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

13776–13800 of 13837

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-1724-2021·2021-06-09
Zavation Surgical Trocars Recalled Due to Sterilization Concerns
Zavation recalled 98 surgical trocars that may not be adequately sterilized. Products were distributed as sterile but may pose infection risks from inadequate sterilization.
Product
ZVplasty Direct Access Bevel Tip Trocar, 11 Gauge, REF VCF-1022-11. 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-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-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-1723-2021·2021-06-09
ZVplasty Biopsy Device Recalled Due to Inadequate Sterilization
Zavation's ZVplasty Biopsy Device (11 Gauge, lot 20061370) is being recalled because distributed units may not have been adequately sterilized. The 34 affected units were distributed nationwide.
Product
ZVplasty Biopsy Device, 11 Gauge, REF VCF-1010-11. For use in Orthopedic / spinal procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1720-2021·2021-06-09
Zavation spinal orthopedic cement delivery kits recalled for inadequate sterilization
Zavation is recalling 122 units of sterile orthopedic cement delivery kits that may not have been adequately sterilized. The kits were distributed nationwide for use in spinal and orthopedic procedures.
Product
10 GAUGE SINGLE CEMENT DELIVERY 4 FILLERS 4 SYRINGES, CODE: INTVM-SCDK. 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-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-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 t
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-1757-2021·2021-06-09
ZVplasty System spinal implant devices recalled for inadequate sterilization
Zavation is recalling 31 ZVplasty System spinal implant devices that may not have been adequately sterilized. Patients who received these implants should contact their physician.
Product
ZVplasty System, 10mm, Pat# VCF-1010-2. 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-1792-2021·2021-06-09
Zimmer Natural Nail cephalomedullary device angle mismatch recall
Zimmer GmbH is recalling its Cephalomedullary Short Nail due to potential mix-up between 125 and 130 degree CCD angle versions. Eight units with Lot 3020731 are affected and distributed to CA, GA, KY, MD, and internationally.
Product
Zimmer Natural Nail -ZNN Cephalomedullary Short Nail 11.5 mm X 21.5 cm 125 CCD Left Ti-6Al-4V Alloy- intended for temporary fracture fixation and stabilization of the bone Item Number: 47-2493-211-11
Category
Medical Device
Distribution
4 states
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-1692-2021·2021-06-09
Draeger Babylog VN600 Critical Care Ventilators Recalled for Software Defects
Draeger Medical is recalling Babylog VN600 ventilators due to three software issues: unexpected unit restarts, incorrect oxygen-level alarms, and failure of the automated weaning protocol. These defects could affect patient care and safety.
Product
Critical Care Ventilator, Catalog Number(s): 8422200: Babylog VN600 - 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-1707-2021·2021-06-09
ZVplasty Surgical Bone Access Kit Recalled for Inadequate Sterilization
Zavation is recalling ZVplasty Direct Bipedicular Bone Access Kits because products distributed as sterile may not have been adequately sterilized. Affected lot numbers 19113043 and 20041107 were distributed nationwide.
Product
ZVplasty, Direct Bipedicular, Bone Access Kit with Coxaial Cannula, REF VCF-DDSKbd. 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-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-1750-2021·2021-06-09
Zavation CEMIX Orthopedic Cement Mixing System Sterilization Recall
Zavation recalled 197 CEMIX cement mixing system units due to inadequate sterilization for orthopedic and spinal surgical use.
Product
CEMIX - CEMENT MIXING SYSTEM STERILE, CODE INTV-MMS. 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-1725-2021·2021-06-09
ZVplasty Directional Cement Cannula Long may lack adequate sterilization
Zavation is recalling 27 units of ZVplasty Directional Cement Cannula Long (Lot 20061365) used in orthopedic and spinal procedures due to inadequate sterilization. Products were distributed nationwide as sterile but may not have undergone proper sterilization processing.
Product
ZVplasty Directional Cement Cannula Long, REF VCF-1080-L. For use in Orthopedic / spinal procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1749-2021·2021-06-09
Zavation Orthopedic Spinal Stylets Recalled for Inadequate Sterilization
Zavation has recalled 10 gauge direct unilateral sterile stylets used in orthopedic and spinal procedures due to inadequate sterilization. Products distributed as sterile may not meet sterilization standards.
Product
10 GAUGE DIRECT UNILATERAL STYLET (1 X DIAMOND 1 X BEVEL) STERILE. 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

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13776–13800 of 13837