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

37551–37575 of 40449

ModerateFDA (Devices)·Z-2260-2013·2013-09-25
Integra Recalls Cranial Access Kits Due to Potential Sterile Seal Compromise
Integra LifeSciences is recalling specific lots of Cranial Access Kits because the sterile package seal may become compromised during shipping.
Product
Cranial Access (CRAK) Kits, Product / Catalogue No.s: INSHITH, INSHITHND, INSHITHRZN The kits allow for access to the subarachnoid space or the lateral ventricles of the brain. The kits are intended to be used with an external drainage and monitoring system in selected…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2209-2013·2013-09-25
Cincinnati Sub-Zero Blanketrol III Manuals Recalled for Labeling Error
Cincinnati Sub-Zero is recalling Blanketrol III manuals because text was incorrectly added back, contradicting the device's approved intended use.
Product
Blanketrol III, Model Number 233, Cincinnati Sub-Zero Products, Inc., 12011 Mosteller Road, Cincinnati, OH 45241 Hyper-Hypothermia device used to lower or to raise a patients temperature and/or maintain a desired patient temperature through conductive heat transfer.
Category
Medical Device
Distribution
41 states
ModerateFDA (Devices)·Z-2202-2013·2013-09-25
Sonogage EyeScan A-Scan Biometer Recalled for Lack of FDA Clearance
Sonogage Inc is recalling 564 EyeScan A-Scan Biometers because the firm lacked FDA registration and 510(k) clearance for the device.
Product
Sonogage EyeScan, A-Scan Biometer, Product Usage: A-Scan Biometer diagnostic device for measurement of axial eye length.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2196-2013·2013-09-25
Assuramed Recalls DiaScreen Liquid Urine Controls Due to Storage Temperature Issues
Assuramed is recalling DiaScreen Liquid Urine Controls because they may have been stored at temperatures outside required conditions.
Product
DiaScreen Liquid Urine Controls: Positive and Negative Assayed Liquid Quality Controls for use with Dipsticks in Routine Urinalysis; Product Number D76004 (4x12 mL bottles) consists of: 2x12mL Positive controls [and] 2x12mL Negative controls; Manufactured for ARKRAY USA, Inc.…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2242-2013·2013-09-25
3M Recalls Scotchcast Cast Padding Due to Water Repellency Issues
3M is voluntarily recalling specific lots of Scotchcast Wet or Dry Cast Padding because the material does not consistently repel water, which may prolong cast drying times.
Product
3M Scotchcast, Wet or Dry Cast Padding, Catalog Numbers WDP2, WDP3, WDP4, and WDP6. Intended for use in constructing casts for either wet or dry immobilization.
Category
Medical Device
Distribution
33 states
LowFDA (Devices)·Z-2255-2013·2013-09-25
King LT-D Oropharyngeal Airways Recalled for Packaging Labeling Error
King Systems Corp. is recalling King LT-D Oropharyngeal Airways because size 5 units were packaged in pouches labeled as size 2.5.
Product
King LT-D Oropharyngeal Airways The King LT-D is intended for use in adult patients (in excess of 25 kg) for controlled ventilation during anesthesia for procedures that are short in duration and when the patient is considered to have a low risk of aspiration of stomach…
Category
Medical Device
Distribution
1 state
CriticalFDA (Devices)·Z-2126-2013·2013-09-18
Siemens Microscan Plus Negative Breakpoint Combo 4 Recalled for Misreads
Siemens Healthcare Diagnostics is recalling Microscan plus Negative Breakpoint Combo 4 panels due to confirmed false susceptible and intermediate misreads for specific antibiotics.
Product
Microscan plus Negative Breakpoint Combo 4 Sold outside of US only. Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification…
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2125-2013·2013-09-18
Siemens Microscan plus Negative Urine Combo 4 Recalled for Misreads
Siemens Healthcare Diagnostics is recalling Microscan plus Negative Urine Combo 4 panels due to confirmed false susceptible and intermediate misreads for specific antibiotics.
Product
Microscan plus Negative Urine Combo 4 Sold outside of US only. Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for…
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2123-2013·2013-09-18
Siemens Microscan Synergies Plus Negative Urine Combo 5 Recall
Siemens is recalling Microscan Synergies Plus Negative Urine Combo 5 panels due to confirmed false susceptibility results for imipenem and meropenum.
Product
Microscan Synergies Plus Negative Urine Combo 5 Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative…
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2124-2013·2013-09-18
Siemens Microscan Plus Negative Combo 3 Recalled for Misreads
Siemens Healthcare Diagnostics is recalling Microscan plus Negative Combo 3 panels due to confirmed false susceptible and intermediate misreads for imipenem and meropenum.
Product
Microscan plus Negative Combo 3 Sold outside of US only. Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2181-2013·2013-09-18
Monoject Heparin Lock Flush Syringes Recalled for Non-Sterile Water Contamination
FDA is recalling Monoject 10 Units/mL Heparin Lock Flush syringes because they may contain non-sterile water instead of the labeled saline or heparin solution.
Product
Monoject 10 Units/mL Heparin Lock Flush, 12 mL Syringe with 10 mL Fill Product ID:8881580121 Product Usage: Both 0.9% Sodium Chloride Flush syringes and 10U/mL or 100U/mL Heparin Lock Flush syringes are sterile, single-use products which are intended for use in flushing and…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2129-2013·2013-09-18
Siemens Microscan rapID/S panels recalled for false susceptibility results
Siemens Healthcare Diagnostics is recalling Microscan rapID/S panels due to confirmed false susceptible and intermediate misreads for imipenem and meropenum.
Product
Microscan rapID/S panels NC3.33 Sold in Japan only. Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2182-2013·2013-09-18
Monoject Heparin Lock Flush Syringes Recalled for Non-Sterile Water Contamination
FDA is recalling Monoject Heparin Lock Flush syringes because they may contain non-sterile water instead of the labeled saline or heparin solution.
Product
Monoject 10 Units/mL Heparin Lock Flush, 12 mL Syringe with 3 mL Fill Product ID: 8881580123 Product Usage: Both 0.9% Sodium Chloride Flush syringes and 10U/mL or 100U/mL Heparin Lock Flush syringes are sterile, single-use products which are intended for use in flushing and…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2179-2013·2013-09-18
Monoject Flush Syringes Recalled for Potential Non-Sterile Water Contamination
FDA is recalling Monoject 0.9% Sodium Chloride Flush Syringes because they may contain non-sterile water. The products are distributed in the US and Bermuda.
Product
Monoject 0.9% Sodium Chloride Flush Syringe, 12 mL Syringe with 3 mL Fill Product ID: 8881570123 Product Usage: Both 0.9% Sodium Chloride Flush syringes and 10U/mL or 100U/mL Heparin Lock Flush syringes are sterile, single-use products which are intended for use in flushing…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2127-2013·2013-09-18
Siemens MicroscanrapID/S panels recalled for antimicrobial misreads
Siemens Healthcare Diagnostics is recalling MicroscanrapID/S panels due to confirmed false susceptible and intermediate results for imipenem and meropenum.
Product
MicroscanrapID/S panels NC3.11 Sold in Japan only. Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2128-2013·2013-09-18
Siemens Microscan rapID/S panels recalled for false susceptibility results
Siemens Healthcare Diagnostics is recalling Microscan rapID/S panels due to confirmed false susceptibility and intermediate misreads for imipenem and meropenum.
Product
Microscan rapID/S panels NC3.12 Sold in Japan only. Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2186-2013·2013-09-18
Monoject Heparin Lock Flush Syringes Recalled for Potential Non-Sterile Water
The FDA is recalling Monoject 100 Units/mL Heparin Lock Flush syringes because they may contain non-sterile water while labeled as saline or heparin.
Product
Monoject 100 Units/mL Heparin Lock Flush, 12 mL Syringe with 5 mL Fill Product ID: 8881590125 Product Usage: Both 0.9% Sodium Chloride Flush syringes and 10U/mL or 100U/mL Heparin Lock Flush syringes are sterile, single-use products which are intended for use in flushing…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2119-2013·2013-09-18
Siemens Microscan Synergies Plus Negative Urine Combo 1 Recalled for Misreads
Siemens Healthcare Diagnostics is recalling Microscan Synergies Plus Negative Urine Combo 1 panels due to confirmed false susceptible and intermediate results for imipenem and meropenum.
Product
Microscan Synergies Plus Negative Urine Combo 1 Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2121-2013·2013-09-18
Siemens Microscan Synergies Plus Negative Panels Recalled for Misreads
Siemens is recalling Microscan Synergies Plus Negative panels due to confirmed false susceptible and intermediate results for imipenem and meropenum.
Product
Microscan Synergies Plus Negative Breakpoint Combo 7 Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2120-2013·2013-09-18
Siemens Microscan Synergies Plus Negative Combo 2 Recall for Misreads
Siemens Healthcare Diagnostics is recalling Microscan Synergies Plus Negative Combo 2 panels due to confirmed false susceptible and intermediate misreads for Imipenem and meropenum.
Product
Microscan Synergies Plus Negative Combo 2 Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative bacteria.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2122-2013·2013-09-18
Siemens Microscan Synergies Plus Negative Urine Combo 2 Recall
Siemens Healthcare Diagnostics is recalling Microscan Synergies Plus Negative Urine Combo 2 panels due to confirmed false susceptible and intermediate misreads for imipenem and meropenum.
Product
Microscan Synergies Plus Negative Urine Combo 2 Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2184-2013·2013-09-18
Monoject Heparin Lock Flush Syringes Recalled for Non-Sterile Water Contamination
FDA is recalling Monoject 100 Units/mL Heparin Lock Flush syringes because they may contain non-sterile water. The products are distributed in the USA and Bermuda.
Product
Monoject 100 Units/mL Heparin Lock Flush, 12 mL Syringe with 10 mL Fill Product ID: 8881590121 Product Usage: Both 0.9% Sodium Chloride Flush syringes and 10U/mL or 100U/mL Heparin Lock Flush syringes are sterile, single-use products which are intended for use in flushing…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1993-2013·2013-09-18
Cardiogenesis Transmyocardial Laser Recalled Due to Sparks and Burns
Cardiogenesis Corporation is recalling 2,498 Transmyocardial Laser devices due to reports of sparks, burns, or smoke incidents.
Product
Cardiogenesis Corporation - Cardiogenesis Transmyocardial Laser. The device is indicated for use in the treatment of patients with angina (Canadian Cardiovascular Society Class 4) refractory to medical treatment and secondary to objectively demonstrated coronary artery…
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2180-2013·2013-09-18
Monoject Flush Syringes Recalled for Potential Non-Sterile Water Contamination
Covidien LLC is recalling Monoject 0.9% Sodium Chloride Flush Syringes because they may contain non-sterile water. The products are distributed in the US and Bermuda.
Product
Monoject 0.9% Sodium Chloride Flush Syringe, 12 mL Syringe with 5 mL Fill Product ID: 8881570125 Product Usage: Both 0.9% Sodium Chloride Flush syringes and 10U/mL or 100U/mL Heparin Lock Flush syringes are sterile, single-use products which are intended for use in flushing…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2185-2013·2013-09-18
Monoject Heparin Lock Flush Syringes Recalled for Potential Non-Sterile Water
FDA Class II recall of Monoject 100 Units/mL Heparin Lock Flush syringes due to potential non-sterile water contamination.
Product
Monoject 100 Units/mL Heparin Lock Flush, 12 mL Syringe with 3 mL Fill Product ID: 8881590123 Product Usage: Both 0.9% Sodium Chloride Flush syringes and 10U/mL or 100U/mL Heparin Lock Flush syringes are sterile, single-use products which are intended for use in flushing…
Category
Medical Device
Distribution
Distributed nationwide

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37551–37575 of 40449