Roscoe MedicalRecalls & reported problems across all models
Drive Devilbiss Healthcare · 4 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one Roscoe Medical model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls
- 1
We found 4 models of Roscoe Medical by Drive Devilbiss Healthcare in the FDA's device registry (GUDID). Together they are named in 7 adverse event reports in the FDA's MAUDE database, received between Sep 19, 2024 and Sep 24, 2026 — classified as 3 injuries, 4 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
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
Roscoe Medical recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Dec 9, 2024Open, Classified
Oxygen concentrator may melt or catch on fire during use.
Z-0795-2025 · Root cause: Component change control · Recall details · FDA record ↗
Most reported Roscoe Medical problems
Device problems
- Insufficient Device Problem Information4
- Adverse Event Without Identified Device or Use Problem1
- Fire1
- No Apparent Adverse Event1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Burn(s)1
- Electric Shock1
- Pain1
Roscoe Medical models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Roscoe Medical O2C5LGenerator, Oxygen, Portable1 recall4 reports
- Roscoe Medical DQ8450Stimulator, Nerve, Transcutaneous, For Pain Relief1 report
- Roscoe Medical DT7202 / DT7202CAStimulator, Nerve, Transcutaneous, Over-The-Counter1 report
- Roscoe Medical NEB-RITE4Nebulizer (Direct Patient Interface)1 report
Recent Roscoe Medical adverse event reports
The 7 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem
Drive Medical was notified of an incident involving an electrotherapy device by the device provider who reported that during use,the end user received two burns requiring wound care treatment. As part of its complaint review and evaluation process, Drive Medical will also notify the manufacturer of the product about this complaint.
Patient problems: Burn(s)
MAUDE report 50880443 ↗InjuryFeb 27, 2026Insufficient Device Problem Information
AFFECTED PRODUCTS: B00NCRE4GO - TENS 7000 DIGITAL TENS UNIT WITH ACCESSORIES - TENS UNIT MUSCLE STIMULATOR FOR BACK PAIN. RELIEF, SHOULDER PAIN RELIEF, NECK PAIN, SCIATICA PAIN RELIEF, NERVE PAIN RELIEF ASIN VARIATIONS: NA. CUSTOMER FEEDBACK: (B)(6) 2024: "DOES NOT STIMULATE. SHOCKS. CAUSED ME TO GO INTO CARDIAC ARREST."
Patient problems: Electric Shock
MAUDE report 24468313 ↗InjuryDec 2, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
LETTER OF REPRESENTATION RECEIVED: CLAIMANT SUSTAINED PERSONAL INJURIES AS THE RESULT OF AN INCIDENT, WHEREBY OUR CLIENT USED THE PRODUCT AND WAS BURNED.AS A RESULT OF THIS INCIDENT, A CLAIM IS BEING MADE AGAINST YOUR INSURED.
Patient problems: Pain
MAUDE report 20828506 ↗MalfunctionNov 15, 2024Fire; Fire
O2 CONCENTRATOR CAUGHT ON FIRE. THEY PUT THE FIRE OUT AND THERE WERE NO INJURIES. PROPERTY MANAGEMENT FOR THE COMPANY STATED UNIT CAUGHT FIRE IN A RESIDENT'S ROOM IN OUR SKILLED NURSING CARE. THE CONTROL AREA OF THE DEVICE IS WHERE THE FIRE STARTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20694910 ↗MalfunctionSep 28, 2024No Apparent Adverse Event; No Apparent Adverse Event
A CONCENTRATOR CAUGHT ON FIRE IN A PATIENT'S BATHROOM. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED WITH THE INFORMATION CURRENTLY AVAILABLE. THE MANUFACTURER CONTINUES TO REQUEST THE RETURN OF THE DEVICE FOR FURTHER ANALYSIS. IT SHOULD BE NOTED THAT THE MANUFACTURER HAS CONDUCTED INDEPENDENT ELECTRICAL TESTING ON A DEVICE FROM A PROXIMAL LOT AND MONTH, (B)(6) (LOT# JA2311, MANUFACTURE DATE: NOVEMBER 24, 2023), AND DETERMINED THE DEVICE TO MEET ELECTRICAL STANDARDS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20328761 ↗MalfunctionSep 19, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
WE HAD A CONCENTRATOR THAT CAUGHT ON FIRE IN A PATIENT'S HOME ON (B)(6) 2024. THE PATIENT HAD NO INJURIES AND DID NOT REQUIRE MEDICAL ATTENTION. THE PATIENT WAS IN A DIFFERENT ROOM FROM THE CONCENTRATOR. THE CONCENTRATOR WAS LOCATED IN THEIR BATHROOM, BECAUSE THEY DID NOT LIKE THE NOISE FROM THE CONCENTRATOR. THE DAUGHTER USED A FIRE EXTINGUISHER TO PUT THE OUT THE FIRE FROM THE CONCENTRATOR. THE FIRE DEPARTMENT WAS CALLED OUT BY THE DAUGHTER AFTER THE FIRE WAS EXTINGUISHED. PER THE DAUGHTER, THE CONCENTRATOR WAS TAKEN BY THE INSURANCE COMPANY. SHE WILL ASK IF SHE CAN GET IT BACK AND LET ME KNOW. THE FAMILY CALLED ME BACK AND THE FIRE INVESTIGATOR HAS THE CONCENTRATOR. THEY JUST SPOKE WITH HIM, AND THEY WILL NOT BE RELEASING THE CONCENTRATOR TO ANYONE. HE SAID THEY WOULD BE HAPPY TO DO A DUAL INVESTIGATION WITH THE MANUFACTURER/COMPANY. THIS EVENT IS NOT CONSIDERED A MANDATORY REPORTABLE EVENT AS THERE WAS NO REPORT OF DEATH OR SERIOUS INJURY. THE PRESENCE OR ABSENCE OF A MALFUNCTION CANNOT BE DETERMINED WITH THE INFORMATION CURRENTLY AVAILABLE. HOWEVER, THE MANUFACTURER HAS DECIDED TO MAKE THE FDA AWARE OF THE INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20256380 ↗MalfunctionSep 19, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
AT APPROXIMATELY 11:47PM ON JUNE 25, 2024, AT (B)(6), A FIRE ALARM SOUNDED ON THE 2 SOUTH UNIT IN ROOM 221. THE STAFF RESPONDED AND SAW HEAT AND SMOKE COMING FROM THE OXYGEN CONCENTRATOR, TRUAIRE-5, IN THE ROOM. THE STAFF EVACUATED THE PATIENTS (2) IN ROOM 221 AND THE PATIENTS IN THE ROOMS IN CLOSE VICINITY TO THE DINING ROOM BEYOND THE SMOKE BARRIER DOORS. THE PATIENTS FROM ROOM 221 WERE ASSESSED AFTER THEY WERE EVACUATED AND THERE WERE NO ADVERSE EFFECTS RELATED TO SMOKE INHALATION. AT THE SAME TIME ANOTHER STAFF MEMBER EXTINGUISHED THE FIRE USING THE FIRE EXTINGUISHER. THE FIRE DEPARTMENT RESPONDED AND ARRIVED AT APPROXIMATELY 11:54PM TO CONTAIN AND DISSIPATE THE SMOKE. THERE WAS NO NOTED DAMAGE TO THE STRUCTURE OF THE ROOM, THE TRUAIRE-5 OXYGEN CONCENTRATOR WAS REMOVED FROM THE ROOM, AND THE PATIENTS WERE ABLE TO RETURN TO THEIR ROOMS WITHIN 24 HOURS. THE PATIENT USING THE TRUAIRE-5 AS WELL AS THE OTHER PATIENTS THAT WERE EVACUATED WERE EVALUATED BY A PULMONARY NP THE NEXT DAY, (B)(6) 2024 AND IT WAS NOTED THAT THE PATIENT IN ROOM 221 RESPIRATORY STATUS WAS UNCHANGED AND HER OXYGEN DEMAND WAS STABLE, AND THE OTHER PATIENTS WERE NOTED TO HAVE RESPIRATORY/MENTAL STATUS AT BASELIN
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20256039 ↗
Other Drive Devilbiss Healthcare products
All Drive Devilbiss Healthcare 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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