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

4676–4700 of 5038

SevereFDA (Devices)·Z-2294-2013·2013-10-09
MedStream Programmable Pump Recalled for Excessive Drug Flow Rates
Codman & Shurtleff is recalling MedStream Programmable Pumps because they may deliver drug flow rates exceeding programmed levels.
Product
MedStream Programmable Pump; 40ml - 91-4201US Usage: The Medstream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market. Refill Kits- are intended for use in the fil
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2300-2013·2013-10-09
MedStream Programmable Pump Recalled for Excessive Drug Flow Rates
Codman & Shurtleff, Inc. is recalling 735 MedStream Programmable Pumps because they may deliver drug flow rates exceeding programmed levels.
Product
MedStream Programmable Pump; 20ml Pump EMEA 91-4200 Product Usage: The Medstream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market. Refill Kits- are intended for
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2293-2013·2013-10-09
MedStream Programmable Pump Recalled for Excessive Drug Flow Rates
Codman & Shurtleff is recalling two MedStream Programmable Pumps because they may deliver drug flow rates exceeding programmed levels.
Product
MedStream Programmable Pump; 20ml - 91-4200US Product Usage: The Medstream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market. Refill Kits- are intended for use in
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2297-2013·2013-10-09
MedStream Refill Kit Recall for Excessive Drug Flow Rates
Codman & Shurtleff is recalling MedStream Refill Kits because they may deliver drug flow rates exceeding programmed levels.
Product
MedStream Refill Kit (6 units), EMEA: 91-4290 Product Usage: The Medstream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market. Refill Kits- are intended for use in
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2299-2013·2013-10-09
Codman MedStream Programmable Pump Recalled for Excessive Drug Flow Rates
Codman & Shurtleff, Inc. is recalling 369 MedStream Programmable Pumps because they may deliver drug flow rates exceeding programmed levels.
Product
MedStream Programmable Pump; 40ml Pump EMEA 91-4201 Product Usage: The Medstream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market. Refill Kits- are intended for
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0006-2014·2013-10-09
H&H Emergency Cricothyrotomy Kit Recall for Weakened Tubing
H & H Associates is recalling 6,619 Emergency Cricothyrotomy Kits because the medical device tubing may become weakened and ineffective.
Product
H&H Emergency Cricothyrotomy Kit (Part No. HHECT01/ HHECTK01, NSN 6515-01-573-0692), vacuum sealed and packaged in a 5 mil poly bags, labeled in part ***H & H Associates, Inc. CAGE 1NNH6 www.gohandh.com Ordinary, VA 23131 (800) 326-5708***. The product is used to maintain fr
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2296-2013·2013-10-09
MedStream Refill Kit Recalled for Excessive Drug Flow Rates
Codman & Shurtleff is recalling MedStream Refill Kits because they may allow drug flow rates to exceed programmed levels.
Product
MedStream Refill Kit (1 unit), EMEA: 91-4289 Product Usage: The Medstream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market. Refill Kits- are intended for use in
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2270-2013·2013-10-02
Invacare Power Wheelchair Recall for Unintended Slowing or Acceleration
Invacare is recalling power wheelchairs with specific joysticks due to unintended slowing or acceleration. Users should stop using the device and contact Invacare.
Product
Invacare Power Wheelchair, one per box To provide mobility to a person restricted to a sitting position.
Category
Medical Device
Distribution
53 states
SevereFDA (Devices)·Z-2188-2013·2013-09-25
B. Braun Outlook ES Infusion Pumps Recalled for Display Error
B. Braun Medical Inc. is recalling Outlook ES pumps because the display may show infusion is active when the pump has actually stopped.
Product
Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets. Used to regulate the flow of primary and secondary fluids when positive pressure is required. The infusion system is capable of delivering fluid from a negative head height (when the IV fluid con
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2227-2013·2013-09-25
Smith & Nephew Recalls OSTEORAPTOR Suture Anchors Due to Sterile Barrier Breach
Smith & Nephew is recalling OSTEORAPTOR suture anchors because pinholes in primary pouches may breach the sterile barrier, posing a risk of infection.
Product
OSTEORAPTOR CURVED 2.3 mm Suture Anchor ULTRABRAID COBRAID Suture, Black; Part Number: 72203291 Biodegradable suture anchor
Category
Medical Device
Distribution
Distributed nationwide
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 fo
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 gra
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 bacte
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 gram-nega
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 atheros
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-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-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 a
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-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 and
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 an
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-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-2178-2013·2013-09-18
Monoject Flush Syringes Recalled for Potential Non-Sterile Water Contamination
The FDA is recalling Monoject flush syringes that may contain non-sterile water instead of saline or heparin, posing a risk of infection.
Product
Monoject 0.9% Sodium Chloride Flush Syringe, 12 mL Syringe with 10 mL Fill Product ID: 8881570121 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-2130-2013·2013-09-04
Stryker Triathlon Tibial Alignment Ankle Clamp Recalled for Cracks
Stryker is recalling 10,537 Triathlon Tibial Alignment Ankle Clamps due to cracks or fractures. The instruments are used in total knee arthroplasty.
Product
Stryker Howmedica Osteonics Triathlon tibial alignment ankle clamp extramedullary (EM) referencing instrument (Cat. No. 6541-2-609), for use in Total Knee Arthroplasty (TKA) when the surgeon elects to use Stryker's Triathlon Total Knee System in conjunction with EM referencing. N
Category
Medical Device
Distribution
Distributed nationwide

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