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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 65321

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

Open FDA event record

Event summary

Timeline bucket
May 23, 2013
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

16 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 16

Stryker Instruments 0400-710-000 T4 Pullover Toga (S/M) Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material.

Z-1489-2013
Recall number
Z-1489-2013
Initiated
May 23, 2013
Classification
Class II
Status
Terminated
Quantity
2,980 units (298 boxes)

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breach in 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

Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the aging of the packaging. Stryker is conducting additional testing and assessing this pr

Code information

1006134, 1101020, 1106424

Distribution pattern

USA Nationwide Distribution

device · product 2 of 16

Stryker Instruments0400-720-000 T4 Pullover Toga (L/XL) Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material.

Z-1490-2013
Recall number
Z-1490-2013
Initiated
May 23, 2013
Classification
Class II
Status
Terminated
Quantity
48,040 units, ( 4804 boxes)

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breach in 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

Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the aging of the packaging. Stryker is conducting additional testing and assessing this pr

Code information

1005105, 1010244, 1101004, 1104289, 1107568, 1005119, 1010261, 1101030, 1104324, 1108625, 1006129, 1011276, 1101047, 1105390, 1108672, 1006140, 1011296, 1102073, 1105355, 1109730, 1007151, 1012314, 1102127, 1106431, 1109782, 1007163, 1012337, 1102131, 1106467, 1109858, 1009213, 1012346, 1104253, 1107515.

Distribution pattern

USA Nationwide Distribution

device · product 3 of 16

Stryker Instruments 0400-720-000S5 T5 Pullover Toga w/Peel Away, Sterile, EO; single use. Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material.

Z-1491-2013
Recall number
Z-1491-2013
Initiated
May 23, 2013
Classification
Class II
Status
Terminated
Quantity
1,980 units (198 boxes)

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breach in 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

Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the aging of the packaging. Stryker is conducting additional testing and assessing this pr

Code information

1007157, 1103202

Distribution pattern

USA Nationwide Distribution

device · product 4 of 16

Stryker Instruments0400-750-000 T4 Toga, Pullover, Regular Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material.

Z-1492-2013
Recall number
Z-1492-2013
Initiated
May 23, 2013
Classification
Class II
Status
Terminated
Quantity
3,000 units (300 boxes)

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breach in 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

Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the aging of the packaging. Stryker is conducting additional testing and assessing this pr

Code information

1005111, 1011282,1107491, 1107492

Distribution pattern

USA Nationwide Distribution

device · product 5 of 16

Stryker Instruments 0400-760-000 T4 Toga, Pullover, Large Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material.

Z-1493-2013
Recall number
Z-1493-2013
Initiated
May 23, 2013
Classification
Class II
Status
Terminated
Quantity
34,640 units (3,464 boxes)

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breach in 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

Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the aging of the packaging. Stryker is conducting additional testing and assessing this pr

Code information

1006134, 1012304, 1104308, 1007152, 1101020, 1105365, 1007170, 1102080, 1106421, 1008188, 1102147, 1106469, 1009205, 1103193, 1108628, 1010229, 1103198, 1108697, 1010253, 1102149, 1109789, 1011277, 1104248

Distribution pattern

USA Nationwide Distribution

device · product 6 of 16

Stryker Instruments 0400-770-000 T4 Toga, Pullover, Ex-Large Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material.

Z-1494-2013
Recall number
Z-1494-2013
Initiated
May 23, 2013
Classification
Class II
Status
Terminated
Quantity
21,660 units (2166 boxes)

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breach in 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

Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the aging of the packaging. Stryker is conducting additional testing and assessing this pr

Code information

1005105, 1009214, 1104308, 1006130, 1010260, 1104312, 1007152, 1012346, 1105378, 1007163, 1012303, 1106460, 1007164, 1101062, 1107542, 1008189, 1101063, 1108660, 1008188, 1102149, 1109760, 1009213, and 1103219.

Distribution pattern

USA Nationwide Distribution

device · product 7 of 16

Stryker Instruments 0400-810-000 T4 Zipper Toga (S/M) Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material.

Z-1495-2013
Recall number
Z-1495-2013
Initiated
May 23, 2013
Classification
Class II
Status
Terminated
Quantity
7960 units (796 boxes)

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breach in 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

Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the aging of the packaging. Stryker is conducting additional testing and assessing this pr

Code information

1006129, 1103201, 1009197, 1105391, 1009198, 1107548, 1012302, 1109788, and 1102127

Distribution pattern

USA Nationwide Distribution

device · product 8 of 16

Stryker Instruments 0400-820-000 T4 Zipper Toga (L/XL) Sterile, O; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material.

Z-1496-2013
Recall number
Z-1496-2013
Initiated
May 23, 2013
Classification
Class II
Status
Terminated
Quantity
334,520 units (33,452 boxes)

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breach in 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

Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the aging of the packaging. Stryker is conducting additional testing and assessing this pr

Code information

1005097, 1009205, 1011294, 1102105, 1104268, 1106463, 1108633, 1109857, 1005098, 1009219, 1012313, 1102109, 1104305, 1106465, 1108648, 1109812, 1005104, 1008192, 1011281, 1102119, 1104307, 1106470, 1108654, 1109860, 1005105, 1009213, 1012325, 1102123, 1104308, 1107493, 1108659, 1109817, 1005110, 1009197, 1012327, 1102141, 1104320, 1107488, 1108666, 1005111, 1009204, 1012335, 1102147, 1104327, 1107497, 1108667, 1005118, 1010227, 1012345, 1102150, 1105370, 1106474, 1108671, 1006123, 1010234, 1101014, 1103170, 1105342, 1107511, 1108675, 1007155, 1010235, 1012344, 1103171, 1105356, 1107512, 1108701, 1006127, 1010251, 1101003, 1103223, 1105110, 1107516, 1108704, 1006133, 1010258, 1101017, 1103189, 1105379, 1107537, 1109778, 1006140, 1010243, 1101002, 1103194, 1105390, 1107546, 1107520, 1008181, 1012314, 1101029, 1103184, 1105401, 1107595, 1108710, 1007163, 1010259, 1101046, 1103227, 1106418, 1107604, 1108713, 1007145, 1010252, 1101053, 1104280, 1106432, 1107561, 1109740, 1007156, 1011266, 1102073, 1104248, 1106453, 1108624, 1109750, 1007169, 1011267, 1102092, 1104259, 1106444, 1107599, 1109729, 1007151, 1011275, 1101055, 1104264, 1106451, 1107567, 1109735, 1008176, 1011280, 1102085, 1104290, 1106437, 1107578, 1109755, 1008178, 1011295, 1102099, 1104278, 1106455, 1107570, 1109781, 1008188, 1011276, 1102080, 1104283, 1106460, 1108619, and 1109809.

Distribution pattern

USA Nationwide Distribution

device · product 9 of 16

Stryker Instruments 0400-820-000S3 T4 Toga w/Inside Shoulder Ties, Sterile, O; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material.

Z-1497-2013
Recall number
Z-1497-2013
Initiated
May 23, 2013
Classification
Class II
Status
Terminated
Quantity
3000 units (300 boxes)

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breach in 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

Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the aging of the packaging. Stryker is conducting additional testing and assessing this pr

Code information

1007145, 1101004, 1107487

Distribution pattern

USA Nationwide Distribution

device · product 10 of 16

Stryker Instruments 0400-820-000S7 T4 XXL Toga w/T3 Cut, Sterile, O; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material.

Z-1498-2013
Recall number
Z-1498-2013
Initiated
May 23, 2013
Classification
Class II
Status
Terminated
Quantity
3,980 units ( 398 boxes)

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breach in 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

Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the aging of the packaging. Stryker is conducting additional testing and assessing this pr

Code information

1005098, 1010228, 1012337, 1105367

Distribution pattern

USA Nationwide Distribution

device · product 11 of 16

Stryker Instruments 0400-820-100 T5 Zipper Toga with Peel Away, Sterile, O; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material.

Z-1499-2013
Recall number
Z-1499-2013
Initiated
May 23, 2013
Classification
Class II
Status
Terminated
Quantity
25,770 units (2,577 boxes)

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breach in 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

Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the aging of the packaging. Stryker is conducting additional testing and assessing this pr

Code information

1006130, 1101034, 1006134, 1102133, 1007151, 1103208, 1007170, 1104297, 1009205, 1105360, 1010228, 1106476, 1010260, 1107569, 1011296, 1108676, 1012336, 11097861006141, 1012303, 1102110, 1104324, and 1108664.

Distribution pattern

USA Nationwide Distribution

device · product 12 of 16

Stryker Instruments 0400-830-000 T4 Toga, Zipper, Regular, Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material.

Z-1500-2013
Recall number
Z-1500-2013
Initiated
May 23, 2013
Classification
Class II
Status
Terminated
Quantity
5,000 units ( 500 boxes)

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breach in 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

Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the aging of the packaging. Stryker is conducting additional testing and assessing this pr

Code information

1006141, 1012303, 1102110, 1104324, and 1108664

Distribution pattern

USA Nationwide Distribution

device · product 13 of 16

Stryker Instruments 0400-840-000 T4 Toga, Zipper, Large, Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material.

Z-1501-2013
Recall number
Z-1501-2013
Initiated
May 23, 2013
Classification
Class II
Status
Terminated
Quantity
9,930 units (993 boxes)

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breach in 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

Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the aging of the packaging. Stryker is conducting additional testing and assessing this pr

Code information

1105390, 1107543

Distribution pattern

USA Nationwide Distribution

device · product 14 of 16

Stryker Instruments 0400-850-000 T4 Toga, Zipper, (XL-Tall) Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material.

Z-1502-2013
Recall number
Z-1502-2013
Initiated
May 23, 2013
Classification
Class II
Status
Terminated
Quantity
88,040 units (8,804 boxes)

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breach in 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

Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the aging of the packaging. Stryker is conducting additional testing and assessing this pr

Code information

1005097, 1008188, 1011281, 1103194, 1106465, 1107519, 1005105, 1008192, 1011296, 1103201, 1107501, 1109763, 1005111, 1009198, 1012303, 1103223, 1107550, 1109777, 1005118, 1009213, 1012314, 1104282, 1107560, 1109822, 1006129, 1009219, 1012325, 1104290, 1107605, 1109850, 1008181, 1009220, 1012335, 1104320, 1107606, 1006135, 1010228, 1012344, 1104312, 1108618, 1007145, 1010236, 1101003, 1105346, 1108663, 1007151, 1010235, 1101030, 1105355, 1108677, 1007156, 1010243, 1101055, 1105378, 1108709, 1007163, 1010252, 1102109, 1106411, 1108714, 1007169, 1010260, 1102123, 1105405, 1109728, 1008183, 1011276, 1102141, 1106430, and 1104275.

Distribution pattern

USA Nationwide Distribution

device · product 15 of 16

Stryker Instruments 0400-850-000S2 T4 Toga, XL, w/Inside Tie) Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material.

Z-1503-2013
Recall number
Z-1503-2013
Initiated
May 23, 2013
Classification
Class II
Status
Terminated
Quantity
2,000 units ( 200 boxes)

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breach in 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

Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the aging of the packaging. Stryker is conducting additional testing and assessing this pr

Code information

1010236, 1108682

Distribution pattern

USA Nationwide Distribution

device · product 16 of 16

Stryker Instruments 0400-850-100 T5 zipper Toga with Peel Away, Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material.

Z-1504-2013
Recall number
Z-1504-2013
Initiated
May 23, 2013
Classification
Class II
Status
Terminated
Quantity
6,990 units ( 699 boxes)

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breach in 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

Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the aging of the packaging. Stryker is conducting additional testing and assessing this pr

Code information

1006124, 1007164, 1010236, 1011296, 1103168, 1105341, and 1108634.

Distribution pattern

USA Nationwide Distribution

Field note

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