The Recall Desk

Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

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.

42976–43000 of 50511

  • HighFDA (Devices)·Z-2037-2013·2013-08-28

    Zimmer Recalls NexGen Knee System Components Due to Unapproved Combinations

    Zimmer, Inc. is recalling NexGen Cruciate Retaining Complete Knee System components because surgeons are implanting them in unapproved combinations.

    Product
    00597106126 Provisional ALL POLY PAT PROV MICRO SZ 26, Rx, Sterile; 00597106129 Provisional ALL POLY PAT PROV MICRO SZ 29, Rx, Sterile; 00597106132 Provisional ALL POLY PAT PROV MICRO SZ 32, Rx, Sterile; 00597106135 Provisional ALL POLY PAT PROV MICRO SZ 35, Rx…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2007-2013·2013-08-28

    Zimmer Recalls NexGen Knee Components Due to Unapproved Combinations

    Zimmer is recalling NexGen Cruciate Retaining knee components because surgeons are implanting them in unapproved combinations. The issue persists despite a previous 2012 recall.

    Product
    00595201201 Femur CR-FLEX POR FEM B-L Rx, Sterile; 00595201202 Femur CR-FLEX POR FEM B-R Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2014-2013·2013-08-28

    Zimmer NexGen Knee Implant Components Recalled for Unapproved Combinations

    Zimmer, Inc. is recalling NexGen Cruciate Retaining knee implant components because surgeons are using them in unapproved combinations with standard parts.

    Product
    00587806126 Patella MICRO POROUS PAT 26MM X 10MM, Rx, Sterile; 00587806129 Patella MICRO POROUS PAT 29MM X 10MM, Rx, Sterile; 00587806132 Patella MICRO POROUS PAT 32MM X 10MM, Rx, Sterile; 00587806135 Patella MICRO POROUS PAT 35MM X 10MM, Rx, Sterile; Used in total…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2016-2013·2013-08-28

    Zimmer NexGen Knee Implant Components Recalled for Unapproved Combinations

    Zimmer, Inc. is recalling NexGen CR Complete Knee System components because surgeons are implanting them in unapproved combinations.

    Product
    00595202010 Articular Surface XLPE CR ART SURF 1,2/PUR 10, Rx, Sterile; 00595202012 Articular Surface XLPE CR ART SURF 1,2/PUR 12, Rx, Sterile; 00595202014 Articular Surface XLPE CR ART SURF 1,2/PUR 14, Rx, Sterile; 00595202017 Articular Surface XLPE CR ART SURF…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1812-2013·2013-08-28

    Mariposa Baking Recalls Vegan Chocolate Cupcakes Due to Unlabeled Coconut

    Mariposa Baking Co. is recalling Penguinos vegan chocolate cupcakes because a consumer found an unlabeled piece of coconut in the product.

    Product
    Penguinos - four cream filled chocolate cupcakes: gluten, wheat & dairy free & vegan; 4 x 2.2oz cupcakes, net wt 8.8 oz. Ingredients: organic unrefined cane sugar, filtered water, expeller pressed canola oil, rice flour, cocoa powder, tapioca starch, potato starch, Ener-G egg…
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2001-2013·2013-08-28

    Zimmer Recalls NexGen Knee System Components Due to Unapproved Combinations

    Zimmer, Inc. is recalling NexGen Cruciate Retaining (CR) Complete Knee System components because surgeons are implanting unapproved combinations of micro and standard parts.

    Product
    65597201131 Femur CR POR FEM SURF HDN HATCP AML Rx, Sterile; 65597201132 Femur CR POR FEM SURF HDN HATCP AMR Rx, Sterile; 65597201231 Femur CR POR FEM SURF HDN HATCP BML Rx, Sterile; 65597201232 Femur CR POR FEM SURF HDN HATCP BMR Rx, Sterile; Used in total knee…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2032-2013·2013-08-28

    Zimmer Recalls NexGen Knee System Components Due to Unapproved Combinations

    Zimmer, Inc. is recalling NexGen Cruciate Retaining Complete Knee System components because surgeons are implanting unapproved combinations of micro and standard parts.

    Product
    00597204109 Articular Surface CR ART SURF 56/STRIPE GRN 9, Rx, Sterile; 00597204110 Articular Surface CR ART SURF 56/STRIPE GRN 10, Rx, Sterile; 00597204112 Articular Surface CR ART SURF 56/STRIPE GRN 12, Rx, Sterile; 00597204114 Articular Surface CR ART SURF 56/STRIPE…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2022-2013·2013-08-28

    Zimmer Recalls NexGen Knee Components Due to Unapproved Combinations

    Zimmer, Inc. is recalling NexGen Cruciate Retaining knee components because surgeons are implanting unapproved combinations of micro and standard parts.

    Product
    00595203110 Articular Surface XLPE CR ART SURF 3,4/SYEL 10, Rx, Sterile; 00595203112 Articular Surface XLPE CR ART SURF 3,4/SYEL 12, Rx, Sterile; 00595203114 Articular Surface XLPE CR ART SURF 3,4/SYEL 14, Rx, Sterile; 00595203117 Articular Surface XLPE CR ART SURF…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1994-2013·2013-08-28

    Getinge AccuFast Biological Indicators Recalled for Potential False Negative Results

    Getinge USA is recalling AccuFast Biological Indicators, Lot SR-430, because exposure to certain conditions may cause false negative results during steam sterilization testing.

    Product
    Getinge Assure Accufast Biological Indicators, Catalog Number 61301606636 (50 Pack) and 61301606637 (100 Pack), STEAM --- Manufactured for: Getinge USA, Inc. 1777 E. Henrietta Rd., Rochester, NY 14623. Getinge Assure AccuFast Biological Indicators (BIs) are designed for…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2025-2013·2013-08-28

    Zimmer Recalls NexGen Knee Components Due to Unapproved Combinations

    Zimmer, Inc. is recalling NexGen Cruciate Retaining Knee System components because surgeons are implanting them in unapproved combinations.

    Product
    90597003109 Articular Surface CR ART SURF 34/STR YEL 09MM, Rx, Sterile; 90597003110 Articular Surface CR ART SURF 34/STR YEL 10MM, Rx, Sterile; 90597003112 Articular Surface CR ART SURF 34/STR YEL 12MM, Rx, Sterile; 90597003114 Articular Surface CR ART SURF 34/STR YEL…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2024-2013·2013-08-28

    Zimmer NexGen Knee System Components Recalled for Unapproved Combinations

    Zimmer is recalling NexGen CR Complete Knee System components because surgeons are implanting unapproved combinations of micro and standard parts.

    Product
    00597003109 Articular Surface CR ART SURF 34/STRIPE YEL 9, Rx, Sterile; 00597003110 Articular Surface CR ART SURF 34/STRIPE YEL 10, Rx, Sterile; 00597003112 Articular Surface CR ART SURF 34/STRIPE YEL 12, Rx, Sterile; 00597003114 Articular Surface CR ART SURF 34/STRIPE…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2044-2013·2013-08-28

    Zimmer Recalls NexGen Knee Components Due to Unapproved Combinations

    Zimmer, Inc. is recalling NexGen CR Complete Knee System components because surgeons are implanting them in unapproved combinations.

    Product
    00597104110 Provisional CR ART SURF PROV 56/STR GRN 10, Rx, Sterile; 00597104112 Provisional CR ART SURF PROV 56/STR GRN 12, Rx, Sterile; 00597104114 Provisional CR ART SURF PROV 56/STR GRN 14, Rx, Sterile; 00597104117 Provisional CR ART SURF PROV 56/STR GRN 17, Rx…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2018-2013·2013-08-28

    Zimmer NexGen Knee Components Recalled for Unapproved Combinations

    Zimmer, Inc. is recalling NexGen Cruciate Retaining knee components because surgeons are implanting them in unapproved combinations.

    Product
    00597002009 Articular Surface CR ART SURF 12/PURPLE 9, Rx, Sterile; 00597002010 Articular Surface CR ART SURF 12/PURPLE 10, Rx, Sterile; 00597002012 Articular Surface CR ART SURF 12/PURPLE 12, Rx, Sterile; 00597002014 Articular Surface CR ART SURF 12/PURPLE 14, Rx…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1999-2013·2013-08-28

    Zimmer Recalls NexGen Knee System Components Due to Unapproved Combinations

    Zimmer, Inc. is recalling NexGen CR Complete Knee System components because surgeons are implanting unapproved combinations of micro and standard parts.

    Product
    00597001131 Femur CR PRC SURF HDN FEM CO-NID AML, Rx, Sterile; 00597001132 Femur CR PRC SURF HDN FEM CO-NID AMR, Rx, Sterile; 00597001231 Femur CR PRC SURF HDN FEM…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2011-2013·2013-08-28

    Zimmer NexGen Knee System Recalled for Unapproved Component Combinations

    Zimmer, Inc. is recalling NexGen Cruciate Retaining Complete Knee System components because surgeons are implanting unapproved combinations of micro and standard parts.

    Product
    00597201303 Femur CR POR FM COMP SIZE CML Rx, Sterile; 00597201304 Femur CR POR FM COMP SIZE CMR Rx, Sterile; 00597201403 Femur CR POR FM COMP SIZE DML Rx, Sterile; 00597201404 Femur CR POR FM COMP SIZE DMR Rx, Sterile; 00597201503 Femur CR POR FM COMP SIZE EML…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2029-2013·2013-08-28

    Zimmer NexGen Knee Components Recalled for Unapproved Combinations

    Zimmer is recalling NexGen Cruciate Retaining knee components because surgeons are implanting unapproved combinations of micro and standard parts.

    Product
    90595204117 Articular Surface XLPE CR ART SURF AE56/STGRN 17, Rx, Sterile; 90595204120 Articular Surface XLPE CR ART SURF AE56/STGRN 20, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2006-2013·2013-08-28

    Zimmer Recalls NexGen Knee System Components Due to Unapproved Combinations

    Zimmer, Inc. is recalling NexGen Cruciate Retaining Complete Knee System components because surgeons are implanting unapproved combinations of micro and standard parts.

    Product
    00595001201 Femur CR-FLEX PCT FEM B-L Rx, Sterile; 00595001202 Femur CR-FLEX PCT FEM B-R Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1967-2013·2013-08-28

    GE Healthcare Recalls Discovery NM/CT 570c Systems for Scanning Error

    GE Healthcare is recalling 10 Discovery NM/CT 570c systems in Connecticut after an incident where the wrong part of a patient's body was scanned during a CT exam.

    Product
    The Discovery NM/CT 570c CT Standalone Scan The Discovery NM/CT 570c hybrid system is a combination of a cardiac dedicated nuclear imaging subsystem and LightSpeed GE CT subsystem. This system is intended for cardiac Nuclear Medicine (NM) diagnostic imaging applications…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2020-2013·2013-08-28

    Zimmer Recalls NexGen Knee Components Due to Unapproved Combinations

    Zimmer, Inc. is recalling NexGen CR Complete Knee System components because surgeons are implanting them in unapproved combinations.

    Product
    00597202009 Articular Surface CR ART SURF 12/PURPLE 09, Rx, Sterile; 00597202010 Articular Surface CR ART SURF 12/PURPLE 10, Rx, Sterile; 00597202012 Articular Surface CR ART SURF 12/PURPLE 12, Rx, Sterile; 00597202014 Articular Surface CR ART SURF 12/PURPLE 14, Rx…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1979-2013·2013-08-28

    Boston Scientific Recalls ENERGEN DR ICD Due to Test Artifacts

    Boston Scientific is recalling one ENERGEN DR ICD (Model E143) because test artifacts related to shock charge time require further investigation.

    Product
    Boston Scientific, ENERGEN DR ICD, Model E143. The device is an Implantable Cardioverter Defibrillator.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2040-2013·2013-08-28

    Zimmer NexGen Knee System Components Recalled for Unapproved Combinations

    Zimmer is recalling NexGen Knee System components because surgeons are implanting them in unapproved combinations, creating a risk of improper fit.

    Product
    00597503110 Provisional AC ARTSURF PROV 34/STRIPE YEL10, Rx, Sterile; 00597503112 Provisional AC ARTSURF PROV 34/STRIPE YEL12, Rx, Sterile; 00597503114 Provisional AC ARTSURF PROV 34/STRIPE YEL14, Rx, Sterile; 00597503117 Provisional AC ARTSURF PROV 34/STRIPE YEL17…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1989-2013·2013-08-28

    GE Healthcare Precision 500D X-Ray Systems Recalled for Monitor Suspension Defect

    GE Healthcare is recalling Precision 500D systems because a locking nut on the overhead video monitor suspension may loosen, posing a risk of impact.

    Product
    GE Healthcare, Precision 500D Product Usage: The Precision 500D is designed to perform radiographic and fluoroscopic x-ray examinations.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2019-2013·2013-08-28

    Zimmer NexGen Knee System Components Recalled for Unapproved Combinations

    Zimmer is recalling NexGen CR Complete Knee System components because surgeons are implanting unapproved micro and standard combinations.

    Product
    90597002009 Articular Surface CR ART SURF 12/PURPLE 09MM, Rx, Sterile; 90597002010 Articular Surface CR ART SURF 12/PURPLE 10MM, Rx, Sterile; 90597002012 Articular Surface CR ART SURF 12/PURPLE 12MM, Rx, Sterile; 90597002014 Articular Surface CR ART SURF 12/PURPLE 14MM…
    Category
    Medical Device
    Distribution
    Distributed nationwide