Hazard

Sterility Compromise recalls

328 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 sterility 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.

126–150 of 328

HighFDA (Devices)·Z-2144-2024·2024-06-26
VICRYL Sutures recalled due to packaging defect compromising sterility
Ethicon recalls 341,532 units of VICRYL surgical sutures worldwide due to holes in primary packaging that compromise sterility and could result in infection.
Product
VICRYL (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic surgery, but not for use in cardiovascular and neurological tissues. PRODUCT CODE: J214H J218H J258H J268H J269H J327H J344H
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2148-2024·2024-06-26
MONOCRYL Surgical Sutures Recalled for Packaging Sterility Defect
Ethicon recalls 306,000 MONOCRYL surgical sutures worldwide due to holes in primary packaging from a manufacturing defect that compromises sterility and could result in infection.
Product
MONOCRYL (poliglecaprone 25) Suture - Intended for use in general soft tissue approximation and/or ligation where an absorbable material is indicated PRODUCT CODE: Y315H Y345H Y359H Y398H Y416H Y417H Y426H Y427H Y935H Y936H Y945H
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2136-2024·2024-06-19
CODMAN BACTISEAL EVD Catheter Set: Sterile packaging defect recalled
Integra LifeSciences is recalling 135 CODMAN BACTISEAL EVD Catheter Sets due to defects in sterile packaging that may compromise product sterility.
Product
CODMAN BACTISEAL EVD Catheter Set - Indicated for gaining access to the ventricles of the brain and can be used with dimensionally compatible devices for draining cerebrospinal fluid (CSF) and other fluids of similar physical characteristics as a means of reducing intracranial p
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2137-2024·2024-06-19
CODMAN EVD BACTISEAL Catheter Sterile Packaging Defect Recall
Integra LifeSciences recalls CODMAN EVD BACTISEAL catheters due to defects in sterile packaging that may compromise product sterility. The defect affects 106 units distributed worldwide.
Product
CODMAN EVD BACTISEAL 1.9mm I.D. Catheter Set- indicated for gaining access to the ventricles of the brain and can be used with dimensionally compatible devices for draining cerebrospinal fluid (CSF) and other fluids of similar physical characteristics as a means of reducing intra
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1873-2024·2024-05-29
Integra Cranial Access Kit Packaging Defects May Compromise Sterility
Integra LifeSciences is recalling 1,822 units of its Cranial Access Kit due to potential holes and tears in the sterile packaging that may compromise device sterility. The kits are used in ventriculostomy procedures.
Product
Integra¿ Cranial access kit (without Prep solutions) Bit and Guard- Used during a ventriculostomy procedure. Catalog Number: INS5HND
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1828-2024·2024-05-22
CoFlex NL Sterile Bandages Recalled for Packaging Seal Gaps
Andover Healthcare Inc. is recalling CoFlex NL sterile flexible cohesive bandages (model 5400S) due to packaging seal gaps that could compromise product sterility. No illnesses have been reported.
Product
Sterile CoFlex NL: Latex Free Flexible Cohesive Bandage, Tan, 4INx5YD (5400S)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1532-2024·2024-04-24
Cook Coons Taper Dilators recalled due to low packaging seal strength
Cook Incorporated is recalling 4,856 Coons Taper Dilators because packaging may have low seal strength, compromising device sterility. These percutaneous dilators are used in vascular and non-vascular procedures and are distributed worldwide.
Product
Dilator - Coons Taper - Used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vascular applications such as in the venous, arterial, biliary and renal systems. REFERENCE PART NUMBER (RPN)/ORDER NUMBER (GPN): 1) JCD10.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1530-2024·2024-04-24
Cook Incorporated Dilators Recalled for Low Packaging Seal Strength
Cook Incorporated is recalling 5,998 dilators worldwide because packaging may not meet seal strength specifications, potentially compromising device sterility.
Product
Dilator - Intended to be used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vascular applications such as in the venous, arterial, biliary and renal systems. 1) JCD10.0-38-20 2) JCD20.0-38-20 3) JCD22.0-38-20 4) JCD6
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1533-2024·2024-04-24
Surgical Sutures Recalled for Sterility Compromise During Transit
Ethicon recalls 395 units of STRATAFIX surgical sutures (lot SHBAEC) due to sterility compromise from environmental exposure during transit and storage. Product is unsuitable for surgical use.
Product
STRATAFIX Spiral MONOCRYL Plus Bidirectional Knotless Tissue Control Device: STRATAFIX SPIRAL MONOCRYL PLUS BI UD 12+12IN(30+30CM) USP3-0(M2) D/A PS PRM- Indicated for use in soft tissue approximation where the use of absorbable sutures is appropriate. Product Code: SXMP2B412
Category
Medical Device
Distribution
9 states
HighFDA (Devices)·Z-1531-2024·2024-04-24
Dilators With AQ Hydrophilic Coating recalled due to packaging seal defects
Cook Incorporated is recalling 1,493 Dilators With AQ Hydrophilic Coating due to packaging that may not maintain proper seal strength, potentially compromising device sterility.
Product
Dilator With AQ Hydrophilic Coating - Intended to be used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vascular applications such as in the venous, arterial, biliary and renal systems. REFERENCE PART NUMBER (RPN)/ORD
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1525-2024·2024-04-24
Chiba Biopsy Needles Recalled for Potential Sterility Compromise
Cook Incorporated is recalling Chiba Biopsy Needles due to packaging that may have low seal strength, potentially compromising device sterility. The recall affects 6,178 units distributed worldwide.
Product
Chiba Biopsy Needle - Used for aspiration biopsy. REFERENCE PART NUMBER (RPN) ORDER NUMBER (GPN): 1) DCHN-18-10.0 G01559 2) DCHN-18-10.0-U G05040 3) DCHN-18-15.0 G00850 4) DCHN-22-10.0 G00852 5) DCHN-22-10.0-U G03978 6) DCHN-22-15.0 G00012 7) DCHN-22-15.0-U G03314 8)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1528-2024·2024-04-24
Peel-Away Introducer medical devices recalled for low packaging seal strength
Cook Incorporated is recalling 55 Peel-Away Introducers due to packaging with low seal strength that may compromise device sterility.
Product
Peel-Away Introducer - Intended for the percutaneous introduction of balloon, electrode and closed or non-tapered end catheters into central and peripheral vasculature, and for nonvascular use. REFERENCE PART NUMBER (RPN)/ ORDER NUMBER (GPN): 1)PLVW-7.0-35 G00925 2)PLVW-8.0
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1529-2024·2024-04-24
Gastrointestinal Suture Anchor Recalled Due to Packaging Seal Defect
Cook Incorporated is recalling the Entuit Secure Adjustable Gastrointestinal Suture Anchor Set due to packaging that may have insufficient seal strength, potentially compromising device sterility. The recalled lot is distributed worldwide.
Product
Entuit Secure Adjustable Gastrointestinal Suture Anchor Set - Intended for anchoring the anterior wall of the stomach to the abdominal wall prior to introduction of interventional catheters. REFERENCE PART NUMBER (RPN): GIAS-SRM-ADJ-2 ORDER NUMBER (GPN): G35562
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1526-2024·2024-04-24
Trocar Needle Recall Due to Packaging Seal Strength Defect
Cook Incorporated recalled 55 Trocar Needles (Lot 15786588) due to packaging that may not meet peel strength specifications, potentially compromising device sterility. Units were distributed nationwide and internationally.
Product
Trocar Needle - Used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vascular applications such as in the venous, arterial, biliary and renal system REFERENCE PART NUMBER (RPN): DTN-18-20.0 ORDER NUMBER (GPN): G013
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1443-2024·2024-04-10
Medline Centurion surgical kits recalled due to weak seal
Medline Industries is recalling Centurion manual surgical kits because they may have weak seals that could compromise product sterility. The defect may not be noticeable to users before the kits are used.
Product
Centurion manual surgical kits labeled as: a) STERILE ALLIS TISS FCP 10", Product Code I68905; b) VAGINAL REPAIR KIT, Product Code MNS11505; c) PTCA ADD-ON KIT, Product Code MNS11545; d) INSTRUMENT SET, Product Code SUT21355
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1454-2024·2024-04-10
Medline wire cut scissors may have weak seal compromising sterility
Medline Industries is recalling 800 units of 4.5-inch wire cut scissors due to a weak seal that could compromise sterility if it fails during use or storage.
Product
MEDLINE 4.5 IN WIRE CUT SCISSORS, Product Code DYND04006
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1437-2024·2024-04-10
Medline Centurion Surgical Forceps Kits Recalled for Defective Seals
Medline Industries recalls 274,410 units of Centurion and Medline branded surgical forceps kits for potentially weak seals that could compromise sterility and may not be detectable during use.
Product
Centurion Forcep kits labeled as: a) STERILE F/P SPLINTER FORCEP (SF6141), Product Code 66165; b) STERILE WEBSTER NEEDLEHOLDER, Product Code 66185; c) STERILE ADSON FORCEP SERR (598), Product Code 66195; d) STERILE DRESSING FORCEP SERR (DF6003), Product Code 66200; e) STERIL
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1246-2024·2024-03-13
Aesculap Disposable Trocars with Dilating Pins Recalled for Packaging Damage
Aesculap Inc is recalling disposable trocars with dilating pins due to potential sterile blister packaging damage that may compromise sterility. The affected product (code EK236SU) was distributed in the US and Canada.
Product
DISP.TROCAR W.DILATING PIN 12/110MM, Product Code EK236SU. For use in laparoscopic procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1244-2024·2024-03-13
Aesculap Hasson trocar recalled due to sterility packaging concerns
Aesculap Inc has recalled Hasson trocar surgical instruments (18 units) because sterile blister packaging may be damaged and sterility compromised. The recall affects the U.S. (Kansas, New Jersey, New York) and Canada.
Product
DISP.HASSON TROCAR 10/110MM, Product Code EK230SU. For use in laparoscopic procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1266-2024·2024-03-13
Knee Implant Tibial Inserts Recalled for Sterile Packaging Breach
Howmedica Osteonics recalls Triathlon knee implant tibial inserts (37 US units) due to potential packaging breaches of inner and outer sterile blisters that may compromise product sterility.
Product
NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 16 MM
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1243-2024·2024-03-13
Aesculap Disposable Trocar with Dilating Pin Recalled for Compromised Sterility
Aesculap Inc is recalling Disposable Trocars with Dilating Pins (Product Code EK224SU) due to potentially damaged sterile blister packaging that may compromise sterility. Affected units were distributed in the US and Canada.
Product
DISP.TROCAR W. DILATING PIN 10/110MM, Product Code EK224SU. For use in laparoscopic procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1247-2024·2024-03-13
Aesculap Hasson Trocar Recall Due to Potentially Compromised Sterile Packaging
Aesculap Inc recalls Disposable Hasson Trocars (EK240SU) due to potentially damaged sterile packaging that may compromise sterility. Batch 52581648 distributed in KS, NJ, NY, and Canada requires immediate discontinuation.
Product
DISP.HASSON TROCAR 12/110MM, Product Code EK240SU. For use in laparoscopic procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1245-2024·2024-03-13
Aesculap Disposable Trocars Recalled Due to Sterile Packaging Damage Risk
Aesculap Inc is recalling disposable trocars with dilating pins (Product Code EK234SU) because their sterile blister packaging may be damaged, potentially compromising sterility. This Class II recall affects units distributed in the US and Canada.
Product
DISP.TROCAR W.DILATING PIN 12/110MM, Product Code EK234SU. For use in laparoscopic procedures.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1093-2024·2024-03-06
Medline Bronchoscopy Tray Components Recalled for Potential Lack of Sterility
Medline Industries is recalling certain Nurse Assist components used in Bronchoscopy Trays due to potential lack of sterility. Affected irrigation solutions and saline flush syringes may be non-sterile.
Product
MEDLINE BRONCHOSCOPY TRAY, REF DYNDL1350A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1197-2024·2024-03-06
Integra Cranial Access Kit Recalled Due to Packaging Integrity Defect
Integra LifeSciences is recalling 188 units of the Integra Cranial Access Kit because defective sterile packaging may have compromised product sterility.
Product
Ref No: INS7250 / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.
Category
Medical Device
Distribution
Distributed nationwide