PlainRecalls

Datascope Corporation

Compiled from official public sources by the editorial team.

67 recalls on record · Latest: Nov 2, 2022

Datascope Corporation Recall Insight

Datascope Corporation appears on 67 federal recall records indexed by PlainRecalls, out of 101,704 total recalls tracked across the FDA, CPSC, and NHTSA. That represents approximately 0.066% 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 Nov 2, 2022, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 17 entries, severity tagging shows 0 critical, 16 moderate, and 1 lower-severity recalls. Affected-unit counts are disclosed on 17 of 17 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 (17). The date window on this page runs from Sep 10, 2014 to May 16, 2018.

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 Moderate May 16, 2018

BEQ-TOP 25500 ECC 3/8 w/QiD, Custom Tubing Kit, Catalog No. 701052461

FDA Devices Moderate May 16, 2018

BEQ-TOP 24202 ADULT ECC, Catalog No. 701054295

FDA Devices Moderate May 16, 2018

BEQ-TOP 40700 HUNTINGTON, Catalog No. 701062899

FDA Devices Moderate May 16, 2018

BEQ-TOP 8504 1/4X1/4 PACK W/QP, Custom Tubing Kit, Catalog No. 701066949R02

FDA Devices Moderate May 16, 2018

BEQ-TOP 50903 Custom ECC Pack-Pedriatric , Custom Tubing Kit, Catalog No. 709000078

FDA Devices Moderate May 16, 2018

BEQ-TOP 33500 3/8" ECC PACK, Catalog No. 701053752

FDA Devices Moderate May 16, 2018

Small Patient ECC Pack BEQ-TOP 22301, Catalog No. 701049513

FDA Devices Moderate May 16, 2018

BEQ-TOP 50900 Custom ECC Pack-Neonatal 1/4, Custom Tubing Kit, Catalog No. 709000069R02

FDA Devices Moderate May 16, 2018

BEQ-T 25501 3/8" Better Bladder Pack, Custom Tubing Kit, Catalog No. 709000370

FDA Devices Moderate Apr 25, 2018

Intra-Aortic Balloon Catheter Mega 7.5FR 30cc Product Usage: The intra-aortic balloon catheter and accessories are used to provide counter pulsat…

FDA Devices Moderate Apr 25, 2018

Intra-Aortic Balloon Catheter Mega 7.5FR 40cc Product Usage: The intra-aortic balloon catheter and accessories are used to provide counter pulsat…

FDA Devices Moderate Apr 25, 2018

Intra-Aortic Balloon Catheter Mega 8FR 50cc Product Usage: The intra-aortic balloon catheter and accessories are used to provide counter pulsation …

FDA Devices Moderate May 31, 2017

SENSATION PLUS¿ 8Fr. 50cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK¿ Product Code/Part Number: 0684-00-0576-01U is a cardiac assis…

FDA Devices Moderate Apr 19, 2017

Custom Tubing Pack with Bioline Coating UDI code: 00607567208230 Part Number: 709000058 The HLM Tubing Sets with Bioline Coating are for single …

FDA Devices Moderate Jun 22, 2016

Small Patient ECC Pack, REF BEQ-TOP 24100, Product Usage: The HLM Tubing Sets with Bioline Coating are for single use only. They may be sold sterile…

FDA Devices Moderate Jun 15, 2016

MEGA¿ 7.5Fr. 30cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK¿ MEGA¿ 7.5Fr. 40cc Intra-Aortic Balloon Catheter with Insertion Kit …

FDA Devices Low Sep 10, 2014

LINEAR 7.5 FR. 40cc IAB Catheter Maquet Getinge Group

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Data Sources

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

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Recalls are aggregated across FDA, CPSC and NHTSA filings that name this firm; the total reflects the federal record, not an independent investigation. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.