SharpointRecalls & reported problems across all models

We found 5 models of Sharpoint by Surgical Specialties México, S. de R.L. de C.V. in the FDA's device registry (GUDID). Together they are named in 6 adverse event reports in the FDA's MAUDE database, received between Dec 9, 2022 and Jan 14, 2026 — classified as 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Dull, Blunt” (2 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

Sharpoint 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.

1. Apr 23, 2026Open, Classified

   3.0mm surgical knives labeled and packaged as 2.2mm surgical knives.

   Z-2309-2026 · Root cause: Mixed-up of materials/components · Recall details · FDA record ↗

Most reported Sharpoint problems

Sharpoint models

5 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Sharpoint 72-2231

  Knife, ophthalmic
  1 recall0 reports
• Sharpoint 72-1501

  Knife, ophthalmic
  2 reports
• Sharpoint 74-1010

  Knife, ophthalmic
  2 reports
• Sharpoint 72-2961

  Knife, ophthalmic
  1 report
• Sharpoint 62-2450G

  Knife, ophthalmic
  1 report

Recent Sharpoint adverse event reports

The 6 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryJan 14, 2026Dull, Blunt

  IT WAS REPORTED ON 18 DECEMBER 2025 THAT A BLADE WAS DULL, INTRAOPERATIVELY. PATIENT INJURY OCCURRED WHICH RESULTED IN A DELAY TO SURGERY. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Laceration(s)

  MAUDE report 24069344 ↗
• InjuryDec 31, 2025Dull, Blunt; Dull, Blunt

  IT WAS REPORTED ON (B)(6) 2025, THAT A BLADE WAS DULL, INTRAOPERATIVELY. PATIENT INJURY OCCURRED WHICH RESULTED IN A DELAY TO SURGERY. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Laceration(s)

  MAUDE report 23936407 ↗
• MalfunctionSep 24, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED ON AUGUST 30, 2024 THAT THE KNIFE DID NOT PERFORM AS EXPECTED DURING THE INCISION LEADING TO THE WOUND NOT SEALING PROPERLY AND SUTURES WERE ADDED AFTER THE INCISION. NO ADDITIONAL INJURIES REPORTED; HOWEVER, THE FAILURE RESULTED IN A SIGNIFICANT PROCEDURAL DELAY AS SURGICAL INTERVENTION WAS REQUIRED.

  Patient problems: Laceration(s)

  MAUDE report 20292443 ↗
• MalfunctionJul 17, 2024Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED DURING THE SURGICAL PROCEDURE WHEN THE SURGEON USED THE KNIFE TO MAKE THE INCISION, THE BLADE TURNED OVER RESULTING IN DAMAGING THE CORNEAL ENDOTHELIUM. THE SURGEON REMOVED THE KNIFE AND REPLACED WITH A NEW ONE. NO ADDITIONAL INJURIES REPORTED.

  Patient problems: Eye Injury; Laceration(s)

  MAUDE report 19762186 ↗
• InjuryJun 27, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE BLADE WAS TURNING DURING THE SURGICAL PROCEDURE. A KNIFE WAS USED TO MAKE AN AUXILIARY INCISION WITH AN OPHTHALMIC SCALPEL AND IT WAS FOUND THAT THE BLADE OF THE KNIFE WAS TURNED OVER, WHICH RESULTED IN UNEVENNESS OF THE INCISION AND DAMAGE TO THE CORNEAL ENDOTHELIUM AFTER PUNCTURE. INTERVENTION WAS MADE DURING THE SURGICAL PROCEDURE TO REDUCE THE INFECTION CAUSED BY POOR INCISION CLOSURE AND COMPLETED THE SURGICAL PROCEDURE. THE PATIENT WAS TREATED WITH AN OPERATION CALLED "ULTRASONIC EMULSIFICATION REMOVAL OF CATARACT AND IOL IMPLANTATION IN THE RIGHT EYE" UNDER LOCAL ANESTHESIA.

  Patient problems: Laceration(s)

  MAUDE report 19629618 ↗
• InjuryDec 9, 2022Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2022, DURING THE SURGERY, THERE WAS DEFORMATION OF THE BLADE, THE PATIENT''S EYES WERE ITCHY AFTER SURGERY, AND THERE WAS INFECTION. THE PATIENT REQUIRED A SECOND SURGERY TO REMEDY THE INFECTION DUE TO DAMAGE TO THE EXTERNAL TISSUES, AND THE SUBSEQUENT SURGERY WAS SUCCESSFUL, AND THE PATIENT STATUS WAS STABLE. ADRS REPORT CODE (B)(4).

  Patient problems: Bacterial Infection; Itching Sensation

  MAUDE report 15947839 ↗

Other Surgical Specialties México, S. de R.L. de C.V. products

• Stratafix Spiral24 models · 118 reports · 2 recalls