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.

176–200 of 290

HighFDA (Devices)·Z-1328-2023·2023-04-12
Medtronic Grafton Matrix surgical strips: potential sterile barrier packaging defects
Medtronic is recalling Grafton Matrix Strips due to potential defects in the sterile packaging barrier. Non-conforming packaging could allow sterile barrier compromise in this surgical implant product.
Product
Medtronic Grafton Matrix Strips: a) DBM S42275 8MMX1CMX10CM 2EA MATRIX STRPS, REF S42275; b) DBM S42280 8MMX1CMX20CM 2EA MATRX STRPS, REF S42280; c) DBM T42275 8MMX1CMX10CM 2 EACH GRAFTON M, REF T42275; d) DBM T42275AUS 8MMX1CMX10CM 2 EA GRFTON S, REF T42275AUS; e) DBM
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1323-2023·2023-04-12
Medtronic Grafton Putty Bone Matrix Packaging Sterile Barrier Non-Conformance
Medtronic recalls 186,889 units of Grafton Putty demineralized bone matrix product due to potential packaging defects that could compromise sterile barrier integrity. No illnesses reported.
Product
Medtronic Grafton Putty: a) DBM S43101 GRAFTON 0.5CC PUTTY, REF S43101; b) DBM S43102 GRAFTON 1CC PUTTY, REF S43102; c) DBM S43103 GRAFTON 2.5CC PUTTY, REF S43103; d) DBM S43105 GRAFTON 5CC PUTTY, REF S43105; e) DBM S43110 GRAFTON 10CC PUTTY, REF S43110; f) DBM
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1324-2023·2023-04-12
Medtronic Grafton Crunch sterile pouch packaging non-conformance recall
Medtronic is recalling Grafton Crunch demineralized bone matrix products due to potential packaging non-conformances that may compromise sterile barriers. 5,308 units are affected globally.
Product
Medtronic Grafton Crunch a) DBM S44105 GRAFTON 5CC CRUNCH, REF S44105; b) DBM S44115 GRAFTON 15CC CRUNCH, REF S44115; c) DBM T44105 5CC GRAFTON CRUNCH, REF T44105; d) DBM T44105INT 5CC GRAFTON CRUNCH, REF T44105INT; e) DBM T44115 15CC GRAFTON CRUNCH, REF T44115; f) DB
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1334-2023·2023-04-12
Medtronic XPANSE Bone Insert Recalled for Sterile Packaging Non-Conformances
Medtronic is recalling XPANSE Bone Insert products due to packaging defects that may compromise the sterile barrier. Non-sterile packaging could allow contamination before surgical implantation.
Product
Medtronic XPANSE Bone Insert: a) DBM T600106 XPANSE SMALL-C 6, REF T600106; b) DBM T600206 XPANSE MEDIUM-C 6, REF T600206; c) DBM T600209 XPANSE MEDIUM-C 9, REF T600209; d) DBM T600306 XPANSE LARGE-C 6, REF T600306; e) DBM T600309 XPANSE LARGE-C 9, REF T600309;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1331-2023·2023-04-12
Medtronic Grafton DBF Inject bone matrix products recalled for packaging defects
Medtronic is recalling Grafton DBF Inject demineralized bone matrix products due to potential packaging non-conformances that may compromise the sterile barrier. Over 10,000 units distributed worldwide are affected.
Product
Medtronic Grafton DBF Inject: a) GRAFTON T50303 DBF INJECT 3CC, REF T50303; b) GRAFTON T50306 DBF INJECT 6CC, REF T50306; c) GRAFTON T50309 DBF INJECT 9CC, REF T50309; Demineralized Bone Matrix (DBM) product
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1332-2023·2023-04-12
Medtronic Accelerate Grafton DBF Bone Matrix Packaging Defect Recall
Medtronic is recalling Accelerate Grafton DBF bone matrix products due to potential packaging non-conformances in the sterile pouch system that may compromise the sterile barrier. The recall affects 3,037 units distributed worldwide.
Product
Medtronic Accelerate Grafton DBF a) ACCELERATE BG SET T50203 GRAFTON DBF 3CC, REF T50203; b) ACCELERATE BG SET T50206 GRAFTON DBF 6CC, REF T50206; c) ACCELERATE BG SET T50209 GRAFTON DBF 9CC, REF T50209; d) ACCELERATE BG SET T50212 GRAFTON DBF12CC, REF T50212; Deminera
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1213-2023·2023-03-15
Baxter peritoneal dialysis cap incorrectly sealed, risks inadequate disinfection
Baxter MiniCap Disconnect Cap pouches may have faulty seals allowing air exposure, risking inadequate disinfection of the sterile connector used in peritoneal dialysis.
Product
Baxter MiniCap Disconnect Cap with Povidone-Iodine Solution, 5C4466P; Accessory to disposable administration set for peritoneal dialysis
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1128-2023·2023-02-22
Surgical Convenience Kits Recalled Due to Non-Sterile Outer Packaging
Medline and Centurion Medical Products are recalling surgical convenience kits because the outer packaging has perforations that prevent sterility, leaving only the contents inside the kit wrapping sterile.
Product
Surgical convenience kits labeled as: a) MEDLINE HAND PACK, Reorder Number DYNJ67850; b) MEDLINE SHOULDER SUSPENSION II-LF, Reorder Number DYNJSHOULDER2; c) MEDLINE TRAY BONE MARRO ASC LTX SAFE, Reorder Number P429589A; d) MEDLINE LUMBAR TRAY, Reorder Number SPEC0177;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1123-2023·2023-02-22
Surgical Convenience Kits Recalled for Outer Wrapping Sterility Defect
Medline is recalling 1376 surgical convenience kits nationwide due to a packaging defect that compromises the sterility of the outer wrapping. Only the kit contents remain sterile.
Product
Surgical convenience kits labeled as: MEDLINE PREP TRAY, Reorder Number DYNDL1643A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1112-2023·2023-02-22
Medline CABG surgical convenience kits recalled due to sterility issue
Medline is recalling 80 units of MEDLINE CABG PACK surgical convenience kits (Lot #22HMH432) nationwide because the perforated bag design cannot maintain sterility of the outer packaging wrapping.
Product
Surgical convenience kits labeled as: MEDLINE CABG PACK, Reorder Number DYNDA2827
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1117-2023·2023-02-22
Surgical convenience kits recalled due to sterile packaging failure
Medline Industries is recalling 138 surgical convenience kits nationwide because the outer packaging does not maintain sterility. Only the contents inside the kit wrapper are sterile, creating a contamination risk.
Product
Surgical convenience kits labeled as: CENTURION MEDICAL PRODUCTS L & D TRAY, Reorder Number MNS9065
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1124-2023·2023-02-22
Surgical convenience kits recalled for compromised external packaging sterility
Medline Industries is recalling 1,588 surgical kits nationwide due to a perforated bag design that prevents the outside of the kit wrapping from remaining sterile.
Product
Surgical convenience kits labeled as: a) CENTURION MEDICAL PRODUCTS CENTRAL LINE DRESSING CHANGE K, Reorder Number DT21400; b) CENTURION MEDICAL PRODUCTS CUSTOM PORT ACCESS KIT, Reorder Number DT22255; c) MEDLINE CVC DRESSING CHANGE KIT, Reorder Number DYNDC1022GB,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1125-2023·2023-02-22
Surgical Convenience Kits Recalled for Compromised Sterility Assurance
Medline Industries is recalling surgical convenience kits with reorder number DYNJCD0063 due to a perforated bag that fails to keep the kit's outer wrapping sterile. Affected units were distributed nationwide.
Product
Surgical convenience kits labeled as: MEDLINE ARM/MINOR DRAPE CSTM, Reorder Number DYNJCD0063
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1116-2023·2023-02-22
Surgical Convenience Kits Recalled Due to Non-Sterile Outer Wrapping
MEDLINE surgical convenience kits are recalled due to a perforated outer bag that prevents the kit's outer wrapping from remaining sterile. Only the contents inside the wrapper are guaranteed sterile.
Product
Surgical convenience kits labeled as: MEDLINE PLASTICS/PEDS KIT, Reorder Number DYNDA2489
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1096-2023·2023-02-15
Medline Sterile Procedural Trays Recalled Due to Packaging Puncture Risk
Medline recalls sterile procedural trays because blades may puncture the foil packaging, potentially compromising sterility. The recall affects over 227,000 units distributed worldwide.
Product
Sterile Procedural Trays, labeled as the following: a. SPINAL b. SPINE CDS c. TOTAL ORTHO CDS d. TOTAL KNEE CDS e. CDS HIP-LF f. KNEE TOTAL PACK-LF g. EXTREMITY CDS h. SHOULDER ARTHRO CDS i. GLENNON EXTREMITY CDS j. KNEE ARTHROSCOPY k. TOTAL KNEE l. TOTAL HIP REPLACEMENT m. TO
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1095-2023·2023-02-15
Sterile Ophthalmic Procedure Trays Recalled for Packaging Integrity Risk
Medline Industries is recalling sterile ophthalmic procedure trays because blades in the kits can puncture the outer foil packaging, potentially compromising sterility. The recall affects 1,200 units distributed worldwide.
Product
Sterile Procedural Trays, labeled as the following: a. BASIC EYE PACK-LF b. VITRECTOMY PACK-LF c. EYE PACK-EAST-LF d. OSC OCULAR PLASTIC PACK-LF e. EYE PACK f. OCULOPLASTIC PACK g. EYE PLASTIC PACK h. PLASTIC EYE PACK i. DR H BLEPH PACK j. BLEPH PACK k. OPHTHALMOLO
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0925-2023·2023-01-18
Guarded Luer Connectors Recalled for Compromised Sterility in Blister Packaging
International Medical Industries recalls 228,000 Prep-Fill Guarded Luer Connectors due to unsealed blister packages compromising product sterility. The Class II recall affects medical devices distributed nationwide.
Product
Prep-Fill Guarded Luer Connector (GLC): a. Part Number 57-400, Female Lock - Female Lock Guarded Luer Connector, Sterile; b. Part number 57-400W, Female Lock - Female Lock Guarded Luer Connector, Sterile; c. Part number 57-401, Female Lock - Male Lock Guarded Luer Co
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0944-2023·2023-01-18
Stradis Healthcare TCTR Convenience Kit recalled for potential sterility compromise
Stradis Healthcare is recalling the TCTR Convenience Kit due to potential pinhole leaks near the seal that could compromise the kit's sterility. The recall affects 80 units distributed across ten states.
Product
Stradis Healthcare TCTR Convenience Kit. Manufactured by Stradis Healthcare.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0931-2023·2023-01-18
Stradis Healthcare Foley Catheter Insertion Tray Recalled for Sterility Breach Risk
Stradis Healthcare is recalling Foley Catheter Insertion Trays due to potential pinhole leaks in the outer bag that could compromise sterility. The recall affects 920 units distributed across multiple US states.
Product
Stradis Healthcare Foley Catheter Insertion Tray with preconnected bag and catheter, Sterile
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0948-2023·2023-01-18
Neonatal PICC Tray Recalled Due to Potential Sterility Breach
Vital Care Products' Neonatal PICC Tray kits may have pinhole leaks in the outer bag near the seal, potentially compromising sterility. Affected units were distributed nationwide.
Product
Vital Care Products NEONATAL PICC TRAY, Sterile, QTY 20. Manufactured for Vital Care Products, Inc.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0933-2023·2023-01-18
Cystoscopy kits recalled for potential sterility breach from packaging defects
Henry Shein CYSTO SET UP PACK units are being recalled due to potential pinhole leaks in the outer bag that could compromise the sterility of the kit.
Product
Henry Shein CYSTO SET UP PACK, 20 per case. Distributed by Henry Schein.
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-0941-2023·2023-01-18
HCT MAX BARRIER PICC Insertion Tray Recalled for Potential Sterility Breach
Stradis Healthcare is recalling HCT MAX BARRIER PICC Insertion Trays due to potential pinhole leaks in the outer bag that may compromise sterility. No illnesses have been reported, but affected healthcare facilities should immediately discontinue use of the affected lot.
Product
HCT MAX BARRIER PICC INSERTION TRAY 12 per case. Distributed by Health Care Technology
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0538-2023·2022-12-21
Stradis Healthcare Thoracic Surgery Kits Recalled for Sterility Risk
Thoracic Phleb procedure kits from Stradis Healthcare are being recalled due to incomplete outer bag sealing during manufacturing, which may compromise kit sterility.
Product
STRADIS HEALTHCARE, Thoracic Phleb, Item No.682-1228,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0164-2023·2022-11-09
Medline Dental Pack Recall Due to Breather Pouch Seal Defect
Medline is recalling Dental Pack surgical kits (Lot 22DBE139) because breather pouches have openings in their seals that could compromise sterility. Affected units were distributed to healthcare facilities in eight US states.
Product
MEDLINE DENTAL PACK, REF DYNJ66983. Convenience kit used in medical procedures.
Category
Medical Device
Distribution
Distributed nationwide