PlainHospital
2026 data FDA MAUDE openFDA FDA Class II

Sterilizer, Chemical

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 §880.6860 (General Hospital panel).

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FDA MAUDE casebook

openFDA event book Sterilizer, Chemical LIGHT-BOOK · MAUDE

#308 of 1000 · 5,242 reports · 1995–2026

  • BOOK 5,242 reports
  • RANK #308 of 1000
  • DEATH 4 death-typed
  • INJ 262 injury-typed
  • MALF 4,746 malfunction
  • SPAN 1995–2026
  • PEAK 2013: 541
  • PHOTO System

Nearest event-volume peer: System, X-Ray, Tomography, Computed (1 report gap)

Sterilizer, Chemical sits #308 of 1000 among tracked device types with 5,242 MAUDE reports spanning 1995–2026. 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 run above the device-type norm

Sterilizer, Chemical carries 90.5% MALFUNCTION-coded reports, 25.7pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.1% corpus 1.5% · below corpus mean (-1.4 pp)
  • INJ 5.0% corpus 30.3% · below corpus mean (-25.3 pp)
  • MALF 90.5% corpus 64.8% · above corpus mean (+25.7 pp)

Lead product-problem code Device Emits Odor is 33% of coded problems · Lead manufacturer ADVANCED STERILIZATION PRODUCTS accounts for 100% of manufacturer-tagged reports · Top event location is 65% of location-tagged rows .

Sterilizer, Chemical in the event-volume neighbourhood

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

reports

What this shows Sterilizer, Chemical carries 5,242 MAUDE reports, ranked #308 of 1000.

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

Event Types

Malfunction 4,746 (90.5%)
Injury 262 (5.0%)
157 (3.0%)
Other 73 (1.4%)
Death 4 (0.1%)

Patient Outcomes

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

4,967 (94.5%)
Other 226 (4.3%)
Required Intervention 30 (0.6%)
Hospitalization 14 (0.3%)
R 7 (0.1%)
L 3 (0.1%)
Death 3 (0.1%)
H 2 (0.0%)
O 2 (0.0%)
S 1 (0.0%)
Disability 1 (0.0%)

Top Product Problems

Device Emits Odor 1,813
Other (for use when an appropriate device code cannot be identified) 1,045
Environmental Particulates 962
Appropriate Device Problem Term/Code Not Available 292
Use of Device Problem 263
Unknown (for use when the device problem is not known) 183
Chemical Problem 179
Adverse Event Without Identified Device or Use Problem 121
Smoking 105
Insufficient Device Problem Information 70
Fluid/Blood Leak 64
Leak/Splash 62
Device Handling Problem 55
Chemical Spillage 42
Improper or Incorrect Procedure or Method 39
Fumes or Vapors 38
Human-Device Interface Problem 37
Device-Device Incompatibility 34
Device Operates Differently Than Expected 27
Fogging 26

Yearly Trend

95
1995: 4
96
1996: 1
97
1997: 3
98
1998: 8
99
1999: 5
00
2000: 19
01
2001: 17
02
2002: 13
03
2003: 10
04
2004: 7
05
2005: 231
06
2006: 84
07
2007: 272
08
2008: 536
09
2009: 433
10
2010: 210
11
2011: 34
12
2012: 101
13
2013: 541
14
2014: 399
15
2015: 412
16
2016: 286
17
2017: 279
18
2018: 289
19
2019: 222
20
2020: 174
21
2021: 202
22
2022: 188
23
2023: 140
24
2024: 44
25
2025: 47
26
2026: 31

Reports fell to 47 in 2025, down from an average of 92 in the two years before.

Related Entities for Sterilizer, Chemical

Top Manufacturers

ADVANCED STERILIZATION PRODUCTS 4,537

Event Locations

3,401 (64.9%)
I 1,756 (33.5%)
HOSPITAL 68 (1.3%)
OUTPATIENT DIAGNOSTIC FACILITY 4 (0.1%)
UNKNOWN 4 (0.1%)
NO INFORMATION 3 (0.1%)
AMBULATORY SURGICAL FACILITY 2 (0.0%)
OTHER 2 (0.0%)
INVALID DATA 1 (0.0%)
OUTPATIENT TREATMENT FACILITY 1 (0.0%)

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Sterilizer, Chemical: 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 (5,242 here).

System, X-Ray, Tomography, Computed 5,243 Expander, Surgical, Skin Graft 5,240 Dilator, Esophageal 5,224 Light, Surgical, Ceiling Mounted 5,203

Similar death-typed counts

Nearest other device types by death-typed report count (4 here), distinct from the volume row.

Catheter, Urethral 4 Disinfectant, Medical Devices 4 Drill, Surgical, Ent Including Handpiece 4 Electrode 4

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

Disclaimer: MAUDE figures for Sterilizer, Chemical 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 Sterilizer, Chemical; 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.