AnchorFast GuardRecalls & reported problems across all models
Hollister Incorporated · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one AnchorFast Guard model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls
- 1
We found 2 models of AnchorFast Guard by Hollister Incorporated in the FDA's device registry (GUDID). Together they are named in 6 adverse event reports in the FDA's MAUDE database, received between Jun 13, 2023 and Aug 7, 2026 — classified as 5 injuries, 1 malfunction.
The most frequently reported specific device problem is “Break” (1 report).
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
AnchorFast Guard 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.
- Dec 23, 2024Open, Classified
Hollister received reports of decreased skin barrier wear time which could can lead to tube migration
Z-1181-2025 · Root cause: Process change control · Recall details · FDA record ↗
Most reported AnchorFast Guard problems
Device problems
- Adverse Event Without Identified Device or Use Problem4
- Break1
- Loss of or Failure to Bond1
Patient problems
- Pressure Sore/Ulcer2
- Foreign Body In Patient1
- Insufficient Information1
- Tissue Breakdown1
- Unspecified Tissue Injury1
AnchorFast Guard models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- AnchorFast Guard 9800DEVICE, FIXATION, TRACHEAL TUBE1 recall4 reports
- AnchorFast Guard 9800DEVICE, FIXATION, TRACHEAL TUBE2 reports
Recent AnchorFast Guard adverse event reports
The 6 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryAug 7, 2026Break
It was reported that while a patient was using a Hollister AnchorFast Guard Oral Endotracheal Tube Fastener, the clip thumbtab broke during an endotracheal tube (ETT) adjustment. It was further reported that the broken clip migrated into the patient's airway, requiring extensive investigations to determine its location. It was additional reported that the clip was subsequently identified in the left lower lobe bronchus and was retrieved via bronchoscopy on (b)(6) 2026. No residual patient harm was reported following retrieval of the device.
Patient problems: Foreign Body In Patient
MAUDE report 50175659 ↗InjuryMar 31, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A SKIN INJURY WAS OBSERVED BENEATH THE ADHESIVE BARRIER CHEEK PAD DURING REMOVAL OF THE HOLLISTER ANCHORFAST GUARD DEVICE. IT WAS REPORTED THAT THE DEVICE HAD BEEN IN PLACE FOR 7 DAYS AND DURING A PERIOD OF THAT TIME, THE PATIENT HAD BEEN PLACED IN THE LATERAL POSITION. IT WAS REPORTED THAT A MEDICATED OINTMENT AND A SKIN BARRIER WERE USED AS TREATMENT FOR THE INJURY. HOLLISTER HAS SINCE PROVIDED EDUCATION TO THE ACCOUNT.
Patient problems: Pressure Sore/Ulcer
MAUDE report 24749193 ↗InjuryFeb 17, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AN INTUBATED PATIENT DEVELOPED A STAGE IV UPPER LIP PRESSURE INJURY WITH FULL-THICKNESS SKIN AND TISSUE LOSS AND EXPOSED TEETH WHILE USING THE HOLLISTER ANCHORFAST GUARD ENDOTRACHEAL TUBE HOLDER. IT WAS FURTHER REPORTED THAT THE WOUND EVOLVED QUICKLY AND THE PATIENT REQUIRED DEBRIDEMENT OF THE WOUND AND SURGICAL REPAIR OF HIS LIP BY MAXILLOFACIAL ORAL SURGERY.
Patient problems: Pressure Sore/Ulcer
MAUDE report 24367433 ↗InjuryFeb 17, 2026Loss of or Failure to Bond
IT WAS REPORTED TO HOLLISTER THROUGH AN FDA MEDWATCH THE FOLLOWING: DURING HEAD TURN OF A PRONE PATIENT, THE ANCHORFAST CLIP BROKE CAUSING ENDOTRACHEAL TUBE DISLODGEMENT.
Patient problems: Insufficient Information
MAUDE report 24367086 ↗InjuryDec 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT WHO WAS USING A HOLLISTER ANCHORFAST GUARD ORAL ENDOTRACHEAL TUBE FASTENER EXPERIENCED AN UPPER LIP INJURY. IT WAS REPORTED THAT THE ANCHORFAST GUARD HAD BEEN IN PLACE FOR 16 DAYS OVER MULTIPLE DEVICES AND THAT THEY USED A FOAM DRESSING UNDER THE LIP FOAM ONCE THEY NOTICED EVIDENCE OF PRESSURE STARTING. IN ADDITION, THEY REPORTED THAT THE PATIENT WAS SWEATY, AND THE PRODUCT WAS SLIPPING. THEY FURTHER REPORTED THAT THE PATIENT EXPERIENCED A FULL THICKNESS UPPER LIP INJURY AND REQUIRED MEDICAL TREATMENT TO ADDRESS.
Patient problems: Tissue Breakdown
MAUDE report 20923755 ↗MalfunctionJun 13, 2023Adverse Event Without Identified Device or Use Problem
PATIENT DEVELOPED A NON-STAGEABLE INJURY TO THE MUCOSAL LIP WHERE THE ANCHORFAST WAS LOCATED.
Patient problems: Unspecified Tissue Injury
MAUDE report 17117083 ↗
Other Hollister Incorporated products
All Hollister Incorporated devices →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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