The Recall Desk

Hazard

Sterility Compromise recalls

2,235 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
2,235
Critical
4
Severe
260
Most recent
2026-09-30

Of the 2,235 sterility compromise recalls we have scored against our rubric, 4 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 260 (12%) 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 sterility compromise 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.

751–775 of 2235

  • SevereFDA (Devices)·Z-0536-2019·2018-12-12

    Zimmer Biomet Recalls Humeral Guide Wires Due to Sterility Compromise

    Zimmer Biomet is recalling 8,027 Humeral Guide Wires because creases in the sealing area may compromise product sterility.

    Product
    Zimmer Humeral Guide Wire - Ball Tip, 2.4 mm Diameter, 70 cm Length Item Number: 47-2255-008-00 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0533-2019·2018-12-12

    Zimmer Biomet Recalls Guide Wires Due to Sterility Compromise

    Zimmer Biomet is recalling 2,080 units of ZMS Intramedullary Fixation Smooth Guide Wires because creases in the packaging may compromise sterility.

    Product
    Zimmer ZMS¿ Intramedullary Fixation Smooth Guide Wire, 2.4 mm Diameter, 100 cm Length Item Number: 47-2237-033-00 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0539-2019·2018-12-12

    Zimmer Biomet Recalls Natural Nail System Guide Wires Due to Sterility Compromise

    Zimmer Biomet is recalling 3,764 units of Natural Nail System Tear Drop Guide Wires because creases in the packaging seal may compromise sterility.

    Product
    Zimmer Natural Nail¿ System - Tear Drop Guide Wire, 2.4 mm Diameter, 100 cm Length Item Number: 47-2490-097-01 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0532-2019·2018-12-12

    Zimmer Biomet Recalls Humeral Guide Wires Due to Sterility Compromise

    Zimmer Biomet is recalling 780 Humeral Guide Wires because creases in the packaging may compromise sterility. The product is a single-use surgical instrument.

    Product
    Zimmer M/DN¿ Intramedullary Fixation Humeral Guide Wire - Bullet Tip, 2.4 mm Diameter, 70 cm Length Item Number: 00-2255-026-00 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0538-2019·2018-12-12

    Zimmer Biomet Recalls Natural Nail System Guide Wires Due to Sterility Compromise

    Zimmer Biomet is recalling 57,241 Natural Nail System Tear Drop Guide Wires because creases in the sealing area may compromise product sterility.

    Product
    Zimmer Natural Nail¿ System - Tear Drop Guide Wire, 3.0 mm Diameter, 100 cm Length Item Number: 47-2490-097-00 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0542-2019·2018-12-12

    Zimmer Biomet Recalls Pressure Sentinel Guide Wires Due to Sterility Compromise

    Zimmer Biomet is recalling 1,676 Pressure Sentinel Guide Wires because creases in the packaging seal may compromise sterility. The defect could increase the risk of infection during orthopaedic surgery.

    Product
    Zimmer Pressure Sentinel¿ Intramedullary Reaming System, Guide Wire, Bullet Tip, 2.4 mm Diameter Item Number: 00-2228-024-00 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0534-2019·2018-12-12

    Zimmer Biomet Recalls Guide Wires Due to Sterility Compromise

    Zimmer Biomet is recalling 9,387 units of ZMS Intramedullary Fixation Smooth Guide Wires because creases in the sealing area compromise product sterility.

    Product
    Zimmer ZMS¿ Intramedullary Fixation Smooth Guide Wire, 3.0 mm Diameter, 100 cm Length Item Number: 47-2237-037-00 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0531-2019·2018-12-12

    Zimmer Biomet Recalls Humeral Guide Wires Due to Sterility Compromise

    Zimmer Biomet is recalling specific lots of M/DN Intramedullary Fixation Humeral Guide Wires because creases in the packaging may compromise sterility.

    Product
    Zimmer M/DN¿ Intramedullary Fixation Humeral Guide Wire - Smooth, 2.4 mm Diameter, 70 cm Length Item Number: 00-2255-025-00 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0535-2019·2018-12-12

    Zimmer Biomet Recalls Guide Wires Due to Sterility Compromise

    Zimmer Biomet is recalling ZMS Intramedullary Fixation Smooth Guide Wires because creases in the sealing area may compromise product sterility.

    Product
    Zimmer ZMS¿ Intramedullary Fixation Smooth Guide Wire - Bullet Tip, 3.0 mm Diameter, 100 cm Length Item Number: 47-2237-038-00 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0530-2019·2018-12-12

    Zimmer Biomet Recalls Pressure Sentinel Guide Wires Due to Sterility Compromise

    Zimmer Biomet is recalling Pressure Sentinel Guide Wires because creases in the sealing area compromise product sterility. The recall affects 48,320 units distributed worldwide.

    Product
    Zimmer Pressure Sentinel¿ Intramedullary Reaming System, Guide Wire, Bullet Tip, 2.4 mm Diameter Item Number: 00-2228-024-00 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0537-2019·2018-12-12

    Zimmer Biomet Recalls Smooth Guide Wires Due to Sterility Compromise

    Zimmer Biomet is recalling Smooth Guide Wires because creases in the sealing area may compromise product sterility. The recall affects 48,320 units distributed worldwide.

    Product
    Zimmer Smooth Guide Wire - Bullet Tip, 3.0 mm Diameter, 100 cm Length Item Number: 47-2255-008-01 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0540-2019·2018-12-12

    Zimmer Biomet Recalls Natural Nail System Guide Wires Due to Sterility Concerns

    Zimmer Biomet is recalling 12,724 units of Natural Nail System Tear Drop Guide Wires because creases in the packaging may compromise sterility.

    Product
    Zimmer Natural Nail¿ System - Tear Drop Guide Wire, 3.0 mm Diameter, 70 cm Length Item Number: 47-2490-098-00 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0541-2019·2018-12-12

    Zimmer Biomet Recalls Natural Nail System Tear Drop Guide Wires

    Zimmer Biomet is recalling Natural Nail System Tear Drop Guide Wires due to creases in the sealing area that compromise sterility.

    Product
    Zimmer Natural Nail¿ System - Tear Drop Guide Wire, 2.4 mm Diameter, 70 cm Length Item Number: 47-2490-098-01 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0473-2019·2018-11-28

    LeMaitre Vascular Recalls Unsealed Polyurethane Carotid Shunts

    LeMaitre Vascular is recalling 46 units of Pruitt F3-S Polyurethane Outlying Carotid Shunts because the pouches are not sealed, compromising sterility.

    Product
    LeMaitre Vascular Pruitt F3¿-S Polyurethane Outlying Carotid Shunt, Sterile Model # 2014-10
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0373-2019·2018-11-14

    Howmedica Recalls 15 Pouches of Sterile Knee Instruments Due to Barrier Risk

    Howmedica Osteonics Corp. is recalling 15 pouches of sterile knee instruments because the outer sterile barrier may be compromised.

    Product
    Sterile Knee Instruments Disposable Fluted Headless Pins, DIA 3.2mm LNTH 89mm, REF 7650-2038A - Product Usage: Howmedica Osteonics Corp. (Stryker, Joint Reconstructive Division) Sterile Instrumentation consists of manual surgical instrumentation intended for use during hip…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0282-2019·2018-11-07

    Arrow Multi-Lumen CVC Kit Recalled for Expired Product Documentation Error

    Arrow International Inc. is recalling 105 units of Arrow AGB + Multi-Lumen CVC Kits because shipping documentation listed an incorrect expiration date, though the product lidstock is correct.

    Product
    Arrow AGB + Multi-Lumen CVC Kit, Cat. No. CDC-42703-B1A. Product Usage - The Arrow CVC is intended to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access, including, but not limited to the following: Lack…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0243-2019·2018-10-31

    CHS Cotton Tip Applicators Recalled Due to Sterility Compromise

    Custom Healthcare Systems is recalling 150 units of CHS Cotton Tip Applicators because incorrect sealing specifications compromised product sterility.

    Product
    CHS Custom Convenience Kit-COTTON TIP APPLICATORS, 10'S (6") Product Number:R1112B
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-0246-2019·2018-10-31

    CHS Custom Convenience Kit-PAD recalled for compromised sterility

    Custom Healthcare Systems is recalling 160 units of CHS Custom Convenience Kit-PAD, COTTON SINGLE because incorrect sealing specifications compromised product sterility.

    Product
    CHS Custom Convenience Kit-PAD, COTTON SINGLE Product Number:R1178
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-0241-2019·2018-10-31

    Custom Healthcare Systems Recalls Injection Trays Due to Sterility Compromise

    Custom Healthcare Systems is recalling 40 units of CHS Custom Convenience Kit-INJECTION TRAY because incorrect sealing specifications compromised product sterility.

    Product
    CHS Custom Convenience Kit-INJECTION TRAY Product Number: B9-17201
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-0260-2019·2018-10-31

    Custom Healthcare Systems Recalls Penrose Drain Kits Due to Sterility Compromise

    Custom Healthcare Systems is recalling 24 units of Penrose Drain Convenience Kits because incorrect sealing specifications compromised product sterility.

    Product
    CHS Custom Convenience Kit- PENROSE DRAIN (.75" X 18") Product Number:D8-9425B
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-0250-2019·2018-10-31

    CHS Custom Convenience Kits Recalled for Sterility Compromise

    Custom Healthcare Systems is recalling 630 CHS Custom Convenience Kits because incorrect sealing specifications compromised product sterility.

    Product
    CHS Custom Convenience Kit-GENERAL UTILITY TRAY Product Number:S1528-02
    Category
    Medical Device
    Distribution
    9 states