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

10776–10800 of 39932

HighFDA (Devices)·Z-0923-2023·2023-01-18
Adult Craniotome Attachment Recalled for Ball Bearing Failure Risk
The ANSPACH CRANI-A Adult Craniotome Attachment is recalled because ball bearings can separate during use or removal, creating an intra-operative hazard. The Anspach Effort, Inc. is recalling 6,059 units distributed nationwide and internationally.
Product
6.5 cm Pediatric Craniotome Attachment. Use with XMax¿, microMax, and eMax¿ Systems Ref: CRANI-P Intended for cutting and shaping bone including the spine and cranium
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0920-2023·2023-01-18
Large Craniotome Attachment Ball Bearings Risk Loosening During Surgery
Ball bearings in The Anspach Effort's 7.5 cm Large Craniotome Attachment may come loose during removal or surgery, potentially causing serious patient injury. 6,059 units are affected worldwide.
Product
7.5 cm Large Craniotome Attachment Use with XMax¿, microMax, and eMax¿ Systems. Ref: CRANI-L Intended for cutting and shaping bone including the spine and cranium
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0914-2023·2023-01-18
Medtronic Vanta Seqenita LT Neurostimulation Device Recalled for Software Anomalies
Medtronic is recalling 1,337 Vanta Seqenita LT neurostimulation programmer units worldwide due to software anomalies that generate specific error messages in the clinician application.
Product
Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900D
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0953-2023·2023-01-18
Medtronic RadiaLux Lighted Retractor recalled for defective sterile pouch seal
Medtronic is recalling 2,317 RadiaLux Lighted Retractor units due to defects in the sterile pouch seal that increase contamination risk and potential post-operative infection.
Product
RadiaLux Lighted Retractor (Pink), REF: 50-101-1
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0933-2023·2023-01-18
Cystoscopy kits recalled for potential sterility breach from packaging defects
Henry Shein CYSTO SET UP PACK units are being recalled due to potential pinhole leaks in the outer bag that could compromise the sterility of the kit.
Product
Henry Shein CYSTO SET UP PACK, 20 per case. Distributed by Henry Schein.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0921-2023·2023-01-18
Adult Craniotome Ball Bearing Separation Risk During Neurosurgery
The Anspach Adult Craniotome Large attachment ball bearings may separate during surgical removal or intra-operatively, potentially causing serious patient injury.
Product
Adult Craniotome, Large Ref: CRANI-L-G1 Intended for cutting and shaping bone including the spine and cranium
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0942-2023·2023-01-18
Stradis Healthcare Neonatal PICC Trays recalled for potential sterility breach
Stradis Healthcare is recalling 2,500 units of Neonatal PICC Trays due to potential pinhole leaks in the outer bag that could compromise sterility. The affected trays were distributed nationwide.
Product
Stradis Healthcare NEONATAL PICC Tray *PGBK* 20 trays per case. Manufactured by Stradis Healthcare, Distributed by Med Alliance Group
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0939-2023·2023-01-18
HCT 6 CC Syringe Kits recalled for potential sterility breach from packaging leaks
Stradis Healthcare recalls 76,260 HCT 6 CC Syringe Kits due to potential pinhole leaks in outer packaging that may compromise sterility. The kits were distributed nationwide.
Product
HCT 6 CC SYRINGE KIT, 25/TRAY, 4 TRAYS/BAG, 5 BAGS/CASE. Distributed by Health Care Technology.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0952-2023·2023-01-18
Medical device software bug may cause patient sample order mismatches in rare cases
A software bug in Roche Diagnostics' cobas infinity central lab may cause orders to be mismatched to wrong patient samples under rare circumstances. The issue affects 224 US units and 2,797 devices worldwide.
Product
cobas infinity central lab, Material Number 07154003001
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0944-2023·2023-01-18
Stradis Healthcare TCTR Convenience Kit recalled for potential sterility compromise
Stradis Healthcare is recalling the TCTR Convenience Kit due to potential pinhole leaks near the seal that could compromise the kit's sterility. The recall affects 80 units distributed across ten states.
Product
Stradis Healthcare TCTR Convenience Kit. Manufactured by Stradis Healthcare.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0910-2023·2023-01-18
Source Administration Set medical device recalled for contamination
The FDA has recalled 2,840 units of the Source Administration Set, a medical device used for PET imaging, due to contamination with black specks on needles.
Product
Source Administration Set (SAS) used with the Medrad Intego PET Infusion System, Sterile Catalog number: INT CSS Affected material number: 86566621 Intended to deliver accurate doses of 18F Fluorodeoxyglucose (FDG) or 18F Sodium Fluoride (NaF) radiopharmaceuticals and…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0937-2023·2023-01-18
Sterile EVA Medical Bags Recalled Due to Pinhole Leak Risk
Stradis Healthcare recalls HCT 50mL sterile EVA bags due to potential pinhole leaks near the seal that could compromise sterility. Approximately 2,779 units were distributed nationwide.
Product
HCT 50mL EVA BAGS, 2 Port, Sterile, Tripple Packaged, 20 EVA BAGS/Pack, 7 Packs PER CASE. Distributed by Health Care Technology.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0916-2023·2023-01-18
Craniotome Attachment Ball Bearings May Detach During Surgery
The Anspach 6.5 cm Adult Rotating Craniotome Attachment may have ball bearings that detach during surgical use or removal. The manufacturer recommends following inspection intervals to prevent serious patient injury.
Product
6.5 cm Adult Rotating Craniotome Attachment. Use with XMax¿, microMax, and eMax¿ Systems. Ref: CRANI-A Intended for cutting and shaping bone including the spine and cranium
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0940-2023·2023-01-18
Central Line Insertion Trays Recalled for Potential Sterility Breaches
Stradis Healthcare is recalling HCT Central Line Insertion Trays due to potential pinhole leaks in the outer bag that may compromise sterility. Approximately 1,176 units were distributed nationwide.
Product
HCT CENTRAL LINE Insertion Tray, I2 per case. Distributed by Health Care Technology
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0946-2023·2023-01-18
Tacy Medical Syringe Convenience Packs Recalled Due to Potential Sterility Loss
Tacy Medical syringe convenience packs may have pinhole leaks near the seal that compromise sterility. Affected lots 222270319 and 220834335 were distributed across 10 U.S. states.
Product
Tacy Medical, Inc Syringe Convenience Pack, IML L/L, Sterile, 60 packs per bag, 5 bags per case. Manufactured for Tracy Medical, Inc.
Category
Medical Device
Distribution
Distributed nationwide
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 (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 (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 (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

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10776–10800 of 39932