Stryker Instruments Div. of Stryker Corporation: 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

Agency Publication Date: June 6, 2013

Affected Products

Product: 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.

1006134, 1101020, 1106424

Product: 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.

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.

Product: 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.

1007157, 1103202

Product: 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.

1005111, 1011282,1107491, 1107492

Product: 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.

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

Product: 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.

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

Product: 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.

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

Product: 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.

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.

Product: 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.

1007145, 1101004, 1107487

Product: 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.

1005098, 1010228, 1012337, 1105367

Product: 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.

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

Product: 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.

1006141, 1012303, 1102110, 1104324, and 1108664

Product: 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.

1105390, 1107543

Product: 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.

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.

Product: 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.

1010236, 1108682

Product: 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.

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

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 65321

Status: Resolved

Manufacturer: Stryker Instruments Div. of Stryker Corporation

Manufactured In: United States

Units Affected: 16 products (2,980 units (298 boxes); 48,040 units, ( 4804 boxes); 1,980 units (198 boxes); 3,000 units (300 boxes); 34,640 units (3,464 boxes); 21,660 units (2166 boxes); 7960 units (796 boxes); 334,520 units (33,452 boxes); 3000 units (300 boxes); 3,980 units ( 398 boxes); 25,770 units (2,577 boxes); 5,000 units ( 500 boxes); 9,930 units (993 boxes); 88,040 units (8,804 boxes); 2,000 units ( 200 boxes); 6,990 units ( 699 boxes))

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

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