The Recall Desk

Hazard

Sterility Compromise recalls

2,228 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
2,228
Critical
3
Severe
255
Most recent
2026-08-19

Of the 2,228 sterility compromise recalls we have scored against our rubric, 3 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 255 (11%) are Severe.

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.

1601–1625 of 2228

  • ModerateFDA (Devices)·Z-1138-2016·2016-03-23

    Zimmer Manufacturing Recalls Anti-Rotation Screws Due to Sealer Calibration Issues

    Zimmer Manufacturing B.V. is recalling seven ITST Anti-Rotation Screws because of insufficient sealer calibration data. The affected sterile products were distributed nationwide in the US.

    Product
    Product 40 consists of all product under product code: HSB and same usage: Item no: 225706565 ITST ANTI-ROTATION SCREW 225707065 ITST ANTI-ROTATION SCREW 225708065 ITST ANTI-ROTATION SCREW 225708565 ITST ANTI-ROTATION SCREW 225709065 ITST ANTI-ROTATION SCREW Product Us
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1170-2016·2016-03-23

    Zimmer Zimtron Hip Arthroplasty Heads Recalled for Sealer Calibration Issues

    Zimmer Manufacturing B.V. is recalling 226 sterile Zimtron hip arthroplasty heads due to insufficient sealer calibration data. The affected units were packaged between August 2010 and April 2013.

    Product
    Product 72 consists of all product code: JDI and same usage: Item no: 805002202 ZIMTRON HEAD 12/14 0X22 MM For use in total or hemi hip arthroplasty
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1108-2016·2016-03-23

    Zimmer Manufacturing Recalls Sterile Bone Fixation Screws Due to Sealer Calibration

    Zimmer Manufacturing B.V. is recalling specific lots of sterile 4.5 x 26 Cortical Screws due to insufficient sealer calibration data during packaging.

    Product
    Product 10consists of all product under product code HWC, and same usage: Item no: 47484502601 4.5 X 26 CORT SCREW SELF Product Usage: A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1143-2016·2016-03-23

    Zimmer Manufacturing Recalls Sterile Knee Arthroplasty Bone Screws

    Zimmer Manufacturing B.V. is recalling 3,696 sterile MGII Knee Self-Tap Bone Screws due to insufficient sealer calibration data.

    Product
    Product 45 consists of all product under product code: JWH and same usage: Item no: 511007020 MGII KNEE SLF-TAP BONE ST 511007025 MGII KNEE SLF-TAP BONE ST 511007030 MGII KNEE SLF-TAP BONE ST 511007035 MGII KNEE SLF-TAP BONE ST 511007040 MGII KNEE SLF-TAP BONE ST 5110070
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1104-2016·2016-03-23

    Zimmer Manufacturing Recalls Sterile Bone Fixation Screws Due to Calibration Issues

    Zimmer Manufacturing B.V. is recalling 12 sterile bone fixation screws due to insufficient sealer calibration data. The products were distributed nationwide in the US.

    Product
    Product 6 consists of all products under product code HWC, and same usage: Item no: 47493501001 3.5 X 10 CORT SCREW SELFT 47493501801 3.5 X 18 CORT SCREW SELFT Product Usage: A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that c
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1165-2016·2016-03-23

    Zimmer Versys Advocate Cemented Hip Implants Recalled for Calibration Data Issues

    Zimmer Manufacturing B.V. is recalling 5,013 units of Versys Advocate Cemented hip implants due to insufficient sealer calibration data. The affected sterile products were distributed nationwide.

    Product
    Product 67 consists of all product under product code: JDI and same usage: Item no: 785001100 VERSYS ADVOCATE CEMENTED 785001200 VERSYS ADVOCATE CEMENTED 785001220 VERSYS ADVOCATE CEMENTED 785001300 VERSYS ADVOCATE CEMENTED 785001320 VERSYS ADVOCATE CEMENTED 785001400 VER
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1145-2016·2016-03-23

    Zimmer Modular Hip Cups Recalled for Insufficient Sealer Calibration Data

    Zimmer Manufacturing B.V. is recalling sterile modular hip cups due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.

    Product
    Product 47 consists of all product under product code: LPH and same usage: Item no: 611004022 MODULAR CUP 10 DEGREE LIN 611004428 MODULAR CUP 10 DEGREE LIN 611004628 MODULAR CUP 10 DEGREE LIN 611004828 MODULAR CUP 10 DEGREE LIN 611004832 MODULAR CUP 10 DEGREE LIN 6110050
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1158-2016·2016-03-23

    Zimmer Manufacturing Recalls Sterile Intramedullary Fixation Rods Due to Sealer Calibration

    Zimmer Manufacturing B.V. is recalling 1,394 sterile intramedullary fixation rods and reconstruction screws due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.

    Product
    Product 60 consists of all product under product code: HSB and same usage: Item no: 225207055 RECON SCREW LG 5.5MM DIA 225207555 RECON SCREW LG 5.5MM DIA 225208055 RECON SCREW LG 5.5MM DIA 225208555 RECON SCREW LG 5.5MM DIA 225209055 RECON SCREW LG 5.5MM DIA 225209555 REC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1136-2016·2016-03-23

    Zimmer Manufacturing Recalls Interlocking Intramedullary Screws Due to Sealer Calibration Issues

    Zimmer Manufacturing B.V. is recalling 4,752 sterile interlocking intramedullary screws due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.

    Product
    Product 38 consists of all product under product code: HSB and same usage: Item no: 225303255 INTERLOCKING IM SCREW LG 225303555 INTERLOCKING IM SCREW LG 225303755 INTERLOCKING IM SCREW LG 225307055 INTERLOCKING IM SCREW LG 225302742 INTERLOCKING IM SCREW MED 225303242 I
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1112-2016·2016-03-23

    Zimmer Manufacturing Recalls Sterile Intramedullary Fixation Rods Due to Calibration Issues

    Zimmer Manufacturing B.V. is recalling sterile intramedullary fixation rods and lag screws due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.

    Product
    Product 14 consists of all product under product code HSB , and same usage: Item no: 225600230 ASIA ONE-PIECE LAG SCREW 225600232 ASIA ONE-PIECE LAG SCREW 225600235 ASIA ONE-PIECE LAG SCREW 225600237 ASIA ONE-PIECE LAG SCREW 225600240 ASIA ONE-PIECE LAG SCREW 225600242
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1105-2016·2016-03-23

    Zimmer Manufacturing Recalls Sterile Cortical Screws Due to Sealer Calibration Issues

    Zimmer Manufacturing B.V. is recalling 109 sterile 3.5mm cortical screws due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.

    Product
    Product 7 consists of all products under product code HWC, and same usage: Item no: 47234801435 3.5MM CORT SCR X 14MM 47234801635 3.5MM CORT SCR X 16MM 47234806535 3.5MM CORT SCR X 65MM 47234807035 3.5MM CORT SCR X 70MM 47234807535 3.5MM CORT SCR X 75MM 47234808035 3.5MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1106-2016·2016-03-23

    Zimmer Manufacturing Recalls 3.5mm Cortical Screws Due to Sealer Calibration Issues

    Zimmer Manufacturing B.V. is recalling 99 units of 3.5mm cortical screws due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.

    Product
    Product 8 consists of all products under product code HWC, and same usage: Item no: 47483501201 3.5MM CORT. SCREW 12MM LN 47483501401 3.5MM CORT. SCREW 14MM LN 47483501601 3.5MM CORT. SCREW 16MM LN 47483501801 3.5MM CORT. SCREW 18MM LN 47483503601 3.5MM CORT. SCREW 36MM LN
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1116-2016·2016-03-23

    Zimmer Manufacturing Recalls 83 Sterile Bone Fixation Screws

    Zimmer Manufacturing B.V. is recalling 83 sterile bone fixation screws due to insufficient sealer calibration data. The products were distributed nationwide in the US.

    Product
    Product 18 consists of all product under product code: HWC and same usage: Item no: 47248001441 CANC SCR 4.0MM X 14MM FUL 47248001641 CANC SCR 4.0MM X 16MM FUL 47248001840 CANC SCR 4.0MM X 18MM 47248001841 CANC SCR 4.0MM X 18MM FUL 47248002041 CANC SCR 4.0MM X 20MM FUL 4
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0867-2016·2016-03-02

    Stryker T2 K-Wire Recall Due to Potential Pouch Seal Integrity Issues

    Stryker is recalling T2 K-Wires because a packaging review found the pouch seal integrity may be decreased, potentially affecting sterility.

    Product
    Stryker, T2 K-Wire 1.8 x 310 mm, Sterile Product Usage: Intended for the temporary stabilization of bone segments or fragments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0868-2016·2016-03-02

    Stryker Recalls Metaizeau Intramedullary Pins Due to Packaging Seal Concerns

    Stryker is recalling 147,838 Metaizeau Intramedullary Pins because packaging seal integrity may be decreased, potentially affecting sterility.

    Product
    Stryker, METAIZEAU Intramedullary Pin, 2.0 x 400 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0873-2016·2016-03-02

    Stryker T2 K-Wire Recalled Due to Potential Packaging Seal Integrity Issues

    Stryker Howmedica Osteonics Corp. is recalling T2 K-Wires because a packaging review found that the seal integrity of the pouch may be decreased.

    Product
    Stryker, T2 K-Wire, 3x285 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0874-2016·2016-03-02

    Stryker T2 K-Wire Recall Due to Potential Packaging Seal Integrity Issues

    Stryker is recalling T2 K-Wires because the packaging seal integrity may be decreased, potentially affecting the sterility of the medical devices.

    Product
    Stryker, T2 K-Wire with washer, 7.8 x 3 x 285mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0881-2016·2016-03-02

    Stryker T2 Guidewire Recalled for Potential Pouch Seal Integrity Issues

    Stryker Howmedica Osteonics Corp. is recalling T2 Guidewires because a packaging review found that the seal integrity of the pouch may be decreased.

    Product
    Stryker, T2 Guidewire, Ball Tipped, 3 x 1250mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0872-2016·2016-03-02

    Stryker Gamma3 K-Wire Recall Due to Potential Packaging Seal Integrity Issues

    Stryker Howmedica Osteonics Corp. is recalling Gamma3 K-Wires because the packaging seal integrity may be decreased, potentially affecting the sterile barrier.

    Product
    Stryker, Gamma3 K-Wire with Washer, 13x3.2x500 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0878-2016·2016-03-02

    Stryker T2 Guidewire Recalled for Potential Packaging Seal Integrity Issues

    Stryker Howmedica Osteonics Corp. is recalling T2 Guidewires because a packaging review found that the seal integrity of the pouch may be decreased.

    Product
    Stryker, T2 Guidewire, Ball-Tipped, 3 x 1000mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0879-2016·2016-03-02

    Stryker T2 Guidewire Recalled Due to Potential Pouch Seal Integrity Issues

    Stryker Howmedica Osteonics Corp. is recalling T2 Guidewires because the packaging seal integrity may be decreased, potentially affecting the sterile barrier.

    Product
    Stryker, T2 Guidewire, Smooth-Tipped, 3 x 800mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0875-2016·2016-03-02

    Stryker T2 Guidewire Recalled Due to Potential Packaging Seal Integrity Issues

    Stryker Howmedica Osteonics Corp. is recalling T2 Guidewires because a packaging review found that the seal integrity of the pouch may be decreased.

    Product
    Stryker, T2 Guidewire, Ball-Tipped, 3x800 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0871-2016·2016-03-02

    Stryker Gamma Guide Pin Recalled for Potential Packaging Seal Integrity Issues

    Stryker Howmedica Osteonics Corp. is recalling Gamma Guide Pins because a packaging review indicated that the seal integrity of the pouch may be decreased.

    Product
    Stryker, Gamma Guide Pin, 4x400 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0882-2016·2016-03-02

    Stryker T2 Fixation K-Wire Recall Due to Packaging Seal Integrity Concerns

    Stryker Howmedica Osteonics Corp. is recalling T2 Fixation K-Wires because a packaging review found that the seal integrity of the pouch may be decreased.

    Product
    Stryker, T2 Fixation K-Wire 3 x 285mm WCH coated Product Usage: Intended for the temporary stabilization of bone segments or fragments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0877-2016·2016-03-02

    Stryker T2 Guidewire Recalled Due to Potential Packaging Seal Integrity Issues

    Stryker Howmedica Osteonics Corp. is recalling T2 Guidewires because a packaging review indicated that the seal integrity of the pouch may be decreased.

    Product
    Stryker, T2 Guidewire, Ball-Tipped, 2.5 x 1000mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
    Category
    Medical Device
    Distribution
    Distributed nationwide