The Recall Desk

Hazard

Manufacturing Variation recalls

3 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
3
Critical
0
Severe
0
Most recent
2026-01-21

Of the 3 manufacturing variation recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all manufacturing variation recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

1–3 of 3

  • HighFDA (Devices)·Z-1042-2026·2026-01-21

    Angioplasty balloon catheters recalled over inflation and deflation difficulty

    Boston Scientific is recalling 21 Coyote over-the-wire PTA balloon dilatation catheters over the potential for inflation and deflation difficulty during use in the peripheral vasculature.

    Product
    Boston Scientific Coyote OVER-THE-WIRE PTA Balloon Dilation Catheter, 4F, 1) 2.5mm x120mm, 150 cm, UPM/Model No. REF H74939186251210; 2) 3.5mm x120mm, 150 cm, UPM/Model No. REF H74939186351210; Catheter, Angioplasty, Peripheral, Transluminal
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0502-2022·2022-01-26

    Blood Collection Tubes Recalled Due to Lithium Heparin Variation

    Greiner Bio-One is recalling 889,200 blood collection tubes (Lot #B21053QG) due to variation in lithium heparin that may cause blood clotting. The tubes were distributed to ten U.S. states.

    Product
    greiner bio-one VACUETTE TUBE, 5 ml LH Lithium Heparin Sep, 13x100 green cap-yellow ring, non-ridged, 24 racks of 50 pcs., 1200 pcs. in total, REF 456087P
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-0724-2017·2016-12-14

    Halyard C-Section Drapes Recalled for Manufacturing Variation

    Halyard Health is recalling specific lots of C-Section drapes because a manufacturing variation may prevent the removal of coated release paper, inhibiting easy access to the surgical site.

    Product
    Halyard C-Section Drape with Clear Screen and Full Incise (Non-Sterile), Product Code 44965 NS; C-Section Drape with Clear Screen and Full Incise (Sterile), Product Code 44966 00; C-Section Drape with Clear Screen (Non-Sterile), Product Code 44967 NS; C-Section Drape with Clear S
    Category
    Medical Device
    Distribution
    Distributed nationwide