Hazard

Packaging Integrity recalls

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

What the numbers show

Total: 76
Critical: 0
Severe: 2
Most recent: 2026-07-08

Of the 76 packaging integrity recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2 (3%) 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 integrity 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.

51–75 of 76

HighFDA (Devices)·Z-2342-2014·2014-09-10
Customed Recalls EO Sterilized Surgical Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling 5,574 units of EO sterilized surgical packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
0.B. PACK - - (1) TABLE COVER 44" x 90" (1) UNDERBUTTOCK DRAPE WITH POUCH (2) LEGGINS WITH 7" CUFF 30" x 42" (1) GOWN IMPERVIOUS REINFORCED LARGE SMS (3) TOWELS ABSORBENT 15" x 20" (1) PAD OBSTETRICAL X-LARGE (1) VAGINAL SPONGE XRD (10) GAUZE SPONGES 4" X 4" 12PLY XRD (
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2551-2014·2014-09-03
Zimmer Recalls Moore & Thompson Hip Stems Due to Packaging Failures
Zimmer, Inc. is recalling Moore & Thompson Hip Stems because packaging design verification tests failed, resulting in compromised seal integrity or breached trays.
Product
Moore & Thompson Hip Stems: FNSTRD HIP 38HDX127ST FNSTRD HIP 40HDX127ST FNSTRD HIP 41HDX127ST FNSTRD HIP 42HDX127ST FNSTRD HIP 43HDX127ST FNSTRD HIP 44HDX127ST FNSTRD HIP 45HDX140ST FNSTRD HIP 46HDX140ST FNSTRD HIP 47HDX140ST FNSTRD HIP 48HDX140ST FNSTRD HIP 49HDX140ST
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2548-2014·2014-09-03
Zimmer Recalls Endo and Unipolar Femoral Heads Due to Packaging Failures
Zimmer, Inc. is recalling 972,125 units of Endo and Unipolar Femoral Heads because packaging design verification tests failed, potentially compromising sterility.
Product
Endo & Unipolar Femoral Heads: ENDO FEMORAL HEAD 43MM DIA, ENDO FEMORAL HEAD 53MM DIA, ENDO FEMORAL HEAD 47MM DIA, ENDO FEMORAL HEAD 50MM DIA, ENDO FEMORAL HEAD 42MM DIA, ENDO FEMORAL HEAD 54MM DIA, ENDO FEMORAL HEAD 48MM DIA, ENDO FEMORAL HEAD 41MM DIA, ENDO FEMORAL HEAD 42MM D
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2550-2014·2014-09-03
Zimmer Recalls Trauma Tubes and Plates Due to Packaging Failures
Zimmer, Inc. is recalling specific trauma tubes and plates because packaging design verification tests failed, resulting in compromised seal integrity.
Product
Trauma Tubes and Plates: TUBE & SCP PLT 90DX150LG TUBE & SCP PLT 90DX205LG TUBE & SCP PLT 90DX255LG TUBE & SCP PLT 95DX150LG TUBE & SCP PLT 95DX205LG TUBE & SCP PLT 95DX255LG TUBE&SCP PLT 130DX8H TUBE&SCP PLT 130DX10H TUBE&SCP PLT 130DX12H TUBE&SCP PLT 130DX14H TUBE&SC
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2549-2014·2014-09-03
Zimmer Recalls Trauma Large Screws Due to Packaging Design Failures
Zimmer, Inc. is recalling 972,125 units of sterile-packaged Trauma Large Screws because packaging design verification tests failed, resulting in compromised seal integrity.
Product
Trauma Large Screws: CANN BONE SCREW 7.0MMX100MMLG CANN BONE SCREW 7.0X105LG CANN BONE SCREW 7.0X105LG CANN BONE SCREW 7.0MMX105MMLG CANN BONE SCREW 7.0X110LG CANN BONE SCREW 7.0X110LG CANN BONE SCREW 7.0MMX110MMLG CANN BONE SCREW 7.0X115LG CANN BONE SCREW 7.0X115LG CAN
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2552-2014·2014-09-03
Zimmer Recalls Knee Stem Extensions Due to Packaging Design Failures
Zimmer, Inc. is recalling specific knee stem extensions and impactor sleeves because packaging design verification tests failed, potentially compromising device sterility.
Product
Knee Stem Extensions & Impactor Sleeve: STEM IMPLANT 20MMDX145MM STEM IMPLANT 22MMDX145MM STEM IMPLANT 24MMDX145MM SHARP FLUTED ST 20MMDX75MM SHARP FLUTED ST 22MMDX75MM SHARP FLTD ST 24MMDX75MM SHARP FLUTED ST 20MMDX130MM SHARP FLUTED ST 22MMDX130MM SHARP FLUTED ST 24MMD
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2003-2014·2014-07-16
Teleflex Medical Recalls Aquapak 340 SW Respiratory Gas Humidifier Adaptors
Teleflex Medical is recalling Aquapak 340 SW respiratory gas humidifier adaptors because creased packaging seals may affect integrity. The recall covers units distributed in the US and 12 other countries.
Product
Aquapak 340 SW, 340, mL w/040 Adaptor, International, Teleflex Medical, respiratory gas humidifier adaptor .
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2016-2014·2014-07-16
Teleflex Medical Recalls Humidifier Adaptor 040 Due to Packaging Seal Issues
Teleflex Medical is recalling Humidifier Adaptor 040 units because creased packaging seals may affect integrity. The recall covers 7,758,650 units distributed worldwide.
Product
Humidifier Adaptor 040, Teleflex Medical, respiratory gas humidifier adaptor.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2010-2014·2014-07-16
Teleflex Medical Recalls Respiratory Gas Humidifier Adaptors Due to Packaging Seal Issues
Teleflex Medical is recalling Aqua 540 SW and 540 w/040 Adaptors because creased packaging seals may affect integrity. The recall covers units distributed in the US and 12 other countries.
Product
Aqua 540 SW, 540 w/040 Adaptor, Teleflex Medical, respiratory gas humidifier adaptor.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2011-2014·2014-07-16
Teleflex Aquapak SW/EAU Sterile Respiratory Gas Humidifier Adaptor Packaging Recall
Teleflex Medical is recalling Aquapak SW/EAU Sterile respiratory gas humidifier adaptors because creased packaging seals may affect integrity.
Product
Aquapak SW/EAU Sterile, 650 mL w/Adaptor, Teleflex Medical, respiratory gas humidifier adaptor.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2017-2014·2014-07-16
Teleflex Medical Recalls Humidifier Adaptors Due to Packaging Seal Issues
Teleflex Medical is recalling 7.7 million Humidifier Adaptors because creased packaging seals may affect integrity. The products were distributed in the US and 12 other countries.
Product
Humidifier Adaptor, 040 Shelf Pak, French, Teleflex Medical, respiratory gas humidifier adaptor.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2005-2014·2014-07-16
Teleflex Medical Recalls Aquapak 101 SW Respiratory Gas Humidifier Adaptors
Teleflex Medical is recalling Aquapak 101 SW respiratory gas humidifier adaptors because creased packaging seals may affect integrity.
Product
Aquapak 101 SW, 190, mL w/040 Adaptor, Japan, Teleflex Medical, respiratory gas humidifier adaptor
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2012-2014·2014-07-16
Teleflex Medical Recalls Aquapak 640 SW Respiratory Gas Humidifier Adaptors
Teleflex Medical is recalling Aquapak 640 SW respiratory gas humidifier adaptors because creased packaging seals may affect integrity.
Product
Aquapak 640 SW, 650 mL w/040 Adaptor, Teleflex Medical, respiratory gas humidifier adaptor.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2014-2014·2014-07-16
Teleflex Medical Recalls Aquapak 640 SW Respiratory Gas Humidifier Adaptors
Teleflex Medical is recalling Aquapak 640 SW respiratory gas humidifier adaptors because creased packaging seals may affect integrity. The recall covers units distributed in the US and 12 other countries.
Product
Aquapak 640 SW, 650 mL w/040 Adaptor, Japan, Teleflex Medical, respiratory gas humidifier adaptor.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2008-2014·2014-07-16
Teleflex Aquapak 340 SW Respiratory Gas Humidifier Adaptor Packaging Recall
Teleflex Medical is recalling Aquapak 340 SW respiratory gas humidifier adaptors because creased packaging seals may affect integrity.
Product
Aquapak 340 SW, 340, mL w/040 Adaptor, French, Teleflex Medical, respiratory gas humidifier adaptor.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2006-2014·2014-07-16
Teleflex Medical Recalls Aquapak 340 SW Respiratory Gas Humidifier Adaptors
Teleflex Medical is recalling Aquapak 340 SW respiratory gas humidifier adaptors because creased packaging seals may affect integrity. The recall covers units distributed in the US and 12 other countries.
Product
Aquapak 340 SW, 340, mL w/040 Adaptor, Teleflex Medical, respiratory gas humidifier adaptor.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2009-2014·2014-07-16
Teleflex Medical Recalls Aquapak 340 SW Respiratory Gas Humidifier Adaptors
Teleflex Medical is recalling Aquapak 340 SW respiratory gas humidifier adaptors because creased packaging seals may affect integrity.
Product
Aquapak 340 SW, 340, mL w/040 Adaptor, Japan, Teleflex Medical, respiratory gas humidifier adaptor.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2013-2014·2014-07-16
Teleflex Medical Recalls Aquapak 640 SW Respiratory Gas Humidifier Adaptors
Teleflex Medical is recalling Aquapak 640 SW respiratory gas humidifier adaptors because creased packaging seals may affect integrity. The recall covers units distributed in the US and 11 other countries.
Product
Aquapak 640 SW, 650 mL w/040 Adaptor, French, Teleflex Medical, respiratory gas humidifier adaptor.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2004-2014·2014-07-16
Teleflex Medical Recalls Aquapak Respiratory Gas Humidifier Adaptors for Packaging Defects
Teleflex Medical is recalling Aquapak 640 SW and 650 mL respiratory gas humidifier adaptors because creased packaging seals may affect integrity.
Product
Aquapak 640 SW, 650, mL w/040 Adaptor, International, Teleflex Medical, respiratory gas humidifier adaptor .
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2015-2014·2014-07-16
Teleflex Medical Recalls Respiratory Gas Humidifier Adaptors Due to Packaging Seal Issues
Teleflex Medical is recalling 7,758,650 respiratory gas humidifier adaptors because creased packaging seals may affect integrity. The recall covers units distributed in the US and 11 other countries.
Product
Adaptor, 040 Hum, International, Teleflex Medical, respiratory gas humidifier adaptor.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2007-2014·2014-07-16
Teleflex Medical Recalls Aquapak SW/EAU Respiratory Gas Humidifier Adaptors
Teleflex Medical is recalling Aquapak SW/EAU respiratory gas humidifier adaptors because creased packaging seals may affect integrity.
Product
Aquapak SW/EAU, Sterile, 340 mL, w/Adaptor, Teleflex Medical, respiratory gas humidifier adaptor.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0991-2014·2014-02-26
Biocardia Recalls Morph Accesspro Steerable Introducers Due to Packaging Wear
Biocardia is recalling 11 units of Morph Accesspro Steerable Introducers because worn Tyvek packaging may cause loss of package integrity.
Product
MORPH ACCESSPRO Steerable Introducer; 6F introducer, 90 cm working length: Sterile in unopened, undamaged pouch. Sterilized by EtO gas, Non-pyrogenic: BioCardia Inc. San Carlos, CA 94070 Intended to provide a pathway through which medical instruments such as balloon dilati
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-0098-2014·2013-11-06
Small Bone Innovations Recalls Radial and Ulnar Stem Implants
Small Bone Innovations is recalling 2,036 radial and ulnar stem implants due to a risk of sterile packaging breach.
Product
Small Bone Innovations (SBi) rHead Radial Stem, rHead Recon Radial System, rHead Radial Stem Lateral Assembly, rHead Radial Stem 6mm Collar, rHead Recon Radial Stem 6mm Collar, rHead Radial Stem Lateral Assembly 6mm Collar, rHead Standard Extended Stem, rHead Radial Stem Plasma C
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2174-2013·2013-09-18
Advanced Sterilization Products Recalls STERRAD 100NX Cassettes Due to Packaging Data Gaps
Advanced Sterilization Products is recalling 1,923 STERRAD 100NX Cassettes because it lacks adequate data to support the packaging's leak indicator effectiveness for the full 15-month shelf life.
Product
STERRAD 100NX Cassettes, Product Code: 10144 The STERRAD Sterilization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1543-2013·2013-06-19
Utah Medical Products Recalls Deltran Disposable Pressure Transducer Kits
Utah Medical Products is recalling 1,800 Deltran Disposable Pressure Transducer Kits due to complaints regarding the packaging integrity of the sterile devices.
Product
Deltran Disposable Pressure Transducer Kit (DPT Kit) Extracorporeal disposable pressure transducer and tubing set with integral stopcock and flush device, Product Usage: Deltran is a disposable pressure transducer that provides consistent and accurate readings during
Category
Medical Device
Distribution
Distributed nationwide