Use caution Medical device recall · FDA · Published July 12, 2024
Datex-Ohmeda Aisys CS2 Anesthesia Machine Recall: Mistaken Connection Risk
Datex-Ohmeda recalls Aisys CS2 anesthesia machines with Et Control due to risk of patient injury if breathing circuit limb is mistakenly connected to Auxiliary Common Gas Outlet port. All units with AGCO option affected.
Use caution until it’s fixed
Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.
Contact the company
Recalling firmDatex-Ohmeda, Inc.3030 Ohmeda Dr · Madison, WI 53718-6704
What happened, in plain English
Datex-Ohmeda is recalling Aisys CS2 anesthesia machines with Et Control because a mistake in connecting a patient's breathing circuit could cause injury. This affects all units with the AGCO option, which are used by medical professionals in hospitals. Read more at govinfonow.com/recall/54652-datex-ohmeda-aisys-cs2-anesthesia-machine-recall-mistaken-connection-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/54652-datex-ohmeda-aisys-cs2-anesthesia-machine-recall-mistaken-connection-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0083-2025
Cite this page
“Datex-Ohmeda Aisys CS2 Anesthesia Machine Recall: Mistaken Connection Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/54652-datex-ohmeda-aisys-cs2-anesthesia-machine-recall-mistaken-connection-risk. Based on FDA recall #Z-0083-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0083-2025%22&limit=1).
Why it’s dangerous
If a patient's breathing circuit limb is accidentally connected to the Auxiliary Common Gas Outlet (ACGO) port instead of the correct port, it could cause improper gas delivery and potentially lead to patient injury.
Who’s affected
Medical professionals using the Aisys CS2 anesthesia machines in hospitals are most at risk. All units with the Auxiliary Common Gas Outlet (AGCO) option are affected, regardless of serial number.
How to tell if you have this one
Check if your machine has the AGCO option. All Aisys CS2 with Et Control units, including those with serial numbers, are affected. The model number is 1011-9055-000.
- Brand
Datex-Ohmed: Aisys- Product
Datex-Ohmeda, Inc. recalls Aisys CS2 with Et Control. This anesthesia gas machine is intended to provide general inhalation anesthesia and- Category
Medical device
All 11 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class I- Status
Ongoing- Distribution
Worldwide distribution - US Nationwide and the countries of Aland Islands, ALBANIA, Algeria, Argentina, Australia, Austria, Azerbaijan, BAHAMAS, Bahrain, Bangladesh, BARBADOS, BELARUS, Belgium, Benin, Bermuda, Bolivia, BONAIRE, Bosnia and Herzegovina, Brazil, Brunei, Bulgaria, Cambodia, Cameroon, Canada, Chile, CHINA, Colombia, Costa Rica, Croatia, Curacao, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, ETHIOPIA, Falkland Islands, Finland, France, French Polynesia, Gabon, Georgia, Germany, Ghana, Gilbrator, Greece, Guadeloupe, Guatemala, Guyana, Honduras, Hong Kong, Hungary, ICELAND, India, Indonesia, Iran, IRAQ, Ireland, Israel, Italy, Jamaica, JAPAN, Jordan, Kazakhstan, KENYA, Korea (Republic Of), Korea, Republic of, Kuwait, Laos, LATVIA, Lebanon, Libya, LITHUANIA, Macedonia, Malaysia, Maldives, Malta, MAURITIUS, Mexico, Moldova, Montenegro, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, North Macedonia, Norway, Oman, PAKISTAN, Palestine, State of, Panama, Paraguay, Peru, Philippines, Poland, Portugal, PUERTO RICO, Qatar, REUNION, ROMANIA, Russia, San Marino, Saudi Arabia, Senegal, Serbia, SINGAPORE, Slovakia, Slovenia, South Africa, Spain, Sudan, Sweden, Switzerland, Syria, Taiwan, Tanzania, THAILAND, Trinidad and Tobago, Tunisia, Turkey, T¿rkiye, Uganda, UKRAINE, United Arab Emirates, United Kingdom, Uruguay, UZBEKISTAN, Venezuela, Vietnam, Yemen.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0074-2025 | Aespire 7100, 7100 (Variant), and Aespire 7100 S/5 Protiva configurations. These anesthesia gas machines are intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.; a. Aespire 7100 - GTIN: 00840682102261. Model Number: 1009-9000-000. All Serial Numbers. b. Aespire 7100 (Variant) - GTIN: 00840682102261. Model Numbers: 1009-9101-000 and 1009-9101-000. All Serial Numbers. c. Aespire 7100 S/5 Protiva - No GTIN. Model Number: 1009-9004-000. All Serial Numbers. Not model or lot specific. All devices of the indicated products configured with the AGCO option are potentially affected. | 20,097 units |
| Z-0075-2025 | Aespire 100. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.; GTIN: 00840682102261 | N/A |
| Z-0076-2025 | Aespire 7900. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.; GTIN: 00840682102261. Model Number: 1009-9012-000. All Serial Numbers. Not model or lot specific. All devices of the indicated products configured with the AGCO option are potentially affected. | 12,036 units |
| Z-0077-2025 | Aespire View. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.; GTIN: 00840682102285. Model Numbers: 1009-9212-000-117639, 1009-9212-000-136105, 1009-9212-000-518222, 1009-9212-000-521025, 1009-9212-000-552778, 1009-9212-000-090755, 1009-9212-000-059245, 1009-9212-000-110073, 1009-9212-000-203581, 1009-9212-000-423283, 1009-9212-000-419502, 1009-9212-000-427555, 1009-9212-000-460867, 1009-9212-000-478499, 1009-9212-000-109510, 1009-9212-000-521303, 1009-9212-000-097620, 1009-9212-000-102602, 1009-9212-000-520908, 1009-9212-000-098765, 1009-9212-000-076846, 1009-9212-000-070149, 1009-9212-000-189720, 1009-9212-000-140832, 1009-9212-000-036279, 1009-9212-000-484467, 1009-9212-000-520055, 1009-9212-000-516124, 1009-9212-000-182799, 1009-9212-000-161253, 1009-9212-000-121684, 1009-9212-000-117998, 1009-9212-000-499121, 1009-9212-000-405786, 1009-9212-000-425988, 1009-9212-000-309943, 1009-9212-000-045250, 1009-9212-000-121264, 1009-9212-000-478484, 1009-9212-000-184939, 1009-9212-000-513915, 1009-9212-000-049292, 1009-9212-000-467900, 1009-9212-000-521309, 1009-9212-000-243610, 1009-9212-000-431587, 1009-9212-000-089004, 1009-9212-000-248292, 1009-9212-000-308148, 1009-9212-000-115588, 1009-9212-000-479608, 1009-9212-000-048968, 1009-9212-000-486460, 1009-9212-000-421908, 1009-9212-000-050573, 1009-9212-000-309081, 1009-9212-000-091588, 1009-9212-000-051332, 1009-9212-000-097158, 1009-9212-000-276899, 1009-9212-000-053315, 1009-9212-000-081578, 1009-9212-000-109837, 1009-9212-000-049346, 1009-9212-000-090939, 1009-9212-000-078248, 1009-9212-000-327595, 1009-9212-000-419939, 1009-9212-000-087052, 1009-9212-000-098097, 1009-9212-000-485388, 1009-9212-000-478445, 1009-9212-000-093971, 1009-9212-000-395920, 1009-9212-000-208521, 1009-9212-000-509210, 1009-9212-000-363293, 1009-9212-000-521749, 1009-9212-000-376941, 1009-9212-000-198472, 1009-9212-000-456812, 1009-9212-000-107405, 1009-9212-000-306850, 1009-9212-000-536898, 1009-9212-000-258372, 1009-9212-000-517270, 1009-9212-000-161437, 1009-9212-000-505558, 1009-9212-000-249707, 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1009-9212-000-141489, 1009-9212-000-076650, 1009-9212-000-054353, 1009-9212-000-096943, 1009-9212-000-259132, 1009-9212-000-535385, 1009-9212-000-532475, 1009-9212-000-515662, 1009-9212-000-077555, 1009-9212-000-554236, 1009-9212-000-065564, 1009-9212-000-392814, 1009-9212-000-070095, 1009-9212-000-212132, 1009-9212-000-506712, 1009-9212-000-140089, 1009-9212-000-080258, 1009-9212-000-110337, 1009-9212-000-555039, 1009-9212-000-514978, 1009-9212-000-054915, 1009-9212-000-139427, 1009-9212-000-047388, 1009-9212-000-117857, 1009-9212-000-071109, 1009-9212-000-117679, 1009-9212-000-145786, 1009-9212-000-080958, 1009-9212-000-183258, 1009-9212-000-048398, 1009-9212-000-471840, 1009-9212-000-065565, 1009-9212-000-093950, 1009-9212-000-107842, 1009-9212-000-210481, 1009-9212-000-160187, 1009-9212-000-080818, 1009-9212-000-498484, 1009-9212-000-544026, 1009-9212-000-084762, 1009-9212-000-344393, 1009-9212-000-423319, 1009-9212-000-185541, 1009-9212-000-092367, 1009-9212-000-146320, 1009-9212-000-076140, 1009-9212-000-418361, 1009-9212-000-141571, 1009-9212-000-048868, 1009-9212-000-067380, 1009-9212-000-098076, 1009-9212-000-525824, 1009-9212-000-048871, 1009-9212-000-076829, 1009-9212-000-158867, 1009-9212-000-298874, 1009-9212-000-356496, 1009-9212-000-422510, 1009-9212-000-050353, 1009-9212-000-118000, 1009-9212-000-553021, 1009-9212-000-055437, 1009-9212-000-091670, 1009-9212-000-064401, 1009-9212-000-090074, 1009-9212-000-097159, 1009-9212-000-394486, 1009-9212-000-284713, 1009-9212-000-068616, 1009-9212-000-474791, 1009-9212-000-403039, 1009-9212-000-101806, 1009-9212-000-229743, 1009-9212-000-521243, 1009-9212-000-077182, 1009-9212-000-046598, 1009-9212-000-424460, 1009-9212-000-045997, 1009-9212-000-052771, 1009-9212-000-073085, 1009-9212-000-084634, 1009-9212-000-199153, 1009-9212-000-380221, 1009-9212-000-524962, 1009-9212-000-154721, 1009-9212-000-399996, 1009-9212-000-094885, 1009-9212-000-521981, 1009-9212-000-074668, 1009-9212-000-418440, 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1009-9212-000-049525, 1009-9212-000-073466, 1009-9212-000-086140, 1009-9212-000-509441, 1009-9212-000-510213, 1009-9212-000-046925, 1009-9212-000-280521, 1009-9212-000-416999, 1009-9212-000-298692, 1009-9212-000-087171, 1009-9212-000-541250, 1009-9212-000-112034, 1009-9212-000-049246, 1009-9212-000-058137, 1009-9212-000-424095, 1009-9212-000-075391, 1009-9212-000-051629, 1009-9212-000-055895, 1009-9212-000-200169, 1009-9212-000-467712, 1009-9212-000-122353, 1009-9212-000-197283, 1009-9212-000-371531, 1009-9212-000-385369, 1009-9212-000-420979, 1009-9212-000-121953, 1009-9212-000-077474, 1009-9212-000-517447, 1009-9212-000-423988, 1009-9212-000-456572, 1009-9212-000-094170, 1009-9212-000-103980, 1009-9212-000-093910, 1009-9212-000-079246, 1009-9212-000-499619, 1009-9212-000-252101, 1009-9212-000-048161, 1009-9212-000-332475, 1009-9212-000-110948, 1009-9212-000-175403, 1009-9212-000-086414, 1009-9212-000-110965, 1009-9212-000-423320, 1009-9212-000-180559, 1009-9212-000-080479, 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1009-9212-000-053716, 1009-9212-000-368478, 1009-9212-000-171775, 1009-9212-000-060194, 1009-9212-000-069116, 1009-9212-000-074707, 1009-9212-000-063200, 1009-9212-000-520595, 1009-9212-000-379703, 1009-9212-000-044734, 1009-9212-000-393606, 1009-9212-000-507361, 1009-9212-000-048057, 1009-9212-000-086655, 1009-9212-000-081913, 1009-9212-000-094903, 1009-9212-000-120128, 1009-9212-000-070283, 1009-9212-000-081558, 1009-9212-000-094881, 1009-9212-000-093106, 1009-9212-000-086654, 1009-9212-000-410461, 1009-9212-000-059405, 1009-9212-000-078869, 1009-9212-000-047737, 1009-9212-000-094882, 1009-9212-000-408275, 1009-9212-000-529944, 1009-9212-000-380746, 1009-9212-000-241410, 1009-9212-000-068795, 1009-9212-000-093516, 1009-9212-000-056217, 1009-9212-000-139628, 1009-9212-000-138608, 1009-9212-000-297055, 1009-9212-000-174562, 1009-9212-000-416147, 1009-9212-000-239169, 1009-9212-000-048822, 1009-9212-000-589851, 1009-9212-000-584249, 1009-9212-000-583811, 1009-9212-000-599077, 1009-9212-000-599007, 1009-9212-000-599100, 1009-9212-000-502918, 1009-9212-000-073687, 1009-9212-000-082332, 1009-9212-000-145888, 1009-9212-000-252517, 1009-9212-000-496012, 1009-9212-000-509269, 1009-9212-000-431481, 1009-9212-000-149081, 1009-9212-000-461422, 1009-9212-000-189821, 1009-9212-000-104691, 1009-9212-000-067540, 1009-9212-000-075145, 1009-9212-000-153201, 1009-9212-000-390541, 1009-9212-000-423506, 1009-9212-000-297321, 1009-9212-000-147680, 1009-9212-000-136985, 1009-9212-000-048973, 1009-9212-000-071865, 1009-9212-000-359021, 1009-9212-000-472003, 1009-9212-000-069543, 1009-9212-000-069075, 1009-9212-000-250517, 1009-9212-000-056856, 1009-9212-000-100120, 1009-9212-000-100062, 1009-9212-000-138527, 1009-9212-000-090646, 1009-9212-000-070989, 1009-9212-000-115668, 1009-9212-000-135367, 1009-9212-000-119456, 1009-9212-000-137908, 1009-9212-000-160391, 1009-9212-000-046628, 1009-9212-000-197982, 1009-9212-000-144787, 1009-9212-000-440014, 1009-9212-000-523180, 1009-9212-000-081872, 1009-9212-000-082810, 1009-9212-000-420862, 1009-9212-000-083660, 1009-9212-000-502293, 1009-9212-000-342003, 1009-9212-000-119774, 1009-9212-000-228045, 1009-9212-000-274351, 1009-9212-000-356956, 1009-9212-000-414006, 1009-9212-000-414326, 1009-9212-000-418266, 1009-9212-000-426630, 1009-9212-000-443108, 1009-9212-000-467201, 1009-9212-000-467212, 1009-9212-000-497186, 1009-9212-000-509277, 1009-9212-000-521881, 1009-9212-000-524838, 1009-9212-000-526150, 1009-9212-000-054855, 1009-9212-000-191343, 1009-9212-000-045077, 1009-9212-000-438034, 1009-9212-000-501230, 1009-9212-000-275056, 1009-9212-000-156481, 1009-9212-000-444128, 1009-9212-000-040642, 1009-9212-000-047901, 1009-9212-000-091217, 1009-9212-000-193023, 1009-9212-000-274450, 1009-9212-000-527543, 1009-9212-000-243952, 1009-9212-000-412706, 1009-9212-000-412488, 1009-9212-000-065643, 1009-9212-000-370776, 1009-9212-000-443151, 1009-9212-000-055515, 1009-9212-000-302712, 1009-9212-000-390181, 1009-9212-000-173824, 1009-9212-000-367694, 1009-9212-000-137567, 1009-9212-000-517261, 1009-9212-000-411700, 1009-9212-000-388321, 1009-9212-000-086342, 1009-9212-000-102927, 1009-9212-000-105125, 1009-9212-000-390501, 1009-9212-000-450448, 1009-9212-000-361198, 1009-9212-000-411660, 1009-9212-000-187124, 1009-9212-000-251482, 1009-9212-000-056075, 1009-9212-000-094614, 1009-9212-000-107628, 1009-9212-000-078132, 1009-9212-000-052612, 1009-9212-000-390976, 1009-9212-000-499791, 1009-9212-000-526781, 1009-9212-000-367713, 1009-9212-000-046044, 1009-9212-000-431245, 1009-9212-000-306268, 1009-9212-000-264332, 1009-9212-000-257036, 1009-9212-000-046656, 1009-9212-000-057080, 1009-9212-000-163012, 1009-9212-000-231001, 1009-9212-000-259575, 1009-9212-000-283028, 1009-9212-000-086022, 1009-9212-000-154164, 1009-9212-000-069785, 1009-9212-000-103306, 1009-9212-000-105537, 1009-9212-000-052819, 1009-9212-000-276130, 1009-9212-000-384306, 1009-9212-000-303632, 1009-9212-000-532343, 1009-9212-000-059802, 1009-9212-000-215368, 1009-9212-000-181917, 1009-9212-000-070284, 1009-9212-000-110451, 1009-9212-000-086021, 1009-9212-000-165424, 1009-9212-000-275632, 1009-9212-000-302173, 1009-9212-000-509751, 1009-9212-000-174761, 1009-9212-000-222027, 1009-9212-000-070064, 1009-9212-000-105426, 1009-9212-000-508350, 1009-9212-000-055415, 1009-9212-000-449366, 1009-9212-000-377235, 1009-9212-000-170705, 1009-9212-000-151441, 1009-9212-000-169703, 1009-9212-000-496155, 1009-9212-000-467453, 1009-9212-000-391302, 1009-9212-000-069783, 1009-9212-000-260773, 1009-9212-000-414049, 1009-9212-000-509161, 1009-9212-000-559203, 1009-9212-000-296296, 1009-9212-000-421197, 1009-9212-000-518108, 1009-9212-000-172099, 1009-9212-000-245232, 1009-9212-000-245234, 1009-9212-000-381686, 1009-9212-000-077829, 1009-9212-000-082234, 1009-9212-000-053516, 1009-9212-000-105664, 1009-9212-000-343033, 1009-9212-000-389781, 1009-9212-000-057274, 1009-9212-000-113328, 1009-9212-000-244531, 1009-9212-000-187521, 1009-9212-000-216605, 1009-9212-000-050472, 1009-9212-000-103067, 1009-9212-000-115148, 1009-9212-000-150722, 1009-9212-000-362034, 1009-9212-000-175923, 1009-9212-000-535977, 1009-9212-000-386897, 1009-9212-000-095000, 1009-9212-000-052692, 1009-9212-000-358356, 1009-9212-000-524002, 1009-9212-000-105424, 1009-9212-000-110552, 1009-9212-000-176044, 1009-9212-000-244532, 1009-9212-000-514239, 1009-9212-000-045786, 1009-9212-000-095900, 1009-9212-000-103788, 1009-9212-000-391295, 1009-9212-000-091593, 1009-9212-000-114652, 1009-9212-000-060732, 1009-9212-000-053975, 1009-9212-000-403518, 1009-9212-000-496876, 1009-9212-000-067855, 1009-9212-000-388584, 1009-9212-000-182439, 1009-9212-000-362057, 1009-9212-000-399436, 1009-9212-000-107846, 1009-9212-000-439434, 1009-9212-000-094603, 1009-9212-000-165825, 1009-9212-000-190163, 1009-9212-000-436254, 1009-9212-000 | 10,338 units |
| Z-0078-2025 | Avance. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.; GTIN: 00840682102322. Model Number: 1009-9002-000. All Serial Numbers. Not model or lot specific. All devices of the indicated products configured with the AGCO option are potentially affected. | 9,349 units |
| Z-0079-2025 | Amingo. OUS only.; GTIN: 00840682102322. Model Number: 1009-9013-000. All Serial Numbers. Not model or lot specific. All devices of the indicated products configured with the AGCO option are potentially affected. | 77 units |
| Z-0080-2025 | Avance CS2 and Avance CS2 Pro. These anesthesia gas machines are intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.; GTIN: 00840682102322. Model Numbers: 1009-9050-000, 1011-9050-000, 1009-9002-000, 1009-9212-000. All Serial Numbers. Not model or lot specific. All devices of the indicated products configured with the AGCO option are potentially affected. | 12,559 units |
| Z-0081-2025 | Aisys. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.; GTIN: 00840682102292. Model Number: 1011-9000-000. All Serial Numbers. Not model or lot specific. All devices of the indicated products configured with the AGCO option are potentially affected. | 4,790 units |
| Z-0082-2025 | Aisys CS2. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.; GTIN: 00840682102292. Model Number: 1011-9050-000. All Serial Numbers. Not model or lot specific. All devices of the indicated products configured with the AGCO option are potentially affected. | 15,739 units |
| Z-0083-2025 | Aisys CS2 with Et Control. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.; GTIN: 00195278588128. Model Number: 1011-9055-000. All Serial Numbers. Not model or lot specific. All devices of the indicated products configured with the AGCO option are potentially affected. | 92 units |
| Z-0084-2025 | Auxiliary Common Gas Outlet (ACGO) conversion/install kits sold under product names CONV KIT SCGO TO ACGO and ACGO ASSY FIELD INSTL. These kits are not affected specifically, however are included due to being purchased with or later used to convert to ACGO.; No GTIN. Spare Part Numbers: 1009-8249-000, 1011-8071-000. Not model or lot specific. All devices of the indicated products configured with the AGCO option are potentially affected. | 649 units |
What to do — step by step
Check Connection
Verify that the patient's breathing circuit limb is connected to the correct port, not the Auxiliary Common Gas Outlet (ACGO) port.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide distribution - US Nationwide and the countries of Aland Islands, ALBANIA, Algeria, Argentina, Australia, Austria, Azerbaijan, BAHAMAS, Bahrain, Bangladesh, BARBADOS, BELARUS, Belgium, Benin, Bermuda, Bolivia, BONAIRE, Bosnia and…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 4 months after the firm started it.
- Firm started the recall
- FDA classified it Class I
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0083-2025 (July 12, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0083-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.