Hazard

Packaging Defect recalls

1,604 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total: 1,604
Critical: 2
Severe: 82
Most recent: 2026-09-09

Of the 1,604 packaging defect recalls we have scored against our rubric, 2 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 82 (5%) are Severe.

Which agencies issued them

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.

1401–1425 of 1604

ModerateFDA (Food)·F-1540-2014·2014-02-26
Abbott Nutrition Recalls Similac Human Milk Fortifier Powder Packets
Abbott Nutrition is recalling Similac Human Milk Fortifier Powder packets in Canada due to incomplete seals that may allow air entry, causing oxidation or powder leakage.
Product
Similac Human Milk Fortifier Powder, .9 g packets. Label reads in part, "ADDITIONAL IRON MAY BE NECESSARY ADD ONLY TO HUMAN MILK - DO NOT ADD WATER NET WT 0.031 OZ (0.90g)***CONTAINS MILK AND SOY INGREDIENTS***USE BY***ABBOTT LABORATORIES"
Category
Food
Distribution
0 states
ModerateFDA (Devices)·Z-1042-2014·2014-02-26
Zimmer Recalls Sterile Orthopedic Screws Due to Packaging Validation Issues
Zimmer is recalling 7 million sterile orthopedic screws because packaging operations at its Puerto Rico facility were not properly validated, despite passing subsequent seal integrity tests.
Product
1.5 X 6 CORT SCREW HEX/SE 2.0 X 6 CORT SCREW HEX/SE 2.0 X 10 CORT SCREW CRUCI 2.0 X 12 CORT SCREW CRUCI 2.0 X 14 CORT SCREW CRUCI 2.0 X 16 CORT SCREW HEX/S 2.0 X 16 CORT SCREW CRUCI 2.0 X 18 CORT SCREW CRUCI 2.0 X 20 CORT SCREW CRUCI 2.0 X 26 CORT SCREW CRUCI 2.0 X 28 C
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1041-2014·2014-02-26
Zimmer Recalls Self-Tapping Cortical Screws Due to Packaging Validation Issues
Zimmer, Inc. is recalling 7,044,680 self-tapping cortical screws because packaging operations at a Puerto Rico facility were not properly validated, raising concerns about sterile barrier integrity.
Product
2.7 X 6 CORT SCREW/SELFTA 2.7 X 7 CORT SCREW/SELFTA 2.7 X 8 CORT SCREW/SELFTA 2.7 X 9 CORT SCREW/SELFTA 2.7 X 10 CORT SCREW/SELFT 2.7 X 12 CORT SCREW/SELFT 2.7 X 14 CORT SCREW/SELFT 2.7 X 16 CORT SCREW/SELFT 2.7 X 18 CORT SCREW/SELFT 2.7 X 20 CORT SCREW/SELFT 2.7 X 22 C
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1031-2014·2014-02-26
Zimmer Recalls 12/14 Femoral Heads Due to Packaging Validation Issues
Zimmer is recalling 12/14 femoral heads because packaging operations at its Puerto Rico facility were not properly validated, despite passing subsequent seal integrity tests.
Product
12/14 COCR FEMORAL HEAD (2, 3 and 4); 12/14 FEMORAL HEAD (+7X28M and 7X32M)
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1038-2014·2014-02-26
Zimmer Recalls Bone Screws Due to Unvalidated Packaging Operations
Zimmer is recalling 7,044,680 units of Herbert Bone Screws and Cannulated Bone Screws because packaging operations at a Puerto Rico facility were not properly validated.
Product
HERBERT BONE SCREW, 3.0MM and HERBERT CANNULATED BONE S
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1009-2014·2014-02-26
Zimmer Recalls Interlocking IM Screws and Tibial Nails Due to Packaging Validation
Zimmer is recalling interlocking IM screws and tibial nails sterile packaged at a Puerto Rico facility because packaging operations were not properly validated.
Product
INTERLOCKING IM SCREW SML, MED and LRG; M/DN TIBIAL I/M NAIL 6 MM to 15 MM. Some items starting with codes 0022530, 0022531, 002532, 0022533, 0022534
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1002-2014·2014-02-26
Zimmer Recalls Bone Screws Due to Packaging Validation Deficiencies
Zimmer is recalling specific bone screws because packaging operations at its Puerto Rico facility were not properly validated, despite passing subsequent seal integrity tests.
Product
HERBERT MINI BONE SCREW 2 and HERBERT/WHIPPLE C ANN BONE. Items starting with 0011500 and 0011520.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1004-2014·2014-02-26
Zimmer Recalls Sterile Orthopedic Screws Due to Packaging Validation Issues
Zimmer is recalling specific sterile orthopedic screws because packaging operations at a Puerto Rico facility were not properly validated, despite passing seal integrity tests.
Product
Item codes starting with 001930 LAG SCR 12.7D X 55MM SHOR up to 155 MM, LAG SCR 12.7D X 55 MM SHO up to 100MM, LAG SCR 12.7D X 55MM STAN up to 155 MM, LAG SCR 15.8D X 55MM LARG up to 155 MM
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1043-2014·2014-02-26
Zimmer Recalls 3.5 Compression Plates Due to Packaging Validation Issues
Zimmer is recalling 3.5 compression plates sterile packaged at its Puerto Rico facility because packaging operations were not properly validated, despite passing seal integrity tests.
Product
3.5 COMP PLT, 4 HOLE 3.5 COMP PLT, 5 HOLE 3.5 COMP PLT, 6 HOLE 3.5 COMP PLT, 8 HOLE 3.5 COMP PLT, 9 HOLE 3.5 COMP PLT, 10 HOLE
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1027-2014·2014-02-26
Zimmer Recalls Pressfit Femoral Stems Due to Packaging Validation Issues
Zimmer, Inc. is recalling 7,044,680 units of Pressfit Femoral Stems because packaging operations at a Puerto Rico facility were not properly validated.
Product
PRESSFIT FEM ST FX 16 X 1
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1044-2014·2014-02-26
Zimmer Recalls Self-Tapping Cortical Screws Due to Packaging Validation Issues
Zimmer is recalling 7 million self-tapping cortical screws because packaging operations at a Puerto Rico facility were not properly validated, despite passing seal integrity tests.
Product
3.5 X 10 CORT SCREW SELFT 3.5 X 12 CORT SCREW SELFT 3.5 X 14 CORT SCREW SELFT 3.5 X 16 CORT SCREW SELFT 3.5 X 18 CORT SCREW SELFT 3.5 X 20 CORT SCREW SELFT 3.5 X 22 CORT SCREW SELFT 3.5 X 24 CORT SCREW SELFT 3.5 X 26 CORT SCREW SELFT 3.5 X 28 CORT SCREW SELFT 3.5 X 30 C
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1006-2014·2014-02-26
Zimmer Recalls Versa-FX Orthopedic Implants Due to Packaging Validation Issues
Zimmer is recalling specific Versa-FX orthopedic implant lots because packaging operations at its Puerto Rico facility were not properly validated, despite passing seal integrity tests.
Product
VERSA-FX KEYLESS 90D X 8 and X 11, VERSA-FX KEYLESS 95D X 8, X 11, and X 14, VERSA-FX KEYLESS 140D X 4 and X 5, VERSA-FX KEYLESS 135D X 4 and X 5, VERSA-FX SHORT TUBE, 130D, 135D and 140D, VERSA-FX STANDARD TUBE, 1 and VERSA-FX SPRCNDLR TUBE, 9 Item codes starting with 001980,
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1040-2014·2014-02-26
Zimmer Recalls Orthopedic Screws Due to Packaging Validation Deficiencies
Zimmer is recalling 7,044,680 orthopedic screws because packaging operations at its Puerto Rico facility were not properly validated, raising concerns about sterile barrier integrity.
Product
PERI SCR. 3.5MM X 10MM PERI SCR. 3.5MM X 12MM PERI SCR. 3.5MM X 14MM PERI SCR 3.5MM X 44MM STE PERI SCR. 3.5MM X 65MM PERI. SCR 4.0MM X24MM PERI. SCR 4.0MM X40MM PERI SCR. 4.0MMX14MM FULL PERI SCR. 4.0MMX32MM FULL PERI SCR. 4.0MMX38MM FULL 3.5MM CORT
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1029-2014·2014-02-26
Zimmer Recalls Versys Femoral Stems Due to Packaging Validation Issues
Zimmer is recalling Versys femoral stems because packaging operations at its Puerto Rico facility were not properly validated, despite passing subsequent seal integrity tests.
Product
12/14 UNIPOLAR FEMORAL HE VERSYS CEM LD/FX SZ 11X12 VERSYS CEM LD/FX SZ 12X12 VERSYS CEM LD/FX SZ 14X13 VERSYS CEM LD/FX SZ 16X14 VERSYS CEM LD/FX ST 18X15 VERSYS PRESS FIT LD/FX ST VERSYS PRESS FIT LD/FX SZ VERSYS ADVOCATE CEMENTED VERSYS ADVOCATE V-LIGN CE VERSYS CEM
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1010-2014·2014-02-26
Zimmer Recalls Interlocking IM Screws Due to Packaging Validation Issues
Zimmer is recalling Interlocking IM Screws because packaging operations at a Puerto Rico facility were not properly validated, despite passing subsequent seal integrity tests.
Product
INTERLOCKING IM SCREW 4.5 and INTERLOCKING IM SCREW LG Some items starting with codes 0022530
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0939-2014·2014-02-19
RTI Surgical Recalls OPTEFORM Allograft Paste Due to Incorrect Dispenser
RTI Surgical, Inc. is recalling 14 units of OPTEFORM Allograft Paste 5cc because they may contain a 10cc fluid dispenser with incorrect fill lines.
Product
***REF 606-01-05***OPTEFORM Allograft Paste 5 cc, bone void filler of bony defects in dental and orthopedic applications.***STERILE Using Radiation. ***Rx Only***Distributor: EXACTECH 2320 NW 66th Court, Gainesville, FL 32653 USA***Manufacturer: RTI Biologicals, Inc. 11621 Resea
Category
Medical Device
Distribution
1 state
LowFDA (Drugs)·D-1072-2014·2014-02-12
Timolol Maleate Eye Drops Recalled for Exterior Bottle Residue
PACK Pharmaceuticals is recalling Timolol Maleate eye drops due to white solid residue found on the exterior of the bottles.
Product
Timolol Maleate Sterile Ophthalmic Solution, USP 0.5%, 5mL, (NDC 16571-141-50). The products are packaged in Low Density Polyethylene (LDPE) Blow Fill Seal containers equipped with a dropper tip. The filled bottles are individually packaged into fiberboard cartons.
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-1068-2014·2014-02-12
PACK Pharmaceuticals Recalls Ofloxacin Ophthalmic Solution Due to Container Defects
PACK Pharmaceuticals is recalling 32,029 bottles of Ofloxacin Ophthalmic Solution because stability samples showed white solid residue on the exterior of the bottles.
Product
Ofloxacin Ophthalmic Solution, USP 0.3%, 5mL, (NDC 16571-130-50). The products are packaged in Low Density Polyethylene (LDPE) Blow Fill Seal containers equipped with a dropper tip. The filled bottles are individually packaged into fiberboard cartons.
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-1070-2014·2014-02-12
PACK Pharmaceuticals Recalls Timolol Maleate Eye Drops Due to Container Defects
PACK Pharmaceuticals is recalling specific lots of Timolol Maleate eye drops because stability samples showed white solid residue on the exterior of the bottles.
Product
Timolol Maleate Sterile Ophthalmic Solution, USP 0.25%, 5mL, (NDC 16571-140-50). The products are packaged in Low Density Polyethylene (LDPE) Blow Fill Seal containers equipped with a dropper tip. The filled bottles are individually packaged into fiberboard cartons.
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-1069-2014·2014-02-12
PACK Pharmaceuticals Recalls Ofloxacin Ophthalmic Solution Due to Container Defects
PACK Pharmaceuticals is recalling 126 bottles of Ofloxacin Ophthalmic Solution 0.3% because stability samples showed white solid residue on the exterior of the bottles.
Product
Ofloxacin Ophthalmic Solution, USP 0.3%, 10mL, (NDC 16571-130-11). The products are packaged in Low Density Polyethylene (LDPE) Blow Fill Seal containers equipped with a dropper tip. The filled bottles are individually packaged into fiberboard cartons.
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-1073-2014·2014-02-12
PACK Pharmaceuticals Recalls Timolol Maleate Eye Drops Due to Exterior Residue
PACK Pharmaceuticals is recalling Timolol Maleate Sterile Ophthalmic Solution due to white solid residue found on the exterior of bottles.
Product
Timolol Maleate Sterile Ophthalmic Solution, USP 0.5%, 10mL, (NDC 16571-141-10). The products are packaged in Low Density Polyethylene (LDPE) Blow Fill Seal containers equipped with a dropper tip. The filled bottles are individually packaged into fiberboard cartons.
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-1071-2014·2014-02-12
Timolol Maleate Eye Drops Recalled Due to Exterior Residue
PACK Pharmaceuticals is recalling Timolol Maleate Sterile Ophthalmic Solution due to white solid residue found on the exterior of the bottles.
Product
Timolol Maleate Sterile Ophthalmic Solution, USP 0.25%, 10mL, (NDC 16571-140-10). The products are packaged in Low Density Polyethylene (LDPE) Blow Fill Seal containers equipped with a dropper tip. The filled bottles are individually packaged into fiberboard cartons.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-736-2014·2014-01-22
Sigma-Tau Recalls Oncaspar Injection Due to Sterility Concerns
Sigma-Tau Pharmaceuticals is voluntarily recalling five lots of Oncaspar Injection because a crack under the crimp seal caused a leak, compromising sterility.
Product
PEGASPARGASE ONCASPAR Injection, 3750 International Units Per 5mL vial, Rx ONLY, sigma-tau PHARMACEUTICALS INC, 9841 Washingtonian Blvd, Gaithersburg, MD 20878 NDC 54482-301-01
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-342-2014·2013-12-18
VistaPharm Recalls Phenytoin Oral Suspension Due to Container Defects
VistaPharm is recalling specific lots of Phenytoin Oral Suspension because a lidding defect caused the product to fail stability tests for assay and viscosity.
Product
Phenytoin Oral Suspension USP 125mg/5mL, 50 cups per case, For Oral Administration Only, Rx Only, Manufactured by: VistaPharm Inc, Largo, FL 33771, NDC 66689-036-50
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0446-2014·2013-12-11
Smith & Nephew Recalls Genesis II Knee Inserts Due to Seal Defect
Smith & Nephew is recalling 80 Genesis II knee inserts because the Tyvek lid may not be adequately sealed, potentially compromising sterility.
Product
GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 3-4, 9 MM QTY: (1), REF 71421508, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic
Category
Medical Device
Distribution
1 state