PlainRecalls

Advanced Sterilization Products

21 recalls on record · Latest: Feb 22, 2017

Advanced Sterilization Products Recall Insight

Advanced Sterilization Products appears on 21 federal recall records indexed by PlainRecalls, out of 83,949 total recalls tracked across the FDA, CPSC, NHTSA, and USDA FSIS. That represents approximately 0.025% 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 Feb 22, 2017, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 21 entries, severity tagging shows 0 critical, 18 moderate, and 3 lower-severity recalls. Affected-unit counts are disclosed on 21 of 21 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 (21). The date window on this page runs from Sep 5, 2012 to Feb 22, 2017.

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 Feb 22, 2017

STERRAD NX Sterilization System, Product Code: 10033, 10033-002

FDA Devices Moderate Jun 17, 2015

EVOTECH Endoscope Cleaner and Reprocessing System 220-230V, P/N 50004-002. The ASP EVOTECH ECR Endoscope Cleaner and Reprocessor is a washer/disin…

FDA Devices Moderate Apr 1, 2015

Tyvek Pouch/Roll with STERRAD Chemical Indicator, P/N 12425

FDA Devices Moderate Dec 31, 2014

STERRAD NX, Product Code 10133 The STERRAD Cassettes are used on STERRAD Sterilization System which is a low temperature general purpose sterilize…

FDA Devices Moderate Dec 31, 2014

STERRAD 200, Product Code 10118 The STERRAD Cassettes are used on STERRAD Sterilization System which is a low temperature general purpose steriliz…

FDA Devices Moderate Jan 22, 2014

STERRAD 100S Sterilization System, Product Code: 10101 The STERRAD 100S Sterilization System is a general purpose, low temperature sterilizer which …

FDA Devices Moderate Jan 22, 2014

STERRAD NX Sterilization System, Product Code: 10033 The STERRAD NX Sterilization System is a general purpose, low temperature sterilizer which us…

FDA Devices Moderate Jan 8, 2014

STERRAD Cyclesure Biological Indicator (BI, Part No. 14324. Intended to be used as a standard method for frequent monitoring of the STERRAD Steril…

FDA Devices Low Dec 11, 2013

STERITITE Containers: STERITITE Container Kit, 1/4 size, 3" high, product code: 13902; STERITITE Mini Mid Size, 3" high, product code: 13903; STERITI…

FDA Devices Moderate Dec 4, 2013

STERRAD 100NX, Product Code: 10104 The STERRAD Steri lization System is a low temperature general purpose sterilizer used to sterilize heat and mo…

FDA Devices Moderate Dec 4, 2013

STERRAD NX, Product Code: 10033 The STERRAD Steri lization System is a low temperature general purpose sterilizer used to sterilize heat and moist…

FDA Devices Moderate Nov 20, 2013

Sterrad 100NX, Product Code: 10104. Used to sterilize heat and moisture sensitive reusable medical devices.

FDA Devices Moderate Oct 30, 2013

STERRAD 100NX Cassettes The STERRAD Sterilization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensi…

FDA Devices Moderate Sep 18, 2013

STERRAD 100NX Cassettes, Product Code: 10144 The STERRAD Sterilization System is a low temperature general purpose sterilizer used to sterilize he…

FDA Devices Moderate May 8, 2013

STERRAD CYCLESURE 24 Biological Indicator (BI) The STERRAD CYCLESURE 24 Biological Indicator (BI), is intended to be used as a standard method for…

FDA Devices Moderate Apr 24, 2013

EVOTECH Endoscope Cleaner and Reprocessor System, P/N 50004. Designed to automatically clean and high-level disinfect flexible, submersible video …

FDA Devices Moderate Apr 10, 2013

STERRAD 200 Sterilization System, P/N 10201 Product Usage: The STERRAD 200 Sterilization System is a general purpose, low temperature sterilizer …

FDA Devices Moderate Apr 3, 2013

STERRAD 200 System Carriage, P/N 10208. Used as a tool to expedite loading and unloading processed items from a STERRAD 200 sterilizer.

FDA Devices Low Sep 19, 2012

STERRAD NX Cassette, Batch # 12A078. The STERRAD 100S and STERRAD NX sterilizations systems are low-temperature general purpose sterilizers used t…

FDA Devices Low Sep 19, 2012

STERRAD 100S Cassette, Batch # 12A077. The STERRAD 100S and STERRAD NX sterilizations systems are low-temperature general purpose sterilizers used…

FDA Devices Moderate Sep 5, 2012

CIDEX OPA, High Level Disinfectant Solution, Glutaraldehyde-free (0.55% ortho-phthaladehyde) solution. The CIDEX OPA solution is intended for automat…

Nearby Manufacturers

Other firms with recall activity tracked in the PlainRecalls index.

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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