PlainRecalls

Abbott

13 recalls on record · Latest: Oct 22, 2025

Abbott Recall Insight

Abbott appears on 13 federal recall records indexed by PlainRecalls, out of 83,949 total recalls tracked across the FDA, CPSC, NHTSA, and USDA FSIS. That represents approximately 0.015% of the federal archive — a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated Oct 22, 2025, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 13 entries, severity tagging shows 4 critical, 9 moderate, and 0 lower-severity recalls. Affected-unit counts are disclosed on 13 of 13 entries — unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 1 distinct product categories, with issuing agencies dominated by FDA Devices (13). The date window on this page runs from May 23, 2018 to Oct 22, 2025.

Manufacturer-level browsing is useful when monitoring a single firm for patterns — whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current — deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement — always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.

FDA Devices Critical Oct 22, 2025

TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, FJ, (BiD Curve F-J), REF A-TFSE-FJ; cardiac catheter

FDA Devices Critical Oct 22, 2025

TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DD, (BiD Curve D-D), REF A-TFSE-DD; cardiac catheter

FDA Devices Critical Oct 22, 2025

TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, D, (UniD Curve D), REF A-TFSE-D; cardiac catheter

FDA Devices Moderate Apr 30, 2025

Amplatzer TorqVue LP Delivery System (TVLP), Model nos. 9-TVLP4F90/060 and 9-TVLP4F90/080

FDA Devices Moderate Apr 30, 2025

Amplatzer TorqVue LP Catheter (TVLPC), Model no. 9-TVLPC4F90/080

FDA Devices Moderate Nov 8, 2023

Abbott NT2000iX Radiofrequency (RF) generator, REF RFG-NT-2000, lesioning generator

FDA Devices Moderate Jun 8, 2022

FIRMap" Catheter, 60mm Basket

FDA Devices Moderate Apr 27, 2022

Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter, Bi-D, Curve DD, Model A-TCSE-DD, Sterile.

FDA Devices Moderate Apr 27, 2022

Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter, Bi-D, Curve D-F, Model A-TCSE-DF, Sterile.

FDA Devices Moderate Apr 13, 2022

Amplatzer Steerable Delivery Sheath

FDA Devices Moderate Jan 5, 2022

Ultimum HEMOSTASIS INTRODUCER 5f 1.67 MM

FDA Devices Moderate Jul 15, 2020

TactiCath Quartz Contact Force Ablation Catheter, Model Numbers: PN-004 065 (GTIN 07640157990033) and PN-004 075 (GTIN 07640157990040) - Product Usa…

FDA Devices Critical May 23, 2018

Thoratec HeartMate 3 LVAS Implant Kit, Rx Only, Catalog # 106524US, 106524, 10652INT - LVAS KIT, HM 3 Indicated for providing short-term hemodynam…

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Data Sources

  • Source: FDA + CPSC + NHTSA + USDA FSIS — federal recall filings naming this firm. Verify with FDA, CPSC, NHTSA, or USDA FSIS directly.
  • Source: PlainRecalls Manufacturer Index — firm-level aggregation across all four federal recall feeds