Hazard

Sterile Barrier Compromise recalls

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

What the numbers show

Total: 123
Critical: 0
Severe: 1
Most recent: 2026-05-20

Of the 123 sterile barrier 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 1 (1%) 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 barrier 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.

101–123 of 123

HighFDA (Devices)·Z-1630-2013·2013-07-10
Surgical Instrument Service And Savings Recalls 73 Medical Devices with Compromised Sterile Seals
Surgical Instrument Service And Savings, Inc. is recalling 73 surgical instruments and accessories because their sterile seals may be compromised, allowing product to fall out of the pouch.
Product
- Average Medium Blade 9mm x 25mm x 0.38mm Ref. 2296-3-111 Lot 122590, 122447 - Cannulated Drill Bit, Quick Coupling, For 3.5 & 4mm Cannulated Screws, 1.35mm Cannulation 2.7mm x 160mm Ref. 310.67 Lot 122289 - Hall MicroChoice, Oscillating Blade, Fine, Flat, Stainless Steel
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1638-2013·2013-07-10
Surgical Instrument Service And Savings Recalls Compression Sleeves Due to Seal Failure
Surgical Instrument Service And Savings, Inc. is recalling 229 units of compression sleeves and garments because the sterile barrier seal may be compromised, allowing product to fall out of the pouch.
Product
- Calf Garment Standard Ref. L501-M Lot 122549, 122985 - Calf Garment, DVT10 Standard Ref. DVT10 Lot 122570, 12546 - Calf Garment, DVT20 Large Ref. DVT20 Lot 122549, 122570 - SCD Express Compression Sleeve, Knee Length, (White) Large Ref. 9789 Lot 122574 - SCD Expr
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1635-2013·2013-07-10
Surgical Instrument Service And Savings Recalls Orthopedic Drill Bits
Surgical Instrument Service And Savings, Inc. is recalling 10 orthopedic drill bits because the sterile barrier seal was compromised, allowing product to fall out of the pouch.
Product
- Cannulated Drill Bit for Mini TightRope Ref. AR-8911DC Lot 122511 - Drill Bit, Straight Shank 2.7mm x 12.7cm Ref. 2318-027-00 Lot 122322 - Drill Bit, w/Depth Mark, Quick Coupling (Red) 2.0mm x 140mm Ref. 323.062 Lot 122347 - Fast Cutting Drill Bit 2.0mm Ref. FDB 2.0
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1636-2013·2013-07-10
Surgical Instrument Service And Savings Recalls Suture Graspers Due to Seal Compromise
Surgical Instrument Service And Savings, Inc. is recalling two lots of IDEAL Suture Graspers because the sterile barrier seal may be compromised, allowing the product to fall out of the pouch.
Product
- IDEAL 30 Suture Grasper (Green) 30 Degree Ref. 251721 Lot 122511 - IDEAL 60 Suture Grasper (Pink) 60 Degree Ref. 251723 Lot 122631 Passer
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1631-2013·2013-07-10
Surgical Instrument Service And Savings Recalls 30 Surgical Instrument Motors and Accessories
Surgical Instrument Service And Savings, Inc. is recalling 30 surgical instrument motors and accessories because the sterile barrier seal may be compromised, allowing product to fall out of the pouch.
Product
- Acorn Bur, Long, For Use With TPS Universal Drill, Long "AM" Attachment Head: 7.5mm Dia. x 9.5mm Length Ref. 5130-30-75 Lot 122665 - Cannulated Drill Bit, for 3.0mm Cannulated Screws, 1.2mm Cannulation, Quick Coupling 2.0mm x 150mm Ref. 310.221 Lot 122289 - Drill Bit, For
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1270-2013·2013-05-15
Baxter Recalls Non-DEHP Catheter Extension Sets Due to Sterile Barrier Compromise
Baxter Healthcare is recalling specific lots of Non-DEHP Catheter Extension Set Kits because separating packages can compromise the sterile barrier of adjacent units.
Product
A) Product Code 2N8220: Non-DEHP Catheter Extension Set Kit, Single use only, includes: 1) 7.7", Vol. 1.10 mL, Luer Activated Valve for IV Access, Male Luer Lock Adapter, 2) Medium Catheter Stabilization Device, and 3) Foam Tape Strips; B) Product Code 2N8221: Non-DEHP Cathe
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1268-2013·2013-05-15
Baxter Recalls Non-DEHP Catheter Extension Sets Due to Sterile Barrier Compromise
Baxter Healthcare is recalling specific lots of Non-DEHP catheter extension sets because separating packages can compromise the sterile barrier of adjacent units.
Product
A) Product Code 2N1191: Non-DEHP Y-Type Catheter Extension Set, 4.8", Vol. 0.6 mL, Male Luer Lock Adapter, Single use only; B) Product Code 2N1206: Non-DEHP I.V. Catheter Extension Set, 5.7", Vol. 0.7 mL, Male Luer Lock Adapter with Retractable Collar, Single use only P
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1271-2013·2013-05-15
Baxter Recalls Non-DEHP Y-Type Catheter Extension Set Kits
Baxter Healthcare is recalling 513,000 units of IV extension tubing kits because separating packages can compromise the sterile barrier.
Product
A) Product Code 2N8371: Non-DEHP Y-Type Catheter Extension Set Kit, 6.0", Vol. 1.0 mL, 2 Luer Activated Valves, Male Luer Lock Adapter, Single use only Product Usage: The IV extension tubing kits are intended to provide users with a ready to use set up for the administrat
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0721-2013·2013-01-30
ConMed Recalls Goldvac UltraClean Accessory Electrodes Due to Compromised Sterile Seals
ConMed is recalling Goldvac UltraClean Accessory Electrodes because some sterile pouch seals were compromised. No illnesses or injuries have been reported.
Product
Goldvac(TM) UltraClean(R) Accessory Electrode 6 inch Coated Blade with Extended Insulation, REF/Catalog No. 60-7523-001, Sterile, Rx ONLY -- CONMED CORPORATION, Electrosurgical, Cutting and Coagulation and Accessories.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0733-2013·2013-01-30
ConMed Recalls UltraClean Accessory Electrode Due to Compromised Sterile Seals
ConMed is recalling UltraClean Accessory Electrodes because some sterile pouch seals were compromised. No illnesses or injuries have been reported.
Product
UltraClean(R) Accessory Electrode 6 inch Coated Blade, REF/Catalog No. 139107, Single Use, Sterile, Rx ONLY -- CONMED CORPORATION, Electrosurgical, Cutting and Coagulation and Accessories.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0725-2013·2013-01-30
ConMed Recalls TUR Endoscopic Cables Due to Compromised Sterile Pouch Seals
ConMed is recalling 313,190 TUR/Endoscopic Cables because some sterile pouch seals were compromised. No illnesses or injuries have been reported.
Product
TUR/Endoscopic Cable, 10 feet (3.05 mm), REF/Catalog No. 135171, Disposable, Sterile, Rx ONLY -- CONMED CORPORATION Electrosurgical, Cutting and Coagulation and Accessories.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0728-2013·2013-01-30
ConMed Recalls Electrosurgical Tip Cleaners Due to Compromised Sterile Seals
ConMed is recalling 313,190 Electrosurgical Tip Cleaners because some sterile pouch seals were compromised. No illnesses or injuries have been reported.
Product
Electrosurgical Tip Cleaner, REF/Catalog No. 138029, Single Use, Sterile, Rx ONLY -- Distributed By: CONMED CORPORATION Electrosurgical, Cutting and Coagulation and Accessories.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0729-2013·2013-01-30
ConMed Recalls UltraClean Accessory Electrodes Due to Compromised Sterile Seals
ConMed is recalling UltraClean Accessory Electrodes because some sterile pouch seals were compromised. No illnesses or injuries have been reported.
Product
UltraClean(R) Accessory Electrode, 1 inch Coated Blade, REF/Catalog No. 139100, Single Use, Sterile, Rx ONLY --CONMED CORPORATION, Electrosurgical, Cutting and Coagulation and Accessories.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0720-2013·2013-01-30
ConMed Recalls Goldvac UltraClean Electrode Blades Due to Compromised Sterile Seals
ConMed is recalling Goldvac UltraClean Accessory Electrode Blades because some sterile pouch seals were compromised. No illnesses or injuries have been reported.
Product
Goldvac(TM) UltraClean(R) Accessory Electrode 1 inch Coated Blade with Extended Insulation, REF/Catalog No. 60-7521-001, Sterile, Rx ONLY -- CONMED CORPORATION Electrosurgical, Cutting and Coagulation and Accessories.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0736-2013·2013-01-30
ConMed Recalls UltraClean Accessory Electrode Blades Due to Seal Compromise
ConMed is recalling UltraClean Accessory Electrode 4 inch Coated Blades because some sterile pouch seals were compromised. No illnesses or injuries have been reported.
Product
UltraClean(R) Accessory Electrode 4 inch Coated Blade, REF/Catalog No. 139112, Single Use, Sterile, Rx ONLY -- CONMED CORPORATION Electrosurgical, Cutting and Coagulation and Accessories.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0724-2013·2013-01-30
ConMed Recalls ABC Nozzles Due to Compromised Sterile Pouch Seals
ConMed is recalling 313,190 ABC Nozzles because some sterile pouch seals were compromised. No illnesses or injuries have been reported.
Product
ABC(R) NOZZLE, Single Patient Use Nozzle, (For use with 130500 Reusable ABC(R) Handpiece), REF/Catalog No. 130343, Sterile, Rx ONLY -- CONMED CORPORATION Electrosurgical, Cutting and Coagulation and Accessories.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0732-2013·2013-01-30
ConMed Recalls UltraClean Accessory Electrodes Due to Compromised Sterile Seals
ConMed is recalling UltraClean Accessory Electrodes because some sterile pouch seals were compromised. No illnesses or injuries have been reported.
Product
UltraClean(R) Accessory Electrode 1 inch Coated Needle with Extended Insulation, REF/Catalog No. 139105EXT, Single Use, Sterile, Rx ONLY -- CONMED CORPORATION Electrosurgical, Cutting and Coagulation and Accessories.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0722-2013·2013-01-30
ConMed Recalls Goldvac UltraClean Accessory Electrode Due to Compromised Sterile Seals
ConMed is recalling Goldvac UltraClean Accessory Electrodes because some sterile pouch seals were compromised. No illnesses or injuries have been reported.
Product
Goldvac(TM) UltraClean(R) Accessory Electrode 4 inch Coated Blade, REF/Catalog No. 60-7524-001, Sterile, Rx ONLY -- CONMED CORPORATION Electrosurgical, Cutting and Coagulation and Accessories.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0726-2013·2013-01-30
ConMed Recalls Electrosurgical Safety Holsters Due to Compromised Sterile Seals
ConMed is recalling 313,190 electrosurgical safety holsters because some sterile pouch seals were compromised. No illnesses or injuries have been reported.
Product
CONMED(R) ELECTROSURGICAL SAFETY HOLSTER, Disposable Safety Holster, REF/Catalog No. 137668, Sterile, Rx ONLY -- CONMED CORPORATION Electrosurgical, Cutting and Coagulation and Accessories.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0731-2013·2013-01-30
ConMed Recalls UltraClean Accessory Electrode Due to Compromised Sterile Seals
ConMed is recalling UltraClean Accessory Electrodes because some sterile pouch seals were compromised. No illnesses or injuries have been reported.
Product
UltraClean(R) Accessory Electrode 1 inch Coated Blade with Extended Insulation, REF/Catalog No. 139104EXT, Single Use, Sterile, Rx ONLY -- CONMED CORPORATION 525 Electrosurgical, Cutting and Coagulation and Accessories.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0735-2013·2013-01-30
ConMed Recalls UltraClean Accessory Electrodes Due to Compromised Sterile Seals
ConMed is recalling 313,190 UltraClean Accessory Electrodes because some sterile pouch seals were compromised. No illnesses or injuries have been reported.
Product
UltraClean(R) Accessory Electrode 6 inch Coated Blade with Extended Insulation, REF/Catalog No. 139110EXT, Single Use, Sterile, Rx ONLY -- CONMED CORPORATION Electrosurgical, Cutting and Coagulation and Accessories.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0718-2013·2013-01-30
ConMed Recalls Disposable Hyfrecator Electrodes Due to Compromised Sterile Seals
ConMed is recalling 313,190 disposable Hyfrecator electrodes because some sterile pouch seals were compromised. No illnesses or injuries have been reported.
Product
ELECTROLASE(R) HYFRECATOR(R) ELECTRODES - SHARP, Disposable Hyfrecator(R) Tips, REF/Catalog No. 7-100-8CS, Sterile, Rx ONLY -- CONMED CORPORATION Electrosurgical, Cutting and Coagulation and Accessories.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1946-2012·2012-07-18
Argon Safedraw Venous Close Loop System Recalled for Pouch Seal Defect
Argon Medical Devices is recalling 10 Safedraw Venous Close Loop System blood sampling sets in Missouri due to a potential pouch seal defect that may compromise the sterile barrier.
Product
Safedraw Venous Close Loop System, Blood Sampling Set, packaged in a tyvek bag, Model/Part Number 688695, Argon Critical Care Systems, Singapore Pte. Ltd., 198 Yishun Avenue 7, Singapore 768028. The blood sampling set is intended to be used for closed-loop blood sampling from
Category
Medical Device
Distribution
1 state