STERRADRecalls & reported problems across all models
Advanced Sterilization Products Services Inc. · 12 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 873
- Deaths reported
- 0
- Injuries reported
- 13
- Recalls
- 0
We found 12 models of STERRAD by Advanced Sterilization Products Services Inc. in the FDA's device registry (GUDID). Together they are named in 873 adverse event reports in the FDA's MAUDE database, received between Feb 9, 2018 and Jun 24, 2026 — classified as 13 injuries, 860 malfunctions.
The most frequently reported specific device problem is “Environmental Particulates” (485 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported STERRAD problems
Device problems
- Environmental Particulates485
- Device Emits Odor315
- Smoking57
- Device Handling Problem23
- Fluid/Blood Leak15
- Use of Device Problem13
- Chemical Problem11
- Appropriate Device Problem Term/Code Not Available9
Patient problems
- No Consequences Or Impact To Patient422
- No Clinical Signs, Symptoms or Conditions320
- Skin Irritation26
- Insufficient Information23
- Headache22
- No Code Available21
- Burning Sensation19
- Skin Discoloration17
STERRAD models
12 models, most reported first. Each model has its own page with its reports, recalls and device details.
- STERRAD™ 10104Sterilizer, chemical259 reports
- Sterrad 10101Sterilizer, ethylene-oxide gas258 reports
- STERRAD™ 10104-007Sterilizer, chemical153 reports
- STERRAD™ 10104-003Sterilizer, chemical92 reports
- STERRAD™ 10144Sterilizer, chemical44 reports
- STERRAD™ 10104-002Sterilizer, chemical23 reports
- STERRAD™ 10104-006Sterilizer, chemical14 reports
- STERRAD™ 10104-008Sterilizer, chemical13 reports
- STERRAD™ 10104-005Sterilizer, chemical10 reports
- STERRAD™ 10104-004Sterilizer, chemical3 reports
- STERRAD™ 10113Sterilizer, chemical2 reports
- STERRAD™ 14100Indicator, physical/chemical sterilization process2 reports
Recent STERRAD adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryJun 24, 2026Environmental Particulates
IT WAS REPORTED FROM A HOSPITAL IN (B)(6), A FEMALE HEALTH CARE WORKER (HCW) WITH A HISTORY OF ASTHMA EXPERIENCED A RESPIRATORY REACTION AND SOUGHT EMERGENCY CARE RELATED TO OIL MIST FROM A STERRAD 100S STERILIZER. REGARDING THIS EVENT, PREVIOUS CYCLES WERE RUN, THEN A SHORT CYCLE STARTED AND THE HCW LEFT THE ROOM, AND THE DOOR WAS CLOSED. UPON RETURN IT WAS NOTED THAT OIL MIST HAD FILLED THE ROOM. CLINICAL DETAILS WERE PROVIDED BY THE OCCUPATIONAL HEALTH PHYSICIAN, WHO REPORTED THE HCW EXPERIENCED SHORTNESS OF BREATH AND WAS EVALUATED IN THE EMERGENCY DEPARTMENT WHERE SHE RECEIVED THE FOLLOWING TREATMENT: SUBCUTANEOUS ADRENALINE, OXYGEN VIA NASAL CANNULA, IV MEDICATION AND INHALATION THERAPY (SPECIFIC NAMES OF MEDICATION NOT KNOWN). LASTLY, IT WAS REPORTED SHE IS WELL, WITH NO COMPLICATIONS, AND SHE CONTINUES TO WORK IN THE DEPARTMENT WITH THE STERRAD UNIT. REGARDING THE ROOM WHERE THE STERILIZER IS LOCATED, IT WAS REPORTED THAT IT IS SMALL, AND ISOLATED WHEN THE DOOR IS CLOSED AND NOT WELL VENTILATED. THERE ARE NO WINDOWS, ONLY AIR CONDITIONING. AIR EXCHANGES HAVE NOT BEEN MEASURED. THIS COMPLAINT IS DEEMED REPORTABLE AS A SERIOUS INJURY. THE HCW RECEIVED MEDICATION TO TREAT HER
Patient problems: Dyspnea
MAUDE report 25616029 ↗InjuryApr 8, 2026Adverse Event Without Identified Device or Use Problem
ADVANCED STERILIZATION PRODUCTS (ASP) RECEIVED A VOLUNTARY MEDWATCH REPORT FROM THE FDA ON MARCH 12, 2026. IT WAS REPORTED BY A FAMILY MEMBER, A HEALTH CARE WORKER (HCW) IN THE UNITED STATES EXPERIENCED RESPIRATORY SYMPTOMS ON (B)(6) 2026, WHEN HE WAS EXPOSED TO VAPOR/CHEMICAL EMISSIONS WHILE OPERATING OR WORKING NEAR A STERRAD 100NX STERILIZER. IT WAS ALLEGED HE WAS EXPOSED TO FUMES RELEASED FROM THE UNIT OR SURROUNDING AREA, AND SHORTLY AFTER EXPOSURE HE DEVELOPED CHEST TIGHTNESS, COUGHING, SHORTNESS OF BREATH, AND LUNG IRRITATION. IT WAS REPORTED HIS SYMPTOMS PERSISTED AND REQUIRED MEDICAL EVALUATION; HOWEVER, IT WAS NOT REPORTED WHAT TYPE OF MEDICAL TREATMENT WAS RECEIVED. MEDICATIONS WERE LISTED IN THE REPORT AS FOLLOWS: ALBUTEROL, ELIQUIS, PREDNISONE, AND TRELEGY; HOWEVER, IT IS NOT CONFIRMED IF ANY OF THESE WERE GIVEN TO TREAT HIS REPORTED SYMPTOMS AT THE TIME OF THE ALLEGED EVENT OR WERE MEDICATIONS HE TAKES REGULARLY. THE HCW¿S MEDICAL HISTORY IS NOT KNOWN, INCLUDING ANY PRE-EXISTING RESPIRATORY CONDITIONS SUCH AS ASTHMA OR COPD. THE FAMILY MEMBER WHO REPORTED THIS EVENT ASKED TO REMAIN CONFIDENTIAL; THEREFORE, NO FOLLOW-UP CAN BE DONE. LASTLY, IT CANNOT BE CONFIRMED A SER
Patient problems: Chest Pain; Cough; Dyspnea; Unspecified Respiratory Problem
MAUDE report 24821202 ↗InjuryOct 15, 2025Mechanical Problem; Material Integrity Problem; Mechanical Problem; Material Integrity Problem
IT WAS REPORTED BY A HOSPITAL IN JAPAN TO ASP JAPAN BY MEANS OF THE COMPLAINT PROCESS, THAT AFTER A LOAD WAS STERILIZED, A FEMALE HEALTH CARE WORKER (HCW) PULLED OUT THE TOP SHELF OF A STERRAD 100NX STERILIZER AND IT SLIPPED AND FELL PARTIALLY OUT. IT WAS NOTED SHE ¿PANICKED¿ AND TRIED TO STOP THE SHELF FROM FALLING WITH HER FINGER AND FRACTURED HER MIDDLE FINGER ON HER RIGHT HAND. IT WAS NOTED THE HCW DID NOT GET HER FINGERS STUCK IN BETWEEN THE SHELF RAILS WHEN SHE PANICKED. AFTER CHECKING INSIDE THE CHAMBER, IT WAS NOTED THAT THE UPPER CHAMBER STOP WAS LOOSE ON THE RIGHT SIDE. CLINICAL DETAILS WERE PROVIDED, WHICH REPORTED THE HCW RECEIVED MEDICAL ATTENTION, AND A BONE FRACTURE WAS DIAGNOSED AND CONFIRMED BY X-RAY. A ¿CAST¿ OR SPLINT WAS APPLIED WHICH IS CONSIDERED STANDARD OF CARE. NO MEDICATION WAS GIVEN. THE HCW IS EXPECTED TO MAKE A FULL RECOVERY BY (B)(6) 2025, AND IT WAS REPORTED SHE HAD ALREADY COME BACK TO WORK. THIS COMPLAINT IS DEEMED REPORTABLE AS A SERIOUS INJURY. THE CUSTOMER REPORTED THAT A HCW PANICKED AND FRACTURED HER FINGER WHEN TRYING TO STOP THE SHELF FROM FALLING.
Patient problems: Bone Fracture(s)
MAUDE report 23303621 ↗MalfunctionJan 2, 2025Use of Device Problem; Use of Device Problem
A CUSTOMER REPORTED A FEMALE HEALTH CARE WORKER (HCW) IN HER FIFTIES EXPERIENCED A ¿LOW-TEMPERATURE BURN¿ WHEN SHE OPENED A NEW STERRAD® 100NX CASSETTE PACKAGE. THE HCW WAS WEARING WATERPROOF GLOVES, BUT SHE DID NOT WEAR PERSONAL PROTECTIVE EQUIPMENT (PPE). THE HYDROGEN PEROXIDE LEAKED DOWN HER ARM AND THE SKIN TURNED WHITE. SHE WASHED THOROUGHLY WITH RUNNING WATER AND THE H2O2 SKIN REACTION LASTED ONE DAY. SHE DID NOT RECEIVE MEDICAL ATTENTION, AND IT WAS REPORTED SHE ¿TOTALLY RECOVERED¿. THE H2O2 ¿LOW-TEMPERATURE BURN" WAS ASSESSED TO BE A MINOR INJURY SINCE IT RESOLVED WITHOUT MEDICAL INTERVENTION; HOWEVER, THIS EVENT IS BEING REPORTED AS A MALFUNCTION REPORT SUBSEQUENT TO A PREVIOUS SERIOUS INJURY.
Patient problems: Skin Discoloration
MAUDE report 21060192 ↗InjuryAug 27, 2024Device Handling Problem; Device Handling Problem
A CUSTOMER REPORTED A MALE HEALTH CARE WORKER (HCW) EXPERIENCED AN INJURY TO THE LEFT RING FINGER WHILE ATTEMPTING TO PLACE A USED VELOCITY BIOLOGICAL INDICATOR INSIDE THE STERRAD® 100NX STERILIZER CHAMBER AS THE DOOR WAS CLOSING, AND HE CLAIMED THE SAFETY FEATURE ON THE DOOR DID NOT FUNCTION PROPERLY. AFTER THIS EVENT OCCURRED, THE CUSTOMER CONFIRMED USE ERROR. THE SUPERVISOR REPORTED THE HCW WAS RETRAINED TO NOT PUT HIS HAND IN THE CHAMBER OF THE UNIT WHEN THE DOOR IS IN THE PROCESS OF CLOSING. OTHER USE ERROR WAS ALSO IDENTIFIED, AND THE HCW WAS RETRAINED ON THE CORRECT PROCEDURE AS PER THE STERRAD® 100NX USER GUIDE. HCW DID NOT SEEK MEDICAL ATTENTION ON THE DAY OF THE EVENT BUT VISITED THE EMERGENCY ROOM (ER) THE DAY AFTER BECAUSE THE AFFECTED AREA BECAME SWOLLEN AND PURPLE. X-RAYS WERE TAKEN IN THE ER, AND HE WAS DIAGNOSED WITH CRUSHING INJURY OF FINGER, SUBUNGUAL HEMATOMA, AND CLOSED FRACTURE OF TUFT OF DISTAL PHALANX OF FINGER. THE AFFECTED AREA WAS SPLINTED IN THE ER. HCW REPORTED HE TOOK A COUPLE OF DAYS OFF WORK AND WAS PLACED ON "LIGHT RESTRICTION" BY OCCUPATIONAL HEALTH. HE RETURNED TO WORK ON JUNE 4, 2024. NINE DAYS AFTER THE EVENT, HCW REPORTED THE PURPLE AREA ON FING
Patient problems: Bone Fracture(s); Hematoma; Pain; Swelling/ Edema
MAUDE report 20081752 ↗MalfunctionAug 27, 2024Use of Device Problem; Use of Device Problem
A CUSTOMER REPORTED A FEMALE HEALTH CARE WORKER (HCW) EXPERIENCED A SKIN REACTION OF TINGLING SENSATION WHEN SHE PUT HER BARE PALM DOWN ON THE COUNTER WHERE TWO USED STERRAD® 100NX CASSETTES HAD BEEN PREVIOUSLY LAYING FOR DISPOSAL. SHE DID NOT TOUCH THE ACTUAL CASSETTES. IT WAS REPORTED NO RESIDUAL H2O2 LIQUID FROM THE CASSETTES WAS NOTED ON THE COUNTER NOR ON THE USED CASSETTES. THE AFFECTED AREA WAS WASHED, AND NO MEDICAL TREATMENT WAS RECEIVED. THE AFFECTED AREA WAS WASHED, AND NO MEDICAL TREATMENT WAS RECEIVED THE H2O2 SKIN REACTION WAS ASSESSED TO BE A MINOR INJURY SINCE IT RESOLVED WITHOUT MEDICAL INTERVENTION; HOWEVER, THIS EVENT IS BEING REPORTED AS A MALFUNCTION REPORT SUBSEQUENT TO A PREVIOUS SERIOUS INJURY.
Patient problems: Skin Burning Sensation; Skin Discoloration
MAUDE report 20081750 ↗MalfunctionAug 27, 2024Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT A COMPANY REPRESENTATIVE EXPERIENCED A H2O2 SKIN REACTION OF A "TINGLING" SENSATION AND WHITE DISCOLORATION WHEN TAKING OUT TWO STERRAD® 100NX CASSETTES OUT OF THE COLLECTION BOX FOR DISPOSAL, WITHOUT GLOVES. NO RESIDUAL H2O2 WAS NOTED IN THE USED CASSETTES, THE COLLECTION BOX, NOR THE COUNTER. THE AFFECTED AREA WAS RINSED IMMEDIATELY WITH WATER, THEN WASHED. THE WHITE DISCOLORATION WAS GONE IN TWO HOURS AND THE SENSATION LASTED 30-45 MINUTES. NO MEDICAL TREATMENT WAS NEEDED, AND HE STATED HE WAS "FINE". THE H2O2 SKIN REACTION WAS ASSESSED TO BE A MINOR INJURY SINCE IT RESOLVED WITHOUT MEDICAL INTERVENTION; HOWEVER, THIS EVENT IS BEING REPORTED AS A MALFUNCTION REPORT SUBSEQUENT TO A PREVIOUS SERIOUS INJURY.
Patient problems: Skin Burning Sensation; Skin Discoloration
MAUDE report 20081574 ↗MalfunctionAug 15, 2024Use of Device Problem; Use of Device Problem
A CUSTOMER REPORTED A MALE HEALTH CARE WORKER (HCW) EXPERIENCED A "H2O2 BURN" WHEN HE REMOVED A USED STERRAD® 100NX CASSETTE FROM THE COLLECTION BOX WITHOUT GLOVES. THE AFFECTED AREA ON HIS HAND TURNED WHITE, BUT THE SKIN REACTION RESOLVED, AND HE IS REPORTED "OKAY". HE VISITED THE DOCTOR/CLINICIAN; HOWEVER, IT IS IT IS UNKNOWN IF MEDICAL TREATMENT WAS RECEIVED. THE "H2O2 BURN" WAS ASSESSED TO BE A MINOR INJURY SINCE IT RESOLVED WITHOUT MEDICAL INTERVENTION; HOWEVER, THIS EVENT IS BEING REPORTED AS A MALFUNCTION REPORT SUBSEQUENT TO A PREVIOUS SERIOUS INJURY.
Patient problems: Skin Discoloration
MAUDE report 19994101 ↗MalfunctionMay 17, 2024Use of Device Problem; Use of Device Problem
A CUSTOMER REPORTED A FEMALE HEALTHCARE WORKER (HCW) EXPERIENCED ¿BURNS¿ RELATED TO A STERRAD® 100NX CASSETTE. IT WAS REPORTED SHE HANDLED THE CASSETTE WITHOUT GLOVES AND NOTICED HER HANDS WERE WET, THEN SHE GAVE THE CASSETTE TO ANOTHER COLLEAGUE. THE H2O2 SKIN REACTION WAS WHITE ON HER HANDS AND RED ON ARMS, AND SHE RINSED WITH WATER AND THE REACTION RESOLVED IN 4-5 HOURS. IT WAS ALSO NOTED SHE HAD THROAT ¿IRRITATION¿ RELATED TO HANDLING THE CASSETTE THAT LASTED 4-5 HOURS. SHE RECEIVED MEDICAL ATTENTION FROM A DOCTOR IN THE HOSPITAL AND RECEIVED LORATADINE (ANTIHISTAMINE) AND DEXAMETHASONE (CORTICOSTEROID), WHICH CAN BE PURCHASED OVER-THE-COUNTER. LASTLY, IT WAS REPORTED SHE IS ¿WORKING AS USUAL¿ AND IS ¿FINE¿. THE H2O2 SKIN REACTION AND RESPIRATORY REACTION WERE ASSESSED TO BE A MINOR INJURY SINCE THERE IS NO REPORT THAT MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED TO PRECLUDE A PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE; HOWEVER, THIS EVENT IS BEING REPORTED AS A MALFUNCTION REPORT SUBSEQUENT TO A PREVIOUS SERIOUS INJURY. REFER TO MANUFACTURER REPORT NUMBER 2084725-2024-00018 FOR THE ADDITIONAL HCW INVOLVED IN THIS EVENT.
Patient problems: Erythema; Skin Discoloration; Unspecified Respiratory Problem
MAUDE report 19340481 ↗MalfunctionMay 17, 2024Use of Device Problem; Use of Device Problem
A CUSTOMER REPORTED A MALE HEALTHCARE WORKER (HCW) EXPERIENCED ¿BURNS¿ RELATED TO A STERRAD® 100NX CASSETTE. IT WAS REPORTED HE HANDLED THE CASSETTE AFTER ANOTHER COLLEAGUE GAVE IT TO HIM, AND HE WAS NOT WEARING GLOVES. THE H2O2 SKIN REACTION WAS WHITE, AND HE WASHED WITH WATER AND SOAP AND THE REACTION RESOLVED IN 4-5 HOURS. HE RECEIVED MEDICAL ATTENTION FROM A DOCTOR IN THE HOSPITAL AND RECEIVED LORATADINE (ANTIHISTAMINE), PARACETAMOL (ACETAMINOPHEN), AND ¿CLOFERAMINA COMPUESTA¿ (ANTIHISTAMINE), WHICH CAN BE PURCHASED OVER-THE-COUNTER. LASTLY, IT WAS REPORTED HE IS ¿WORKING AS USUAL¿ AND IS ¿FINE¿. THE H2O2 SKIN REACTION WAS ASSESSED TO BE A MINOR INJURY SINCE THERE IS NO REPORT THAT MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED TO PRECLUDE A PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE; HOWEVER, THIS EVENT IS BEING REPORTED AS A MALFUNCTION REPORT SUBSEQUENT TO A PREVIOUS SERIOUS INJURY. REFER TO MANUFACTURER REPORT NUMBER 2084725-2024-00017 FOR THE ADDITIONAL HCW INVOLVED IN THIS EVENT.
Patient problems: Skin Discoloration
MAUDE report 19340478 ↗MalfunctionDec 22, 2023Device Handling Problem; Device Handling Problem
A CUSTOMER REPORTED A HEALTH CARE WORKER (HCW) CAME IN CONTACT WITH HYDROGEN PEROXIDE WHILE INSERTING A NEW STERRAD® 100NX CASSETTE WITHOUT WEARING GLOVES. THE HCW EXPERIENCED SKIN REACTIONS DESCRIBED AS ITCHINESS AND WHITE SKIN DISCOLORATION ON TWO FINGERS. IT WAS REPORTED THE HCW WENT TO THE EMERGENCY ROOM; HOWEVER, IT IS UNKNOWN WHETHER MEDICAL INTERVENTION WAS RECEIVED. BASED ON THE INFORMATION AVAILABLE AT THE TIME OF THIS REPORT, THE H2O2 SKIN REACTION WAS ASSESSED TO BE MINOR INJURY; HOWEVER, THIS EVENT IS BEING REPORTED AS A MALFUNCTION REPORT SUBSEQUENT TO A PREVIOUS SERIOUS INJURY.
Patient problems: Itching Sensation; Skin Discoloration
MAUDE report 18387007 ↗MalfunctionNov 3, 2023Use of Device Problem; Use of Device Problem
A CUSTOMER REPORTED A FEMALE HEALTH CARE WORKER (HCW) EXPERIENCED ¿CHEMICAL BURNS¿ WHEN SHE REMOVED USED STERRAD® 100NX CASSETTE FROM THE COLLECTION BOX FOR DISPOSAL. IT WAS REPORTED THE HCW WAS NOT WEARING GLOVES. HER HAND TURNED WHITE, AND SHE REPORTED THE REACTION WENT AWAY IN A COUPLE HOURS. THE HCW WASHED THE AFFECTED AREA AND APPLIED LOTION, AND REPORTED SHE DID NOT SEEK MEDICAL ATTENTION FOR THE REACTION. THE H2O2 SKIN REACTION WAS ASSESSED TO BE A MINOR INJURY SINCE IT RESOLVED WITHOUT MEDICAL INTERVENTION; HOWEVER, THIS EVENT IS BEING REPORTED AS A MALFUNCTION REPORT SUBSEQUENT TO A PREVIOUS SERIOUS INJURY.
Patient problems: Skin Discoloration
MAUDE report 18069416 ↗InjurySep 28, 2023Device Handling Problem; Device Handling Problem
A CUSTOMER REPORTED A FEMALE HEALTH CARE WORKER (HCW) SUFFERED AN INJURY TO THE RIGHT RING FINGER WHILE REMOVING A NON-ASP TRAY/BOX (MANUFACTURER UNKNOWN) FROM THE STERRAD® 100NX STERILIZER AFTER A COMPLETED STANDARD CYCLE. THE CUSTOMER STATED THAT ONLY THE TOP SHELF OF THE STERILIZER WAS USED, AND THE TRAY/BOX WITH THE LOAD CONTENTS WEIGHED A TOTAL OF 10 KG (WEIGHT LIMIT EXCEEDED AS PER THE STERRAD® 100NX USER'S GUIDE). THE CUSTOMER REPORTED THAT THE TOP SHELF DID NOT FALL, BUT THE SHELF ¿DERAILED,¿ AND THE NON-ASP TRAY/BOX FELL AND ¿DISLOCATED¿ THE HCW¿S FINGER BACKWARDS, RESULTING IN IMMEDIATE PAIN AND SWELLING. THE CUSTOMER CONFIRMED THAT ONLY THE NON-ASP TRAY/BOX MADE CONTACT WITH THE INJURED AREA. THE HCW WAS SEEN BY AN ORTHOPEDIC HAND SPECIALIST ON (B)(6) 2023 AND REPORTED THAT THE SYMPTOMS PERSISTED ON (B)(6) 2023, NOTING ¿THE CASE IS SURGICAL.¿ THE CUSTOMER REPORTED THAT NO MEDICAL DOCUMENTATION WAS AVAILABLE BUT STATED THAT THE DOCTOR REPORTED THE HCW HAD A TORN LIGAMENT (GRADE UNKNOWN) ON THE RING FINGER. AT THE TIME OF THIS REPORT, IT IS UNKNOWN IF MEDICAL OR SURGICAL INTERVENTION HAS BEEN PERFORMED, HOWEVER, IT WAS NOTED THE HCW IS ¿RECOVERING WELL¿ AND UNDER OBSERVATI
Patient problems: Damage to Ligament(s); Pain; Swelling/ Edema
MAUDE report 17840053 ↗MalfunctionSep 25, 2023Device Emits Odor; Device Emits Odor
A CUSTOMER REPORTED AN EVENT OF A ¿SMELL¿ OR ODOR EMITTING FROM THE STERRAD® 100NX STERILIZER. THERE WAS NO REPORT OF ANY INJURIES OR HUMAN REACTIONS. THE CUSTOMER WAS INSTRUCTED TO POWER OFF THE UNIT AND DISCONTINUE USE. AN ASP FIELD SERVICE ENGINEER WAS DISPATCHED TO ASSESS THE UNIT ONSITE. THIS EVENT IS BEING REPORTED AS A MALFUNCTION REPORT SUBSEQUENT TO A PREVIOUS SERIOUS INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17808144 ↗MalfunctionSep 22, 2023Environmental Particulates; Environmental Particulates
A CUSTOMER REPORTED AN EVENT OF A ¿SMOKE¿ OR MIST/HAZE EMITTING FROM ¿THE FILTER OF THE VACUUM PUMP¿ OF THE STERRAD® 100S STERILIZER. THERE WAS NO REPORT OF ANY INJURIES OR HUMAN REACTIONS. THE CUSTOMER WAS INSTRUCTED TO POWER OFF THE UNIT AND DISCONTINUE USE. THIS EVENT IS BEING REPORTED AS A MALFUNCTION REPORT SUBSEQUENT TO A PREVIOUS SERIOUS INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17803960 ↗
Other Advanced Sterilization Products Services Inc. products
All Advanced Sterilization Products Services Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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