU, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY. Countries of Austria, Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Hong Kong, Hungary, India, Indonesia, Iran, Israel, Italy, Japan, Jordan, Lithuania, Mexico, Netherlands, Norway, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, UAE, and UK.

device · product 8 of 8

Synchro2, 0.014in x 300cm STANDARD PRE-SHAPED Guidewire with Hydrophilic Coating, UPN Product No. M00326520, REF 2652, STERILE: EO - Product Usage: product is intended for general intravascular use, including neurovascular and peripheral vasculatures.

Z-0232-2020
Recall number
Z-0232-2020
Initiated
June 08, 2018
Classification
Class II
Status
Terminated
Recalling firm
Stryker Neurovascular
Quantity
305

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.036mm) for the Guidewire Outer Diameter dimension. The inches dimension (0.014in) on the label is correct. The correct values are 0.014in (0.36mm). 0.036mm represents a typographical error.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.036mm) for the Guidewire Outer Diameter dimension. The inches dimension (0.014in) on the label is correct. The correct values are 0.014in (0.36mm). 0.036mm represents a typographical error.

Code information

UPN: M00326520 Lot Numbers/UDI: 0000002431/ (01)04546540688798(17)201231(10)0000002431; 0000002645/ (01)04546540688798(17)201231(10)0000002645; 0000002771/ (01)04546540688798(17)201231(10)0000002771; 0000006204/ (01)04546540688798(17)210331(10)0000006204; 0000006875/ (01)04546540688798(17)210401(10)0000006875; 0000007429/ (01)04546540688798(17)210430(10)0000007429;

Distribution pattern

Worldwide distributions- U.S. Nationwide including the states of AL, AZ, AR, CA, CO, CT, DC, DE, FL, GA, GU, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY. Countries of Austria, Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Hong Kong, Hungary, India, Indonesia, Iran, Israel, Italy, Japan, Jordan, Lithuania, Mexico, Netherlands, Norway, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, UAE, and UK.