Injector CAT01857Recalls & reported problems
Stryker Corporation · INJECTOR II NEEDLE CARTRIDGE · Class 1
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07613252633105), received between May 3, 2021 and Sep 30, 2026 — classified as 8 malfunctions.
The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (5 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Device Contaminated During Manufacture or Shipping5
- Delivered as Unsterile Product2
- Break1
- Material Integrity Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions8
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Delivered as Unsterile Product
It was reported that the Injector 2 needle cartridge was opened and the sterile packaging that the needle comes in was already opened.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948626 ↗MalfunctionFeb 1, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT THERE WAS FOREIGN MATERIAL INSIDE THE STERILE PACKAGING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18623710 ↗MalfunctionNov 14, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT THERE WAS FOREIGN MATERIAL INSIDE THE STERILE PACKAGING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18136476 ↗MalfunctionNov 14, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT THERE WAS FOREIGN MATERIAL INSIDE THE STERILE PACKAGING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18136394 ↗MalfunctionNov 14, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT THERE WAS FOREIGN MATERIAL INSIDE THE STERILE PACKAGING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18136391 ↗MalfunctionNov 14, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT THERE WAS FOREIGN MATERIAL INSIDE THE STERILE PACKAGING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18136390 ↗MalfunctionOct 18, 2022Break; Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT THE NEEDLE BROKE DURING THE PROCEDURE. THE NEEDLE WAS RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15621024 ↗MalfunctionMay 3, 2021Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT THERE WAS FOREIGN MATERIAL INSIDE THE STERILE PACKAGING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11761576 ↗
Other NEEDLE, SUTURING, DISPOSABLE devices
- Quattro® Suture Passer Needle CM-9011Cayenne Medical, Inc. · Needle, Suturing, Disposable28 reports
- Richard-Allan® Needle 1/2 Circle Taper 216706Aspen Surgical Products, Inc. · NEEDLE, SUTURING, DISPOSABLE4 reports
- Richard-Allan® Needle 1/2 Circle Taper 216704Aspen Surgical Products, Inc. · NEEDLE, SUTURING, DISPOSABLE4 reports
- Richard-Allan® Needle 1/2 Circle Taper 216735Aspen Surgical Products, Inc. · NEEDLE, SUTURING, DISPOSABLE4 reports
- Versipass Suture Passer Needle 4727Lincotek Medical LLC · Needle, Suturing, Disposable2 reports
- Richard-Allan® Needle 1/2 Circle Taper 216701Aspen Surgical Products, Inc. · NEEDLE, SUTURING, DISPOSABLE2 reports
- Richard-Allan® Needle 1/2 Circle Taper 216705Aspen Surgical Products, Inc. · NEEDLE, SUTURING, DISPOSABLE2 reports
- NA 223173Medos International Sàrl · NEEDLE, SUTURING, DISPOSABLE1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.