Hazard

Sterile Field Compromise recalls

15 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total: 15
Critical: 0
Severe: 0
Most recent: 2023-07-26

Of the 15 sterile field compromise recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all sterile field compromise recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

1–15 of 15

HighFDA (Devices)·Z-2179-2023·2023-07-26
Medline Ultrasound Probe Cover Kits Recalled for Inadequate Seam Barrier
Medline has recalled approximately 3.7 million ultrasound probe cover kits due to inadequate barriers at the seams that could affect sterile field integrity during diagnostic procedures.
Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) NO-CATH RADIAL ARTERIAL PREMIU, Model Number ARTNC115; b) MAJOR VASCULAR, Model Number CDS980752I; c) PICC LINE DOUBLE LUMEN CDS, Model Number CDS982858F; d) PICC LINE TRIPLE LUMEN CDS,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1619-2023·2023-05-31
Medical Device Spine Pack Light Handles May Separate During Surgical Use
Windstone Medical Packaging recalls Aligned Medical Solutions Spine Pack kits due to light handle covers that may separate during surgery. This could delay procedures and compromise the sterile field, potentially injuring patients.
Product
Aligned Medical Solutions Spine Pack, REF: AMS4599(C, containing P 2 Cover Light Handle Blue STE, Sterile EO
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1620-2023·2023-05-31
Aligned Medical Solutions hand pack light covers may separate during use
Windstone Medical Packaging recalls the Aligned Medical Solutions Minor Hand Pack because light handle covers may detach during procedures. This could delay surgery and compromise the sterile field, risking patient injury.
Product
Aligned Medical Solutions Minor Hand Pack, REF: AMS6539E, containing P 2 Cover Light Handle Blue STE, Sterile EO
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1621-2023·2023-05-31
Aligned Medical Solutions Hand Pack covers may detach during surgical use
Windstone Medical Packaging is recalling Aligned Medical Solutions Hand Pack kits because light handle covers may detach during surgical procedures, potentially compromising the sterile field.
Product
Aligned Medical Solutions Hand Pack, REF: AmS4601E, containing P 2 Cover Light Handle Blue STE, Sterile EO
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1476-2023·2023-05-10
Steris Light Handle Covers May Detach During Surgical Use
Steris Corporation is recalling 263,280 surgical light handle covers worldwide because they may separate from the light handle during procedures, potentially compromising the sterile field.
Product
Steris Lighting and Visualization Systems, Sterile Light handle Cover LB44 -Sterilizable consumables (disposable, single use) used to drape the lighthandle of STERIS surgical lighting systems for the purpose of maintaining a sterile surgical environment. REF: LB44
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1073-2023·2023-02-15
Sterile Procedural Trays Recalled for Potential Blade Puncture
Medline sterile procedural trays for minor and breast biopsies are being recalled because sterile blades may puncture the outer foil packaging, compromising sterility. The recall affects 237 cases (1,242 units) distributed worldwide.
Product
Sterile Procedural Trays, labeled as the following: a. MINOR/BREAST BIOPSY-LF b. BREAST BIOPSY-LF
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1649-2017·2017-04-05
Recall of Regard Custom Procedure Trays Due to Sterile Field Compromise
Resource Optimization & Innovation Llc is recalling 436 Regard custom procedure trays because a light glove component can split, breaking the sterile field.
Product
Regard, Item Number: 800411003, Sterile, NU0480C- Neuro PK - Spohn
Category
Medical Device
Distribution
2 states
ModerateFDA (Devices)·Z-2314-2013·2013-10-09
Atrium Flixene Grafts Recalled Due to Difficult Tray Removal
Atrium Medical Corporation is recalling Flixene Trumpet Grafts because the inner tray label may adhere to the outer tray, making it difficult to remove the tray onto the sterile field.
Product
Flixene Trumpet Grafts >or= 6mm Flixene GW and GWT Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2308-2013·2013-10-09
Atrium Medical Recalls Advanta SST Bifurcated Grafts Due to Label Adhesion
Atrium Medical Corporation is recalling Advanta SST Bifurcated Grafts because the inner tray label may adhere to the outer tray, making it difficult to remove the tray onto the sterile field.
Product
Advanta SST Bifurcated Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2304-2013·2013-10-09
Atrium Medical Recalls Advanta VXT Vascular Grafts Due to Label Adhesion
Atrium Medical Corporation is recalling Advanta VXT Vascular Grafts because the inner tray label may adhere to the outer tray, making it difficult to remove the tray onto the sterile field.
Product
Advanta VXT Vascular Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2310-2013·2013-10-09
Atrium Flixene Grafts Recalled Due to Difficult-to-Remove Inner Tray Label
Atrium Medical Corporation is recalling Flixene Grafts because the inner tray label may adhere to the outer tray, making it difficult to remove the tray onto the sterile field.
Product
Flixene Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2102-2012·2012-08-08
Intuitive Surgical Recalls Specific Lots of da Vinci Instrument Arm Drapes
Intuitive Surgical is recalling specific lots of da Vinci Instrument Arm Drapes because the sterile adaptor may have difficulty engaging an instrument.
Product
KIT,DISPOSABLE ACCESSORY,3ARM,IS2000,5 PACK; Product Usage: The intended use of the Instrument arm drape is to protect equipment from contamination and to maintain a sterile field during surgical procedures using the da Vinci Surgical Systems.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2104-2012·2012-08-08
Intuitive Surgical Recalls Specific Lots of da Vinci Instrument Arm Drapes
Intuitive Surgical is recalling specific lots of da Vinci Instrument Arm Drapes because the sterile adaptor may have difficulty engaging an instrument.
Product
KIT,DISPOSABLE ACCESSORY,3ARM,IS3000,5 PACK; Product Usage: The intended use of the Instrument arm drape is to protect equipment from contamination and to maintain a sterile field during surgical procedures using the da Vinci Surgical Systems.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2106-2012·2012-08-08
Intuitive Surgical Recalls Instrument Arm Drapes Due to Adaptor Engagement Issues
Intuitive Surgical is recalling specific lots of Instrument Arm Drapes because the sterile adaptor may have difficulty engaging an instrument during surgery.
Product
ACCESSORY BASE STARTER KIT,IS3000; Product Usage: The intended use of the Instrument arm drape is to protect equipment from contamination and to maintain a sterile field during surgical procedures using the da Vinci Surgical Systems.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2105-2012·2012-08-08
Intuitive Surgical Recalls Specific Lots of da Vinci Instrument Arm Drapes
Intuitive Surgical is recalling specific lots of da Vinci Instrument Arm Drapes because the sterile adaptor may have difficulty engaging an instrument.
Product
KIT,DISPOSABLE ACCESSORY,4ARM,IS3000,5 PACK; Product Usage: The intended use of the Instrument arm drape is to protect equipment from contamination and to maintain a sterile field during surgical procedures using the da Vinci Surgical Systems.
Category
Medical Device
Distribution
Distributed nationwide