Retractor
FDA adverse event reports and recall history for retractor (product code GAD), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 1,642
- Deaths
- 4
- Injuries
- 312
- Malfunctions
- 1,248
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2026-07-09Open, ClassifiedLabeling design
OmniTract Surgical Retractor System, which includes 633 of the firm s product codes.
The current Omni-Tract Surgical Retractor System IFU states a dry time of 30 minutes. Integra LifeSciences has identified that the dry time needs to be extended to 90 minutes, 110 minutes, or 120 minutes depending on the sterilization cycle exposure time used.
- 2025-05-15Open, ClassifiedUnder Investigation by firm
Centurion Sterile Weitlaner Retractor, Reorder: 67315
Three is the potential for the retractors to puncture through the sterile packaging.
- 2025-01-16Open, ClassifiedUnder Investigation by firm
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE ARMY RETR (SET OF 2) STER CS25, Model Number 96-2243; 2) ECONO STERILE ARMY RETR (SET OF 2)STRL CS/25, Model Number 96-2243M; 3) ECONO STERILE SENN RETR DE BL 6.25"STRLCS/25, Model Number 96-2267; 4) ECONO STERILE SENN RETR DE BL 6.25"STRLCS/25, Model Number 96-2267A; 5) ECONO STERILE SENN RETR DE SH 6.25"STRLCS/25, Model Number 96-2269A; 6) ECONO STERILE MINI HOHMANN 6MM 6.5" STERCS25, Model Number 96-2959; retractors
Reports of various packaging issues that may result in a breach of the sterile barrier.
- 2024-06-28Open, ClassifiedUnder Investigation by firm
Brand Name: Fathom Pedicle-Based Retractor Product Name: C/C Blade, 35-55mm Model/Catalog Number: MR2102035 Product Description: Cranial Caudal Blade Component: Yes, a component of a retractor blade
Cranial Caudal Blades manufactured incorrectly could result in fracture and/or damage to the bone structure
- 2024-06-28Open, ClassifiedUnder Investigation by firm
Brand Name: Fathom Pedicle-Based Retractor Product Name: C/C Blade, 50-80mm Model/Catalog Number: MR2102050 Product Description: Cranial Caudal Blade Component: Yes, a component of a retractor blade
Cranial Caudal Blades manufactured incorrectly could result in fracture and/or damage to the bone structure
- 2024-03-29Open, ClassifiedProcess control
Centurion retractor kits labeled as: a) STERILE 6-1/2" SENN RETRACTOR (ST7185), Product Code 66795; b) STERILE RAGNELL RETRACTOR (RR602), Product Code 67525; c) ST. SENN RETRACTOR 3 PRG BLUNT (ST7085), Product Code 37535
Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
- 2024-02-23Open, ClassifiedDevice Design
Rebstock Holding rod for fixation -For holding and fixation of flexible Leyla Arms and spatula Art. No. 06-06-285 and 06-06-285MOD. surgical instrument.
Holding arm could move (twist) uncontrollably in the front area. This could lead to a serious deterioration of patient's safety if the movement is transferred to the spatula, which is attached to the holding arm.
- 2023-07-05Open, ClassifiedOther
Pilling LOWSLEY PROSTATIC TRACTOR CVD, REF 243200; retractor
There are incomplete pre-cleaning instructions within the Instructions for Use (IFU).
- 2023-07-05Open, ClassifiedOther
Pilling LOWSLEY PROSTATIC TRACTOR STR, REF 243201; retractor
There are incomplete pre-cleaning instructions within the Instructions for Use (IFU).
- 2023-01-12Open, ClassifiedEquipment maintenance
RadiaLux Lighted Retractor (Pink), REF: 50-101-1
Defect in sterile pouch seal, incomplete seal, of lighted Retractors, increases the risk of contamination, which can lead to post-operative infection.
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