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 13836

HighFDA (Devices)·Z-2082-2021·2021-07-28
Hemodialysis concentrate recalled for freezing exposure during transport
Fresenius Medical Care recalls Granuflo and Naturalyte hemodialysis concentrate affected by freezing temperatures during refrigerated truck transport. Freezing may compromise product sterility and safety.
Product
(1) 08-4078-BB BIBAG 650 GRAMS/BAG 16 BAGS/CASE (2) 08-4080-BB BIBAG 900 grams/bag 12 bags/case For patients with acute and chronic end stage renal disease going under PD in healthcare or home setting GRANUFLO & NATURALYTE: Concentrate is formulated to be used in conjunct
Category
Medical Device
Distribution
1 state
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 formula
Category
Medical Device
Distribution
1 state
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-2130-2021·2021-07-28
Exactech Connexion GXL hip implant liners risk edge-loading and wear
Exactech Connexion GXL acetabular polyethylene liners used in hip replacements may experience edge-loading and premature wear in certain patients due to implant configuration or surgical positioning. Approximately 89,050 units were distributed nationwide.
Product
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 138-22-XX, Novation GXL 10 deg Liner, G00, 22mm ID. Orthopedic hip implant component.
Category
Medical Device
Distribution
Distributed nationwide
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-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-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-2124-2021·2021-07-28
Hip implant liners recalled for edge-loading and premature wear
Exactech Connexion GXL hip implant liners are recalled due to risk of edge-loading and premature wear in certain configurations. About 89,050 units distributed nationwide are affected.
Product
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 134-28-XX, Acumatch GXL, Ext Cov Liner, 28mm. Orthopedic hip implant component.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2111-2021·2021-07-28
Ultrasound Imaging Software Recalled for Inaccurate Measurement Estimates
Caption Health recalled ultrasound imaging software version 1.2.0 due to a bug that includes unintended video frames in its analysis, potentially resulting in incorrect automated ejection fraction and image quality score estimates. The recall affects approximately 15 systems distributed across five U.S. states.
Product
Version: 1.2.0 (1.2.0+85ela410) Caption Health, Caption AI, Ultrasound Imaging System Application Software (GMDN: 40873), UDI: (01)00860003586303(10)1.2.0)
Category
Medical Device
Distribution
5 states
HighFDA (Devices)·Z-2132-2021·2021-07-28
Exactech Hip Implant Liners Recalled Due to Premature Wear Risk
Exactech is recalling Connexion GXL hip implant liners due to edge-loading and premature wear risk in certain patient configurations. The recall affects 89,050 units distributed nationwide.
Product
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 138-32-XX, Novation GXL Liner, 10 Deg Face, 32mm. Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 138-36-XX, Acumatch GXL
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-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-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-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-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-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-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-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-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-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-2089-2021·2021-07-28
MTS Set dialysis accessory recalled for freezing temperature exposure during transport
Fresenius is recalling MTS Sets distributed to Texas due to exposure to freezing temperatures from refrigerated truck malfunctions. This exposure may compromise the sterility of the device.
Product
The MTS Set is a single-use, sterile (EO), non-pyrogenic, optional accessory that provides additional connections/disconnections when used with a stay"safe compatible cycler set during acute and chronic PD treatment. The MTS Set utilizes the same PIN engagement technology used in
Category
Medical Device
Distribution
1 state
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-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-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

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13401–13425 of 13836