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 deaths or serious injuries are reported, 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.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

13401–13425 of 13837

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, N
Category
Medical Device
Distribution
1 state
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-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-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-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 t
Category
Medical Device
Distribution
1 state
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 implant
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-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 th
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-2128-2021·2021-07-28
Hip Implant Liners Recalled Due to Premature Wear Risk
Exactech Connexion GXL acetabular polyethylene liners used in hip replacement systems are recalled due to risk of edge-loading and premature wear in certain patients. The 89,050 affected units were distributed nationwide.
Product
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 136-36-XX, Novation GXL Liner, +5mm Lateralized, 36mm. Orthopedic hip implant component.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2126-2021·2021-07-28
Exactech GXL Hip Implant Liners Recalled for Premature Wear Risk
Exactech is recalling its Connexion GXL acetabular polyethylene liners used in hip implants because they may experience edge-loading and premature wear in certain patient configurations and surgical positioning. A total of 89,050 units were distributed nationwide.
Product
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 136-28-XX, Novation GXL Liner, +5mm Lateralized, 28mm; and Novation GXL Liner, +5mm Lateralized, G0, 22mm ID. Orthopedic hip implant component.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2129-2021·2021-07-28
Exactech Hip Implant Liners Recalled for Premature Wear Risk
Exactech Connexion GXL hip implant liners are recalled due to risk of edge-loading and premature wear in certain patient configurations. No injuries have been reported.
Product
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 136-40-XX, Novation GXL Liner, +5mm Lateralized, 40mm. Orthopedic hip implant component.
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-2115-2021·2021-07-28
Exactech Hip Implant Liners Recalled Due to Premature Wear Risk
Exactech is recalling 89,050 Connexion GXL acetabular polyethylene hip implant liners due to risk of premature prosthesis wear in certain patient configurations and surgical positioning scenarios.
Product
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-22-XX, Novation GXL Neutral Liner, G00, 22mm ID. Orthopedic hip implant component.
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-2093-2021·2021-07-28
Laboratory Information System SoftGenomics Recalled for Displaying Incorrect Results
SoftGenomics version 4.1.15.6, a laboratory information system used in clinical laboratories, has been recalled due to reports that the software displays incorrect results and PDF reports do not match the hospital information system.
Product
SoftGenomics version 4.1.15.6 SoftGenomics is a laboratory workflow and information management system to be used in a clinical molecular or cytogenetics laboratory or medical research laboratory setting by knowledgeable and trained users. SoftGenomics is used to record and tra
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2106-2021·2021-07-28
Cell Marque MSH6 Antibody Recalled for Distribution Without FDA Clearance
Cell Marque Corporation is recalling Cell Marque Antibodies, MSH6 (44), Mouse Monoclonal Antibody because the product was distributed as an in-vitro diagnostic device without FDA clearance.
Product
Cell Marque Antibodies, MSH6 (44), Mouse Monoclonal Antibody, REF: 287M-10, IVD, CE, GTIN: 00841683104513
Category
Medical Device
Distribution
18 states
HighFDA (Devices)·Z-2099-2021·2021-07-28
Medical Device Calibration Standard Assigned Incorrectly in NEFA CAL Kit
Randox Laboratories recalls NEFA CAL IVD calibration standard kits (Batch 544642) due to incorrectly assigned calibration values that could cause measurement errors up to 8% in quality control and patient test results.
Product
NEFA CAL (Non-Esterified Fatty Acids)- IVD Standard for measurement of NEFA Catalog Number: FA115
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2107-2021·2021-07-28
Suture Anchor Products Recalled Due to Improper Sterilization
Arthrex is recalling 3,985 BioComposite SwiveLock C suture anchors due to improper sterilization from seal defects. The affected lots (12758314 and 13022357) were distributed nationwide.
Product
Suture Anchor, BioComposite SwiveLock C, 5.5 mm x 19.1 mm, Closed Eyelet, REF AR-2323BCC
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-2131-2021·2021-07-28
Exactech Hip Implant Liners Recalled Due to Premature Wear Risk
Exactech is recalling certain acetabular polyethylene hip implant liners due to risk of edge-loading and premature wear in specific implant configurations and surgical positions.
Product
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 138-28-XX, Acumatch GXL 15 Degree, +5 Lat Liner, 28mm; Novation GXL 10 Deg Liner, G0, 28mm; and Novation GXL Liner, 10 Deg Face, 28mm. Orthopedic hip implant component.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2096-2021·2021-07-28
Mediana Vital Signs Monitor May Fail to Power Up or Respond
Mediana AVSM3 SNF vital signs monitors may fail to power up or have unresponsive button controls, potentially preventing patient vital sign monitoring. The company is recalling 618 units distributed in Wisconsin.
Product
AVSM3 SNF, Vital Signs Monitor The monitor is intended to be used to monitor noninvasive blood pressure (NIBP), functional arterial oxygen saturation (SpO2), pulse rate (PR), temperature (Temp) for adult, pediatric and neonatal patients in all areas of a hospital and hospital-
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2119-2021·2021-07-28
Exactech Connexion GXL Hip Implant Liners Risk Premature Wear
Exactech hip implant liners may experience premature wear and edge-loading in certain patient configurations, according to this Class II recall of 89,050 units distributed nationwide.
Product
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-40-XX, Novation GXL Liner, Neutral, 40mm. Orthopedic hip implant component.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2086-2021·2021-07-28
Medical dialysis concentrates recalled for freezing temperature exposure
Fresenius Medical Care recalls Citrasate and NaturaLyte hemodialysis acid concentrates due to exposure to freezing temperatures during refrigerated truck transport. The affected products were distributed exclusively to Texas.
Product
Citrasate Liquid Acid Concentrate and NaturaLyte Liquid 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 us
Category
Medical Device
Distribution
1 state
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

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13401–13425 of 13837