Hazard

Packaging Defect recalls

290 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 packaging defect 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.

76–100 of 290

HighFDA (Devices)·Z-2641-2024·2024-08-28
Bottle Decanter REF 2004S Recalled for Sterile Barrier Packaging Defects
Microtek Medical Inc. is recalling Bottle Decanter REF 2004S units due to pin holes and tears found in the sterile barrier packaging during testing. Compromised packaging could allow contamination of the medical device.
Product
Bottle Decanter, REF 2004S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products to a case (cs).
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2643-2024·2024-08-28
Transfer Device REF 2008S Sterile Barrier Packaging Defect Recall
Microtek Medical's Transfer Device REF 2008S is being recalled due to pin holes and tears in the sterile packaging barrier identified during testing. These defects compromise sterility and could allow contamination.
Product
Transfer Device, REF 2008S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products to a case (cs).
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2541-2024·2024-08-14
Everest Bipolar Cutting Forceps Recalled for Potential Sterility Breach
Olympus is recalling Everest Bipolar Cutting Forceps due to fractures and breakages in packaging trays and Tyvek covers that may result in a sterility breach. Approximately 6985 units are affected and were distributed worldwide.
Product
The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm or 10-mm cannula, depending on the model/outer diameter size of the forceps. Coagulation is achieved using electrosurgical energy under visualization. The device is to be used with bipolar outputs of c
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2540-2024·2024-08-14
Olympus Everest Bipolar Cutting Forceps Recalled for Packaging Defects
Olympus is recalling Everest Bipolar Cutting Forceps surgical instruments due to fractures and breakages in packaging trays and Tyvek covers that may compromise sterility. Affected batches: FR150448, FR154445, FR173022.
Product
The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm or 10-mm cannula, depending on the model/outer diameter size of the forceps. Coagulation is achieved using electrosurgical energy under visualization. The device is to be used with bipolar outputs of c
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2542-2024·2024-08-14
Olympus Everest Bipolar Cutting Forceps Recalled for Packaging Defects
Olympus is recalling Everest Bipolar Cutting Forceps due to fractures and breakages in packaging trays and Tyvek covers that may compromise sterility. The recall affects 4,364 units distributed worldwide.
Product
The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm or 10-mm cannula, depending on the model/outer diameter size of the forceps. Coagulation is achieved using electrosurgical energy under visualization. The device is to be used with bipolar outputs of c
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2236-2024·2024-07-10
Acumatch L-Series Hip Implant Liners Recalled for Packaging Defect
Exactech is recalling Acumatch L-Series hip implant liners because some units were packaged without the specified protective ethylene vinyl alcohol (EVOH) layer, which is required for proper device protection.
Product
Acumatch L-Series BIPOLAR LINER, 22mm (BIPOLAR ENDOPROSTHESIS-Hip), Item Numbers: a) 100-22-19, SZ. L; b) 100-22-20, SZ. M; c) 100-22-21, SZ. N; d) 100-22-22, SZ. P; e) 100-22-23, SZ. R; f) 100-22-24, SZ. S; g) 100-22-25, SZ. T
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2158-2024·2024-06-26
Exactech OPTETRAK Knee Implants Recalled for Out-of-Specification Vacuum Bag Packaging
Exactech is recalling OPTETRAK Advanced Patella knee implant components packaged in vacuum bags that did not meet manufacturing specifications. Improper packaging could compromise product sterility.
Product
OPTETRAK, Advanced Patella, 3 Peg Implant, Item Numbers: a) 200-07-26, 26MM; b) 200-07-29, 29MM; c) 200-07-32, 32MM; d) 200-07-35, 35MM; e) 200-07-38, 38MM
Category
Medical Device
Distribution
0 states
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-2145-2024·2024-06-26
FDA Recalls VICRYL Plus Antibacterial Sutures Due to Packaging Defect
Ethicon is recalling VICRYL Plus Antibacterial Sutures due to a packaging machine defect that created holes in the primary packaging, potentially compromising product sterility. Affected sutures may pose an infection risk.
Product
VICRYL Plus Antibacterial (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, except for ophthalmic, cardiovascular and neurological tissues. PRODUCT CODE: VCP196H VCP417H VCP602H VCP603H VCP662H VCPB259H VCPB94
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2147-2024·2024-06-26
PDS Plus Antibacterial Surgical Sutures Recalled for Compromised Sterility
Ethicon recalls PDS Plus Antibacterial sutures due to packaging defects that compromised sterility. The affected units may cause infection if used in surgery.
Product
PDS Plus Antibacterial (polydioxanone) Suture - Intended for use in general soft tissue approximation, including use in paediatric cardiovascular tissue, in microsurgery and in ophthalmic surgery. These sutures are particularly useful where the combination of an absorbable suture
Category
Medical Device
Distribution
Distributed nationwide
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
ModerateFDA (Devices)·Z-2156-2024·2024-06-26
OPTETRAK One Peg Patella components recalled for out-of-specification vacuum bags
Exactech is recalling OPTETRAK One Peg Patella knee implants due to vacuum bags packaged below specification. The recall affects units with multiple lot numbers distributed worldwide.
Product
OPTETRAK One Peg Patella,, Item Numbers: a) 200-03-26, 26MM; b) 200-03-29, 29MM; c) 200-03-32, 32MM; d) 200-03-35, 35MM; e) 200-03-38, 38MM; f) 200-03-41, 41MM
Category
Medical Device
Distribution
0 states
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-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-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-1527-2024·2024-04-24
Cook Centesis Catheter Needle recalled for packaging seal defect
Cook Incorporated recalled the Yueh Centesis Disposable Catheter Needle due to packaging with low seal strength that may compromise device sterility. The recall affects 296 units distributed worldwide.
Product
Yueh Centesis Disposable Catheter Needle - Intended for use in percutaneous fluid aspirations, such as paracentesis or thoracentesis. REFERENCE PART NUMBER (RPN): DTVN-5.0-19-10.0- YUEH ORDER NUMBER (GPN): G09490
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-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-1402-2024·2024-04-10
Exactech Equinoxe Glenoid Shoulder Components Recalled for Nonconforming Packaging
Exactech, Inc. is recalling 2,077 units of Equinoxe Glenoid shoulder components due to nonconforming packaging. The affected units were packaged in vacuum bags lacking the required oxygen barrier layer.
Product
Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a), Small, Item Number 314-01-02; b) Medium, Item number 314-01-03; c) Large, Item Number 314-01-04, Shoulder Arthroplasty
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1419-2024·2024-04-10
Exactech Equinoxe Shoulder Implants Recalled Due to Nonconforming Oxygen Barrier Packaging
Exactech is recalling 7,213 units of Equinoxe REVERSE SHOULDER prosthetic liners due to nonconforming packaging. The vacuum bags lack the required oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH) specified for these devices.
Product
Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1411-2024·2024-04-10
Exactech Equinoxe Shoulder Implants Recalled for Nonconforming Packaging
Exactech is recalling 245 units of shoulder implants due to nonconforming packaging that lacks a required oxygen barrier layer. The devices were distributed nationwide and internationally.
Product
Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 16o, RIGHT, FOR CEMENTED USE ONLY, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-06-32, b) 41, 44, 47, 50 head, Medium, Item Number314-06-33, c) 44, 47, 50, 53 head, Large, Item Number 314-06-34, d) 44,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1408-2024·2024-04-10
Exactech Equinoxe shoulder arthroplasty glenoid components recalled for packaging defects
Exactech is recalling 35 units of Equinoxe shoulder arthroplasty glenoid components because packaging lacks required oxygen barrier protection. The components were packaged in vacuum bags without Ethylene Vinyl Alcohol (EVOH) layers.
Product
Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 12o, LEFT, FOR CEMENTED USE ONLY, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-04-22, b) 41, 44, 47, 50 head, Medium, Item Number 314-04-23, c) 44, 47, 50, 53 head, Large, Item Number 314-04-24, d) 44,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1416-2024·2024-04-10
Exactech Equinoxe Reverse Shoulder Humeral Liners Recalled for Packaging Defect
Exactech humeral liners used in shoulder replacement are recalled because the vacuum packaging lacks a required oxygen barrier layer (EVOH), violating established packaging specifications.
Product
Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1407-2024·2024-04-10
Exactech Equinoxe Shoulder Glenoid Components Recalled for Defective Packaging
Exactech is recalling 985 shoulder implant components due to nonconforming packaging that lacks a required oxygen barrier layer. The vacuum bags do not meet packaging specifications.
Product
Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, RIGHT, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-02-32, b) 41, 44, 47, 50 head, Medium, Item Number 314-02-33, c) 44, 47, 50, 53 head, Large, Item Number 314-02-34, d) 44, 47, 50, 53 he
Category
Medical Device
Distribution
Distributed nationwide