Hazard

Sterile Barrier Breach recalls

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

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all sterile barrier breach 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.

101–125 of 140

HighFDA (Devices)·Z-1174-2023·2023-03-08
Monosof nylon sutures recalled for sterile barrier breach
Covidien is recalling Monosof nylon sutures due to sterile barrier breach in the breather pouch, which may cause infection or vision loss in ophthalmic procedures. The recall affects 54,288 units distributed nationwide and globally.
Product
Monosof Monofilament Nylon sutures: Product Description CN-724 MONOSOF* 1 BLK 100CM GS25 X36 CN-791 MONOSOF* 2-0 BLK 100CM GCC90X36 CN-791-12 MONOSOF* 2-0 BLK 100CM GCC90 CN-793 MONOSOF* 1 BLK 100CM GCC90 X36 CN-793-12 MONOSO
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1037-2023·2023-02-08
Turbett Surgical Container TS1200 Recalled Due to Potential Weld Failures
Turbett Surgical Container TS1200 units may have weld failures that could breach the sterile barrier, potentially allowing unsterile instruments to be used in medical procedures and risking infection.
Product
Turbett Surgical Container, TS1200: Indicated for enclosing other medical devices that are to be sterilized by a healthcare provider
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1038-2023·2023-02-08
Turbett Surgical Container TS1000 may have weld failures breaching sterile barrier
Turbett Surgical Container TS1000 may have weld failures that breach the sterile barrier, potentially resulting in unsterile instruments being used in medical procedures and risking patient infection or injury.
Product
Turbett Surgical Container, TS1000: Indicated for enclosing other medical devices that are to be sterilized by a healthcare provider
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0927-2023·2023-01-18
DeRoyal surgical procedure pack recalled for sterile barrier defect
DeRoyal is recalling certain surgical procedure packs containing Medtronic non-absorbable sutures due to a manufacturing error that may breach the sterile barrier protecting the surgical field.
Product
DeRoyal ORGAN RECOVERY PACK PGYBK, a) REF 89-9004.09 and b) 89-9004.10
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1822-2022·2022-10-05
Humidifier Bottle and Syringe Filter Kit Sterile Barrier Breach Recall
CooperSurgical is recalling BT37 benchtop incubator humidifier and filter kits due to a potential sterile barrier breach. The defect may allow unsterilized devices to contaminate and degrade embryos during incubation.
Product
Humidifier bottle and syringe filter kit (6 count of each) for the BT37 Mark I Benchtop Incubator (AY102295). The Mark I model is no longer produced, but the legacy humidifier bottle component design can also be used with the BT37 Mark II Benchtop Incubator.
Category
Medical Device
Distribution
25 states
HighFDA (Devices)·Z-1825-2022·2022-10-05
Bentson Plus Guidewire Recall for Compromised Packaging Sterility Seal
Cook Incorporated is recalling Bentson Plus Wire Guides due to potential packaging seal breaches that may compromise device sterility. Affected devices may not maintain proper sterility before use.
Product
Bentson Plus Wire Guide (Extra Body/20cm Distal Flexibility with Softened Tip), Guidewire; Reference Part Number: TSFBP-35-180 (GPN G09782) TSFBP-35-145 (GPN G09735)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1111-2022·2022-05-25
Turbett Surgical Container TS1500 weld failures breach sterile barrier
The Turbett Surgical Container TS1500 is being recalled because eight units manufactured before June 2019 have exhibited weld failures that breach the sterile barrier during prolonged use.
Product
Turbett Surgical Container, TS1500
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0915-2022·2022-04-20
Boston Scientific ROTAWIRE Drive guide wire devices recalled for open pouch seals
Boston Scientific is recalling ROTAWIRE Drive and ROTAWIRE Drive Floppy guide wire devices because pouch seals may be open, compromising sterility. The recall affects 433 5-packs distributed in the US, territories, Japan, and Canada.
Product
ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Floppy
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0781-2022·2022-03-23
Boston Scientific RX Cholangiogram Kit Recall Due to Sterile Barrier Breach
Boston Scientific is recalling RX Cholangiogram Kits because the sterile barrier has been breached, compromising the sterility of the devices. The affected kits were distributed worldwide.
Product
RX CHOLANGIOGRAM KIT - SINGLE Material Number: M00575240 M00575240 M00575280 M00575320 M00575360 M00575380 M00575400 M00575440 M00575480
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0762-2022·2022-03-23
HYDRATOME RX surgical device recalled due to sterile barrier breach
Boston Scientific recalls 251 HYDRATOME RX 44-30MM/450CM units worldwide due to sterile barrier breach that compromises device sterility.
Product
HYDRATOME RX 44-30MM/450CM Material Number: M00583070
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0752-2022·2022-03-23
Boston Scientific Sphincterotome Recalled for Sterile Barrier Breach
Boston Scientific Corporation is recalling 1,811 units of Dreamtome Cannulating Sphincterotomes worldwide because the sterile barrier is compromised, creating a potential contamination risk.
Product
Dreamtome Cannulating Sphincterotome-DREAMTOME 44-20MM/450CM Material Number: M00584060
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0753-2022·2022-03-23
Boston Scientific DREAMTOME device recalled due to sterile barrier breach
Boston Scientific is recalling 12,067 DREAMTOME devices worldwide due to compromised sterility from a sterile barrier breach. The affected units may not be properly protected from contamination.
Product
DREAMTOME 44-30MM/260CM Material Number: M00584050
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0771-2022·2022-03-23
Medical Device Recall: Boston Scientific JAGTOME RX Sterile Barrier Breach
Boston Scientific is recalling 98 units of the JAGTOME RX 39-30-260-025 medical device due to compromised sterile barrier that affects device sterility. Units were distributed worldwide.
Product
JAGTOME RX 39-30-260-025 Material Number: M00573100
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0779-2022·2022-03-23
Boston Scientific JAGTOME RX Device Recalled for Sterile Barrier Breach
Boston Scientific is recalling 14 JAGTOME RX medical devices worldwide due to a sterile barrier breach that compromises the device's sterility.
Product
JAGTOME RX 49-30-450-035 Material Number: M00573030
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0767-2022·2022-03-23
Boston Scientific Medical Device Recalled Due to Sterile Barrier Breach
Boston Scientific is recalling 3,330 units of JAGTOME REVOLUTION RX devices due to a sterile barrier breach that compromises device sterility. The devices were distributed worldwide.
Product
JAGTOME REVOLUTION RX 39-30-260-025 Material Number: M00584260
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0756-2022·2022-03-23
DREAMTOME medical device recall: sterility compromised by barrier breach
Fifteen Boston Scientific DREAMTOME medical devices are being recalled due to a sterile barrier breach that compromises device sterility. The affected lot number 27802363 requires appropriate action.
Product
DREAMTOME 49-20MM/450CM Material Number: M00584020
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0775-2022·2022-03-23
Boston Scientific JAGTOME RX device recalled for sterile barrier breach
Boston Scientific has recalled 2209 units of the JAGTOME RX medical device worldwide due to compromised sterility from a sterile barrier breach. The affected units were distributed across the US and more than 40 countries.
Product
JAGTOME RX 44-30-260-035 Material Number: M00573060
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0769-2022·2022-03-23
JAGTOME RX medical device recalled for sterile barrier breach
Boston Scientific's JAGTOME RX medical device (367 units) is being recalled worldwide due to a sterile barrier breach that compromises device sterility.
Product
JAGTOME RX 39-20-450-025 Material Number: M00573090
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0778-2022·2022-03-23
Boston Scientific JAGTOME RX Recalled for Sterile Barrier Breach
Boston Scientific is recalling 96 units of JAGTOME RX medical devices due to a sterile barrier breach that compromises device sterility. Patients should contact their physician if they received this device.
Product
JAGTOME RX 49-30-260-035 Material Number: M00573020
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0776-2022·2022-03-23
Medical Device Sterile Barrier Breach: JAGTOME RX Recall
Boston Scientific is recalling JAGTOME RX medical devices because the sterile barrier may be compromised, which could allow contamination. The recall affects 163 units distributed worldwide.
Product
JAGTOME RX 44-30-450-035 Material Number: M00573070
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0774-2022·2022-03-23
Medical Device JAGTOME RX Recalled for Compromised Sterile Barrier
Boston Scientific is recalling 3,578 units of the JAGTOME RX medical device because the sterile barrier is compromised, which can allow contamination. The affected units were distributed worldwide.
Product
JAGTOME RX 44-20-450-035 Material Number: M00573050
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0751-2022·2022-03-23
Boston Scientific Sphincterotome Device Recalled Due to Sterile Barrier Breach
Boston Scientific is recalling 21,309 units of the Dreamtome RX Cannulating Sphincterotome due to a sterile barrier breach that compromises device sterility, creating a potential infection risk to patients.
Product
Dreamtome RX Cannulating Sphincterotome-DREAMTOME 44-20MM/260CM Material Number: M00584040
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0764-2022·2022-03-23
Medical device sterile barrier breach in Boston Scientific HYDRATOME RX
Boston Scientific is recalling HYDRATOME RX 49-30MM/260CM devices worldwide because sterile barriers are compromised. The manufacturing defect affects device sterility.
Product
HYDRATOME RX 49-30MM/260CM Material Number: M00583010
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0754-2022·2022-03-23
Boston Scientific DREAMTOME Medical Device Recalled for Sterile Barrier Breach
Boston Scientific is recalling 142 units of DREAMTOME 44-30MM/450CM medical devices distributed worldwide due to a sterile barrier breach that compromises device sterility. Affected lot numbers are 27625066 and 27805561.
Product
DREAMTOME 44-30MM/450CM Material Number: M00584070
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0777-2022·2022-03-23
Boston Scientific JAGTOME RX Medical Device Recalled for Sterile Barrier Breach
Boston Scientific is recalling 101 units of JAGTOME RX devices due to compromised sterile barriers that could allow contamination and infection. The recall affects devices distributed worldwide.
Product
JAGTOME RX 49-20-260-035 Material Number: M00573000
Category
Medical Device
Distribution
Distributed nationwide