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.

1576–1600 of 2228

  • 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 811400
    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 MI
    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 1146040
    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 IN
    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 ONE
    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 902603
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1102-2016·2016-03-23

    Zimmer Manufacturing Recalls Sterile Bone Fixation Screws Due to Sealer Calibration

    Zimmer Manufacturing B.V. is recalling 154 sterile bone fixation screws distributed nationwide due to insufficient sealer calibration data.

    Product
    Product 4 consists of all products under product code HWC, and same usage: Item no: 47482002603 2.0 X 26 CORT SCREW CRUCI 47482002803 2.0 X 28 CORT SCREW CRUCI 47482003203 2.0 X 32 CORT SCREW CRUCI 47482003403 2.0 X 34 CORT SCREW CRUCI 47482003603 2.0 X 36 CORT SCREW CRUC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1139-2016·2016-03-23

    Zimmer Manufacturing Recalls Sterile Bone Fixation Screws Due to Calibration Issues

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

    Product
    Product 41 consists of all product under product code: KTT and same usage: Item no: 119301042 LAG SCR 12.7D X 100MM STA 119301045 LAG SCR 12.7D X 105MM STA 119301047 LAG SCR 12.7D X 110MM STA 119301050 LAG SCR 12.7D X 115MM STA 119301052 LAG SCR 12.7D X 120MM STA 1193010
    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 rod
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1131-2016·2016-03-23

    Zimmer HGP II Acetabular Cup Recall Due to Sealer Calibration

    Zimmer Manufacturing B.V. is recalling 2,236 HGP II Acetabular Cup components due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.

    Product
    Product 33 consists of all product under product code: JDI and same usage: Item no: 662406515 HGP II ACETABULAR CUP BON 662406520 HGP II ACETABULAR CUP BON 662406525 HGP II ACETABULAR CUP BON 662406530 HGP II ACETABULAR CUP BON 662406535 HGP II ACETABULAR CUP BON 6624065
    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 VER
    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 234800508
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1151-2016·2016-03-23

    Zimmer NexGen Knee Implant Recall Due to Sealer Calibration Issues

    Zimmer Manufacturing B.V. is recalling NexGen knee implant components due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.

    Product
    Product 53 consists of all product under: product code: JWH and same usage: Item no: 597002501 NEXGEN PRECOAT PEG TIB PL 597002502 NEXGEN PRECOAT PEG TIB PL 597003501 NEXGEN PRECOAT PEG TIB PL 597003502 NEXGEN PRECOAT PEG TIB PL 597004501 NEXGEN PRECOAT PEG TIB PL 5970
    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 2252360
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1157-2016·2016-03-23

    Zimmer Manufacturing Recalls Sterile Polyethylene Patches Due to Calibration Issues

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

    Product
    Product 59 consists of all product under product code: JWH and same usage: Item no: 42540000026 PSN ALL POLY PAT PLY 26MM 42540000029 PSN ALL POLY PAT PLY 29MM 42540000032 PSN ALL POLY PAT PLY 32MM 42540000035 PSN ALL POLY PAT PLY 35MM 42540000038 PSN ALL POLY PAT PLY 38MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1127-2016·2016-03-23

    Zimmer Manufacturing Recalls Sterile Femoral Heads Due to Sealer Calibration Issues

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

    Product
    Product 29 consists of all product under product code: LPHand same usage: Item no: 32902603800 FEMORAL HEAD +0.5 X 22 MM 32902604810 FEMORAL HEAD +3.5 X 22 MM 32902604845 FEMORAL HEAD +7.0 X 22 MM For use in total or hemi hip arthroplasty
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1103-2016·2016-03-23

    Zimmer Manufacturing Recalls 2.7mm Cortical Screws Due to Sealer Calibration Issues

    Zimmer Manufacturing B.V. is recalling 60 sterile 2.7mm cortical screws due to insufficient sealer calibration data. The products were distributed nationwide in the US.

    Product
    Product 5 consists of all products under product code HWC, and same usage: Item no: 47482701001 2.7MM CORT. SCREW 10MM, S 47482701201 2.7MM CORT. SCREW 12MM, S 47482701401 2.7MM CORT. SCREW 14MM, S 47482701601 2.7MM CORT. SCREW 16MM, S 47482701801 2.7MM CORT. SCREW 18M
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1132-2016·2016-03-23

    Zimmer Manufacturing Recalls Sterile Knee Patella Components Due to Sealer Calibration

    Zimmer Manufacturing B.V. is recalling 512 sterile I/B II Knee Domed Patella components for total knee arthroplasty due to insufficient sealer calibration data.

    Product
    Product 34 consists of all product under product code: JWH and same usage: Item no: 522001700 I/B II KNEE DOMED PATELLA 522001800 I/B II KNEE DOMED PATELLA 522001900 I/B II KNEE DOMED PATELLA for use in total knee arthroplasty
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1121-2016·2016-03-23

    Zimmer Manufacturing Recalls Hip Stems Due to Insufficient Sealer Calibration Data

    Zimmer Manufacturing B.V. is recalling specific hip stem products because of insufficient sealer calibration data for items packaged in Building II between August 2010 and April 2013.

    Product
    Product 23 consists of all product code: JDI and same usage: Item no: 801100220 CPT 2 HIP STEM, X-OFFSET 801100320 CPT 3 HIP STEM, X-OFFSET 801100420 CPT 4 HIP STEM, X-OFFSET 801100005 CPT HIP STEM PETITE 801100700 CPT HIP STEM SZ 2 LONG 801100800 CPT HIP STEM SZ 3 LONG
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1156-2016·2016-03-23

    Zimmer Manufacturing Recalls 119 Sterile Bone Fixation Appliances

    Zimmer Manufacturing B.V. is recalling 119 sterile bone fixation appliances due to insufficient sealer calibration data. The affected products were packaged between August 2010 and April 2013.

    Product
    Product 58 consists of all product under product code: HRS and same usage: Item no: 234800904 PROXIMAL DORSAL ULNA PLT 234800906 PROXIMAL DORSAL ULNA PLT 234800908 PROXIMAL DORSAL ULNA PLT 234800910 PROXIMAL DORSAL ULNA PLT 234801004 PROXIMAL DORSAL ULNA PLT 234801006 PRO
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1160-2016·2016-03-23

    Zimmer Manufacturing Recalls Trilogy Acet Shell Hip Implant Components

    Zimmer Manufacturing B.V. is recalling 400 units of Trilogy Acet Shell hip implant components due to insufficient sealer calibration data.

    Product
    Product 62 consists of all product under product code: LPH and same usage: Item no: 620003620 TRILOGY ACET SHELL 36MM OD MULTI For use in total hip arthroplasty
    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-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 8114000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1130-2016·2016-03-23

    Zimmer Herbert Bone Screws Recalled for Insufficient Sealer Calibration Data

    Zimmer Manufacturing B.V. is recalling 4,018 units of Herbert bone screws due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.

    Product
    Product 32 consists of all product under product code: HWC and same usage: Item no: 47115401200 HERBERT BONE SCREW, 3.0MM 47115401400 HERBERT BONE SCREW, 3.0MM 47115401600 HERBERT BONE SCREW, 3.0MM 47115401800 HERBERT BONE SCREW, 3.0MM 47115402000 HERBERT BONE SCREW, 3.0M
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1118-2016·2016-03-23

    Zimmer Manufacturing Recalls Compression Screws Due to Sealer Calibration Issues

    Zimmer Manufacturing B.V. is recalling 3,415 sterile compression screws due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.

    Product
    Product 20 consists of all prod oct under poduct code: KTT and same usage: Item no: 47116201900 COMPRESSION SCREW 1/2IN 47116202300 COMPRESSION SCREW 1-1/2IN 47116202200 COMPRESSION SCREW 1-1/4IN 47116202400 COMPRESSION SCREW 1-3/4IN 47116202100 COMPRESSION SCREW 1IN 471
    Category
    Medical Device
    Distribution
    Distributed nationwide