The Recall Desk

Hazard

Product Defect recalls

130 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
130
Critical
1
Severe
14
Most recent
2026-08-26

Of the 130 product defect recalls we have scored against our rubric, 1 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 14 (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 product defect 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.

51–75 of 130

  • HighFDA (Devices)·Z-0393-2022·2021-12-29

    Stryker DARCO Screw Recall: Incorrect Product in Packaging

    Wright Medical Technology Inc is recalling 250 units of Stryker DARCO Screws (Lot #1643355) because the incorrect product was found in the packaging. Affected units were distributed across multiple U.S. states and countries worldwide.

    Product
    Stryker DARCO Screw, Locking, Ti6A14V, REF DC2825016, 2.7mm x 16mm.
    Category
    Medical Device
    Distribution
    7 states
  • LowFDA (Drugs)·D-0268-2022·2021-12-15

    CVS Allergy & Congestion Relief Tablets Recalled for Failed Dissolution

    Dr. Reddy's Laboratories is recalling CVS Allergy & Congestion Relief tablets (fexofenadine HCl 60 mg/pseudoephedrine HCl 120 mg extended-release) nationwide due to failed dissolution specifications.

    Product
    Allergy & Congestion Relief Allergy Relief D, Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg Extended Release Tablets, 20 extended-release tablets, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, Made in India, NDC 69842-249-20
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0275-2022·2021-12-15

    Fexofenadine and Pseudoephedrine Tablets Recalled for Failed Dissolution

    Dr. Reddy's Laboratories is recalling Fexofenadine HCl 60 mg and Pseudoephedrine HCl 120 mg extended-release tablets because they failed to meet dissolution specifications, which may affect how the medication works in the body.

    Product
    FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI — FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI (FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0317-2022·2021-12-08

    HALYARD STERLING ZERO Nitrile Exam Gloves Recall for Discoloration and Loss of Elasticity

    O&M Halyard is recalling HALYARD STERLING ZERO nitrile exam gloves in all sizes due to discoloration and loss of elasticity with aging, making the gloves difficult or impossible to don without tearing. Approximately 5.86 million gloves distributed worldwide are affected.

    Product
    HALYARD STERLING ZERO NITRILE POWDER-FREE EXAM GLOVES, Sizes XS, S, M, L, and XL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0254-2022·2021-11-24

    Out-of-Specification Swabstick Recalled in REGARD Stereotactic Tray

    ROi CPS LLC recalled REGARD Stereotactic Trays due to out-of-specification Povidone-Iodine swabstick components. The recall affects 175 units distributed in Florida, Louisiana, and Missouri.

    Product
    REGARD Stereotactic Tray
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateCPSC·22022·2021-11-23

    Impex Fitness Olympic Dumbbell Handles Recalled for Impact Injury Hazard

    Impex Fitness is recalling about 77,200 Olympic Dumbbell Handles because the locking collars can slip, causing weights to drop and potentially cause impact injuries. No injuries have been reported to date.

    Product
    Olympic Dumbbell Handles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0198-2022·2021-11-10

    Dental implant recalled due to size mismatch with labeling

    Implant Direct Sybron Manufacturing is recalling 83 dental implants from lot 166300 because the implants differ in size from what is labeled on the packaging. The implants were distributed across multiple US states and Japan.

    Product
    ImplantDirect, REF 834713, Legacy 2 Implant 4.7mmD x 13mmL, 4.5mmD Platform,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0316-2021·2021-04-07

    Zydus Recalls Acyclovir Sodium Injection Due to Crystallization

    Zydus Pharmaceuticals is recalling 1,638 packs of Acyclovir Sodium Injection due to customer complaints of crystallization in the finished product.

    Product
    ACYCLOVIR — ACYCLOVIR (ACYCLOVIR)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1078-2021·2021-02-17

    Cardinal Health Recalls Chemo Spill Kits Due to Gown Defects

    Cardinal Health is recalling 137,346 ChemoPlus Chemo Spill Kits because the included gowns may have rips, holes, or foreign material.

    Product
    Covidien ChemoPlus Chemo Spill Kit, Nonsterile, SKU DP5108K
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1079-2021·2021-02-17

    Cardinal Health Recalls Chembloc Preparation Kits Due to Gown Defects

    Cardinal Health is recalling Chembloc Preparation and Administration Kits because the included gowns may have rips, holes, or foreign material.

    Product
    CHEMOBLOC Preparation and Administration Kit, Extra Large Blue Gown, Medium and Large Gloves, Nonsterile, SKU DP5106K
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1082-2021·2021-02-17

    Cardinal Health Recalls Kendall Spill Kits Due to Gown Defects

    Cardinal Health is recalling Kendall Spill Kits because the included gowns may have rips, holes, or foreign material.

    Product
    Kendall Spill Kit, 6 Per Case, NonsterileI, BB6016K
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1083-2021·2021-02-17

    Cardinal Health Recalls ChemoPlus Chemo Prep and Admin Kits

    Cardinal Health is recalling ChemoPlus Chemo Prep & Admin Kits because the included gowns may have defects like rips, holes, or foreign material.

    Product
    ChemoPlus" Chemo Prep & Admin Kit, CT4025
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2919-2020·2020-09-09

    Cardinal Health Recalls PROTEXIS Latex Micro Surgical Gloves Due to Defects

    Cardinal Health is recalling PROTEXIS Latex Micro Surgical Gloves because a degradation defect may cause holes and tears at the cuffs.

    Product
    PROTEXIS Latex Micro Surgical Gloves Size 9.0 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic rubber intended to be worn by operating room personnel to be a barrier protection from contamination. Various thickness for sensiti
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2915-2020·2020-09-09

    Cardinal Health Recalls PROTEXIS Latex Micro Surgical Gloves Due to Defects

    Cardinal Health 200, LLC is recalling PROTEXIS Latex Micro Surgical Gloves because a degradation defect may cause holes and tears at the cuffs.

    Product
    PROTEXIS Latex Micro Surgical Gloves Size 7.0 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic rubber intended to be worn by operating room personnel to be a barrier protection from contamination. Various thickness for sensiti
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2596-2020·2020-07-22

    Skeletal Kinetics Recalls Acumed Impact Bone Void Filler Kits

    Skeletal Kinetics is recalling 41 units of Acumed Impact 5CC bone void filler kits because they may not maintain setting characteristics for the labeled shelf-life.

    Product
    ACUMED IMPACT 5CC. Product Number: 65-0105-S, UDI: 813845020252 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created from traum
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2603-2020·2020-07-22

    Skeletal Kinetics Recalls Craniosculpt Flow Bone Void Filler Kits

    Skeletal Kinetics is recalling Craniosculpt Flow bone void filler kits because they may not maintain setting characteristics for the labeled shelf life.

    Product
    CRANIOSCULPT FLOW, OUS, 10CC. Product Number: C-FLOW10CC-OUS, UDI: 813845020382 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects cr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2633-2020·2020-07-22

    Skeletal Kinetics Recalls Craniosculpt Bone Void Filler Kits

    Skeletal Kinetics is recalling 27 units of Craniosculpt bone void filler kits because they may not maintain setting characteristics for the labeled shelf-life.

    Product
    CRANIOSCULPT, CMF IMPACT, 3CC Product Number: C-CMF3CC, UDI: 813845020931 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2592-2020·2020-07-22

    Skeletal Kinetics Recalls Acumed Callos Bone Void Filler Kits

    Skeletal Kinetics is recalling Acumed Callos bone void filler kits because they may not maintain setting characteristics for the labeled shelf-life, potentially increasing surgical time or causing bone formation issues.

    Product
    ACUMED CALLOS INJECT 10CC. Product Number: 65-0010-S, UDI: 813845020245 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created fr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2602-2020·2020-07-22

    Skeletal Kinetics Recalls Craniosculpt Flow Bone Void Filler Kits

    Skeletal Kinetics is recalling Craniosculpt Flow bone void filler kits because they may not maintain setting characteristics for the labeled shelf-life, potentially increasing surgical time or causing bone formation issues.

    Product
    CRANIOSCULPT FLOW, CAN, 5CC. Product Number: C-FLOW5CC-CAN, UDI: 813845020344 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects crea
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2612-2020·2020-07-22

    Skeletal Kinetics Recalls Osteovation EX Bone Void Filler Kits

    Skeletal Kinetics is recalling Osteovation EX bone void filler kits because they may not maintain setting characteristics for the labeled shelf-life, potentially increasing surgical time or causing bone formation issues.

    Product
    OSTEOVATION EX, 3CC, IMPACT FORMULA. Product Number: 390-0203, UDI: 813845020030 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects c
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2630-2020·2020-07-22

    Skeletal Kinetics Recalls SKAFFOLD RENU FLOW Bone Void Filler Kits

    Skeletal Kinetics is recalling SKAFFOLD RENU FLOW bone void filler kits because they may not maintain setting characteristics for the labeled shelf-life.

    Product
    SKAFFOLD RENU FLOW, 10CC. Product Number: SKMA-FL10, UDI: 813845020856 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created fro
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2621-2020·2020-07-22

    Skeletal Kinetics Recalls Osteovationex Bone Void Filler Kits

    Skeletal Kinetics is recalling Osteovationex 2cc Inject Formula bone void filler kits because they may not maintain setting characteristics for the labeled shelf life.

    Product
    OSTEOVATIONEX 2CC INJECT FORMULA. Product Number: 390-0002, UDI: 813845020009 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects crea
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2616-2020·2020-07-22

    Skeletal Kinetics Recalls Osteovation RMX Bone Void Filler Kits

    Skeletal Kinetics is recalling Osteovation RMX bone void filler kits because they may not maintain setting characteristics for the labeled shelf life, potentially increasing surgical time or causing bone formation issues.

    Product
    OSTEOVATION RMX 5CC. Product Number: 390-6001, UDI: 813845021082 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created from trau
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2629-2020·2020-07-22

    Skeletal Kinetics Recalls SKAFFOLD FLOW Bone Void Filler Kits

    Skeletal Kinetics is recalling SKAFFOLD FLOW bone void filler kits because they may not maintain setting characteristics for the labeled shelf-life, potentially increasing surgical time or causing bone formation issues.

    Product
    SKAFFOLD FLOW, 10CC. Product Number: SKMX-FL10, UDI: 813845020900 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created from tra
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2619-2020·2020-07-22

    Skeletal Kinetics Recalls Osteovation Bone Void Filler Kits

    Skeletal Kinetics is recalling Osteovation bone void filler kits because they may not maintain setting characteristics for the labeled shelf-life, potentially increasing surgical time or causing bone formation issues.

    Product
    OSTEOVATION, 5CC, IMPACT FORMULA. Product Number: 390-2105, UDI: 813845020085 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects crea
    Category
    Medical Device
    Distribution
    Distributed nationwide