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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 79779

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

Open FDA event record

Event summary

Timeline bucket
February 23, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Stryker Instruments Div. of Stryker 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

T4 Pullover Toga, (S/M); Catalog Number: 0400-710-000 Sterile personal protection garment

Z-1500-2018
Recall number
Z-1500-2018
Initiated
February 23, 2018
Classification
Class II
Status
Terminated
Quantity
34,570 total products

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Separation of material layers may occur, causing a potential risk of exposure to contaminants.

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

Separation of material layers may occur, causing a potential risk of exposure to contaminants.

Code information

17071877

Distribution pattern

US Nationwide and Ireland, Japan, South Korea, UK

device · product 2 of 11

T4 Pullover Toga, L/XL; Catalog Number: 0400-720-000 Sterile personal protection garment

Z-1501-2018
Recall number
Z-1501-2018
Initiated
February 23, 2018
Classification
Class II
Status
Terminated
Quantity
34570 total products

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Separation of material layers may occur, causing a potential risk of exposure to contaminants.

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

Separation of material layers may occur, causing a potential risk of exposure to contaminants.

Code information

Lot numbers: 17113078, 17113132, 17113138

Distribution pattern

US Nationwide and Ireland, Japan, South Korea, UK

device · product 3 of 11

T4 Pullover Toga, Regular ; Catalog Number: 0400-750-000 Sterile personal protection garment

Z-1502-2018
Recall number
Z-1502-2018
Initiated
February 23, 2018
Classification
Class II
Status
Terminated
Quantity
34570 total products

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Separation of material layers may occur, causing a potential risk of exposure to contaminants.

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

Separation of material layers may occur, causing a potential risk of exposure to contaminants.

Code information

Lot numbers: 17061792

Distribution pattern

US Nationwide and Ireland, Japan, South Korea, UK

device · product 4 of 11

T4 Pullover Toga, Large; Catalog Number: 0400-760-000 Sterile personal protection garment

Z-1503-2018
Recall number
Z-1503-2018
Initiated
February 23, 2018
Classification
Class II
Status
Terminated
Quantity
34570 total products

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Separation of material layers may occur, causing a potential risk of exposure to contaminants.

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

Separation of material layers may occur, causing a potential risk of exposure to contaminants.

Code information

Lot numbers: 17061767, 17061774, 17061780, 17071948, 17102915, 17113082

Distribution pattern

US Nationwide and Ireland, Japan, South Korea, UK

device · product 5 of 11

T4 Pullover Toga, X-Large; Catalog Number: 0400-770-000 Sterile personal protection garment

Z-1504-2018
Recall number
Z-1504-2018
Initiated
February 23, 2018
Classification
Class II
Status
Terminated
Quantity
34570 total products

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Separation of material layers may occur, causing a potential risk of exposure to contaminants.

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

Separation of material layers may occur, causing a potential risk of exposure to contaminants.

Code information

Lot numbers: 17061775, 17061781, 17061784, 17061793, 17102891, 17102916, 17102925, 17102995, 17113013, 17113083, 17113190

Distribution pattern

US Nationwide and Ireland, Japan, South Korea, UK

device · product 6 of 11

T4 Zipper Toga (S/M); Catalog Number: 0400-810-000 Sterile personal protection garment

Z-1505-2018
Recall number
Z-1505-2018
Initiated
February 23, 2018
Classification
Class II
Status
Terminated
Quantity
34570 total products

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Separation of material layers may occur, causing a potential risk of exposure to contaminants.

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

Separation of material layers may occur, causing a potential risk of exposure to contaminants.

Code information

Lot number: 17061794

Distribution pattern

US Nationwide and Ireland, Japan, South Korea, UK

device · product 7 of 11

T4 Zipper Toga, (L/XL); Catalog Number: 0400-820-000 Sterile personal protection garment

Z-1506-2018
Recall number
Z-1506-2018
Initiated
February 23, 2018
Classification
Class II
Status
Terminated
Quantity
34570 total products

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Separation of material layers may occur, causing a potential risk of exposure to contaminants.

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

Separation of material layers may occur, causing a potential risk of exposure to contaminants.

Code information

Lot numbers: 17061810, 17061814, 17071878, 17071903, 17071918, 17071920, 17071949, 17071960, 17071970, 17071974, 17071997, 17072002, 17072006, 17072016, 17102897, 17102926, 17102936, 17102942, 17102956, 17102971, 17102994, 17102996, 17113021, 17113034, 17113037, 17113084, 17113133, 17113191, 17113197, 17113203, 17113221

Distribution pattern

US Nationwide and Ireland, Japan, South Korea, UK

device · product 8 of 11

T5 Zipper Toga with Peel-Away Face Shield, (L/XL); Catalog number: 0400-820-100 Sterile personal protection garment

Z-1507-2018
Recall number
Z-1507-2018
Initiated
February 23, 2018
Classification
Class II
Status
Terminated
Quantity
34570 total products

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Separation of material layers may occur, causing a potential risk of exposure to contaminants.

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

Separation of material layers may occur, causing a potential risk of exposure to contaminants.

Code information

Lot numbers: 17061816, 17061836, 17061839, 17061853, 17071921, 17072017, 17102944, 17102948, 17113081, 17113141, 17113194

Distribution pattern

US Nationwide and Ireland, Japan, South Korea, UK

device · product 9 of 11

T4 Zipper Toga, Regular; Catalog number: 0400-830-000 Sterile personal protection garment

Z-1508-2018
Recall number
Z-1508-2018
Initiated
February 23, 2018
Classification
Class II
Status
Terminated
Quantity
34570 total products

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Separation of material layers may occur, causing a potential risk of exposure to contaminants.

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

Separation of material layers may occur, causing a potential risk of exposure to contaminants.

Code information

Lot numbers: 17113139, 17113204

Distribution pattern

US Nationwide and Ireland, Japan, South Korea, UK

device · product 10 of 11

T4 Zipper Toga, X-Large; Catalog number: 0400-850-000 Sterile personal protection garment

Z-1509-2018
Recall number
Z-1509-2018
Initiated
February 23, 2018
Classification
Class II
Status
Terminated
Quantity
34570 total products

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Separation of material layers may occur, causing a potential risk of exposure to contaminants.

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

Separation of material layers may occur, causing a potential risk of exposure to contaminants.

Code information

Lot numbers: 17061835, 17061838, 17061857, 17071891, 17071904, 17071928, 17102898, 17102943, 17102957, 17102972, 17111362, 17113014, 17113022, 17113038, 17113080, 17113140, 17113205, 17113223

Distribution pattern

US Nationwide and Ireland, Japan, South Korea, UK

device · product 11 of 11

T5 Zipper Toga with Peel-Away Face Shield, (XL/T); Catalog number: 0400-850-100 Sterile personal protection garment

Z-1510-2018
Recall number
Z-1510-2018
Initiated
February 23, 2018
Classification
Class II
Status
Terminated
Quantity
34570 total products

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Separation of material layers may occur, causing a potential risk of exposure to contaminants.

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

Separation of material layers may occur, causing a potential risk of exposure to contaminants.

Code information

Lot numbers: 17061837, 17061859, 17113164

Distribution pattern

US Nationwide and Ireland, Japan, South Korea, UK