Medline ReNewalRecalls & reported problems across all models
Medline Industries, Inc. · 18 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one Medline ReNewal model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 34
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls
- 1
We found 18 models of Medline ReNewal by Medline Industries, Inc. in the FDA's device registry (GUDID). Together they are named in 34 adverse event reports in the FDA's MAUDE database, received between Nov 1, 2016 and Sep 28, 2026 — classified as 6 injuries, 28 malfunctions.
The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (5 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
Medline ReNewal 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.
- Mar 5, 2025Open, Classified
Medline ReNewal has identified that the drip chambers of affected devices may disconnect from the saline line tubing when under tension.
Z-1546-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported Medline ReNewal problems
Device problems
- Electrical /Electronic Property Problem5
- Appropriate Device Problem Term/Code Not Available4
- Detachment of Device or Device Component4
- Material Fragmentation4
- Break3
- Communication or Transmission Problem2
- Accessory Incompatible1
- Compatibility Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions20
- No Known Impact Or Consequence To Patient9
- Foreign Body In Patient3
- Bone Fracture(s)1
- No Consequences Or Impact To Patient1
Medline ReNewal models
18 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Medline ReNewal MSREP115774ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 recall4 reports
- Medline ReNewal HAREP103635ARTHROSCOPE5 reports
- MEDLINE RENEWAL 279401200RHElectrosurgical, cutting & coagulation accessories, laparoscopic & endoscopic, reprocessed4 reports
- Medline ReNewal N2FOURPORTRTRAP, STERILE SPECIMEN3 reports
- Medline ReNewal REP112994ARTHROSCOPE3 reports
- MEDLINE RENEWAL MAXAROximeter, reprocessed2 reports
- Medline ReNewal REP104845CELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES2 reports
- MEDLINE RENEWAL D11LTRLaparoscope, general & plastic surgery, reprocessed1 report
- Medline ReNewal ULCL500RAPPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED1 report
- MEDLINE RENEWAL 1859ROximeter, reprocessed1 report
- MEDLINE RENEWAL 1860ROximeter, reprocessed1 report
- Medline ReNewal REP110716ARTHROSCOPE1 report
- Medline ReNewal REP114044ARTHROSCOPE1 report
- Medline ReNewal REP120830LAPAROSCOPE, GENERAL & PLASTIC SURGERY, REPROCESSED1 report
- MEDLINE RENEWAL 375542000RArthroscope1 report
- Medline ReNewal IUB5LTRHLAPAROSCOPE, GENERAL & PLASTIC SURGERY, REPROCESSED1 report
- MEDLINE RENEWAL B12LTRLaparoscope, general & plastic surgery, reprocessed1 report
- MEDLINE RENEWAL 214141RPASSER1 report
Recent Medline ReNewal adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Electrical /Electronic Property Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50923295 ↗MalfunctionSep 28, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50923179 ↗MalfunctionSep 25, 2026Crack; Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50902749 ↗MalfunctionSep 25, 2026Electrical /Electronic Property Problem; Unable to Obtain Readings; Low Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50902463 ↗MalfunctionSep 25, 2026Communication or Transmission Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50901743 ↗MalfunctionSep 24, 2026Failure to Read Input Signal; Data Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50890045 ↗MalfunctionSep 23, 2026Fluid/Blood Leak; Free or Unrestricted Flow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50874059 ↗MalfunctionSep 23, 2026Compatibility Problem
It was reported that "when being plugged in - reading expired."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50872207 ↗MalfunctionSep 21, 2026Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50846812 ↗MalfunctionSep 21, 2026Accessory Incompatible
It was reported that the device would not run with the reprocessed Dornoch manifolds once inserted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50840562 ↗MalfunctionSep 19, 2026Corroded; Device Remains Activated
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50831818 ↗MalfunctionSep 16, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50794731 ↗MalfunctionAug 4, 2026Component Missing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50132291 ↗MalfunctionJun 11, 2026Communication or Transmission Problem
IT WAS REPORTED THAT, PLUGGED DEVICE IN AND IT WOULD NOT CONNECT OR REGISTER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25480796 ↗MalfunctionMay 31, 2026No Device Output
IT WAS REPORTED THAT, MANIFOLDS THAT ARE NOT WORKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25344070 ↗
Other Medline Industries, Inc. products
- Centurion Medical Products Corp52 models · 10 reports · 32 recalls
- NAMIC667 models · 229 reports · 22 recalls
- CURAD85 models · 295 reports · 4 recalls
- HUDSON RCI30 models · 190 reports · 2 recalls
- Excelsior8 models · 47 reports · 3 recalls
- BAUSCH and LOMB6 models · 1 reports · 2 recalls
- Guardian15 models · 77 reports
- MEDLINE UNITE10 models · 9 reports · 1 recall
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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