The Recall Desk

Severity 2 of 5

Moderate recalls

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

What “moderate” means here

Severity 2 (Moderate) recalls cover minor labeling errors, low-risk contamination, and voluntary precautionary recalls. The agency's own classification is typically FDA Class III, or the issue is something like incomplete instructions or a small UPC mismatch where the product itself is safe but doesn't meet documentation requirements. Use the same brand-name product safely; follow the manufacturer's instructions for return or exchange if you want a refund.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

15076–15100 of 21645

  • 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…
    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…
    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-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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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…
    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-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…
    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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1155-2016·2016-03-23

    Zimmer Manufacturing Recalls Pressfit Femoral Stems Due to Sealer Calibration

    Zimmer Manufacturing B.V. is recalling sterile pressfit femoral stems used in hip arthroplasty due to insufficient sealer calibration data.

    Product
    Product 57 consists of all product code: JDI and same usage: Item no: 763401000 PRESSFIT FEM ST FX 10 X 115 763401100 PRESSFIT FEM ST FX 11 X 1 763401200 PRESSFIT FEM ST FX 12 X 1 763401300 PRESSFIT FEM ST FX 13 X 1 763401400 PRESSFIT FEM ST FX 14 X 1 763401500 PRESSFIT…
    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…
    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-1166-2016·2016-03-23

    Zimmer Versys Hip Implant Recall Due to Insufficient Sealer Calibration Data

    Zimmer Manufacturing B.V. is recalling 1,220 units of Versus hip implants due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.

    Product
    Product 68 consists of all product under product code: JDI and same usage: Item no: 787101360 VERSYS CEM/REV/CALCAR 13X 787101361 VERSYS CEM/REV/CALCAR 13X 787101362 VERSYS CEM/REV/CALCAR 13X 787101363 VERSYS CEM/REV/CALCAR 13X 787101560 VERSYS CEM/REV/CALCAR 15X…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1167-2016·2016-03-23

    Zimmer Versys Cemented Femoral Stem Recall for Calibration Issues

    Zimmer Manufacturing B.V. is recalling 13 Versys Cemented Femoral Stems due to insufficient sealer calibration data. The affected sterile products were distributed nationwide in the US.

    Product
    Product 69 consists of all product under product code: JDI and same usage: Item no: 785301701 VERSYS CEMENTED FEM STEM 785301521 VERSYS CEMENTED FEM STEM 15X140MM X-OFF 785301601 VERSYS CEMENTED FEM STEM 16X145MM For use in total or hemi hip arthroplasty
    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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1147-2016·2016-03-23

    Zimmer NexGen All-Poly Patella Components Recalled for Calibration Issues

    Zimmer Manufacturing B.V. is recalling NexGen All-Poly Patella and related knee arthroplasty components due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.

    Product
    Product 49 consists of all product under product code: JWH and same usage: Item no: 597206529 NEXGEN ALL-POLY PATELLA, 597206532 NEXGEN ALL-POLY PATELLA, 597206535 NEXGEN ALL-POLY PATELLA, 597206538 NEXGEN ALL-POLY PATELLA, 597206541 NEXGEN ALL-POLY PATELLA, 598801713…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0579-2016·2016-03-23

    Restaurant Depot Recalls Swai Fillets Due to Nitrofuran Detection

    Restaurant Depot is recalling Swai Fillets because routine third-party lab testing found nitrofuran (SCA). The product was distributed in Florida.

    Product
    Swai Fillets ( 7-9 oz.) packaged in a 15 lb. blue and white box with blue and white lettering.
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-0753-2016·2016-03-23

    Faye's Texas Naturals Corn Relish Recalled for pH Testing Violations

    Faye's Texas Naturals is recalling 1,979 jars of Chili Petin Corn Relish because pH levels were not tested as required by acidified food regulations.

    Product
    Faye's Texas Naturals Chili Petin Corn Relish Net Wt. 10 oz./283.59 grams in glass jars; 123 S. Courthouse Square Goliad, Texas 77963 (361)645-3136 FAYESTEXASNATURALS.NET
    Category
    Food
    Distribution
    11 states
  • 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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0754-2016·2016-03-23

    Faye's Texas Naturals Chili Petin Recalled for pH Testing Violations

    Faye's Texas Naturals is recalling 1,140 jars of Chili Petin Picante Caliente because pH levels were not tested as required by acidified food regulations.

    Product
    Faye's Texas Naturals Chili Petin Picante Caliente Net Wt. 16oz./452 grams in glass jars; 123 S. Courthouse Square Goliad, Texas 77963 (361)645-3136 FAYESTEXASNATURALS.NET
    Category
    Food
    Distribution
    11 states
  • 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-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…
    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 (Food)·F-0755-2016·2016-03-23

    Faye's Texas Naturals Chili Petin Pepper Sauce Recalled for pH Testing Failures

    Faye's Texas Naturals is recalling 65 bottles of Chili Petin Pepper Sauce because pH levels were not tested as required by acidified food regulations.

    Product
    Faye's Texas Naturals Chili Petin Pepper Sauce Net Wt. 2 fl. oz./.59 ml in glass jars; South Courthouse Square Goliad, Texas 77963 1-800-231-FAYE
    Category
    Food
    Distribution
    11 states
  • ModerateFDA (Devices)·Z-1107-2016·2016-03-23

    Zimmer Manufacturing Recalls Sterile Orthopedic Fixation Devices Due to Calibration Issues

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

    Product
    Product 9 consists of all product under HRS, and same usage: Item no: 47494502601 4.5 BROAD SCP PLT, 26 HOL Product Usage: Temporary internal fixation devices designed to stabilize fractures during the normal healing process.
    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…
    Category
    Medical Device
    Distribution
    Distributed nationwide