--- title: "Abbott Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search Abbott recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/abbott/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # Abbott recall records **9** reported ongoing 18 records in this archive. Latest source date Jan 15, 2026. 3 published notices do not supply a closure status. FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status Jan 15, 2026 FDA company announcement ### [FreeStyle Libre: FreeStyle Libre 3 and 3 Plus Glucose monitoring sensors](https://isitonrecall.com/recall/fdapress-23e244c6ea16b211-freestyle-libre-freestyle-libre-3-and-3-plus-glucose-monitoring-sensors/) Internal testing determined that some sensors may provide incorrect low glucose readings. Not supplied Published notice; closure not supplied Distribution: Not supplied [Official source for FreeStyle Libre: FreeStyle Libre 3 and 3 Plus Glucose monitoring sensors](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/abbott-initiates-medical-device-correction-certain-freestyle-librer-3-and-freestyle-libre-3-plus) Sep 10, 2025 FDA device enforcement ### [TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, D, (UniD Curve D), REF A-TFSE-D; cardiac catheter](https://isitonrecall.com/recall/fda-device-z-0109-2026-tactiflex-sensor-enabled-ablation-catheter-8f-115-cm-d-unid-curve-d-ref-a-tfse-d-cardiac-catheter/) Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging. Class I Reported ongoing Distribution: Worldwide [Official source for TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, D, (UniD Curve D), REF A-TFSE-D; cardiac ...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0109-2026%22) Sep 10, 2025 FDA device enforcement ### [TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DD, (BiD Curve D-D), REF A-TFSE-DD; cardiac catheter](https://isitonrecall.com/recall/fda-device-z-0110-2026-tactiflex-sensor-enabled-ablation-catheter-8f-115-cm-dd-bid-curve-d-d-ref-a-tfse-dd-cardiac-catheter/) Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging. Class I Reported ongoing Distribution: Worldwide [Official source for TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DD, (BiD Curve D-D), REF A-TFSE-DD; cardi...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0110-2026%22) Sep 10, 2025 FDA device enforcement ### [TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DF, (BiD Curve D-F), REF A-TFSE-DF; cardiac catheter](https://isitonrecall.com/recall/fda-device-z-0111-2026-tactiflex-sensor-enabled-ablation-catheter-8f-115-cm-df-bid-curve-d-f-ref-a-tfse-df-cardiac-catheter/) Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging. Class I Reported ongoing Distribution: Worldwide [Official source for TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DF, (BiD Curve D-F), REF A-TFSE-DF; cardi...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0111-2026%22) Sep 10, 2025 FDA device enforcement ### [TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, FJ, (BiD Curve F-J), REF A-TFSE-FJ; cardiac catheter](https://isitonrecall.com/recall/fda-device-z-0112-2026-tactiflex-sensor-enabled-ablation-catheter-8f-115-cm-fj-bid-curve-f-j-ref-a-tfse-fj-cardiac-catheter/) Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging. Class I Reported ongoing Distribution: Worldwide [Official source for TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, FJ, (BiD Curve F-J), REF A-TFSE-FJ; cardi...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0112-2026%22) Sep 10, 2025 FDA device enforcement ### [TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, F, (UniD Curve F), REF A-TFSE-F; cardiac catheter](https://isitonrecall.com/recall/fda-device-z-0113-2026-tactiflex-sensor-enabled-ablation-catheter-8f-115-cm-f-unid-curve-f-ref-a-tfse-f-cardiac-catheter/) Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging. Class I Reported ongoing Distribution: Worldwide [Official source for TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, F, (UniD Curve F), REF A-TFSE-F; cardiac ...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0113-2026%22) Mar 17, 2025 FDA device enforcement ### [Amplatzer TorqVue LP Delivery System (TVLP), Model nos. 9-TVLP4F90/060 and 9-TVLP4F90/080](https://isitonrecall.com/recall/fda-device-z-1643-2025-amplatzer-torqvue-lp-delivery-system-tvlp-model-nos-9-tvlp4f90-060-and-9-tvlp4f90-080/) Device may have a small breach in the proximal end of the shaft under the strain relief of the delivery system. Breach is not visibly detectable and may lead to prolonged procedure, blood loss, or air ingress with potential for air embolism. Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution. [Official source for Amplatzer TorqVue LP Delivery System (TVLP), Model nos. 9-TVLP4F90/060 and 9-TVLP4F90/080](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1643-2025%22) Mar 17, 2025 FDA device enforcement ### [Amplatzer TorqVue LP Catheter (TVLPC), Model no. 9-TVLPC4F90/080](https://isitonrecall.com/recall/fda-device-z-1644-2025-amplatzer-torqvue-lp-catheter-tvlpc-model-no-9-tvlpc4f90-080/) Device may have a small breach in the proximal end of the shaft under the strain relief of the delivery system. Breach is not visibly detectable and may lead to prolonged procedure, blood loss, or air ingress with potential for air embolism. Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution. [Official source for Amplatzer TorqVue LP Catheter (TVLPC), Model no. 9-TVLPC4F90/080](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1644-2025%22) Jul 31, 2024 FDA company announcement ### [Abbott: FreeStyle Libre® 3 sensors](https://isitonrecall.com/recall/fdapress-e1797ac4f8fa40db-abbott-freestyle-libre-r-3-sensors/) Sensors may provide incorrect high glucose readings Not supplied Published notice; closure not supplied Distribution: Not supplied [Official source for Abbott: FreeStyle Libre® 3 sensors](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/abbott-issues-voluntary-medical-device-correction-small-number-freestyle-librer-3-sensors-us) Sep 28, 2023 FDA device enforcement ### [Abbott NT2000iX Radiofrequency (RF) generator, REF RFG-NT-2000, lesioning generator](https://isitonrecall.com/recall/fda-device-z-0209-2024-abbott-nt2000ix-radiofrequency-rf-generator-ref-rfg-nt-2000-lesioning-generator/) Certain NT2000iX RF generators were serviced using a tool that was subsequently found to be out of tolerance and therefore may not have provided accurate results for potential capacitance failure. Class II Reported ongoing Distribution: US, Taiwan, and Colombia [Official source for Abbott NT2000iX Radiofrequency (RF) generator, REF RFG-NT-2000, lesioning generator](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0209-2024%22) Jun 12, 2023 FDA device enforcement ### [Abbott Amplatzer Steerable Delivery Sheath (ASDS), REF ASDS-14F-075, is a percutaneous catheter (cardiac).](https://isitonrecall.com/recall/fda-device-z-2110-2023-abbott-amplatzer-steerable-delivery-sheath-asds-ref-asds-14f-075-is-a-percutaneous-catheter-cardiac/) There is an overall reported incidence rate of 0.77% related to observed or potential air embolism during procedures in which the ASDS product was used. Class I Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of Slovakia, Czech Republic. [Official source for Abbott Amplatzer Steerable Delivery Sheath (ASDS), REF ASDS-14F-075, is a percutaneous catheter (...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2110-2023%22) Jun 9, 2022 FDA device enforcement ### [Abbott TactiCath Sensor Enabled, Contact Force Ablation Catheter, 8F 115cm FJ, REF A-TCSE-FJ. For mapping of the heart chambers during ablation.](https://isitonrecall.com/recall/fda-device-z-1344-2022-abbott-tacticath-sensor-enabled-contact-force-ablation-catheter-8f-115cm-fj-ref-a-tcse-fj-for-mappin/) When connected to the EnSite Precision Navigation System, an affected TactiCath Contact Force Ablation Catheter, Sensor Enabled may present the error message: "invalid catheter,, or "expired catheter." Class II Reported terminated Distribution: US Nationwide distribution. [Official source for Abbott TactiCath Sensor Enabled, Contact Force Ablation Catheter, 8F 115cm FJ, REF A-TCSE-FJ. For...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1344-2022%22) Apr 28, 2022 FDA device enforcement ### [FIRMap" Catheter, 60mm Basket](https://isitonrecall.com/recall/fda-device-z-1213-2022-firmap-catheter-60mm-basket/) Incorrect product labeling. Class II Reported terminated Distribution: US Nationwide Distribution to states of: MO, CA, OH, WA and OUS internationally to Italy and Netherlands. [Official source for FIRMap" Catheter, 60mm Basket](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1213-2022%22) Mar 24, 2022 FDA device enforcement ### [Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter, Bi-D, Curve D-F, Model A-TCSE-DF, Sterile.](https://isitonrecall.com/recall/fda-device-z-0956-2022-abbott-se-tacticath-sensor-enabled-contact-force-ablation-catheter-bi-d-curve-d-f-model-a-tcse-df-st/) Devices were manufactured with a "First Use Date" preprogrammed in the EEPROM which disables the use of the single-use device. Class II Reported terminated Distribution: Worldwide distribution - US Nationwide - there was government distribution but no military. The countries of Austria, Belgium, Canada, Denmark, France, Germany, Greece, Israel, ... [Official source for Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter, Bi-D, Curve D-F, Model A-TCSE...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0956-2022%22) Mar 24, 2022 FDA device enforcement ### [Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter, Bi-D, Curve DD, Model A-TCSE-DD, Sterile.](https://isitonrecall.com/recall/fda-device-z-0957-2022-abbott-se-tacticath-sensor-enabled-contact-force-ablation-catheter-bi-d-curve-dd-model-a-tcse-dd-ste/) Devices were manufactured with a "First Use Date" preprogrammed in the EEPROM which disables the use of the single-use device. Class II Reported terminated Distribution: Worldwide distribution - US Nationwide - there was government distribution but no military. The countries of Austria, Belgium, Canada, Denmark, France, Germany, Greece, Israel, ... [Official source for Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter, Bi-D, Curve DD, Model A-TCSE-...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0957-2022%22) Feb 17, 2022 FDA company announcement ### [Similac, Alimentum, and EleCare: Powder Infant Formula](https://isitonrecall.com/recall/fdapress-685f92fec7c6083b-similac-alimentum-and-elecare-powder-infant-formula/) Consumer complaints regarding Cronobacter sakazakii, Salmonella Newport. Not supplied Published notice; closure not supplied Distribution: Not supplied [Official source for Similac, Alimentum, and EleCare: Powder Infant Formula](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/abbott-voluntarily-recalls-powder-formulas-manufactured-one-plant) Nov 16, 2021 FDA device enforcement ### [Ultimum HEMOSTASIS INTRODUCER 5f 1.67 MM](https://isitonrecall.com/recall/fda-device-z-0420-2022-ultimum-hemostasis-introducer-5f-1-67-mm/) As a result of a manufacturing error, one (1) lot of Ultimum Hemostasis Introducer devices was manufactured with an incorrect hub and overall length. The devices manufactured were 12 cm in length instead of the intended 5 cm in length. Class II Reported terminated Distribution: Worldwide distribution - US Nationwide distribution in the state of Missouri and the country of Australia. [Official source for Ultimum HEMOSTASIS INTRODUCER 5f 1.67 MM](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0420-2022%22) Nov 9, 2021 FDA device enforcement ### [Amplatzer Steerable Delivery Sheath](https://isitonrecall.com/recall/fda-device-z-0895-2022-amplatzer-steerable-delivery-sheath/) Instructions for use were updated. Class II Reported terminated Distribution: OUS distribution only [Official source for Amplatzer Steerable Delivery Sheath](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0895-2022%22) ## Reasons in these listed records - Internal testing determined that some sensors may provide incorrect low glucose readings. - Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging. - Device may have a small breach in the proximal end of the shaft under the strain relief of the delivery system. Breach is not visibly detectable and may lead to prolonged procedure, blood loss, or air ingress with potential for air embolism. - Sensors may provide incorrect high glucose readings These examples come from this result page and are not a ranking of every recall reason. ## Checking Abbott ### Is there a recall on abbott right now? This archive contains 18 records, including 9 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product. ### How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier. ### Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall. ### What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. [Check source coverage](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/archives/) or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page. ## Keep checking [Search Abbott](https://isitonrecall.com/check/?q=Abbott) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)