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

17676–17700 of 40287

ModerateFDA (Devices)·Z-1742-2020·2020-04-29
Biomerieux Recalls VITEK 2 Gram-positive Susceptibility Cards Due to False Positives
Biomerieux Inc is recalling VITEK 2 Gram-positive Susceptibility Cards because they may produce false positive results for certain Staphylococcus aureus strains.
Product
The VITEK 2 Gram-positive Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in-vitro test to determine susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents when used as instructed.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1783-2020·2020-04-29
Degania Temperature Sensing Foley Catheters Recalled for Inspection Failures
Degania Medical Devices is recalling specific lots of temperature sensing Foley catheters due to inadequate incoming inspection practices for the thermistor sensors.
Product
Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101663MD - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1737-2020·2020-04-29
Boston Scientific Recalls Stretch VL Ureteral Stent Sets Due to Tracking Issues
Boston Scientific is recalling 57 units of Stretch VL Ureteral Stent Sets because they may be difficult to track over a guidewire, potentially delaying procedures.
Product
Stretch VL Ureteral Stent Set 4.8FX22-30CM with .035 Sensor UPN: M006185155080
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1762-2020·2020-04-29
Olympus Pleuravideoscope Recalled Due to Missing Compatibility Data
Olympus Corporation of the Americas is recalling 265 Pleuravideoscope Model LTF-160 units because data validating compatibility with certain endo-therapy devices was missing.
Product
Olympus Pleuravideoscope, Model LTF-160
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1753-2020·2020-04-29
Rayner RaySert PLUS Intraocular Lens Injector Recall for Labeling Error
Rayner Intraocular Lenses Limited is recalling RaySert PLUS RSP01 injectors due to a mismatch between the outer and inner tray expiration dates and lot numbers.
Product
RaySert PLUS RSP01. LOT K030. Expiry of 2024-01 - Product Usage: The single use injectors (Model STWOl and Model RSPOl) are intended to be used to compress and insert into the capsular bag only those intraocular lenses that allow the use of these injectors in their approved…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1743-2020·2020-04-29
Fentanyl Reagent Kit Recalled for Mislabeling as Clinical Diagnostic
Carolina Liquid Chemistries Corp is recalling Fentanyl Reagent Kits sold to clinical labs without FDA clearance. The products were mislabeled for diagnostic use but are intended for forensic use only.
Product
Fentanyl Reagent Kit, Product N. CC444, Contains: FENT R1 Reagent and FENT R2 Reagent
Category
Medical Device
Distribution
8 states
ModerateFDA (Devices)·Z-1728-2020·2020-04-29
Abbott Recalls Architect HAVAB G Reagent Kits Due to Antigen Concentration Error
Abbott is recalling 7,347 Architect HAVAB G Reagent Kits because an erroneous concentration value was used during manufacture, resulting in a decreased amount of antigen.
Product
ARCHITECT HAVAB G Reagent Kit. List Number 6L27 25.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1763-2020·2020-04-29
Olympus Pleuravideoscope Recalled Due to Compatibility Data Gaps
Olympus is recalling 265 Pleuravideoscope units because data validating compatibility with certain endo-therapy devices was missing. Updated manuals are being provided.
Product
Olympus Pleuravideoscope, Model LTF-240
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1749-2020·2020-04-29
Fresenius 2008T BlueStar Hemodialysis Machines Recalled for USB False Alarm
Fresenius Medical Care is recalling 15,342 hemodialysis machines because a false alarm may appear when a USB device is connected.
Product
Fresenius 2008T BlueStar Hemodialysis Machine Part Number Description: 191124 2008T HD SYS. CDX BLUEST AR; 191126 2008T HD SYS. CDX W/BIBAG BLUEST AR; 191128 2008T HD SYS. W/O CDX BLUEST AR; 191130 2008T HD SYS. W/O CDX W/BIBAG BLUEST AR
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1744-2020·2020-04-29
Acuvue Oasys for Astigmatism Contact Lenses Recalled for Package Integrity Failure
Johnson & Johnson Vision Care is recalling specific Acuvue Oasys for Astigmatism contact lenses due to a package integrity failure found during routine testing.
Product
ACUVUE OASYS for ASTIGMATISM Brand Contact Lenses. Lot no. B00NKM0G. Base Curve 8.6, Refractive Power -3.00D-1.25/90.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1787-2020·2020-04-29
Degania Recalls Temperature Sensing Foley Catheters Due to Inspection Failures
Degania Medical Devices is recalling 9,137 temperature sensing Foley catheters because inadequate incoming inspection practices were used on the thermistor sensors.
Product
Temperature Sensing 100% Silicone Foley Catheter, Part Number 102203101463DO - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1790-2020·2020-04-29
CSL Behring Recalls Siemens N Latex CDT Kit for Negative Bias
CSL Behring GmbH is recalling Siemens N Latex CDT Kits due to negative bias in carbohydrate-deficient transferrin measurements observed after 15 months.
Product
Siemens N Latex CDT Kit- IVD quantitative determination of carbohydrate-deficient transferrin (CDT) in human serum. Siemens Material Number (SMN): 10445997
Category
Medical Device
Distribution
5 states
ModerateFDA (Devices)·Z-1751-2020·2020-04-29
Beckman Coulter Recalls Synchron Opiate 2000 ng Reagent Due to Cross-Reactivity
Beckman Coulter is recalling Synchron Opiate 2000 ng Reagent because cross-reactivity testing may not meet instructions for use, potentially causing false positive or negative urine test results.
Product
Synchron Systems Opiate 2000 ng Reagent (OP2 1 x 250); catalogue no. 475006 for use in conjunction with UniCel DxC 600/800 System(s) and SYNCHRON Systems Drugs of Abuse Testing (DAT) Urine Calibrators. The assay provides a rapid screening procedure for presence of the analyte…
Category
Medical Device
Distribution
34 states
ModerateFDA (Devices)·Z-1739-2020·2020-04-29
Boston Scientific Recalls Stretch VL Ureteral Stent Sets Due to Tracking Issues
Boston Scientific is recalling 40 units of Stretch VL Ureteral Stent Sets because they may be difficult to track over a guidewire, potentially delaying procedures.
Product
Stretch VL Ureteral Stent Set 7FX22-30CM with .035 Sensor UPN: M006185157080
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1717-2020·2020-04-22
Sysmex CV-11 Sample Unit Recalled for Combustion Hazard
Sysmex America is recalling 40 CV-11 Sample Units because urine spills on the transport track can reach electrical components, creating a potential for smoke, sparks, and combustion.
Product
Sysmex CV-11 Sample Unit, an integrated modular sampler that conveys specimens to either the UF-5000 or UD-10 analyzers.
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-1700-2020·2020-04-22
Abbott Recalls Merlin PCS 3650 Software Upgrade Kit Due to Anomaly
Abbott is recalling the Merlin PCS 3650 Software Upgrade Kit because a software anomaly may cause the device to use a previously programmed shock energy level without alerting the user.
Product
Merlin PCS 3650 Software Upgrade Kit, REF 3330 St. Jude Medical The MerlinTM Patient Care System (MerlinTM PCS) Model 3650 is a portable, dedicated programming system designed to interrogate, program, display data, and test St. Jude MedicalTM implantable devices and leads.
Category
Medical Device
Distribution
40 states
HighFDA (Devices)·Z-1703-2020·2020-04-22
Sysmex CF-70 Blood Smear Transporter Recalled for Software Mismatch Hazard
Sysmex America is recalling 93 CF-70 instruments because a software mismatch may prevent the device from halting when the cover door is opened.
Product
The CF-70 instrument (product code: LXG; Regulation Number: 862.2050) receives magazines containing stained blood smears from SP-50, selects only smears that require analysis, and transports them to the DI-60 for further analysis. After completing the analysis on DI-60 the…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1693-2020·2020-04-22
Medtronic NavLock Tracker Recalled Due to Incorrect Assembly
Medtronic Navigation is recalling one unit of the NavLock Tracker because incorrect assembly could affect navigation accuracy.
Product
NavLock Tracker *** Rx Only
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1699-2020·2020-04-22
Stago STA-Deficient VIII Plasma Recalled for Cross-Contamination Risk
Diagnostica Stago is recalling STA-Deficient VIII plasma due to a risk of sample-to-sample cross-contamination that may cause falsely increased factor VIII levels.
Product
STA - Deficient VIII, Product Code: 00725. STA - Deficient VIII is an immuno-depleted human plasma intended for use in tests for the determination of factor VIII activity in plasma on STA-R and STA Compact analyzer platforms as follows: (A) STA-R Max, Product Codes: 58989…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1715-2020·2020-04-22
Smiths Medical Recalls Portex Arterial Blood Sampling Syringes with Broken Luer
Smiths Medical ASD, Inc. is recalling Portex LineDraw Arterial Blood Sampling Syringes because the luer connectors may be broken.
Product
Portex LineDraw Arterial Blood Sampling Syringe with Dry Lithium Heparin for Gases and Electrolytes
Category
Medical Device
Distribution
33 states
HighFDA (Devices)·Z-1716-2020·2020-04-22
Smiths Medical Recalls Arterial Blood Sampling Kits with Broken Luer Defect
Smiths Medical is recalling Portex Pro-Vent Arterial Blood Sampling Kits because some lots may have broken luer connectors.
Product
Portex ProVent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes
Category
Medical Device
Distribution
33 states
HighFDA (Devices)·Z-1692-2020·2020-04-22
Encore Medical Recalls djosurgical Linear Neck Trials Due to Retaining Ring Failure
Encore Medical is recalling 28 djosurgical Linear Neck Trials because the retaining ring has a potential to fail inter-operatively.
Product
djosurgical Linear Neck Trials with Spring Sides, Standard, nonsterile, REF S-200635; and djosurgical Linear Neck Trials with Spring Sides, Lateral, nonsterile, REF S-200636. The firm name on the label is djosurgical, Austin, TX.
Category
Medical Device
Distribution
7 states
ModerateFDA (Devices)·Z-1698-2020·2020-04-22
Boston Scientific Recalls Nitinol Thermocouple Electrodes Due to Incorrect Instructions
Boston Scientific is voluntarily correcting 43 units of Nitinol Thermocouple Electrodes because they were packaged with incorrect Instructions for Use.
Product
Nitinol Thermocouple Electrode, 5cm - Product Usage: The TCN Electrode is indicated for use in RF heat lesioning of peripheral nerve tissue only.The Cosman Medical TCN Electrodes are temperature-sensing probes for use in the percutaneous treatment of pain.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1714-2020·2020-04-22
Greiner Bio-One Recalls VACUETTE Coagulation Tubes Due to Anticoagulant Inconsistency
Greiner Bio-One is recalling VACUETTE 2mL 9NC Coagulation Tubes because the sodium citrate anticoagulant levels were inconsistent. The recall affects 1,000,800 units distributed nationwide.
Product
VACUETTE Tube 2ml 9NC Coagulation Sodium Citrate 3.2%. Item no. 454322. Lot no. B1908355.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1724-2020·2020-04-22
Canon Aquilion Prime SP CT Scanner Recalled for Data Loss Risk
Canon Medical System is recalling 10 Aquilion Prime SP CT scanners because a software error may interrupt scanning and cause loss of raw data.
Product
Canon Aquilion Prime SP, Model TSX-303B
Category
Medical Device
Distribution
28 states

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17676–17700 of 40287