Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

20276–20300 of 50413

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
HighFDA (Devices)·Z-1715-2021·2021-06-09
Orthopedic spinal surgical device may lack adequate sterilization
Zavation is recalling its 10G DIRECT SINGLE - ACCESS device used in spinal surgery. Products distributed as sterile may not have been adequately sterilized.
Product
10G DIRECT SINGLE - ACCESS, CODE INTVM-DSBAK. 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-1711-2021·2021-06-09
ZVplasty Direct Access Bevel Tip Trocar Recalled Due to Inadequate Sterilization
Zavation is recalling ZVplasty Direct Access Bevel Tip Trocars used in orthopedic and spinal procedures because products distributed as sterile may not have been adequately sterilized. The recall affects 98 units distributed nationwide.
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-1732-2021·2021-06-09
ZVplasty Cement Delivery Cannula Recalled Due to Sterilization Failure
Zavation recalls 22 ZVplasty Cement Delivery Cannulas (lot 20102490) distributed nationwide because they may not have been adequately sterilized for use in orthopedic and spinal procedures.
Product
ZVplasty Cement Delivery Cannula, REF VCF-1007. For use in Orthopedic / spinal procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1776-2021·2021-06-09
Oral Surgery Scrapers Recalled Due to Potential Sterility Failure
Meta C.G.M. Spa is recalling the REF 3987 SafeScraper Curve Twist oral surgical scrapers distributed in Texas and Florida due to sterility concerns. The single-use sterile devices may not have been adequately sterilized.
Product
REF 3987, SAFESCRAPER CURVE TWIST, CE 0123, STERILE EO. Used in oral surgery.
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-1689-2021·2021-06-09
Vygon Dressing Change Kit Recalled for Sterile Barrier Failure Risk
Vygon U.S.A. is recalling 8,320 units of its Dressing Change w/ Maxiswab kit due to improper adhesion of the sterile Tyvek lid to the tray, which could compromise the sterile barrier and potentially cause infection.
Product
Vygon Dressing Change w/ Maxiswab - Product Usage: Custom Dressing Change kit, Product Code: AMS-8465CS.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0636-2021·2021-06-09
Clio Greek Yogurt Bars Recalled for Possible Metal Fragments
Clio LLC is recalling Clio Greek Yogurt Bar Vanilla 10-packs (UPC 861703000106) distributed nationwide due to the possible presence of metal fragments in the product.
Product
Clio Greek Yogurt Bar Vanilla 50g x 10 Clio Retail 10-pack. UPC Code: 861703000106
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1708-2021·2021-06-09
ZVplasty Bone Access Kit Recalled for Inadequate Sterilization
Zavation has recalled the ZVplasty Direct Unipedicular Bone Access Kit with Drill due to potential sterilization failure. The surgical device is used in orthopedic and spinal procedures, with 11 units distributed nationwide.
Product
ZVplasty Direct Unipedicular Bone Access Kit with Drill, 10 Gauge, REF VCF-DSBAK. For use in Orthopedic / spinal procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1762-2021·2021-06-09
Zavation ZVplasty Orthopedic System Recalled for Inadequate Sterilization
Zavation's ZVplasty System surgical devices may not have been adequately sterilized, creating infection risk. The recall affects 195 units distributed nationwide in the US across multiple lot numbers.
Product
ZVplasty System, 15mm, Part Numbers: a) VCF-1015-2 b) VCF-1015-2A. For use in Orthopedic / spinal procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0634-2021·2021-06-09
Clio No Added Sugar Yogurt Bars Recalled for Possible Metal Fragments
Clio LLC is recalling Clio No Added Sugar Yogurt Bars (Mixed Berry/Peach, 50g) due to possible metal fragments in the product. Approximately 1,880 units were distributed nationwide.
Product
Clio No Added Sugar Yogurt Bar Mixed Berry / Peach 50g x 16 (12pc tray). UPC Code: 854021008220
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1761-2021·2021-06-09
Spinal surgery implant kit recalled for inadequate sterilization
Zavation is recalling ZVplasty 10G spinal implant kits that may not have been properly sterilized. The affected devices were distributed nationwide and may pose infection risk if implanted.
Product
ZVplasty 10G, 15mm, Additional Level Kit, REF VCF-1015-1A. For use in Orthopedic / spinal procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0635-2021·2021-06-09
Clio Greek Yogurt Bars Recalled for Possible Metal Fragments
Clio LLC is recalling Clio Greek Yogurt Bar Vanilla/Strawberry Club pack 50g x 12, 16pc tray due to possible metal fragments in the product. Consumers should not consume the affected product.
Product
Clio Greek Yogurt Bar Vanilla / Strawberry Club pack 50g x 12 , 16pc tray. UPC Code: 854021008121
Category
Food
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0602-2021·2021-06-09
Buspirone Hydrochloride Tablets Recalled for Foreign Tablet Contamination
Oxford Pharmaceuticals is recalling 6,864 bottles of Buspirone Hydrochloride Tablets, 15 mg, distributed nationwide due to the presence of foreign tablets or capsules in the product.
Product
BUSPIRONE HYDROCHLORIDE — BUSPIRONE HYDROCHLORIDE (BUSPIRONE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1774-2021·2021-06-09
Philips BRILLIANCE VOLUME CT System cooling unit may eject from gantry
A cooling unit in the Philips BRILLIANCE VOLUME computed tomography system may unexpectedly eject from the gantry, posing a risk of injury. Two affected units are being recalled.
Product
BRILLIANCE VOLUME system - A Computed Tomography X-Ray System intended to produce images of the head and body. Model Number: 728306
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1714-2021·2021-06-09
Zavation Orthopedic Stylet 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. Affected units were distributed nationwide.
Product
10 GAUGE DIRECT UNILATERAL STYLET(1 X DIAMOND 1 X BEVEL), CODE INTVM-DSSKbd. For use in Orthopedic / spinal procedures.
Category
Medical Device
Distribution
Distributed nationwide