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.

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.

1576–1600 of 2235

  • HighFDA (Devices)·Z-1113-2016·2016-03-23

    Zimmer Astel Femoral Head Recall Due to Sealer Calibration Data

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

    Product
    Product 15 consists of all product code JDI , and same usage: Item no: 805002802 ASTEL FEM HEAD +0X28MM DI 805002805 ASTEL FEM HEAD +10.5X28MM 805002803 ASTEL FEM HEAD +3.5X28MM 805002804 ASTEL FEM HEAD +7X28MM DI 805002801 ASTEL FEM HEAD -3.5X28MM Usage: For use in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1115-2016·2016-03-23

    Zimmer Manufacturing Recalls Sterile Bone Screws Due to Calibration Issues

    Zimmer Manufacturing B.V. is recalling sterile bone screws used in hip arthroplasty due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.

    Product
    Product 17 consists of all product under product code: LPH and same usage: Item no: 625004515 BONE SCREW 4.5X15 SELF-TA 625004520 BONE SCREW 4.5X20 SELF-TA 625004525 BONE SCREW 4.5X25 SELF-TA 625004530 BONE SCREW 4.5X30 SELF-TA 625004535 BONE SCREW 4.5X35 SELF-TA…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1120-2016·2016-03-23

    Zimmer Manufacturing Recalls Hip Arthroplasty Components Due to Sealer Calibration Issues

    Zimmer Manufacturing B.V. is recalling specific hip arthroplasty components due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.

    Product
    Product 22 consists of all product under product code: JDI and same usage: Item no: 811400218 CPT 12/14 COCR REVISION S 811400318 CPT 12/14 COCR REVISION S 811400420 CPT 12/14 COCR REVISION S 811400423 CPT 12/14 COCR REVISION S 811400426 CPT 12/14 COCR REVISION S…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1135-2016·2016-03-23

    Zimmer Manufacturing Recalls Interlocking Intramedullary Screws Due to Calibration Issues

    Zimmer Manufacturing B.V. is recalling 1,777 sterile interlocking intramedullary screws due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.

    Product
    Product 37 consists of all product under product code: HSB and same usage: Item no: 225302055 INTERLOCKING IM SCREW LG 225303055 INTERLOCKING IM SCREW LG 225304055 INTERLOCKING IM SCREW LG 225304555 INTERLOCKING IM SCREW LG 225305055 INTERLOCKING IM SCREW LG 225305555…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1153-2016·2016-03-23

    Zimmer Manufacturing Recalls One-Piece Lag Screws Due to Sealer Calibration Issues

    Zimmer Manufacturing B.V. is recalling 58,320 sterile one-piece lag screws due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.

    Product
    Product 55 consists of all product under product code: HSB and same usage: Item no: 225900132 ONE-PIECE LAG SCREW 11MM 225900135 ONE-PIECE LAG SCREW 11MM 225900137 ONE-PIECE LAG SCREW 11MM 225900140 ONE-PIECE LAG SCREW 11MM 225900142 ONE-PIECE LAG SCREW 11MM 225900145…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1134-2016·2016-03-23

    Zimmer Manufacturing Recalls Interlocking IM Screws Due to Sealer Calibration Issues

    Zimmer Manufacturing B.V. is recalling 268 units of Interlocking IM Screws 4.5 due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.

    Product
    Product 36 consists of all product under product code: HSB and same usage: Item no: 225302745 INTERLOCKING IM SCREW 4.5 225303045 INTERLOCKING IM SCREW 4.5 225303245 INTERLOCKING IM SCREW 4.5 225303545 INTERLOCKING IM SCREW 4.5 225303745 INTERLOCKING IM SCREW 4.5…
    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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1140-2016·2016-03-23

    Zimmer Manufacturing Recalls Sterile Femoral and Humeral Intramedullary Nails

    Zimmer Manufacturing B.V. is recalling 1,622 sterile femoral and humeral intramedullary nails due to insufficient sealer calibration data.

    Product
    Product 42 consists of all product under product code: HSB and same usage: Item no: 225224010 M/DN FEM IM NAIL 10MM DIA 225228010 M/DN FEM IM NAIL 10MM DIA 225230010 M/DN FEM IM NAIL 10MM DIA 225232010 M/DN FEM IM NAIL 10MM DIA 225234010 M/DN FEM IM NAIL 10MM DIA…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1159-2016·2016-03-23

    Zimmer Precoat Tibia Plates Recalled for Sealer Calibration Issues

    Zimmer Manufacturing B.V. is recalling 39 sterile precoat tibia plates used in total knee arthroplasty due to insufficient sealer calibration data.

    Product
    Product 61 consists of all product under product code: JWH and same usage: Item no: 598003712 STD PRECOAT TIBIA PLATE S for use in total knee arthroplasty
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1122-2016·2016-03-23

    Zimmer Manufacturing Recalls Distal Femoral Bone Fixation Appliances

    Zimmer Manufacturing B.V. is recalling 37 sterile distal femoral bone fixation appliances due to insufficient sealer calibration data.

    Product
    Product 24 consists of all product under product code: HRS and same usage: Item no: 234703104 DISTAL MEDIAL FEMORAL CON 234703206 DISTAL MEDIAL FEMORAL CON 234703208 DISTAL MEDIAL FEMORAL CON 234800504 DISTAL POSTERIOR/LATERAL 234800506 DISTAL POSTERIOR/LATERAL…
    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-1144-2016·2016-03-23

    Zimmer Manufacturing Recalls Mini Magna-FX Cann Screws Due to Calibration Data Issues

    Zimmer Manufacturing B.V. is recalling 3,190 units of Mini Magna-FX Cann Screws because of insufficient sealer calibration data for products packaged between August 2010 and April 2013.

    Product
    Product 46 consists of all product under product code: HWC and same usage: Item no: 114204012 MINI MAGNA-FX CANN SCREW 114204016 MINI MAGNA-FX CANN SCREW 114204020 MINI MAGNA-FX CANN SCREW 114204024 MINI MAGNA-FX CANN SCREW 114204028 MINI MAGNA-FX CANN SCREW 114204032…
    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…
    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…
    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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1111-2016·2016-03-23

    Zimmer Manufacturing Recalls 34 Sterile Bone Fixation Screws

    Zimmer Manufacturing B.V. is recalling 34 sterile bone fixation screws due to insufficient sealer calibration data. The affected units were packaged between August 2010 and April 2013.

    Product
    Product 13 consists of all product under product code HWC , and same usage: Item no: 47486510002 6.5 X 100 CANC SCREW, 32M 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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1124-2016·2016-03-23

    Zimmer Distal Femoral Components Recalled for Sterility Concerns

    Zimmer Manufacturing B.V. is recalling specific distal femoral components used in hip arthroplasty due to insufficient sealer calibration data.

    Product
    Product 26 consists of all product under product code: JWH and same usage: Item no: 234703104 DISTAL MEDIAL FEMORAL CON 234703206 DISTAL MEDIAL FEMORAL CON 234703208 DISTAL MEDIAL FEMORAL CON 234800504 DISTAL POSTERIOR/LATERAL 234800506 DISTAL POSTERIOR/LATERAL…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1109-2016·2016-03-23

    Zimmer Manufacturing Recalls Hip Arthroplasty Femoral Heads Due to Sealer Calibration

    Zimmer Manufacturing B.V. is recalling 366 units of 6 Degree COCR Femoral Heads used in hip arthroplasty due to insufficient sealer calibration data.

    Product
    Product 11 consists of all product under product code JDI , and same usage: Item no: 902602500 6 DEGREE COCR FEM HEAD 26 902602600 6 DEGREE COCR FEM HEAD 26 902602700 6 DEGREE COCR FEM HEAD 26 902602800 6 DEGREE COCR FEM HEAD 28 902602900 6 DEGREE COCR FEM HEAD 28…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1114-2016·2016-03-23

    Zimmer Manufacturing Recalls Bipolar Hip Liners Due to Sealer Calibration Issues

    Zimmer Manufacturing B.V. is recalling 8,773 units of bipolar liners and shells for hip arthroplasty due to insufficient sealer calibration data.

    Product
    Product 16 consists of all product under poduct code: KWY and same usage: Item no: 500103822 BIPOLAR LINER 38MM OD X 2 500103922 BIPOLAR LINER 39MM OD X 2 500104022 BIPOLAR LINER 40/41MM OD 500104026 BIPOLAR LINER 40MM OD X 2 500104222 BIPOLAR LINER 42/43 OD X 500104226…
    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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1119-2016·2016-03-23

    Zimmer Manufacturing Recalls Sterile Bone Fixation Appliances Due to Calibration Issues

    Zimmer Manufacturing B.V. is recalling 1,209 units of sterile metallic bone fixation appliances due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.

    Product
    Product 21 consists of all product under product code: JDI and same usage: Item no: 811400218 CPT 12/14 COCR REVISION S 811400318 CPT 12/14 COCR REVISION S 811400420 CPT 12/14 COCR REVISION S 811400423 CPT 12/14 COCR REVISION S 811400426 CPT 12/14 COCR REVISION S…
    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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1142-2016·2016-03-23

    Zimmer Manufacturing Recalls Sterile Orthopedic Screws Due to Calibration Data Issues

    Zimmer Manufacturing B.V. is recalling 4,335 sterile orthopedic screws and bone staples due to insufficient sealer calibration data.

    Product
    Product 44 consists of all product under product code: HWC and same usage: Item no: 114607099 MAGMA-FX CANN SCREW 7.0MM 114604099 MAGNA FX CANN SCREW 7.0MM 114603000 MAGNA-FX CANN SCREW 7.0MM 114603500 MAGNA-FX CANN SCREW 7.0MM 114604000 MAGNA-FX CANN SCREW 7.0MM…
    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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1168-2016·2016-03-23

    Zimmer Versys Heritage Femoral Stem Recall Due to Sealer Calibration

    Zimmer Manufacturing B.V. is recalling 360 units of Versys Heritage Femoral Stems due to insufficient sealer calibration data. The affected sterile products were packaged between August 2010 and April 2013.

    Product
    Product 70 consists of all product under product code: JDI and same usage: Item no: 785701000 VERSYS HERITAGE FEM STEM 785701100 VERSYS HERITAGE FEM STEM 785701200 VERSYS HERITAGE FEM STEM 785701300 VERSYS HERITAGE FEM STEM 785701320 VERSYS HERITAGE FEM STEM 785701400…
    Category
    Medical Device
    Distribution
    Distributed nationwide