PlainHospital
2026 data FDA MAUDE openFDA FDA Class II

Sterilant, Medical Devices

Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.

OpenFDA device adverse-event casebook.

FDA Class II (moderate risk, special controls required), regulated under 21 CFR §880.6885 (General Hospital panel).

Browse devices → Device safety hub

FDA MAUDE casebook

openFDA event book Sterilant, Medical Devices LIGHT-BOOK · MAUDE

#512 of 1000 · 1,870 reports · 1996–2026

  • BOOK 1,870 reports
  • RANK #512 of 1000
  • DEATH 3 death-typed
  • INJ 425 injury-typed
  • MALF 562 malfunction
  • SPAN 1996–2026
  • PEAK 2012: 337
  • PHOTO Bed

Nearest event-volume peer: Bed, Therapeutic, Ac-Powered, Adjustable Home-Use (3 report gap)

Sterilant, Medical Devices sits #512 of 1000 among tracked device types with 1,870 MAUDE reports spanning 1996–2026. Rank counts report volume, not confirmed device fault. Event_type Death / Injury / Malfunction are one code per report — not the same population as patient-outcome rows ( methodology). Read with this device → · Lead manufacturer → · Similar-volume device →

Malfunction reports sit below the device-type norm

Sterilant, Medical Devices carries 30.1% MALFUNCTION-coded reports, 34.8pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.2% corpus 1.5% · below corpus mean (-1.3 pp)
  • INJ 22.7% corpus 30.3% · below corpus mean (-7.6 pp)
  • MALF 30.1% corpus 64.8% · below corpus mean (-34.8 pp)

Lead product-problem code Fluid/Blood Leak is 15% of coded problems · Lead manufacturer ADVANCED STERILIZATION PRODUCTS accounts for 100% of manufacturer-tagged reports · Top event location is 76% of location-tagged rows .

Sterilant, Medical Devices in the event-volume neighbourhood

FDA MAUDE report totals among this device type and nearest nationwide peers

reports

What this shows Sterilant, Medical Devices carries 1,870 MAUDE reports, ranked #512 of 1000.

Source FDA MAUDE via openFDA, aggregated by PlainHospital As of August 2026

Event Types

707 (37.8%)
Malfunction 562 (30.1%)
Injury 425 (22.7%)
Other 173 (9.3%)
Death 3 (0.2%)

Patient Outcomes

FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.

1,213 (63.7%)
Other 537 (28.2%)
Required Intervention 55 (2.9%)
Hospitalization 47 (2.5%)
R 24 (1.3%)
Life Threatening 13 (0.7%)
O 6 (0.3%)
Death 3 (0.2%)
H 2 (0.1%)
L 2 (0.1%)
Congenital Anomaly 1 (0.1%)
Disability 1 (0.1%)

Top Product Problems

Fluid/Blood Leak 297
Other (for use when an appropriate device code cannot be identified) 194
Unknown (for use when the device problem is not known) 182
Leak/Splash 180
Chemical Problem 135
Use of Device Problem 122
Improper or Incorrect Procedure or Method 118
Material Separation 110
Device Operates Differently Than Expected 88
Insufficient Device Problem Information 80
Adverse Event Without Identified Device or Use Problem 74
Fumes or Vapors 58
Device Disinfection Or Sterilization Issue 55
Disconnection 43
Contamination /Decontamination Problem 42
Reaction 42
Appropriate Device Problem Term/Code Not Available 35
Chemical Spillage 34
Device Reprocessing Problem 34
Device Rinsing Issue 32

Yearly Trend

96
1996: 3
98
1998: 1
99
1999: 2
00
2000: 5
01
2001: 39
02
2002: 22
03
2003: 15
04
2004: 68
05
2005: 129
06
2006: 27
07
2007: 34
08
2008: 79
09
2009: 158
10
2010: 89
11
2011: 106
12
2012: 337
13
2013: 140
14
2014: 105
15
2015: 110
16
2016: 135
17
2017: 74
18
2018: 42
19
2019: 35
20
2020: 32
21
2021: 31
22
2022: 16
23
2023: 9
24
2024: 8
25
2025: 9
26
2026: 10

Reports in 2025 (9) held close to the prior two-year average of 9.

Related Entities for Sterilant, Medical Devices

Top Manufacturers

ADVANCED STERILIZATION PRODUCTS 700

Event Locations

1,418 (75.8%)
I 404 (21.6%)
HOSPITAL 28 (1.5%)
NO INFORMATION 7 (0.4%)
AMBULATORY SURGICAL FACILITY 5 (0.3%)
INVALID DATA 4 (0.2%)
OTHER 1 (0.1%)
OUTPATIENT DIAGNOSTIC FACILITY 1 (0.1%)
OUTPATIENT TREATMENT FACILITY 1 (0.1%)
UNKNOWN 1 (0.1%)

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Sterilant, Medical Devices: nearest by total report volume and nearest by death-typed count, each floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (1,870 here).

Bed 1,867 Tubing, Pump, Cardiopulmonary Bypass 1,866 Disinfectant, Medical Devices 1,864 Catheter 1,863

Similar death-typed counts

Nearest other device types by death-typed report count (3 here), distinct from the volume row.

Analyzer, Pacemaker Generator Function 3 Apparatus, Traction, Non-Powered 3 Bronchial Thermoplasty System 3 Bur, Ear, Nose And Throat 3

Read our methodology - how this data is sourced, computed, and verified.

Disclaimer: MAUDE figures for Sterilant, Medical Devices are informational only and are not clinical advice. Report codes do not prove device causation. Consult a qualified clinician before acting on this data.

Every figure on PlainHospital is rendered directly from federal source data, no number is typed in by an editor. Event-type mix on this page is computed from FDA MAUDE codes for Sterilant, Medical Devices; corpus means use device types with ≥100 reports. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.