The Recall Desk

Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means the agency’s own highest classification or reported deaths or serious injuries, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

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14126–14150 of 40151

  • HighFDA (Devices)·Z-2092-2021·2021-07-28

    Blood heater-cooler devices recalled for water contamination and infection risk

    Gentherm's Hemotherm CE blood cooler/heater devices may harbor dangerous organisms including nontuberculous mycobacteria in their water systems that could aerosolize during cardiac surgery, risking patient infection.

    Product
    Hemotherm CE Dual Reservoir Cooler/Heater, Model 400CE, 115V Model, part no. 86022. Used to cool or warm blood during cardiopulmonary bypass procedures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2104-2021·2021-07-28

    DJO Surgical EMPOWR 3D Knee Tibial Insert packaging may contain wrong implant size

    Packaging for DJO Surgical EMPOWR 3D Knee Tibial Insert knee prosthesis implants may be mislabeled, with 12mm packages potentially containing 16mm implants or vice versa, risking incorrect surgical implantation.

    Product
    DJO Surgical EMPOWR 3D Knee Tibial Insert - e-plus, REF: 341-16-711 Left Sz. 11 16mm, CE 0086, Sterile H2O2, UDI: (01)00888912167185
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2112-2021·2021-07-28

    Exactech Connexion GXL Hip Implant Liners Recalled for Premature Wear Risk

    Exactech Connexion GXL hip implant liners are being recalled due to risk of edge-loading and premature wear in certain surgical configurations. Approximately 89,050 units distributed nationwide may be affected.

    Product
    Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 104-28-XX, MCS +5GXL Liner 5/15 DEG and MCS GXL Liner 5/15 DEG. Orthopedic hip implant component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2125-2021·2021-07-28

    Exactech Connexion GXL hip implant liners recalled for premature wear risk

    Exactech is recalling 89,050 hip implant liners due to edge-loading and premature wear risk in a subset of patients with certain implant configurations.

    Product
    Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 136-22-XX, Novation GXL Liner, +5mm Lateralized, G00, 22mm ID. Orthopedic hip implant component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2127-2021·2021-07-28

    Exactech Connexion GXL Hip Implant Liners Recall Risk of Premature Wear

    Exactech is recalling 89,050 Connexion GXL acetabular hip implant liners due to risk of edge-loading and premature wear in certain patient configurations and surgical placements.

    Product
    Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 136-32-XX, Novation GXL Liner, +5mm Lateralized, 32mm. Orthopedic hip implant component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2083-2021·2021-07-28

    Drain Bag Set for Peritoneal Dialysis Exposed to Freezing During Transport

    A Drain Bag Set used in peritoneal dialysis was exposed to freezing temperatures due to refrigerated truck malfunction during distribution. The affected lot was distributed to Texas.

    Product
    The Drain Bag Set (tubings and flexible bags) is a passive, closed drainage system used as an optional receptacle during an APD treatment. The Drain Bag Set is used to collect effluent in bags rather than letting the effluent flow directly to a drain. The Drain Bag Set connects…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2088-2021·2021-07-28

    Fresenius APD Luer-Lock Adapter Recalled Due to Freezing Temperature Exposure

    Fresenius Medical Care is recalling 5 cases of the APD Luer-Lock Adapter (Lot 20LR08111) distributed in Texas after exposure to freezing temperatures during truck transport. Freezing may have compromised device sterility and functionality.

    Product
    The Fresenius APD Luer-Lock Adapter, Catalog number 050-95018, is designed to connect a peritoneal dialysis bag equipped with a luer-lock connector to a Fresenius Automated Peritoneal Dialysis (APD) cycler set that uses the Fresenius Safe-Lock¿ connector (e.g., Liberty¿ cycler…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2120-2021·2021-07-28

    Exactech Hip Implant Liners Recalled for Premature Wear Risk

    Exactech Connexion GXL acetabular polyethylene liners used in hip implants face premature wear risk in certain patient and implant configurations. Consult your orthopedic surgeon if you have this device.

    Product
    Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-22-XX, Novation GXL Liner, G00, 22mm ID; and Novation GXL Liner, Lipped Ant, 28mm. Orthopedic hip implant component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2122-2021·2021-07-28

    Hip Implant Liners Recalled Due to Risk of Premature Wear

    Exactech Connexion GXL hip implant liners are being recalled due to a risk of edge-loading and premature prosthesis wear in patients with certain implant configurations and surgical positioning.

    Product
    Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-36-XX, Acumatch GXL 15 Degree Liner, 36mm, and Novation GXL Liner, Lipped Ant, 36mm; and Novation GXL Liner, Lipped, 36mm. Orthopedic hip implant component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2114-2021·2021-07-28

    Hip implant liners recalled due to risk of premature wear

    Exactech is recalling 89,050 hip implant liners due to risk of edge-loading and premature wear in specific patient and surgical configurations affecting a subset of patients.

    Product
    Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 104-36-XX, MCS +5GXL Liner 5/15 DEG and MCS GXL Liner 5/15 DEG. Orthopedic hip implant component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2098-2021·2021-07-28

    SoftCytogenetics Software Recalled for Incorrect Test Result Transmission

    Soft Computer Consultants, Inc. is recalling SoftCytogenetics software (versions 4.1.11.20, 4.1.12.11, 4.1.15.6) distributed in CA, FL, MN, and NJ because it produces incorrect results for retested specimens that are transmitted to clinical information systems.

    Product
    SoftCytogenetics
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2094-2021·2021-07-28

    Infant Heel Warmer Units Recalled for Rupture and Chemical Splashing Risk

    Cardinal Health is recalling 926,425 infant heel warmers (SKU MH00002T) due to reports of pack rupture or leaking during activation. The heated liquid may splash into a user's eyes or onto an infant, potentially causing rash, burn, or inflammation.

    Product
    Infant Heel Warmer with Attachment Tab, Nonsterile, Active Product SKU MH00002T The infant heel warmer is activated at the point of care by squeezing the pouch. This mixes the substrates inside the pouch causing an exothermic chemical reaction, warming the pouch, which is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2121-2021·2021-07-28

    Exactech GXL Acetabular Hip Implant Liners Recalled for Premature Wear Risk

    Exactech, Inc. is recalling 89,050 Connexion GXL and Novation GXL acetabular hip implant liners due to risk of edge-loading and premature prosthesis wear in certain patients. The risk depends on implant configuration and surgical positioning.

    Product
    Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-28-XX, Acumatch GXL 15 Degree Liner, 28mm; Novation GXL Liner, G0, 28mm ID; Novation GXL Liner, Lipped Ant, 28mm; and Novation GXL Liner, Lipped, 28mm. Orthopedic hip…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2087-2021·2021-07-28

    NaturaLyte Bicarbonate Concentrate Recalled After Freezing Temperature Exposure

    NaturaLyte Dry Bicarbonate Concentrate, used in hemodialysis machines to prepare dialysate, was recalled after exposure to freezing temperatures during transport. The affected lot (21ATBC004) was distributed to facilities in Texas only.

    Product
    NaturaLyte Dry Bicarbonate Concentrate is composed of sodium bicarbonate powder and is used as one component in the preparation of dialysate in a 3-stream proportioning hemodialysis machine according to a physician s prescription. NaturaLyte Dry Bicarbonate Concentrate is…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2084-2021·2021-07-28

    Hemodialysis Acid Concentrates Recalled After Freezing Exposure During Transport

    Fresenius Medical Care is recalling Citrasate and GranuFlo Dry Acid Concentrates after freezing temperature exposure during refrigerated truck transport. Affected lots distributed in Texas should be discontinued immediately.

    Product
    Citrasate Dry Acid Concentrate and GranuFlo Dry Acid Concentrate are each intended to be used as one component in the preparation of dialysate in a 3-stream proportioning hemodialysis machine according to a physician s prescription. Both concentrates are formulated for use in…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2081-2021·2021-07-28

    Moderna COVID-19 Vaccine Administration Kits Recalled for Unsuitable Syringes

    McKesson is recalling 53,388 Moderna COVID-19 vaccine administration kits due to unsuitable 3mL syringes included in the kits. The affected kits were distributed May 4-24, 2021, and should not be used for vaccine administration.

    Product
    ANCILLARY ADULT 140-DOSE CONVENIENCE KIT, ITEM #1189482, for the administration of the Moderna COVID-19 vaccine convenience kit for the administration of the COVID-19 vaccine
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2091-2021·2021-07-28

    Backflush Brush Needles Recalled Due to Incorrect Gauge Labeling

    Dutch Ophthalmic USA is recalling Disposable Replacement Backflush Brush Needles (lot 3420011396) distributed in IL, IN, MO, and PA because the label incorrectly identifies the gauge as 20 gauge/0.9mm when the product is actually 23 gauge/0.6mm.

    Product
    Disposable Replacement Backflush Brush Needles (23 gauge/0.6mm)-for use in vitreoretinal surgery Product Number: labeled as 1281.B1D, product is 1281.B1D06
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-2101-2021·2021-07-28

    Stryker Cortoss Bone Augmentation Material Recalled for Temperature Storage Violation

    Stryker Spine recalled Cortoss Bone Augmentation Material due to a 12-hour temperature excursion at the distribution center that could have compromised product sterility and efficacy.

    Product
    Cortoss Bone Augmentation Material 10cc Cartridge, Catalog Number 2101-0010, GTIN 00808232000979
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2103-2021·2021-07-28

    Knee Prosthesis Recall: Packaging Mixup May Cause Wrong Size Implantation

    Encore Medical recalls DJO Surgical EMPOWR 3D knee prosthetic components because packaging labels may not match the product inside, risking implantation of incorrect prosthesis sizes.

    Product
    DJO Surgical EMPOWR 3D Knee Tibial Insert - e-plus, REF: 341-12-711, Left Sz. 11 12mm, CE0086, Sterile H2O2, UDI: (01)00888912166980
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2100-2021·2021-07-28

    Cortoss Bone Augmentation Material Recalled Due to Storage Temperature Excursion

    Stryker Spine is recalling 559 units of Cortoss Bone Augmentation Material 5cc Cartridges due to a 12-hour temperature excursion at the distribution center. The affected lot may not meet required storage conditions.

    Product
    Cortoss Bone Augmentation Material 5cc Cartridge, Catalog Number 2101-0005, GTIN 00808232000962
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2133-2021·2021-07-28

    Hip implant acetabular liners recalled for edge-loading and premature wear

    Exactech Connexion GXL acetabular polyethylene liners for hip implants are recalled due to risk of edge-loading and premature wear in certain patient configurations and implant positions. Approximately 89,050 units distributed nationwide are affected.

    Product
    Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-32-XX, Acumatch GXL 15 Degree Liner, 32mm; Novation GXL Liner, Lipped Ant, 32mm; and Novation GXL Liner, Lipped, 32mm. Orthopedic hip implant component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2109-2021·2021-07-28

    Stimulen Collagen Moisturizing Lotion recalled for sterilization audit failure

    Southwest Technologies Inc is recalling Stimulen Collagen Moisturizing Lotion, ST9555B (Lot 2104007) due to failure in the sterilization audit process. Approximately 2016 units were distributed to Malaysia.

    Product
    Stimulen Collagen Moisturizing Lotion, ST9555B
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2105-2021·2021-07-28

    Cell Marque Rabbit Monoclonal Antibody Distributed Without FDA Clearance

    Cell Marque recalled 41 kits of a rabbit monoclonal antibody product distributed for in-vitro diagnostic use without required FDA clearance. The product was distributed in 16 US states.

    Product
    Cell Marque, RabMAb,CD17, c-kit (YR145) Rabbit Monoclonal Primary Antibody, REF: 117R-18, IVD, CE, GTIN: 00841683123798
    Category
    Medical Device
    Distribution
    18 states
  • ModerateFDA (Devices)·Z-2085-2021·2021-07-28

    Liberty Drain Line Recalled for Freezing Temperature Exposure During Transport

    Fresenius Medical Care is recalling 6 cases of 026-20036A Liberty Drain Lines distributed in Texas due to exposure to freezing temperatures during refrigerated truck malfunction.

    Product
    026-20036A Liberty Drain Line, Luer Tap For patients with acute and chronic end stage renal disease going under PD in healthcare or home setting
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2108-2021·2021-07-28

    Mindray battery cradle may prevent monitor from powering on

    Mindray is recalling the 3AA battery cradle (Part Number 045-001699-01) used with BeneVision TD60 and TM80 Telepack physiological monitors. The cradle may prevent the monitor from powering on. Approximately 804 units were distributed in the US and Canada.

    Product
    3AA battery cradle (Part Number 045-001699-01) used with BeneVision TD60 Telepack (Model Number 115-047566-00 /115-060044-00) and TM80 Telepack (Model Number 115-047565-00 / 120-018867-00). Used with physiological data monitor.
    Category
    Medical Device
    Distribution
    Distributed nationwide