ReNewRecalls & reported problems across all models
Microline Surgical, Inc. · 45 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one ReNew model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 125
- Deaths reported
- 0
- Injuries reported
- 11
- Recalls
- 4
We found 45 models of ReNew by Microline Surgical, Inc. in the FDA's device registry (GUDID). Together they are named in 125 adverse event reports in the FDA's MAUDE database, received between May 18, 2018 and Aug 20, 2026 — classified as 11 injuries, 114 malfunctions.
The most frequently reported specific device problem is “Fracture” (46 reports).
4 FDA recall records 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
ReNew 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.
- Nov 5, 2024Open, Classified
A lot of ReNew Microscissor Tips exhibited a 2% rate of failure in terms of the heat shrink breaking off.
Z-0663-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Nov 1, 2017Terminated
Certain lots of disposable laparoscopic instrument tips may potentially have a compromised sterile barrier.
Z-1741-2018 · Root cause: Process control · Recall details · FDA record ↗
- Nov 1, 2017Terminated
Certain lots of disposable laparoscopic instrument tips may potentially have a compromised sterile barrier.
Z-1740-2018 · Root cause: Process control · Recall details · FDA record ↗
- Jul 13, 2017Terminated
The heat-shrink insulation tube may split during autoclave sterilization/re-sterilization. If a split occurs, the heat-shrink could fall off during a surgical procedure and if cautery is needed, there is a potential for burn due to insulation failure.
Z-0507-2018 · Root cause: Device Design · names 20 of these models · Recall details · FDA record ↗
Most reported ReNew problems
Device problems
- Fracture46
- Material Fragmentation19
- Insufficient Device Problem Information15
- Arcing13
- Break9
- Detachment of Device or Device Component5
- Electrical /Electronic Property Problem5
- Sparking4
Patient problems
- No Clinical Signs, Symptoms or Conditions69
- No Known Impact Or Consequence To Patient27
- Burn(s)8
- Insufficient Information7
- No Consequences Or Impact To Patient4
- Bowel Burn3
- No Information3
- Device Embedded In Tissue or Plaque2
ReNew models
45 models, most reported first. Each model has its own page with its reports, recalls and device details.
- ReNew 3142Electrosurgical, Cutting & Coagulation & Accessories1 recall10 reports
- ReNew 3122Electrosurgical, Cutting & Coagulation & Accessories1 recall8 reports
- ReNew 3221Electrosurgical, Cutting & Coagulation & Accessories1 recall6 reports
- ReNew 3251Electrosurgical, Cutting & Coagulation & Accessories1 recall1 report
- ReNew 3261Electrosurgical, Cutting & Coagulation & Accessories1 recall1 report
- ReNew 3291Electrosurgical, Cutting & Coagulation & Accessories1 recall1 report
- ReNew 3312Electrosurgical, Cutting & Coagulation & Accessories1 recall0 reports
- ReNew 3201Electrosurgical, Cutting & Coagulation & Accessories1 recall0 reports
- ReNew 3231Electrosurgical, Cutting & Coagulation & Accessories1 recall0 reports
- ReNew 3241Electrosurgical, Cutting & Coagulation & Accessories1 recall0 reports
- ReNew 3271Electrosurgical, Cutting & Coagulation & Accessories1 recall0 reports
- ReNew 3281Electrosurgical, Cutting & Coagulation & Accessories1 recall0 reports
- ReNew 3311Electrosurgical, Cutting & Coagulation & Accessories1 recall0 reports
- ReNew 3321Electrosurgical, Cutting & Coagulation & Accessories1 recall0 reports
- ReNew 3341Electrosurgical, Cutting & Coagulation & Accessories1 recall0 reports
- ReNew 3351Electrosurgical, Cutting & Coagulation & Accessories1 recall0 reports
- ReNew 3361Electrosurgical, Cutting & Coagulation & Accessories1 recall0 reports
- ReNew 3381Electrosurgical, Cutting & Coagulation & Accessories1 recall0 reports
- ReNew 3401Electrosurgical, Cutting & Coagulation & Accessories1 recall0 reports
- ReNew 3411Electrosurgical, Cutting & Coagulation & Accessories1 recall0 reports
- ReNew 3421Electrosurgical, Cutting & Coagulation & Accessories1 recall0 reports
- ReNew 3431Electrosurgical, Cutting & Coagulation & Accessories1 recall0 reports
- ReNew 3301Electrosurgical, Cutting & Coagulation & Accessories1 recall0 reports
- ReNew 3222Electrosurgical, Cutting & Coagulation & Accessories24 reports
- ReNew 3152Electrosurgical, Cutting & Coagulation & Accessories11 reports
- ReNew 3252Electrosurgical, Cutting & Coagulation & Accessories9 reports
- ReNew 3904Electrosurgical, Cutting & Coagulation & Accessories9 reports
- ReNew 3642Electrosurgical, Cutting & Coagulation & Accessories6 reports
- ReNew 3622Electrosurgical, Cutting & Coagulation & Accessories5 reports
- ReNew 3292Electrosurgical, Cutting & Coagulation & Accessories4 reports
- ReNew 3352Electrosurgical, Cutting & Coagulation & Accessories4 reports
- ReNew 3914Electrosurgical, Cutting & Coagulation & Accessories4 reports
- ReNew 3941Electrosurgical, Cutting & Coagulation & Accessories4 reports
- ReNew 3262Electrosurgical, Cutting & Coagulation & Accessories3 reports
- ReNew 6924Electrosurgical, Cutting & Coagulation & Accessories3 reports
- ReNew 3925Electrosurgical, Cutting & Coagulation & Accessories2 reports
- ReNew 6172Electrosurgical, Cutting & Coagulation & Accessories2 reports
- ReNew 3112Electrosurgical, Cutting & Coagulation & Accessories1 report
- ReNew 3322Electrosurgical, Cutting & Coagulation & Accessories1 report
- ReNew 3632Electrosurgical, Cutting & Coagulation & Accessories1 report
- ReNew 3915Electrosurgical, Cutting & Coagulation & Accessories1 report
- ReNew 6182Electrosurgical, Cutting & Coagulation & Accessories1 report
- ReNew 3382Electrosurgical, Cutting & Coagulation & Accessories1 report
- ReNew 3945Electrosurgical, Cutting & Coagulation & Accessories1 report
- ReNew 3362Electrosurgical, Cutting & Coagulation & Accessories1 report
Recent ReNew adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryAug 20, 2026Therapy Delivered to Incorrect Body Area
While treating / ablating tissue (endometrial ablation) unintended tissue was burned. A minor burn occured in the pelvic cavity.
Patient problems: Burn(s)
MAUDE report 50345531 ↗InjuryAug 3, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50116233 ↗MalfunctionApr 7, 2026Sparking
DURING THE PROCEDURE, ABOUT 30 MINUTES AFTER START, A SPARK OCCURRED AT THE JOINT BETWEEN THE HANDPIECE AND THE SCISSORS, CAUSING DAMAGE TO TISSUE OUTSIDE THE TREATMENT AREA. THE TISSUE THAT WAS UNINTENTIONALLY DAMAGED WAS A BLOOD VESSEL; HEMOSTASIS WAS ACHIEVED USING AN ALTERNATIVE DEVICE, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO SIGNIFICANT PROLONGATION OF THE SURGICAL DURATION OR OTHER ISSUES RELATED TO THE HEMOSTASIS WERE OBSERVED. THE PATIENT IS DOING WELL.
Patient problems: Unspecified Tissue Injury
MAUDE report 24803151 ↗MalfunctionMar 3, 2026Break; Fracture
THE TIP OF THE LAPAROSCOPIC GRASPER INSTRUMENT BROKE DURING A NORMAL PROCEDURE. A METAL PART OF THE INSTRUMENT FRACTURED, CREATING A RISK THAT SMALL METAL FRAGMENTS COULD HAVE ENTERED AND REMAINED IN THE PATIENT'S ABDOMINAL CAVITY. THE BROKEN TIP WAS RETRIEVED, AND ALL PIECES APPEARED TO BE ACCOUNTED FOR.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 24499921 ↗MalfunctionNov 6, 2025Fracture; Fracture
MalfunctionOct 2, 2025Break; Break
DURING THE CASE, ONE SIDE OF THE GRASPER TIP SNAPPED OFF INSIDE THE PATIENT. THE SURGEON WAS ABLE TO SAFELY RETRIEVE THE BROKEN PIECE, AND THE PATIENT WAS NOT HARMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23198471 ↗MalfunctionSep 24, 2025Fracture; Fracture
DAMAGE OCCURRED DURING PROCEDURE WHEN GRASPING A ROBOTIC SPONGE (CIGAR) APPROX.4MM IN THICKNESS. UNABLE TO DETERMINE IF A MICRO PIECE OF METAL IS LOST IN PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23137245 ↗MalfunctionAug 1, 2025Use of Device Problem; Device Fell; Use of Device Problem; Device Fell
A WHITE SILICONE BAND WAS INADVERTENTLY LEFT ON THE DEVICE TIP AND SUBSEQUENTLY DISLODGED INTO THE PATIENT'S CHEST CAVITY DURING THE INITIAL PROCEDURE ON (B)(6) 2025. THE SURGEON CLOSED THE CHEST WITHOUT NOTICING THE BAND. DURING A SUBSEQUENT REOPERATION FOR AN UNRELATED REASON ON (B)(6) 2025, THE SILICONE BAND WAS DISCOVERED AND REMOVED. THE SILICON BAND WAS REMOVED SAFELY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22690324 ↗MalfunctionJul 16, 2025Sparking; Sparking
MICROLINE WAS MADE AWARE OF WHAT APPEARED TO BE AN ELECTRICAL SAFETY FAILURE EVENT OF A MICROLINE LAPARSCOPIC HANDPIECE AND A MICROLINE SCISSOR TIP DURING USE OF MONOPOLAR CAUTERIZATION DURING A PROCEDURE. THE PROCEDURE REPORTED WAS A HYSTERECTOMY AND BILATERAL SALPINGECTOMY. PATIENT WAS NOT HARMED, AND THE STAFF HAD NOTICED WHAT APPEARED TO BE MELTING AND CHARGING OF THE DISTAL SHAFT AND SCISSOR TIP OF THE MICROLINE PRODUCT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22520807 ↗MalfunctionJun 13, 2025Fracture; Material Fragmentation; Fracture; Material Fragmentation
A BLACK PLASTIC COMPONENT DETACHED AND FELL INTO THE PATIENT'S ABDOMINAL CAVITY DURING THE PROCEDURE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 22202678 ↗MalfunctionJun 12, 2025Fracture; Fracture
THE TIP BROKE INSIDE THE PATIENT. THE PATIENT WAS NOT HARMED, AND THE GRASPER WAS RETRIEVED INTACT. NO SERIOUS INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22194813 ↗MalfunctionJun 5, 2025Fracture; Fracture
THE TIP BROKE OFF INTO THE ABDOMEN OF THE PATIENT.
Patient problems: Insufficient Information
MAUDE report 22152435 ↗MalfunctionMay 21, 2025Break; Break
DISPOSABLE RENEW SUPER ATRAUMATIC GRABBER TIP BROKE INTO TWO PIECES INSIDE THE PATIENT'S ABDOMEN. THE BROKEN GRASPER CAUSED RETRACTION OF BOWEL TO BE LOST DUE TO INABILITY TO GRASP. ONE SMALL PIECE OF GRASPER FELL FREELY INTO PATIENT'S ABDOMEN. THE PIECE WAS RETRIEVED BY THE SURGEON WITH USE OF LAPAROSCOPE GUIDANCE AND NEW GRASPER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22060238 ↗InjuryMay 1, 2025Arcing; Arcing
PATIENT UNDERWENT A LAPAROSCOPIC OVARIAN CYSTECTOMY. INTRAOPERATIVELY, MONOPOLAR SCISSOR CAUTERIZED AT THE JUNCTION BETWEEN THE SCISSOR TIP AND HANDPIECE HANDLE CAUSING LEFT ILIAC ARTERY BLEED WITH 1000 CC BLOOD LOSS. PATIENT REQUIRED ONE UNIT OF PRBCS TRANSFUSION. VASCULAR SURGERY AND GENERAL SURGERY CONSULTED, AND PATIENT UNDERWENT EMERGENCY LAPAROTOMY WITH LEFT EXTERNAL ILIAC ARTERY REPAIR. UNKNOWN EXTENDED ANESTHESIA TIME. LAPAROSCOPIC OVARIAN CYSTECTOMY PROCEDURE STARTED AT 09:52. INCIDENT OCCURRED AROUND 11:00 AND PATIENT UNDERWENT EMERGENT LAPAROTOMY WITH LEFT EXTERNAL ILIAN ARTERY REPAIR. PROCEDURE ENDED AT 13:22.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Vascular Dissection
MAUDE report 21945330 ↗MalfunctionMar 25, 2025Fracture; Fracture
DURING PROCEDURE FOR PATIENT, WHILE THE RESIDENT WAS USING LAPAROSCOPIC INSTRUMENT WITH MICROLINE GRASPER TIP INSIDE THE PATIENT'S BODY, ONE OF THE PIECE OF GRASPER TIP CAME OFF. RESIDENT WAS ABLE TO RETRIEVE IT. PROVIDED SCRUB NURSE WITH ANOTHER MICROLINE GRASPER TIP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21690235 ↗
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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