Recall archive / FDA device enforcement

Proclaim Plus 5 Implantable Pulse Generator REF 3670 Product Description: The implantable pulse generator (IPG) is an... — FDA record Z-2507-2023

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Jul 18, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product: Proclaim Plus 5 Implantable Pulse Generator REF 3670 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with up to 16 electrodes total. It is powered by a hermetically sealed battery within a titanium case and uses microelectronic circuitry to generate constant-current electrical stimulation. The IPG can deliver stimulation with a single program or with multiple programs. Each program can provide stimulation to a single anatomical area or to multiple areas. The IPG communicates wirelessly with system programmers and controllers, and the IPGs are available in small and large sizes to accommodate different power needs. The Proclaim" XR and Proclaim" Plus IPGs are used for Spinal Cord Stimulation (SCS). The Proclaim" DRG IPG is used for Dorsal Root Ganglion (DRG) stimulation. The Infinity" IPG is used for Deep Brain Stimulation (DBS).
Reason: Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse Generators).
Classification: Class I
Recalling firm: Abbott Medical
Quantity: 2,242 device (US only)
Agency-reported status: Ongoing
Source record identifier: Z-2507-2023

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	Model Number: 3670 UDI-DI Codes: 05415067046383 Serial Numbers: US AAD135.1 AAD136.1 AAD137.1 AAD139.1 AAD141.1 AAD145.1 AAD153.1 AAD158.1 AAD162.1 AAD164.1 AAD165.1 AAD166.1 AAD170.1 AAD171.1 AAD173.1 AAD174.1 AAD176.1 AAD178.1 AAD179.1 AAD181.1 AAD182.1 AAD186.1 AAD191.1 AAD196.1 AAD198.1 AAD205.1 AAD209.1 AAD215.1 AAD217.1 AAD221.1 AAD225.1 AAD226.1 AAD228.1 AAD234.1 AAD236.1 AAD237.1 AAD238.1 AAD242.1 AAD243.1 AAD263.1 AAD265.1 AAD275.1 AAD277.1 AAD278.1 AAD287.1 AAD288.1 AAD289.1 AAD290.1 AAD293.1 AAD296.1 AAD307.1 AAD319.1 AAD324.1 AAD325.1 AAD326.1 AAD331.1 AAD335.1 AAD336.1 AAD338.1 AAD344.1 AAD349.1 AAD351.1 AAD354.1 AAD360.1 AAD362.1 AAD368.1 AAD371.1 AAD375.1 AAD383.1 AAN922.1 AAN926.1 AAN936.1 AAN943.1 AAN944.1 AAN955.1 AAN958.1 AAN960.1 AAN963.1 AAN969.1 AAN973.1 AAN980.1 AAN982.1 AAN984.1 AAN987.1 AAN990.1 AAN991.1 AAN993.1 AAN998.1 AAP004.1 AAP008.1 AAP010.1 AAP011.1 AAP013.1 AAP014.1 AAP018.1 AAP020.1 AAP023.1 AAP024.1 AAP025.1 AAP029.1 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ACK690.1 ACK692.1 ACK700.1 ACK701.1 ACK71...

Label field

Details supplied by the agency

Lot, code or applicability

Model Number: 3670 UDI-DI Codes: 05415067046383 Serial Numbers: US AAD135.1 AAD136.1 AAD137.1 AAD139.1 AAD141.1 AAD145.1 AAD153.1 AAD158.1 AAD162.1 AAD164.1 AAD165.1 AAD166.1 AAD170.1 AAD171.1 AAD173.1 AAD174.1 AAD176.1 AAD178.1 AAD179.1 AAD181.1 AAD182.1 AAD186.1 AAD191.1 AAD196.1 AAD198.1 AAD205.1 AAD209.1 AAD215.1 AAD217.1 AAD221.1 AAD225.1 AAD226.1 AAD228.1 AAD234.1 AAD236.1 AAD237.1 AAD238.1 AAD242.1 AAD243.1 AAD263.1 AAD265.1 AAD275.1 AAD277.1 AAD278.1 AAD287.1 AAD288.1 AAD289.1 AAD290.1 AAD293.1 AAD296.1 AAD307.1 AAD319.1 AAD324.1 AAD325.1 AAD326.1 AAD331.1 AAD335.1 AAD336.1 AAD338.1 AAD344.1 AAD349.1 AAD351.1 AAD354.1 AAD360.1 AAD362.1 AAD368.1 AAD371.1 AAD375.1 AAD383.1 AAN922.1 AAN926.1 AAN936.1 AAN943.1 AAN944.1 AAN955.1 AAN958.1 AAN960.1 AAN963.1 AAN969.1 AAN973.1 AAN980.1 AAN982.1 AAN984.1 AAN987.1 AAN990.1 AAN991.1 AAN993.1 AAN998.1 AAP004.1 AAP008.1 AAP010.1 AAP011.1 AAP013.1 AAP014.1 AAP018.1 AAP020.1 AAP023.1 AAP024.1 AAP025.1 AAP029.1 AAP032.1 AAP034.1 AAP040.1 AAP044.1 AAP047.1 AAP049.1 AAP053.1 AAP054.1 AAP055.1 AAP056.1 AAP059.1 AAP060.1 AAP062.1 AAP069.1 AAP075.1 AAP079.1 AAP081.1 AAP082.1 AAP083.1 AAP089.1 AAP092.1 AAP093.1 AAP094.1 AAP099.1 AAP100.1 AAP106.1 AAP109.1 AAP113.1 AAP115.1 AAP117.1 AAP118.1 AAP119.1 AAP122.1 AAP124.1 AAP125.1 AAP129.1 AAP133.1 AAP134.1 AAP135.1 AAP139.1 AAP144.1 AAP146.1 AAP148.1 AAP157.1 AAP160.1 AAP162.1 AAP166.1 AAP167.1 AAP168.1 AAP173.1 AAP174.1 AAP176.1 AAP179.1 AAP182.1 AAP185.1 AAP190.1 AAP196.1 AAP199.1 AAP202.1 AAP203.1 AAP209.1 AAP211.1 AAP212.1 AAP213.1 AAP214.1 AAP216.1 AAP219.1 AAP221.1 AAP223.1 AAP225.1 AAP228.1 AAP229.1 AAP230.1 AAP233.1 AAP234.1 AAP242.1 AAP243.1 AAP252.1 AAP260.1 AAP261.1 AAP263.1 AAP264.1 AAP268.1 AAP270.1 AAP274.1 AAP275.1 AAP277.1 AAP278.1 AAP280.1 AAP281.1 AAP283.1 AAP285.1 AAP286.1 AAP288.1 AAP289.1 AAP290.1 AAP292.1 AAP294.1 AAP301.1 AAP302.1 AAP305.1 AAP308.1 AAP310.1 AAP311.1 AAP313.1 AAP315.1 AAP319.1 AAP321.1 AAP325.1 AAP326.1 AAP334.1 AAP336.1 AAP338.1 AAP342.1 AAP346.1 AAP351.1 AAP354.1 AAP358.1 AAP359.1 AAP365.1 AAP368.1 AAP372.1 AAP382.1 AAP386.1 AAP389.1 AAP390.1 AAP396.1 AAP411.1 AAT449.1 AAT450.1 AAT452.1 AAT453.1 AAT457.1 AAT460.1 AAT461.1 AAT463.1 AAT465.1 AAT470.1 AAT472.1 AAT473.1 AAT474.1 AAT477.1 AAT479.1 AAT482.1 AAT483.1 AAT484.1 AAT485.1 AAT486.1 AAT487.1 AAT490.1 AAT492.1 AAT504.1 AAT514.1 AAT522.1 AAT523.1 AAT532.1 AAT533.1 AAT538.1 AAT543.1 AAT547.1 AAT552.1 AAT553.1 AAT555.1 AAT559.1 AAT560.1 AAT561.1 AAT562.1 AAT564.1 AAT566.1 AAT568.1 AAT573.1 AAT584.1 AAT594.1 AAT597.1 AAT599.1 AAT608.1 AAT612.1 AAT614.1 AAT617.1 AAT619.1 AAT622.1 AAT624.1 AAT632.1 AAT633.1 AAT635.1 AAT636.1 AAT641.1 AAT642.1 AAT644.1 AAT647.1 AAT649.1 AAT650.1 AAT651.1 AAT653.1 AAT654.1 AAT656.1 AAT659.1 AAT662.1 AAT666.1 AAT669.1 AAT670.1 AAT671.1 AAT673.1 AAT676.1 AAT679.1 AAT680.1 AAT684.1 AAT689.1 AAT690.1 AAT693.1 AAT695.1 AAT697.1 AAT698.1 AAT699.1 AAT700.1 AAT701.1 AAT703.1 AAT705.1 AAT706.1 AAT709.1 AAT717.1 AAT719.1 AAT723.1 AAT728.1 AAT742.1 AAT745.1 AAT746.1 AAT747.1 AAT748.1 AAT753.1 AAT757.1 AAT758.1 AAT762.1 AAT763.1 AAT768.1 AAT770.1 AAT773.1 AAT775.1 AAT777.1 AAT780.1 AAT782.1 AAT784.1 AAT787.1 AAT799.1 AAT800.1 AAT802.1 AAT803.1 AAT806.1 AAT808.1 AAT809.1 AAT811.1 AAT813.1 AAT817.1 AAT822.1 AAT823.1 AAT827.1 AAT828.1 AAT833.1 AAT834.1 AAT837.1 AAT838.1 AAT839.1 AAT840.1 AAT847.1 AAT850.1 AAT851.1 AAT852.1 AAT853.1 AAT856.1 AAT857.1 AAT858.1 AAT859.1 AAT862.1 AAT863.1 AAT864.1 AAT868.1 AAT871.1 AAT875.1 AAT881.1 AAT884.1 AAT886.1 AAT887.1 AAT888.1 AAT892.1 AAT894.1 AAT895.1 AAT896.1 AAT898.1 AAT900.1 AAT901.1 AAT904.1 AAT905.1 AAT914.1 AAT915.1 AAT916.1 AAT917.1 AAT919.1 AAT921.1 AAT922.1 AAT924.1 AAT926.1 AAT930.1 AAT937.1 AAT938.1 AAT940.1 AAT944.1 AAT946.1 AAT947.1 AAT948.1 AAT950.1 AAT951.1 AAT959.1 AAT962.1 AAT969.1 AAT970.1 AAT978.1 AAT981.1 AAT998.1 AAU005.1 AAU007.1 AAU011.1 AAU012.1 AAU014.1 AAU017.1 AAU018.1 AAU019.1 AAU021.1 AAU026.1 AAU027.1 AAU030.1 AAU033.1 AAU035.1 AAU036.1 AAU038.1 AAU042.1 AAU045.1 AAU050.1 AAU053.1 AAU058.1 AAU060.1 AAU061.1 AAU062.1 AAU065.1 AAU066.1 AAU069.1 AAU072.1 AAU076.1 AAU081.1 AAU082.1 AAU083.1 AAU085.1 AAU088.1 AAU089.1 AAU092.1 AAU093.1 AAU099.1 AAU100.1 AAU101.1 AAU102.1 AAU104.1 AAU106.1 AAU109.1 AAU111.1 AAU118.1 AAU119.1 AAU120.1 AAU121.1 AAU123.1 AAU127.1 AAU132.1 AAU133.1 AAU134.1 AAU136.1 AAU137.1 AAU139.1 AAU140.1 AAU141.1 AAU145.1 AAU147.1 AAU149.1 AAU150.1 AAU152.1 AAU154.1 AAU157.1 AAU158.1 AAU159.1 AAU161.1 AAU164.1 AAU165.1 AAU166.1 AAU168.1 AAU169.1 AAU170.1 ABA930.1 ABA931.1 ABA932.1 ABA934.1 ABA938.1 ABA939.1 ABA941.1 ABA944.1 ABA947.1 ABA949.1 ABA951.1 ABA953.1 ABA954.1 ABA955.1 ABA956.1 ABA961.1 ABA967.1 ABA969.1 ABA973.1 ABA975.1 ABA977.1 ABA979.1 ABA981.1 ABA983.1 ABA986.1 ABA987.1 ABA992.1 ABA996.1 ABA997.1 ABA999.1 ABB006.1 ABB009.1 ABB014.1 ABB025.1 ABB026.1 ABB032.1 ABB033.1 ABB038.1 ABB039.1 ABB041.1 ABB044.1 ABB045.1 ABB047.1 ABB050.1 ABB054.1 ABB057.1 ABB058.1 ABB060.1 ABB061.1 ABB062.1 ABB063.1 ABB065.1 ABB066.1 ABB068.1 ABB069.1 ABB070.1 ABB071.1 ABB075.1 ABB078.1 ABB081.1 ABB083.1 ABB084.1 ABB086.1 ABB087.1 ABB089.1 ABB091.1 ABB092.1 ABB093.1 ABB096.1 ABB097.1 ABB098.1 ABB110.1 ABB113.1 ABB117.1 ABB118.1 ABB120.1 ABB123.1 ABB124.1 ABB125.1 ABB126.1 ABB127.1 ABB129.1 ABB130.1 ABB132.1 ABB135.1 ABB136.1 ABB137.1 ABB138.1 ABB142.1 ABB144.1 ABB146.1 ABB147.1 ABB149.1 ABB150.1 ABB152.1 ABB153.1 ABB154.1 ABB157.1 ABB158.1 ABB160.1 ABB161.1 ABB164.1 ABB168.1 ABB171.1 ABB172.1 ABB173.1 ABB176.1 ABB177.1 ABB178.1 ABB179.1 ABJ138.1 ABJ139.1 ABJ146.1 ABJ157.1 ABJ166.1 ABJ168.1 ABJ170.1 ABJ180.1 ABJ182.1 ABJ183.1 ABJ188.1 ABJ190.1 ABJ195.1 ABJ208.1 ABJ212.1 ABJ213.1 ABJ220.1 ABJ229.1 ABJ236.1 ABJ239.1 ABJ246.1 ABJ247.1 ABJ250.1 ABJ252.1 ABJ257.1 ABJ260.1 ABJ261.1 ABJ271.1 ABJ272.1 ABJ273.1 ABJ274.1 ABJ286.1 ABJ287.1 ABJ288.1 ABJ291.1 ABJ292.1 ABJ293.1 ABJ296.1 ABJ299.1 ABJ302.1 ABJ303.1 ABJ306.1 ABJ308.1 ABJ314.1 ABJ332.1 ABJ334.1 ABJ344.1 ABJ350.1 ABJ356.1 ABJ358.1 ABJ361.1 ABJ364.1 ABJ369.1 ABJ375.1 ABJ378.1 ABJ380.1 ABJ387.1 ABJ398.1 ABJ399.1 ABJ403.1 ABJ404.1 ABJ405.1 ABJ407.1 ABJ409.1 ABJ413.1 ABJ416.1 ABJ417.1 ABJ419.1 ABJ420.1 ABJ423.1 ABJ424.1 ABJ426.1 ABJ429.1 ABJ431.1 ABJ438.1 ABJ441.1 ABJ451.1 ABJ459.1 ABJ462.1 ABJ468.1 ABJ481.1 ABJ496.1 ABJ498.1 ABJ511.1 ABJ512.1 ABJ518.1 ABJ520.1 ABJ521.1 ABJ522.1 ABJ523.1 ABJ524.1 ABJ525.1 ABJ527.1 ABJ529.1 ABJ531.1 ABJ532.1 ABJ533.1 ABJ545.1 ABJ567.1 ABJ572.1 ABJ583.1 ABJ588.1 ABJ593.1 ABJ594.1 ABJ595.1 ABJ600.1 ABJ604.1 ABJ607.1 ABJ613.1 ABJ616.1 ABJ617.1 ABJ621.1 ABJ623.1 ABJ630.1 ABM165.1 ABM170.1 ABM174.1 ABM176.1 ABM177.1 ABM180.1 ABM190.1 ABM191.1 ABM193.1 ABM202.1 ABM203.1 ABM204.1 ABM206.1 ABM207.1 ABM208.1 ABM214.1 ABM216.1 ABM223.1 ABM224.1 ABM229.1 ABM230.1 ABM232.1 ABM233.1 ABM235.1 ABM238.1 ABM239.1 ABM240.1 ABM246.1 ABM250.1 ABM252.1 ABM253.1 ABM255.1 ABM258.1 ABM259.1 ABM262.1 ABM264.1 ABM266.1 ABM275.1 ABM276.1 ABM277.1 ABM279.1 ABM281.1 ABM283.1 ABM292.1 ABM294.1 ABM299.1 ABM300.1 ABM301.1 ABM304.1 ABM305.1 ABM318.1 ABM320.1 ABM321.1 ABM322.1 ABM325.1 ABM332.1 ABM333.1 ABM336.1 ABM340.1 ABM341.1 ABM342.1 ABM350.1 ABM354.1 ABM356.1 ABM365.1 ABM366.1 ABM367.1 ABM368.1 ABM369.1 ABM372.1 ABM374.1 ABM376.1 ABM377.1 ABM378.1 ABM379.1 ABM380.1 ABM383.1 ABM384.1 ABM390.1 ABM391.1 ABM393.1 ABM394.1 ABM398.1 ABM401.1 ABM402.1 ABM403.1 ABM405.1 ABM406.1 ABM417.1 ABM418.1 ABM421.1 ABM429.1 ABM433.1 ABM435.1 ABM436.1 ABM437.1 ABM440.1 ABM441.1 ABM449.1 ABM454.1 ABM456.1 ABM458.1 ABM470.1 ABM473.1 ABM479.1 ABM480.1 ABM483.1 ABM488.1 ABM495.1 ABM497.1 ABM499.1 ABM507.1 ABM509.1 ABM513.1 ABM514.1 ABM515.1 ABM516.1 ABM526.1 ABM529.1 ABM531.1 ABM534.1 ABM538.1 ABM543.1 ABM548.1 ABM550.1 ABM560.1 ABM562.1 ABM564.1 ABM567.1 ABM568.1 ABM571.1 ABM573.1 ABM582.1 ABM583.1 ABM586.1 ABM587.1 ABM590.1 ABM596.1 ABM598.1 ABM599.1 ABM610.1 ABM618.1 ABM623.1 ABM626.1 ABM628.1 ABM632.1 ABM634.1 ABM643.1 ABM645.1 ABM647.1 ABM648.1 ABM650.1 ABT691.1 ABT694.1 ABT696.1 ABT698.1 ABT699.1 ABT701.1 ABT718.1 ABT719.1 ABT723.1 ABT729.1 ABT731.1 ABT734.1 ABT741.1 ABT747.1 ABT755.1 ABT756.1 ABT758.1 ABT759.1 ABT764.1 ABT765.1 ABT766.1 ABT769.1 ABT772.1 ABT780.1 ABT781.1 ABT782.1 ABT783.1 ABT790.1 ABT792.1 ABT801.1 ABT813.1 ABT815.1 ABT819.1 ABT823.1 ABT826.1 ABT831.1 ABT833.1 ABT842.1 ABT845.1 ABT855.1 ABT856.1 ABT857.1 ABT858.1 ABT859.1 ABT864.1 ABT865.1 ABT868.1 ABT875.1 ABT876.1 ABT879.1 ABT886.1 ABT889.1 ABT890.1 ABT891.1 ABT895.1 ABT896.1 ABT901.1 ABT904.1 ABT905.1 ABT907.1 ABT909.1 ABT911.1 ABT912.1 ABT933.1 ABT936.1 ABT939.1 ABT941.1 ABT943.1 ABT949.1 ABT951.1 ABT957.1 ABT964.1 ABT966.1 ABT971.1 ABT972.1 ABT976.1 ABT978.1 ABT987.1 ABT993.1 ABT994.1 ABT995.1 ABT999.1 ABU009.1 ABU012.1 ABU016.1 ABU019.1 ABU025.1 ABU029.1 ABU032.1 ABU037.1 ABU038.1 ABU039.1 ABU041.1 ABU044.1 ABU046.1 ABU054.1 ABU055.1 ABU059.1 ABU067.1 ABU072.1 ABU074.1 ABU086.1 ABU087.1 ABU090.1 ABU091.1 ABU098.1 ABU109.1 ABU111.1 ABU112.1 ABU118.1 ABU122.1 ABU124.1 ABU125.1 ABU136.1 ABU137.1 ABU139.1 ABU140.1 ABU148.1 ABU151.1 ABU158.1 ABU159.1 ABU166.1 ABU167.1 ABU169.1 ABU171.1 ABU178.1 ABU180.1 ABU182.1 ACD618.1 ACD625.1 ACD633.1 ACD636.1 ACD637.1 ACD641.1 ACD646.1 ACD647.1 ACD651.1 ACD653.1 ACD658.1 ACD660.1 ACD661.1 ACD662.1 ACD672.1 ACD673.1 ACD679.1 ACD680.1 ACD688.1 ACD692.1 ACD700.1 ACD708.1 ACD717.1 ACD720.1 ACD723.1 ACD726.1 ACD727.1 ACD734.1 ACD735.1 ACD737.1 ACD738.1 ACD740.1 ACD742.1 ACD743.1 ACD744.1 ACD751.1 ACD753.1 ACD754.1 ACD755.1 ACD756.1 ACD759.1 ACD786.1 ACD787.1 ACD788.1 ACD804.1 ACD808.1 ACD816.1 ACD817.1 ACD824.1 ACD827.1 ACD831.1 ACD832.1 ACD837.1 ACD843.1 ACD847.1 ACE645.1 ACE659.1 ACE663.1 ACE668.1 ACE671.1 ACE672.1 ACE673.1 ACE678.1 ACE686.1 ACE687.1 ACE694.1 ACE701.1 ACE703.1 ACE704.1 ACE707.1 ACE710.1 ACE711.1 ACE712.1 ACE713.1 ACE715.1 ACE717.1 ACE718.1 ACE720.1 ACE724.1 ACE726.1 ACE728.1 ACE729.1 ACE730.1 ACE731.1 ACE733.1 ACE734.1 ACE736.1 ACE737.1 ACE746.1 ACE748.1 ACE754.1 ACE755.1 ACE761.1 ACE765.1 ACE773.1 ACE775.1 ACE781.1 ACE789.1 ACE793.1 ACE797.1 ACE798.1 ACE799.1 ACE802.1 ACE803.1 ACE804.1 ACE805.1 ACE810.1 ACE815.1 ACE816.1 ACE817.1 ACE818.1 ACE820.1 ACE825.1 ACE826.1 ACE830.1 ACE833.1 ACE841.1 ACE842.1 ACE844.1 ACE845.1 ACE847.1 ACE851.1 ACE853.1 ACE855.1 ACE859.1 ACE861.1 ACE866.1 ACE870.1 ACE872.1 ACE885.1 ACE886.1 ACE890.1 ACE891.1 ACE895.1 ACE902.1 ACE923.1 ACE924.1 ACE928.1 ACE932.1 ACE934.1 ACE941.1 ACE945.1 ACE946.1 ACE951.1 ACE952.1 ACE955.1 ACE957.1 ACE958.1 ACE963.1 ACE965.1 ACE966.1 ACE968.1 ACE972.1 ACE975.1 ACE976.1 ACE978.1 ACE985.1 ACE988.1 ACE989.1 ACE993.1 ACF012.1 ACF016.1 ACF020.1 ACF021.1 ACF029.1 ACF031.1 ACF033.1 ACF034.1 ACF036.1 ACF041.1 ACF050.1 ACF051.1 ACF052.1 ACF053.1 ACF059.1 ACF066.1 ACF069.1 ACF071.1 ACF077.1 ACF078.1 ACF079.1 ACF080.1 ACF081.1 ACF083.1 ACF086.1 ACF087.1 ACF089.1 ACF090.1 ACF093.1 ACK134.1 ACK137.1 ACK142.1 ACK156.1 ACK157.1 ACK162.1 ACK163.1 ACK172.1 ACK178.1 ACK180.1 ACK185.1 ACK188.1 ACK191.1 ACK197.1 ACK198.1 ACK202.1 ACK203.1 ACK210.1 ACK235.1 ACK236.1 ACK237.1 ACK239.1 ACK246.1 ACK254.1 ACK255.1 ACK262.1 ACK264.1 ACK265.1 ACK267.1 ACK271.1 ACK272.1 ACK274.1 ACK277.1 ACK279.1 ACK280.1 ACK284.1 ACK285.1 ACK292.1 ACK299.1 ACK302.1 ACK306.1 ACK307.1 ACK311.1 ACK312.1 ACK314.1 ACK317.1 ACK320.1 ACK323.1 ACK331.1 ACK332.1 ACK335.1 ACK337.1 ACK344.1 ACK346.1 ACK357.1 ACK358.1 ACK359.1 ACK376.1 ACK377.1 ACK389.1 ACK391.1 ACK398.1 ACK399.1 ACK400.1 ACK401.1 ACK402.1 ACK403.1 ACK404.1 ACK410.1 ACK417.1 ACK423.1 ACK435.1 ACK441.1 ACK446.1 ACK454.1 ACK458.1 ACK459.1 ACK462.1 ACK465.1 ACK466.1 ACK470.1 ACK473.1 ACK474.1 ACK475.1 ACK478.1 ACK481.1 ACK485.1 ACK490.1 ACK491.1 ACK492.1 ACK499.1 ACK504.1 ACK507.1 ACK508.1 ACK510.1 ACK521.1 ACK522.1 ACK524.1 ACK528.1 ACK530.1 ACK542.1 ACK550.1 ACK551.1 ACK553.1 ACK557.1 ACK566.1 ACK571.1 ACK573.1 ACK575.1 ACK582.1 ACK587.1 ACK593.1 ACK600.1 ACK604.1 ACK605.1 ACK616.1 ACK619.1 ACK623.1 ACK627.1 ACK628.1 ACK631.1 ACK633.1 ACK635.1 ACK636.1 ACK643.1 ACK653.1 ACK654.1 ACK656.1 ACK657.1 ACK658.1 ACK659.1 ACK661.1 ACK679.1 ACK680.1 ACK689.1 ACK690.1 ACK692.1 ACK700.1 ACK701.1 ACK71...

The agency lot list is longer than this excerpt. Read the complete list at the official source.

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The countries of Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Costa Rica, Czech Republic, Denmark, Ecuador, Estonia, Finland, France, Germany, Greece, Hungary, India, Iraq, Ireland, Israel, Italy, Japan, Korean, Kuwait, Lithuania, Luxembourg, Mexico, Netherlands, New Zealand, Norway, Pakistan, Poland, Portugal, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date: Sep 20, 2023
Recall initiation date: Jul 18, 2023
Center classification date: Sep 11, 2023

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

What the record says

Lot and product identifiers

Distribution

Dates in the source

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