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.

1551–1575 of 2235

  • ModerateFDA (Devices)·Z-1679-2016·2016-05-25

    Zimmer Manufacturing Recalls Mini MagnaFx Cannulated Bone Screws

    Zimmer Manufacturing B.V. is recalling specific lots of Mini MagnaFx and MagnaFx cannulated bone screws due to a potential small hole in the inner tray of the sterile packaging.

    Product
    Mini MagnaFx Cannulated Screw Fixation System Small Cannulated Bone Screw, Fully Threaded, 5.0 mm Diameter, 20 mm Length 00114205020 Mini Magna-Fx Cannulated Screw Fixation System Small Cannulated Bone Screw, Fully Threaded, 5.0 mm Diameter, 36 mm Length 00114205036 Mini…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1681-2016·2016-05-25

    Zimmer Recalls Sterile Hip and Trauma Implant Screws Due to Tray Defect

    Zimmer Manufacturing B.V. is recalling specific lots of sterile hip and trauma implant screws because a small hole may be present in the inner tray.

    Product
    ITST intertrochanteric/subtrochanteric fixation 4.5 mm diameter cortical screw, 3.5 mm hex head, 57 mm length 00225305745
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1674-2016·2016-05-25

    Zimmer 2.7 mm Cortical Screws Recalled for Potential Tray Hole

    Zimmer Manufacturing B.V. is recalling specific lots of 2.7 mm Cortical Screws because a small hole may be present in the inner tray of the sterile packaging.

    Product
    Zimmer Plates and Screws (ZPS) 2.7 mm Cortical Screw SelfTapping, 14 mm Length 47482701401
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1683-2016·2016-05-25

    Zimmer Manufacturing Recalls Hip and Trauma Implant Screws Due to Tray Defect

    Zimmer Manufacturing B.V. is recalling specific lots of sterile Hip and Trauma Implant Screws because a small hole may be present in the inner tray.

    Product
    Hgp ii acetabular cup bone screw selftap 6.5x15mm 00662406515 Hgp ii acetabular cup bone screw selftap 6.5x20mm 00662406520 Hgp ii acetabular cup bone screw selftap 6.5x25mm 00662406525 Hgp ii acetabular cup bone screw selftap 6.5x35mm 00662406535 Hgp ii acetabular cup bone…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1675-2016·2016-05-25

    Zimmer Universal Locking System Cortical Screws Recalled for Packaging Defect

    Zimmer Manufacturing B.V. is recalling specific lots of sterile hip and trauma implant screws because a small hole may be present in the inner tray.

    Product
    Zimmer universal locking system (ULS) 3.5 mm cortical screw selftapping 18 mm length 47493501801
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1628-2016·2016-05-18

    Baxter Recalls GEM FlowCoupler Devices Due to Packaging Defect

    Baxter Healthcare is recalling 630 units of GEM FlowCoupler devices because the instructions for use booklet may puncture the outer Tyvek lid.

    Product
    GEM(TM), FLOWCOUPLER(R), 2.5 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2753-FC. Product Usage: The FlowCOUPLER Device is a single use, implantable device that is intended to be used in the end-to-end anastomosis of veins and arteries normally encountered in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1625-2016·2016-05-18

    Mallinckrodt Evac Tracheal Tubes Recalled for Unsealed Packaging

    Stryker is recalling four Mallinckrodt Evac Tracheal Tubes because the packaging may not be sealed, potentially compromising sterility.

    Product
    Mallinckrodt Evac Tracheal Tubes Model #124170-MALLINCKRODT & 124175
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1528-2016·2016-05-04

    Corin Trinity Acetabular Shell Recall Due to Packaging Abrasion Risk

    Corin USA Limited is recalling 629 Trinity Acetabular Shells used in total hip replacements because the new packaging system may abrade the sterile barrier pouches.

    Product
    Trinity Acetabular Shell Product Usage Total Hip Replacement.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1527-2016·2016-05-04

    Corin Trinity Acetabular Shell Recalled for Packaging Abrasion Risk

    Corin USA Limited is recalling 629 Trinity Acetabular Shell devices used in total hip replacements due to a potential for abrasion of the sterile barrier pouches in the new packaging system.

    Product
    Trinity Acetabular Shell Product Usage: Total Hip Replacement.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1526-2016·2016-05-04

    Corin Trinity Acetabular System Recalled for Packaging Abrasion Risk

    Corin USA Limited is recalling 629 Trinity Acetabular System devices due to potential abrasion of sterile barrier pouches in the new packaging system.

    Product
    Trinity Acetabular System Product Usage - Total Hip Replacement.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1503-2016·2016-04-27

    Ad-Tech Recalls Sterile Electrode Cables Due to Package Failures

    Ad-Tech is recalling 197 unopened sterile electrode connection cables because package failures compromised the sterile barriers.

    Product
    Ad-Tech Electrode Connection System/Cables. Lightweight TECH-ATTACH Cable Models: 1. L-DCL-4DINX (4 contacts: 1 terminal block with 4 connectors each); 2. L-DCL-6DINX (6 contacts: 1 terminal block with 6 connectors each); 3. L-DCL-8DINX (8 contacts: 1 terminal…
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1266-2016·2016-04-06

    PMBS S.C.O.R.E.S. Unit Recall Due to Potential Sterility Compromise

    PMBS, LLC is recalling 58 S.C.O.R.E.S. Units because water retention in filters may compromise sterility. The units were distributed to seven states.

    Product
    The S.C.O.R.E.S. Unit (self contained operating room equipment sterilization unit)
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-1161-2016·2016-03-23

    Zimmer Manufacturing Recalls Trilogy Acet Shells Due to Calibration Issues

    Zimmer Manufacturing B.V. is recalling 2,063 units of Trilogy Acet Shells used in total hip arthroplasty due to insufficient sealer calibration data.

    Product
    Product 63 consists of all product under product code: LPH and same usage: Item no: 620004020 TRILOGY ACET SHELL 40MM O 620004220 TRILOGY ACET SHELL 42MM O 620004420 TRILOGY ACET SHELL 44MM O 620004620 TRILOGY ACET SHELL 46MM O 620004621 TRILOGY ACET SHELL 46MM O…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1101-2016·2016-03-23

    Zimmer Manufacturing Recalls Unipolar Femoral Heads Due to Sterility Concerns

    Zimmer Manufacturing B.V. is recalling 2,239 unipolar femoral heads used in hip arthroplasty due to insufficient sealer calibration data, raising concerns about the sterility of the devices.

    Product
    Product 3 consists of all products under product code JDI, and same usage: Item no:781803800 12/14 UNIPOLAR FEMORAL HE 781804000 12/14 UNIPOLAR FEMORAL HE 781804100 12/14 UNIPOLAR FEMORAL HE 781804200 12/14 UNIPOLAR FEMORAL HE 781804300 12/14 UNIPOLAR FEMORAL HE 781804400…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1100-2016·2016-03-23

    Zimmer Manufacturing Recalls Hip Femoral Heads Due to Calibration Issues

    Zimmer Manufacturing B.V. is recalling 35,032 hip femoral heads due to insufficient sealer calibration data. The affected sterile products were packaged between August 2010 and April 2013.

    Product
    Product 2 consists of all products product code LPH, and same usage: 801802202 12/14 COCR FEMORAL HEAD 2 801802220 12/14 COCR FEMORAL HEAD 2 801802230 12/14 COCR FEMORAL HEAD 2 801802601 12/14 COCR FEMORAL HEAD 2 801802602 12/14 COCR FEMORAL HEAD 2 801802603 12/14 COCR…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1126-2016·2016-03-23

    Zimmer Manufacturing Recalls Sterile Femoral Hip Implant Components

    Zimmer Manufacturing B.V. is recalling specific sterile femoral hip implant components due to insufficient sealer calibration data.

    Product
    Product 28 consists of all product under product code: JDI and same usage: Item no: 32902605000 FEMORAL HD 28MM MEDIUM 32902604000 FEMORAL HD 28MM SHORT 32902604035 FEMORAL HD 28MM SHT+ 3.5M For use in total or hemi hip arthroplasty
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1150-2016·2016-03-23

    Zimmer NexGen Osteotomy Cortical Bone Screws Recalled for Sterility Concerns

    Zimmer Manufacturing B.V. is recalling NexGen Osteotomy Cortical Bone Screws due to insufficient sealer calibration data, raising concerns about the sterility of the devices.

    Product
    Product 52 consists of product code: HWC and same usage: Item no: 525004530 NEXGEN OSTEOTOMY CORT BON 525004540 NEXGEN OSTEOTOMY CORT BON 525006545 NEXGEN OSTEOTOMY CORT BON 525006560 NEXGEN OSTEOTOMY CORT BON 525006565 NEXGEN OSTEOTOMY CORT BON for use in total knee…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1164-2016·2016-03-23

    Zimmer Versys Advocate Hip Implants Recalled for Calibration Issues

    Zimmer Manufacturing B.V. is recalling Versys Advocate hip implants due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.

    Product
    Product 66 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
  • HighFDA (Devices)·Z-1110-2016·2016-03-23

    Zimmer Manufacturing Recalls 6 Degree COCR Femoral Heads for Sterility Concerns

    Zimmer Manufacturing B.V. is recalling 209 units of 6 Degree COCR Femoral Heads due to insufficient sealer calibration data. The affected sterile products were distributed nationwide in the US.

    Product
    Product 12 consists of all product under product code JDI , and same usage: Item no: 902602935 6 DEGREE COCR FEM HEAD 28 902602835 6 DEGREE COCR FEM HEAD 28 902603235 6 DEGREE COCR FEM HEAD 32 902603335 6 DEGREE COCR FEM HEAD 32 902603600 6 DEGREE COCR FEM HEAD 36…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1154-2016·2016-03-23

    Zimmer Manufacturing Recalls Sterile Bone Fixation Screws Due to Sealer Calibration

    Zimmer Manufacturing B.V. is recalling 56 sterile bone fixation screws due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.

    Product
    Product 56 consists of all product under product code: HWC and same usage: Item no: 47234702032 PERI SCR 3.5MM X 32MM STE 47234702018 PERI SCR. 3.5MM X 18MM ST 47234702020 PERI SCR. 3.5MM X 20MM ST 47234702022 PERI SCR. 3.5MM X 22MM ST 47234702026 PERI SCR. 3.5MM X 26MM…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1163-2016·2016-03-23

    Zimmer Versa-FX II Keyless Bone Fixation Devices Recalled for Sterility Concerns

    Zimmer Manufacturing B.V. is recalling 5,538 units of Versa-FX II Keyless bone fixation devices due to insufficient sealer calibration data affecting sterility.

    Product
    Product 65 consists of all product under product code: KTT and same usage: Item no: 119413594 VERSA-FX II KEYLESS SHORT 119413595 VERSA-FX II KEYLESS SHORT 119413596 VERSA-FX II KEYLESS SHORT 119413004 VERSA-FX II KEYLESS TUBE 119413005 VERSA-FX II KEYLESS TUBE 119413006…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1128-2016·2016-03-23

    Zimmer Manufacturing Recalls Free-Lock Lag Screws Due to Sterility Concerns

    Zimmer Manufacturing B.V. is recalling 3,500 units of Free-Lock Lag Screws and related bone fixation products due to insufficient sealer calibration data affecting sterility.

    Product
    Product 30 consists of all product under product code: KTT and same usage: Item no: 118100527 FREE-LOCK LAG SCREW, 12.7 118100535 FREE-LOCK LAG SCREW, 12.7 118100540 FREE-LOCK LAG SCREW, 12.7 118100542 FREE-LOCK LAG SCREW, 12.7 118101022 FREE-LOCK LAG SCREW, 12.7…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1169-2016·2016-03-23

    Zimmer Versis Press Fit Hip Components Recalled for Sterility Concerns

    Zimmer Manufacturing B.V. is recalling 2,388 Versis Press Fit hip arthroplasty components due to insufficient sealer calibration data, raising concerns about the sterility of the devices.

    Product
    Product 71 consists of all product under product code: JDI and same usage: Item no: 783401000 VERSYS PRESS FIT LD/FX ST 783401100 VERSYS PRESS FIT LD/FX SZ 783401200 VERSYS PRESS FIT LD/FX SZ 783401300 VERSYS PRESS FIT LD/FX SZ 783401400 VERSYS PRESS FIT LD/FX SZ…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1152-2016·2016-03-23

    Zimmer NexGen Taper Plug Recalled for Insufficient Sealer Calibration Data

    Zimmer Manufacturing B.V. is recalling 1,767 NexGen Taper Plugs used in total knee arthroplasty due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.

    Product
    Product 54 consists of all product under product code: JWH and same usage: Item no: 596009900 NEXGEN TAPER PLUG for use in total knee arthroplasty
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1141-2016·2016-03-23

    Zimmer Manufacturing Recalls Sterile Intramedullary Nails Due to Sealer Calibration Issues

    Zimmer Manufacturing B.V. is recalling 1,102 sterile intramedullary nails distributed nationwide. The recall is due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.

    Product
    Product 43 consists of all product under product code: HSB and same usage: Item no: 224001016 M/DN R-F IM NAIL 10MM DIA 224001018 M/DN R-F IM NAIL 10MM DIA 224001020 M/DN R-F IM NAIL 10MM DIA 224001022 M/DN R-F IM NAIL 10MM DIA 224001024 M/DN R-F IM NAIL 10MM DIA…
    Category
    Medical Device
    Distribution
    Distributed nationwide