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.

51–75 of 140

HighFDA (Devices)·Z-0945-2025·2025-01-22
Gynecological Procedure Kits Recalled for Potential Sterile Barrier Packaging Defects
Sklar Instruments is recalling ECONO STERILE gynecological procedure kits due to packaging issues that may compromise the sterile barrier. The affected kits may no longer maintain their sterile condition.
Product
ECONO STERILE medical procedure kits labeled as: ECONO STERILE KOGAN ENDOCERV SPEC STER CS/5, Model Number 96-4142A, gynecological procedures
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0932-2025·2025-01-22
ECONO STERILE Nail Nippers and Tissue Nippers Recalled for Sterile Barrier Issues
Sklar Instruments is recalling ECONO STERILE nail nipper and tissue nipper kits due to packaging defects that may compromise their sterile barrier. The affected kits were distributed nationwide.
Product
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE D/A NAIL NIPPER 5.75" STER CS5, Model Number 96-2424A; 2) ECONO STERILE TISS NIPPER 14MM CVX 5"CS/25, Model Number 96-2427; 3) ECONO STERILE NAIL NIPPER 4.5" STERILE 25, Model Number 96-2666; 4) ECONO STER
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0953-2025·2025-01-22
ECONO STERILE Orthopedic Probes Recalled for Sterile Barrier Breach Risk
Sklar Instruments recalls 2,500 ECONO STERILE orthopedic probe kits due to packaging issues that may breach the sterile barrier. No illnesses or injuries have been reported.
Product
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE PROBE W/EYE CS/50, Model Number 94-5923; 2) ECONO STERIL" PROBE W/EYE 5.5" STERL CS/25, Model Number 96-2361; orthopedic probe
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0950-2025·2025-01-22
Strabismus Surgical Scissors Kits Recalled Due to Sterile Barrier Packaging Issues
Sklar Instruments is recalling 350 strabismus surgical scissors kits nationwide due to packaging issues that may compromise the sterile barrier.
Product
Medical procedure kits labeled as: 1) ECONO STERILE STRABIS SCISS STR 4.5"STER 50, Model Number 96-2540; 2) ECONO STERILE STRABIS SCISS CVD 4.5"STER 50, Model Number 96-2541; 3) ECONO STERILE STRABIS SCISS STR 4.5"STER 25, Model Number 96-2542; 4) ECONO STERILE STRABISM
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0948-2025·2025-01-22
Sklar Instruments IUD Extractor Kits Recalled for Sterile Barrier Packaging Issues
Sklar Instruments is recalling ECONO STERILE IUD Extractor kits (Model 96-4146A) due to packaging defects that may compromise the sterile barrier. Nationwide distribution.
Product
ECONO STERILE medical procedure kits labeled as: ECONO STERILE IUD EXTRACTOR DBL HK 10.5"CS25, Model Number 96-4146A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0928-2025·2025-01-22
Sklar Instruments Recalls ECONO STERILE Gynecological Procedure Kits for Packaging Defects
Sklar Instruments is recalling ECONO STERILE gynecological procedure kits (Model 96-2478) due to packaging issues that may breach the sterile barrier and create contamination risk.
Product
ECONO STERILE medical procedure kits labeled as: ECONO STERILE SIMS UTERINE SND GRD 13"STER25, Model Numbers: 96-2478 (gynecological use)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0943-2025·2025-01-22
ECONO STERILE medical procedure kits recalled for potential sterile barrier breach
Sklar Instruments is recalling three models of ECONO STERILE medical procedure kits nationwide due to packaging issues that may breach the sterile barrier. No injuries or illnesses have been reported.
Product
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE SIMS UTERINE CURETTE #3 STER25, Model Number 96-4113; 2) ECONO STERILE KEVORK ENDO CURET W/BAS STER25, Model Number 96-4144A; 3) ECONO STERILE KEVORKIAN CURET W/O BAS STER25, Model Number 96-4145A; cervical
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0927-2025·2025-01-22
Sklar Instruments Recalls ECONO STERILE Trousseau Dilator Kits for Packaging Defects
Sklar Instruments is recalling ECONO STERILE trousseau dilator kits (Model 941-0191) distributed nationwide due to packaging issues that may compromise the sterile barrier. Affected healthcare providers should stop use immediately.
Product
ECONO STERILE medical procedure kits labeled as: ECONO STERILE TROUSSEAU DILATOR CS/25, Model Number 941-0191 (tracheal procedures)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0926-2025·2025-01-22
ECONO STERILE Medical Procedure Kits Recalled for Packaging Defects
Sklar Instruments is recalling ECONO STERILE medical procedure kits due to packaging issues that may compromise the sterile barrier and allow contamination.
Product
ECONO STERILE brand medical procedure kits labeled as: 1) ECONO STERILE FREER ELEV DE S/B 7.25" CS/25, Model Number 96-2483 (multiple purpose); 2) ECONO STERILE LOCKE ELEV #94 NARROW STER 25, Model Number 96-2484 (foot procedures)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0925-2025·2025-01-22
ECONO STERILE ear cleaning kits recalled for packaging sterile barrier issues
Sklar Instruments is recalling ECONO STERILE medical procedure kits for ear cleaning due to packaging issues that may result in a breach of the sterile barrier. The kits have been distributed nationwide.
Product
ECONO STERILE brand medical procedure kits labeled as: 1) ECONO STERILE" BUCK EAR CUR BL STR#0STRLCS/25, Model Number 96-2273; 2) ECONO STERILE" BILLEAU EAR LOOP MD STRL CS/25, Model Number 96-2283; for ear cleaning
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0949-2025·2025-01-22
Sklar Instruments ECONO STERILE surgical procedure kits recalled due to packaging defect
Sklar Instruments is recalling ECONO STERILE ALFONSO INFANT SPEC STRL sterile surgical procedure kits nationwide due to packaging issues that may breach the sterile barrier.
Product
ECONO STERILE medical procedure kits labeled as: ECONO STERILE ALFONSO INFANT SPEC STRL CS/10, Model Number 96-3814; eyelid surgery
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0946-2025·2025-01-22
Gynecological dilator kits recalled for potential sterile barrier compromise
Sklar Instruments is recalling ECONO STERILE gynecological dilator kits nationwide due to packaging issues that may breach the sterile barrier, potentially affecting product safety.
Product
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE HEGAR DILATOR 11&12MM STRLCS25Model Number 96-0960; 2) ECONO STERILE HEGAR DILATOR 9&10MM STRL CS25Model Number 96-0961; 3) ECONO STERILE HEGAR DILATOR 7&8MM STRL CS25Model Number 96-0962; 4) ECONO STERILE
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0941-2025·2025-01-22
Sklar Instruments Sterile Surgical Kits Recalled for Packaging Defects
Sklar Instruments is recalling 252,865 sterile surgical kits nationwide due to packaging defects that may compromise the sterile barrier, risking instrument contamination.
Product
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE IRIS SCISS 4 1/2" CVD CASE/50,Model Number 941-0918; 2) ECONO STERILE METZENBAUM SCIS STR 9"STER C25,Model Number 941-1556; 3) ECONO STERILE MAYO SCISS STRT STRL 9" CS/25,Model Number 941-1613; 4) ECONO ST
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0942-2025·2025-01-22
Sklar Instruments ECONO STERILE Blackhead Extractor Kits Recall
Sklar Instruments is recalling ECONO STERILE blackhead extractor kits (Model 96-2395M) due to packaging issues that may compromise the sterile barrier. The kits were distributed nationwide.
Product
ECONO STERILE medical procedure kits labeled as: ECONO STERILE SCHAMBERG EXTRCT SQ STER CS25, Model Number 96-2395M; blackhead extractor
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0581-2025·2024-12-11
BIORAPTOR Suture Anchors Recalled for Sterile Barrier Packaging Breach
Smith & Nephew is recalling BIORAPTOR Suture Anchors due to inadequate packaging design that fails to maintain sterile barriers, potentially contaminating the implant. No injuries or illnesses have been reported.
Product
BIORAPTOR Suture Anchors. Tendon/ligament, non-bioabsorbable bone anchor.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0064-2025·2024-10-23
Blue Diamond Digital Inflation Devices Recalled for Sterile Barrier Defect
Merit Medical Systems is recalling Blue Diamond Digital Inflation Devices due to potential sterile barrier defects. Affected devices may have small holes that could allow exposure to pathogens, creating infection risk.
Product
Blue Diamond Digital Inflation Device, REF: IN7152/C, IN7352/C, IN7403/C, IN7802/C, IN7852/C, IN7130/C
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0059-2025·2024-10-23
Monarch Inflation Device Recalled Due to Sterile Barrier Breaches
Merit Medical Systems is recalling 1,120 Monarch Inflation Devices due to manufacturing defects causing holes and breaches in the sterile Tyvek barrier. Affected devices distributed worldwide may pose contamination risk during cardiac interventions.
Product
Monarch Inflation Device 30 atm/bar MAP302 Honor Hemostasis Valve Metal Insertion Tool Torque Device REF IN2330 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syringe is used to inflate and deflate balloon angioplasty catheters and to measur
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0061-2025·2024-10-23
Monarch Inflation Device Syringe Recalled for Sterile Barrier Defect
Merit Medical Systems is recalling 51,900 Monarch Inflation Device syringes due to manufacturing defects causing breaches in the sterile barrier. The devices are used in balloon angioplasty procedures. No injuries have been reported.
Product
Monarch Inflation Device 30 atm/bar MAP152 AssessPLUS Large Bore Hemostasis Valve Metal Insertion Tool Torque Device REF IN2530 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syringe is used to inflate and deflate balloon angioplasty cathete
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0062-2025·2024-10-23
Monarch Balloon Angioplasty Syringes Recalled Due to Sterile Barrier Defects
Merit Medical Systems is recalling 432 Monarch 30 ATM syringes used in balloon angioplasty procedures due to manufacturing defects creating holes in the sterile Tyvek barrier.
Product
Melrose Wakefield Hospital REF K05T-2159 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syringe is used to inflate and deflate balloon angioplasty catheters and to measure the pressure within the balloon during the procedure. It is also used
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0072-2025·2024-10-23
basixTOUCH Inflation Device May Have Sterile Barrier Defect
Merit Medical Systems is recalling basixTOUCH Inflation Devices due to a potential hole in the sterile barrier. The defect may expose patients to pathogens and pyrogens, increasing infection risk.
Product
basixTOUCH Inflation Device, REF: IN8130/JPC, IN8152/C, IN8302/C, IN8352/C, IN8802/C, IN8130/C, IN8130/C
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0069-2025·2024-10-23
MONARCH Inflation Device Recalled Due to Sterile Barrier Defect Risk
Merit Medical Systems recalled 12,910 MONARCH Inflation Devices worldwide due to a potential hole in the sterile barrier. The defect could expose the device to pathogens and pyrogens, potentially leading to infection.
Product
MONARCH Inflation Device, REF: IN2430/B, IN2530/B, IN2130/B
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0070-2025·2024-10-23
Custom Inflation Kits Recalled Due to Sterile Barrier Defect and Infection Risk
Merit Medical Systems is recalling Custom Inflation Kits due to a small hole in the sterile barrier that could expose users to pathogens and pyrogens, increasing infection risk.
Product
Custom Inflation Kit, REF: K05-00052M, K05-00053H, K05-00109G, K05-00137K, K05-00296L, K05-00399D, K05-00404C, K05-00410G, K05-00438G, K05-00502F, K05-00564L, K05-00587D, K05-00612Q, K05-00704F, K05-00724F, K05-00793B, K05-00798, K05-00890D, K05-00890D, K05-00944D, K05-00956D, K0
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0073-2025·2024-10-23
Merit Medical StabiliT TOUCH Syringe Sterile Barrier Defect Recall
Merit Medical Systems is recalling 202 StabiliT TOUCH Syringes with potential small holes in the sterile barrier. Affected devices may expose users to pathogens and pyrogens, which could cause infection.
Product
StabiliT TOUCH Syringe, REF: IN8VCF/B
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1157-2024·2024-09-25
Medline Contro-Bulb Syringe Recalled for Potential Sterile Barrier Breach
Medline is recalling 4,831 Contro-Bulb Syringes due to potential sterile barrier breach during transportation. The recall affects two lot numbers and applies nationwide.
Product
Medline Contro-Bulb Syringe, REF DYND20125; bulb irrigation syringe
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2406-2024·2024-07-24
Surgical Hemostatic Device Recalled for Compromised Sterile Barrier
Ethicon is recalling SURGICEL FIBRILLAR hemostatic pads due to torn foil pouches that compromise the sterile barrier, traced to a specific packaging machine defect.
Product
SURGICEL FIBRILLAR 1INX2IN(2.5CMX5.1CM), Product Number: 1961
Category
Medical Device
Distribution
Distributed nationwide