Device manufacturer, as written on reports

Medline Industries: medical device reports filed with FDA

33,900 reports name it as the manufacturer of the device involved, 1992–2026.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

33,900
reports naming it as manufacturer: 0.1% of all MAUDE reports; 26,850
reports, 12 months to August 2026: 984 in the 12 months before; 87.7%
classified as malfunction: 62.3% across all reports; 0.3%
classified as death, as reported: 0.9% across all reports

33,900 medical device reports received by FDA give Medline Industries as the manufacturer of the device involved, 0.1% of the MAUDE database, from May 1992 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

26,850 reports arrived in the 12 months to August 2026, up 2629% from 984 in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are malfunction (87.7%), injury (10.1%) and other (1.7%). Manufacturers are required to report events they learn of, so a large manufacturer with many products in use files many reports. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Brands named most often

Brand	Device type	Reports	Latest 12 months	Classified as death
Medline	Walker, mechanical	25,305	26,184	0.1%
Medline Industries, Inc.	General surgery tray	388	100	0.2%
Guardian	Walker, mechanical	333	350	0.4%
Hudson RCI	Humidifier, respiratory gas, (direct patient interface)	119	121	1.3%
Equate	Tape and bandage, adhesive	23	37	0.3%
Foley Catheter	Catheter, urological	11	2	0.8%
Latex Exam Gloves	Latex patient examination glove	3	0	0.1%
Latex Foley Catheter	Catheter, coude	2	7	0%
Arrow	System, balloon, intra-aortic and control	1	65	3.4%
Conmed	Electrosurgical, cutting & coagulation & accessories	1	89	0.2%
LigaSure	Electrosurgical, cutting & coagulation & accessories	1	879	0.2%

Brands with a page on this site, ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Device types

Product code	Device type	Reports	Share
ITJ	Walker, mechanical	5,713	16.9%
LLI	Bed, therapeutic, ac-powered, adjustable home-use	3,179	9.4%
IOR	Wheelchair, mechanical	3,038	9%
BTI	Compressor, air, portable	2,589	7.6%
INM	Chair, with casters	1,995	5.9%
ILS	Adaptor, hygiene	1,734	5.1%
FSA	Lift, patient, non-ac-powered	1,158	3.4%
LRO	General surgery tray	995	2.9%
DXN	System, measurement, blood-pressure, non-invasive	906	2.7%
OSI	Bariatric bed	697	2.1%

Reports by month, five years

FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.

Event type

Death0.3%90

Injury10.1%3,423

Malfunction87.7%29,719

Other1.7%587

Not given0.2%81

Grey bar: all 26,136,888 MAUDE reports. Event type is the filer's classification and is not verified by FDA.

Questions about Medline Industries reports

How many FDA device reports name Medline Industries as manufacturer?

33,900 reports through August 2026, 26,850 of them in the latest 12 months.

Which of its brands appear most often?

Medline (25,305), Medline Industries, Inc. (388), Guardian (333), Hudson RCI (119) and Equate (23).

Which device types does it report on?

walker, mechanical (16.9%), bed, therapeutic, ac-powered, adjustable home-use (9.4%), wheelchair, mechanical (9%) and compressor, air, portable (7.6%).

Does a high count say something about the manufacturer?

Not by itself. Manufacturers must file a report for every event they become aware of, so report volume follows the number of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. Manufacturer names are pooled after company suffixes (Inc., LLC, GmbH and similar) are dropped; names that read as a person rather than an organisation are never published. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.