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.

14776–14800 of 53092

HighFDA (Devices)·Z-0949-2023·2023-01-18
IMMULITE 2000 Thyroglobulin test kits recalled for reduced analytical sensitivity
Siemens is recalling 717 IMMULITE 2000 Thyroglobulin test kits because they may not accurately measure thyroglobulin levels. Inaccurate results could affect monitoring of thyroid cancer patients.
Product
IMMULITE 2000 Thyroglobulin (US)- For in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers (IMMULITE 2000/ IMMULITE 2000 XPi) for the quantitative measurement of thyroglobulin in serum or heparinized plasma, as an aid in monitoring patients who have undergone…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0924-2023·2023-01-18
Pediatric Craniotome Recalled for Ball Bearing Detachment Risk
The Anspach Effort, Inc. is recalling 6,059 Pediatric Craniotome units (CRANI-P-G1) because ball bearings in the CRANI-A attachment may detach during surgery, potentially causing serious patient injury.
Product
Pediatric Craniotome Ref:CRANI-P-G1
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0261-2023·2023-01-18
Take and Bake Blueberry Biscuits Recalled for Missing Allergen Labeling
Hippos and Hashbrowns is recalling Take & Bake Blueberry Biscuits due to missing common allergen names on the label. The product contains milk and wheat but the packaging does not clearly identify these allergens.
Product
Take & Bake Blueberry Biscuits no UPC packaged in metal tin with clear plastic nonflexible lid
Category
Food
Distribution
1 state
HighFDA (Drugs)·D-0111-2023·2023-01-18
FDA Recalls Prostaglandin E1 Injection for Lack of Sterility Assurance
Northern VA Compounders PLLC is recalling Prostaglandin E1 Injection Solution due to lack of sterility assurance. The recall affects 108 vials distributed nationwide.
Product
Prostaglandin (E1) Injection Solution, 25mcg/ml, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0931-2023·2023-01-18
Stradis Healthcare Foley Catheter Insertion Tray Recalled for Sterility Breach Risk
Stradis Healthcare is recalling Foley Catheter Insertion Trays due to potential pinhole leaks in the outer bag that could compromise sterility. The recall affects 920 units distributed across multiple US states.
Product
Stradis Healthcare Foley Catheter Insertion Tray with preconnected bag and catheter, Sterile
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0918-2023·2023-01-18
Adult Craniotome Bearings May Detach During Surgical Use
Ball bearings in the Anspach Adult Craniotome attachment may detach during removal or during surgery. Failure to follow recommended inspection intervals increases the risk of serious patient injury.
Product
Adult Craniotome Ref: CRANI-A-G1 Intended for cutting and shaping bone including the spine and cranium
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0934-2023·2023-01-18
Henry Shein Sterile Gloves Recalled for Potential Sterility Breach
Stradis Healthcare is recalling Henry Shein sterile gloves due to pinhole leaks in outer packaging that may compromise sterility. The recall affects approximately 21,755 units distributed nationwide.
Product
Henry Shein GLOVES, packaged in the following sizes and descriptions: a. Glove 6.5 Pack, 25 Pairs, 10 packs per case; b. Glove 7.0 Pack, 25 Pairs, 10 packs per case; c. Glove 7.5 Pack, 25 Pairs, 10 packs per case; d. Glove 8.0 Pack, 25 Pairs, 10 packs per case…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0107-2023·2023-01-18
Injectable Drug Recall: QuadMix Standard 001 Lacks Sterility Assurance
Northern VA Compounders recalls QuadMix Standard 001 injectable vials due to lack of sterility assurance. No illnesses reported.
Product
QuadMix Standard 001 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 10mcg/30mg/1mg/0.2mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0108-2023·2023-01-18
Compounded Injectable Drug Recalled Due to Lack of Sterility Assurance
Northern VA Compounders has recalled QuadMix Super 002 injectable medication due to lack of assurance of sterility. The affected lot is distributed nationwide.
Product
QuadMix Super 002 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 40mcg/30mg/4mg/0.4mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0922-2023·2023-01-18
Surgical Craniotome Attachment Ball Bearings Have Detached During Surgery
The Anspach 7.5 cm Large Rotating Craniotome Attachment ball bearings have come out during surgery or device removal. Failure to follow proper inspection intervals may result in serious patient injury.
Product
7.5 cm Large Rotating Craniotome Attachment. Use with XMax¿, microMax, and eMax¿ Systems Ref: CRANI-L-R Intended for cutting and shaping bone including the spine and cranium
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0913-2023·2023-01-18
Medtronic Neurostimulation Programmer Software Errors Affect 18 Devices
Medtronic is recalling 18 units of its Vanta/Seqenita LT Clinician Programmer Application due to software anomalies causing error messages that may prevent proper operation.
Product
Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900C
Category
Medical Device
Distribution
0 states
HighFDA (Drugs)·D-0110-2023·2023-01-18
Prostaglandin Injectable Recalled Nationwide Due to Sterility Assurance Concerns
Northern VA Compounders PLLC is recalling a compounded Prostaglandin (E1) Injection due to lack of sterility assurance. Patients should consult their healthcare provider immediately.
Product
Prostaglandin (E1) Injection Solution, 20 mcg/ml, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0947-2023·2023-01-18
Stradis Healthcare Recalls Sterile Port Access Tray Kits for Potential Sterility Breach
Stradis Healthcare is recalling 600 units of Tacy Medical sterile port access trays due to potential pinhole leaks in the outer packaging that could compromise sterility.
Product
Tacy Medical, Inc PORT ACCESS TRAY, Sterile, QTY 20. Manufactured for Tracy Medical, Inc.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0928-2023·2023-01-18
BD Pyxis MedBank System may dispense wrong medication due to software error
The BD Pyxis MedBank medication dispensing system has a software error that may cause the wrong medication to be loaded in a drawer compared to what the label shows, risking patient harm.
Product
BD Pyxis MedBank System - Product Label/labeling pending
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0907-2023·2023-01-18
VENTANA PD-L1 (SP142) Assay kits recalled for light staining causing false-negative results
Ventana Medical Systems recalled 8,927 VENTANA PD-L1 (SP142) Assay kits worldwide due to light staining that can cause false-negative immunotherapy marker test results affecting cancer treatment decisions.
Product
VENTANA PD-L1 (SP142) VENTANA PD-L1 (SP142) Assay (Class III, US IVD) 07709374001 VENTANA PD-L1 (SP142) Assay (CE IVD Predictive) 08008540001 VENTANA PD-L1 (SP142) IHC Assay (CE IVD Analytical) 07011571001
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0911-2023·2023-01-18
Neurostimulation Clinician Programmer Software Anomalies Affecting Device Control
Medtronic Neuromodulation is recalling 440 units of the Vanta/Seqenita LT Clinician Programmer Application due to software anomalies causing error messages that interfere with device control. Affected units were distributed worldwide.
Product
Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900A
Category
Medical Device
Distribution
0 states
HighFDA (Drugs)·D-0105-2023·2023-01-18
Injectable drug recalled due to lack of sterility assurance
Northern VA Compounders PLLC recalls compounded injectable QuadMix Super 001 (56 vials) nationwide due to lack of assurance of sterility. Affected lot #11162022@7, expiration 12/31/2022.
Product
QuadMix Super 001 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 40mcg/30mg/2mg/0.4mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-0250-2023·2023-01-18
Sanders Milk Chocolate Sea Salt Caramels Recalled for Foreign Material
Sanders Candy LLC is recalling Sanders Milk Chocolate Sea Salt Caramels due to potential cleaning brush bristles contamination. The product poses a choking and injury hazard.
Product
Sanders Milk Chocolate Sea Salt Caramels: UPC 0-35900-27636-1 36OZ Tub UPC 0-35900-25551-9 .5OZ Individual Wrapped UPC 0-35900-27436-7 28OZ Tub UPC 0-35900-27636-1 2 pack 36OZ Tub UPC 0-35900-30781-2 6OZ Pouch UPC 0-35900-30970-0 18OZ Tub UPC 0-35900-30986-1 18OZ Tub UPC…
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0951-2023·2023-01-18
FDA Recalls BIOSTOP G Cement Restrictor Due to Elevated Endotoxin Levels
DePuy Ireland is recalling all lots of BIOSTOP G Bioresorbable Cement Restrictor because endotoxin levels exceeded FDA regulatory guidance. Endotoxins can cause inflammatory responses, from mild fever to potential organ damage.
Product
BIOSTOP G BIORESORBABLE CEMENT RESTRICTOR Catalog Numbers: 546308000 (Size 8); 546310000 (Size 10); 546312000 (Size 12); 546314000 (Size 14); 546316000 (Size 16); 546318000 (Size 18); 546320000 (Size 20)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0225-2023·2023-01-18
Smoked Nova Salmon Recalled for Possible Pathogen and Toxin Formation
ACME Smoked Nova Salmon products from Lidl are being recalled due to possible pathogen growth and toxin formation. Affected products should not be consumed.
Product
ACME Smoked Nova Salmon Net Wt. 4 OZ (113G) UPC: 23384104065
Category
Food
Distribution
10 states
HighFDA (Devices)·Z-0948-2023·2023-01-18
Neonatal PICC Tray Recalled Due to Potential Sterility Breach
Vital Care Products' Neonatal PICC Tray kits may have pinhole leaks in the outer bag near the seal, potentially compromising sterility. Affected units were distributed nationwide.
Product
Vital Care Products NEONATAL PICC TRAY, Sterile, QTY 20. Manufactured for Vital Care Products, Inc.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0938-2023·2023-01-18
Syringe Kit Recall: Potential Sterility Breach from Outer Bag Leaks
Stradis Healthcare is recalling HCT 12 CC Syringe Kits due to potential pinhole leaks in the outer bag that could compromise sterility. The recall affects 112,675 units distributed nationwide.
Product
HCT 12 CC SYRINGE KIT, 20/TRAY,5 TRAYS/BAG, 5 BAGS /CASE HCT. Distributed by Health Care Technology.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0226-2023·2023-01-18
Smoked salmon recalled for possible pathogen growth and toxin formation
ACME Everything Bagel Smoked Salmon products are being recalled due to possible pathogen growth and toxin formation. The recall involves 11,391 units distributed to stores across multiple states.
Product
ACME Everything Bagel Smoked Salmon Net Wt. 4 OZ (113G) UPC:2338410420
Category
Food
Distribution
10 states
HighFDA (Devices)·Z-0927-2023·2023-01-18
DeRoyal surgical procedure pack recalled for sterile barrier defect
DeRoyal is recalling certain surgical procedure packs containing Medtronic non-absorbable sutures due to a manufacturing error that may breach the sterile barrier protecting the surgical field.
Product
DeRoyal ORGAN RECOVERY PACK PGYBK, a) REF 89-9004.09 and b) 89-9004.10
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0950-2023·2023-01-18
IMMULITE 2000 Thyroglobulin Diagnostic Kit Accuracy Issues
Siemens is recalling 7,543 kits of IMMULITE 2000 Thyroglobulin diagnostic tests due to potential accuracy and precision issues affecting diagnostic reliability.
Product
IMMULITE 2000 Thyroglobulin (OUS). For in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers for the quantitative measurement of thyroglobulin in serum or heparinized plasma, as an aid in monitoring patients who have undergone thyroidectomy. Catalog # Catalog #…
Category
Medical Device
Distribution
Distributed nationwide