The Recall Desk

Hazard

Packaging Damage recalls

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

What the numbers show

Total
41
Critical
0
Severe
1
Most recent
2026-08-12

Of the 41 packaging damage recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (2%) 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 damage 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.

1–25 of 41

  • HighFDA (Devices)·Z-2869-2026·2026-08-12

    Intramedullary Bone Saw Blade Assemblies Recalled Due to Potential Packaging Damage

    Biomet, Inc. is recalling various sizes of Intramedullary Bone Saw Blade Assemblies because an exposed saw blade may have damaged the sterile barrier packaging.

    Product
    Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475630 Product Description: Intramedullary Bone Saw Blade Assembly 14mm
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2870-2026·2026-08-12

    Intramedullary Bone Saw Blade Assembly Recall for Packaging Damage

    Zimmer Biomet recalls Intramedullary Bone Saw Blade Assemblies due to potential sterile barrier packaging damage from exposed saw blades. FDA Class II medical device recall.

    Product
    Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475635 Product Description: Intramedullary Bone Saw Blade Assembly 15mm
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2867-2026·2026-08-12

    Intramedullary Bone Saw Blade Assembly Recalled Due to Potential Packaging Damage

    Biomet, Inc. is recalling certain Intramedullary Bone Saw Blade Assemblies because an exposed saw blade may have damaged the sterile barrier packaging.

    Product
    Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475620 Product Description: Intramedullary Bone Saw Blade Assembly 12mm
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1367-2026·2026-02-25

    Catheter cutdown trays recalled over damage to the outer tray

    Bard Peripheral Vascular is recalling 14,935 Broviac 4.2 Fr single-lumen CV catheter cutdown trays because damage to the outer tray can potentially compromise the sterile barrier.

    Product
    Broviac 4.2 Fr Single-Lumen CV Catheter Cutdown Tray with SureCuff Tissue Ingrowth Cuff Cat 60060
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0017-2026·2025-10-08

    Dental implants recalled after import under non compliant temperature and storage conditions

    S.I.N. Implant System is recalling 4,367 Epikut Plus dental implants imported under temperature and storage conditions that do not comply with the instructions for use.

    Product
    IMPLANT EPIKUT PLUS MT16 3,5X10,0MM, REF: ILM 3510N; IMPLANT EPIKUT PLUS MT16 3.8X11.5MM, REF: ILM 3511N; IMPLANT EPIKUT PLUS MT16 3,5X13,0MM, REF: ILM 3513N; IMPLANT EPIKUT PLUS MT16 3,5X15,0MM, REF: ILM 3515N; IMPLANT EPIKUT PLUS MT16 3,8X10,0MM, REF: ILM 3810N; IMPLANT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0283-2025·2024-11-06

    West Pharmaceutical Recalls Vial2Bag Advanced Devices Due to Sterile Barrier Risk

    West Pharmaceutical Services is recalling Vial2Bag Advanced 20mm Admixture Devices because heat exposure during shipping may have compromised the sterile barrier.

    Product
    Brand Name: Vial2Bag Advanced¿ Product Name: Vial2Bag Advanced¿ 20mm Admixture Device Model/Catalog Number: 6070030 Software Version: Not applicable Product Description: The Vial2Bag Advanced 20mm Admixture Device is a single use, fluid transfer device that allows for the rec
    Category
    Medical Device
    Distribution
    33 states
  • HighFDA (Devices)·Z-3206-2024·2024-10-02

    BARD MAGNUM Biopsy Needles Recalled Due to Packaging Damage Risk

    Bard Peripheral Vascular is recalling BARD MAGNUM Disposable Core Tissue Biopsy Needles due to possible packaging damage from manufacturing that may compromise sterility.

    Product
    BARD MAGNUM Disposable Core Tissue Biopsy Needle REF: MN1410 MN 1420 MN1610 MN1616 MN1820 MN2010 The Magnum Biopsy System (instrument and needles) is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, breast, spleen, lymph nodes and
    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-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-2643-2023·2023-10-04

    B. Braun NORM-JECT Sterile Syringes Recalled Due to Packaging Damage

    B. Braun NORM-JECT Luer Solo 10 ml sterile syringes are recalled because blister packaging may be damaged, potentially compromising sterility. Approximately 534,000 units are affected; lot numbers 22M28C8 and 23A09C8 are included.

    Product
    B. Braun NORM-JECT Luer Solo, 10 ml, Sterile-Intended to be used to deliver (inject) or withdraw an accurate metered dose of a fluid to/from the body. Distributed by: Air-Tite Products Co., Inc, 565 Central Drive, Virginia Beach, VA 23454. REF: NJ-4606108-02
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2644-2023·2023-10-04

    B.Braun NORM-JECT Luer Lock Solo 10ml Syringe Sterility Recall

    B.Braun NORM-JECT Luer Lock Solo 10ml sterile syringes are being recalled because the sterile blister packaging may be damaged, potentially compromising sterility. The recall affects 604,800 units distributed nationwide.

    Product
    B.Braun NORM-JECT Luer Lock Solo, 10 ml, Sterile-Intended to be used to deliver (inject) or withdraw an accurate metered dose of a fluid to/from the body. Distributed by: Air-Tite Products Co., Inc, 565 Central Drive, Virginia Beach, VA 23454. REF: NJ-4606728-02
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1639-2023·2023-06-07

    Maquet QUADROX-i Adult Oxygenator recalled for packaging damage compromising sterile barrier

    Maquet Medical Systems is recalling QUADROX-i Adult Oxygenators due to potential packaging damage that may compromise sterile barriers, risking infection during cardiopulmonary bypass surgery.

    Product
    BEQ-HMO 71000-USA /QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass Item no. 701067829
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1643-2023·2023-06-07

    Maquet QUADROX-iR Cardiopulmonary Bypass Device Recalled for Packaging Damage

    Maquet Medical Systems USA is recalling QUADROX-iR cardiopulmonary bypass devices due to damaged packaging that may compromise sterility. This could result in infection, sepsis, or ischemia.

    Product
    QUADROX-iR, used during cardiopulmonary bypass Model Item No. Description BEQ-HMO 51100-USA 701067936 Small Adult with filter, with BIOLINE Coating BEQ-HMO 71100-USA 701067880 Adult with filter, with BIOLINE Coating HMO 5
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1085-2023·2023-02-15

    Sterile Procedural Trays Recalled Due to Blade Puncture Risk

    Medline Industries is recalling Sterile Procedural Trays (LS MS PACK) because the sterile blade inside can potentially puncture the outer packaging layer, compromising sterility.

    Product
    Sterile Procedural Trays, labeled as the following: LS MS PACK
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1043-2022·2022-05-18

    Medtronic IN.PACT AV Balloon Catheter: Damaged Packaging May Affect Sterility

    Medtronic is recalling IN.PACT AV paclitaxel-coated balloon catheters because packaging damage may result in loss of sterility. The devices were distributed worldwide and in the United States.

    Product
    Medtronic IN.PACT AV, Paclitaxel-coated PTA Balloon Catheter, REF: IAV06008008P, Sterile EO, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0949-2022·2022-04-27

    Terumo Cardiovascular Procedure Kit Recall for Shipping Damage

    Terumo Cardiovascular Systems Corp is recalling two lots of cardiovascular procedure kits due to packaging damage that occurred during shipping. The recall affects 64 units distributed in California and Indiana.

    Product
    Cardiovascular Procedure Kit catalog # 76645 & 73806
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0531-2022·2022-02-02

    FlexDex 8mm Needle Driver Damaged Packaging Inspection Guidance

    FlexDex Inc. is reinforcing instructions for the 8mm FlexDex Needle Driver (Product Code FD-335 ND). Users should not use the product if packaging shows any damage, including pinholes or tears.

    Product
    8mm FlexDex Needle Driver, Product Code FD-335 ND
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2606-2021·2021-10-06

    Corin Trinity Liner hip implant components recalled due to packaging damage

    Corin Ltd is recalling specific Trinity Liner ECIMA hip implant components because packaging damage could compromise device sterility or cause contamination. Five units were distributed nationwide between July 22-26, 2021.

    Product
    Corin Trinity Liner ECIMA, diameter 40mm Neutral Offset, Taper Size 4, REF 322.04.640, Sterile; and Corin Trinity Liner ECIMA, diameter 36mm Neutral 4mm EPW, Taper Size 4 (Elevated Wall), REF 322.04.936, Sterile; both are components of the Trinity Acetabular System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2603-2021·2021-10-06

    Corin TriFit TS Orthopedic Implant Recall Due to Packaging Damage and Sterility Loss

    Corin Ltd is recalling Corin TriFit TS orthopedic implants due to packaging damage that may cause sterility loss and device contamination. The affected devices were shipped in July 2021 to multiple US states.

    Product
    Corin TriFit TS, Size 8, Standard Tapered Stem, REF 694.0008, Sterile.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2604-2021·2021-10-06

    Corin Trinity Bone Screws Recalled for Potential Packaging Damage and Sterility Loss

    Corin Ltd is recalling specific lots of Trinity Acetabular System bone screws due to potential packaging damage that could result in loss of sterility or device contamination.

    Product
    Corin Trinity Screw, diameter 6.5mm 35mm Length, Cancellous Bone Screw, REF 321.035, Sterile; and Corin Trinity Screw, diameter 6.5mm 50mm Length, Cancellous Bone Screw, REF 321.050, Sterile, both are components of the Trinity Acetabular System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2608-2021·2021-10-06

    Corin Trinity Dual Mobility Hip Implant Components Recalled for Sterility Loss Risk

    Corin Ltd is recalling specific Trinity Dual Mobility hip implant components due to packaging damage that may compromise sterility. The affected products were distributed to medical facilities in nine states.

    Product
    Corin Trinity Dual Mobility, Size 4, Dual Mobility CoCr Liner, REF 321.04.540, Sterile, and Corin Dual Mobility, Size 4 42 insert/28 head, REF 325.04.042, Sterile; both are components of the Trinity Dual Mobility System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1316-2021·2021-04-07

    DePuy ATTUNE Rotating Platform Total Knee System Recalled for Damaged Packaging

    DePuy Orthopaedics is recalling 355 units of the ATTUNE Rotating Platform Total Knee System due to potential damaged packaging. The affected tibial bases are used in cemented total knee arthroplasty.

    Product
    The ATTUNE¿ Rotating Platform (RP) Total Knee System - Product Usage: consists of multiple components intended to replace the femoral, tibial, and patellar articular surfaces of the knee joint.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1315-2021·2021-04-07

    DePuy Orthopaedics Recalls Mobile Bearing Total Knee Systems Due to Packaging Damage

    DePuy Orthopaedics is recalling specific lots of the LCS COMPLETE P.F.C. SIGMA RP Mobile Bearing Total Knee System because of potential damaged packaging.

    Product
    The LCS COMPLETE P.F.C.TM SIGMA RP Mobile Bearing Total Knee System - Product Usage: consists of three components intended to replace the femoral, tibial, and patellar articular surfaces of the knee joint.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1506-2020·2020-03-25

    TeDan Surgical Innovations Recalls Quick Start Distraction Screws Due to Packaging Damage

    TeDan Surgical Innovations is recalling sterile distraction screws because damaged packaging may have exposed them to non-sterile conditions, posing an infection risk.

    Product
    DS-0024 QUICK START DISTRACTION SCREW 14MM 5/BOX STERILE - Product Usage: These products are intended to be used by trained surgeons and are designed for use with TSI distractors and screwdrivers.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1503-2020·2020-03-25

    TeDan Surgical Recalls 3COR Distraction Screws Due to Packaging Damage

    TeDan Surgical Innovations LLC is recalling 3COR Distraction Screws because damaged packaging may have exposed the sterile products to non-sterile conditions, posing an infection risk.

    Product
    D-0012 3COR 12MM DISTRACTION SCREWS, 5/BOX, STERILE - Product Usage: The 3COR Distraction Screws and the TSI Quick Start Distraction Screws products are intended for the distraction in the anterior approach to the cervical spine from C2 thru C7. The products are to be used by tra
    Category
    Medical Device
    Distribution
    0 states