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.

Agency

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

11626–11650 of 27470

HighFDA (Devices)·Z-1696-2021·2021-06-09
K2M Cascadia AN Interbody Lumbar Implants recalled for mislabeled dimensions
K2M, Inc is recalling Cascadia AN Interbody Convex lumbar implants (Lot NCMT-4437923) due to product labeling that references incorrect length or height dimensions. Seven units were distributed to the US and internationally.
Product
Cascadia AN Interbody Convex 10x22x15mm Catalog Number: 6101-2102215NC-G2 Lumbar implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as anadjunct…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1782-2021·2021-06-09
Tranberg Laser Applicator Devices Recalled Due to Inadequate Sterilization
Clinical Laserthermia Systems recalls 90 units of Tranberg Laser Applicator devices distributed worldwide because single-use sterile devices may not have been adequately sterilized.
Product
Tranberg Laser Applicator Non-cooled, 1.7mm/ 15G, 15 mm, Diffuser, 12 m, REF: 4017-02, Rx Only, Sterile EO - Product Usage: used with the Tranberg¿ MR Introducer; a device used to aid the insertion of the Laser Applicator into the tissue.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1744-2021·2021-06-09
Zavation Orthopedic Cement Delivery System Recalled for Sterilization Failure
Zavation recalled its 10-gauge orthopedic cement delivery system because products distributed as sterile may not have been adequately sterilized. Healthcare providers and patients with concerns should contact Zavation.
Product
10 GAUGE SINGLE CEMENT DELIVERY 4 FILLERS 4 SYRINGES STERILE. For use in Orthopedic / spinal procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1754-2021·2021-06-09
Orthopedic Bone Access Tools May Lack Proper Sterilization
Zavation is recalling InterV 10G Bone Access Tools (Lot 11613ZV) distributed nationwide because they may not have been adequately sterilized. No illnesses have been reported.
Product
InterV 10G Bone Access Tools/Kit, REF INTVM-FLNK. For use in Orthopedic / spinal procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1740-2021·2021-06-09
Zavation Orthopedic Cement Delivery Kit Recalled for Inadequate Sterilization
Zavation is recalling its 10G Single Cement Delivery Kit used in spinal procedures because products distributed as sterile may not have been adequately sterilized. This is an FDA Class II recall.
Product
10G SINGLE CEMENT DELIVERY KIT (5 FILLERS). For use in Orthopedic / spinal procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1710-2021·2021-06-09
FDA Recalls ZVplasty Cement Delivery Cannula Over Sterilization Failure
Zavation recalled ZVplasty Bipedicular Cement Delivery Cannulas (Lot 19123174) because products distributed as sterile may not have been adequately sterilized. These cannulas are used in spinal procedures; inadequate sterilization poses an infection risk.
Product
ZVplasty Bipedicular Cement Delivery Cannula, 11 Gauge, REF VCF-DCDK-11. For use in Orthopedic / spinal procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1693-2021·2021-06-09
Babylog VN800 Critical Care Ventilator Recalled for Software Malfunctions
Draeger Medical is recalling critical care ventilators due to software defects causing unexpected unit restarts, incorrect oxygen level alarms, and suspension of weaning therapy. Twelve units were distributed nationwide.
Product
Critical Care Ventilator, Catalog Number(s): 8422400: Babylog VN800 - Product Usage: used for treating patients who require temporary or longer term respiratory support for different medical reasons.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1765-2021·2021-06-09
Orthopedic Spinal Procedure Kit Recalled for Inadequate Sterilization
Zavation's ZVplasty spinal surgical kit is being recalled because distributed units may not have been adequately sterilized. The recall affects 302 units distributed nationwide.
Product
ZVplasty 10G, 20mm, Traditional Unipedicular Kit, REF VCF-1020-1. For use in Orthopedic / spinal procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1728-2021·2021-06-09
Zavation recalls ZVplasty Diamond Tip Trocar due to sterilization failure
Zavation is recalling 113 units of ZVplasty Direct Access Diamond Tip Trocars (11 Gauge) due to inadequate sterilization. The devices were distributed nationwide and may not be safe for use in orthopedic and spinal procedures.
Product
ZVplasty Direct Access Diamond Tip Trocar, 11 Gauge, REF VCF-1023-11. For use in Orthopedic / spinal procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1700-2021·2021-06-09
Zavation Spinal Stylet Instruments Recalled for Inadequate Sterilization
Zavation is recalling 56 units of 10 Gauge Direct Unilateral Stylets used in spinal procedures because products distributed as sterile may not have been adequately sterilized. Patients who received this device should contact their healthcare provider.
Product
10 GAUGE DIRECT UNILATERAL STYLET(1 X DIAMOND 1 X BEVEL), INTVM-DSSKBD. For use in Orthopedic / spinal procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1745-2021·2021-06-09
10G Coaxial Cannulas Recalled Due to Inadequate Sterilization in Spinal Procedures
Zavation's 10G Coaxial Cannulas for spinal procedures may not have been adequately sterilized. The nationwide recall addresses potential infection risk from non-sterile surgical instruments.
Product
10G COAXIAL CANNULA WITH TUOHY CONNECTION STERILE. For use in Orthopedic / spinal procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1730-2021·2021-06-09
Zavation Coaxial Cannula Lot 20102495 Recalled for Inadequate Sterilization
Zavation's 10G Coaxial Cannula with Tuohy Connection (Lot 20102495) used in spinal and orthopedic procedures has been recalled due to inadequate sterilization. Patients should contact their healthcare provider if they received this product.
Product
10 G Coxaxial Cannula with Tuohy Connection, CODE: INTVM-CC. For use in Orthopedic / spinal procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1703-2021·2021-06-09
Zavation ZVplasty Direct Access Beveled Tip Surgical Trocars Recalled for Inadequate Sterilization
Zavation is recalling 335 units of ZVplasty Direct Access Beveled Tip Trocars (10 Gauge) used in orthopedic and spinal procedures because affected units may not have been adequately sterilized.
Product
ZVplasty Direct Access Beveled Tip Trocar, 10 Gauge, REF VCF-1022. For use in Orthopedic / spinal procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1770-2021·2021-06-09
Orthopedic Spinal Balloon Kit Recalled for Inadequate Sterilization Risk
Zavation's VERTEBREX single balloon kit for spinal procedures is being recalled because distributed units may not have been adequately sterilized, creating a potential infection risk.
Product
VERTEBREX SINGLE BALLOON KIT, REF VBRX-20-SBK-10. For use in Orthopedic / spinal procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1716-2021·2021-06-09
Zavation 10 Gauge Direct Access Diamond Tip Devices Recalled for Sterilization
Zavation is recalling 89 units of 10 Gauge Direct Access Diamond Tip devices (Lot 11285ZV, 2001200) distributed nationwide for orthopedic spinal procedures because they may not have been adequately sterilized.
Product
10 GAUGE DIRECT ACCESS DIAMOND TIP, CODE: INTVM-DWCd. For use in Orthopedic / spinal procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1709-2021·2021-06-09
ZVplasty Unipedicular Cement Delivery Cannula Kit May Not Be Adequately Sterilized
Zavation recalls ZVplasty Unipedicular Cement Delivery Cannula Kit (72 units nationwide) due to sterilization failure. Products distributed as sterile may not have been adequately sterilized.
Product
ZVplasty Unipedicular Cement Delivery Cannula Kit, 10 Gauge, REF VCG-SCDK. For use in Orthopedic / spinal procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1748-2021·2021-06-09
Zavation 10G Beveled Trocar/Cannula recalled for inadequate sterilization
Zavation is recalling 10G Beveled Trocar/Cannula surgical instruments distributed nationwide because they may not have been adequately sterilized. Patients who received these instruments in orthopedic or spinal procedures should consult their healthcare provider.
Product
10G BEVELED TROCAR/CANNULA. For use in Orthopedic / spinal procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1746-2021·2021-06-09
Zavation 10 Gauge Sterile Surgical Drill Recalled for Inadequate Sterilization
Zavation is recalling 10 gauge sterile surgical drills used in orthopedic and spinal procedures because products distributed as sterile may not have been adequately sterilized. Products were distributed nationwide.
Product
10 GAUGE DRILL STERILE. For use in Orthopedic / spinal procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1783-2021·2021-06-09
Elekta MOSAIC Oncology Information System Recalled Due to Malware Attack
Elekta recalled versions 2.62, 2.64, 2.70, 2.81, 2.82, and 2.83 of the MOSAIC Oncology Information System due to a malware attack. Forty units were distributed nationwide.
Product
Elekta MOSAIC Oncology Information System versions: 2.62, 2.64, 2.70, 2.81, 2.82, and 2.83 hosted on Classic Cloud
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1737-2021·2021-06-09
Orthopedic Trocar and Cannula Recalled for Sterilization Failure
Zavation's 11G Diamond Trocar/Cannula, used in orthopedic and spinal procedures, may not have been adequately sterilized. The manufacturer is recalling affected units distributed nationwide.
Product
11G DIAMOND TROCAR/CANNULA. For use in Orthopedic / spinal procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1727-2021·2021-06-09
Orthopedic spinal surgical device recalled for inadequate sterilization
Zavation recalls orthopedic spinal devices distributed as sterile but potentially inadequately sterilized. Patients who received these devices should consult their healthcare provider.
Product
10G DIRECT SINGLE - ACCESS, CODE: INTV-DWCb. For use in Orthopedic / spinal procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1768-2021·2021-06-09
Zavation OsteoFlex Cement Surgical System Recalled Due to Sterilization Concerns
Zavation is recalling OsteoFlex Cement and Mixing System used in spinal and orthopedic surgery due to potential sterilization failures. The 846 units distributed nationwide may not be adequately sterilized, creating a contamination risk.
Product
OsteoFlex Cement and Mixing System, REF VCF-OSFL. For use in Orthopedic / spinal procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1767-2021·2021-06-09
ZVPlasty Orthopedic Spinal Device Recalled for Inadequate Sterilization
Zavation is recalling ZVPlasty spinal orthopedic devices that may not have been properly sterilized, creating a risk of infection. The recall affects 49 units distributed nationwide.
Product
ZVPlasty, 11G, 15mm Traditional Bipedicular Kit, REF VCF-1115-2. For use in Orthopedic / spinal procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1756-2021·2021-06-09
OsteoFlex Bone Cement Recalled Due to Inadequate Sterilization
Zavation's OsteoFlex bone cement distributed nationwide may not have been adequately sterilized. Patients who received this sterile surgical product in orthopedic or spinal procedures should contact their healthcare provider.
Product
OsteoFlex BONE CEMENT, REF Numbers: a) INTV-OSFL b) INTV-OSFL-LV. For use in Orthopedic / spinal procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1793-2021·2021-06-09
Zimmer Femoral Nail Recall: Risk of Commingled Angle Versions
Zimmer is recalling 16 units of its Natural Nail femoral implant due to potential commingling between two versions with different CCD angles (130 and 125 degrees). Wrong angle components could result in improper fracture fixation.
Product
Zimmer Natural Nail- ZNN Cephalomedullary Short Nail 11.5 mm X 21.5 cm 130 CCD Left Ti-6Al-4V Alloy-is intended for temporary fracture fixation and stabilization of the bone Item Number: 47-2493-213-11
Category
Medical Device
Distribution
4 states

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11626–11650 of 27470