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

35901–35925 of 40449

ModerateFDA (Devices)·Z-1540-2014·2014-05-14
Alere Triage BNP Test Recalled for Potential Out-of-Range Results
Alere San Diego, Inc. is recalling specific lots of the Alere Triage BNP Test because they may not recover within range when tested with certain controls.
Product
Alere Triage BNP Test for the Beckman Coulter Access Family of Immunoassay Systems, Model Number 98200, Lot Numbers: 329599, 331265. The Alere Triage BNP test is intended to be used as an aid in the diagnosis of congestive heart failure (heart failure), as an aid in the…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1545-2014·2014-05-14
Siemens CLINITEK Status+ Analyzer Recalled for Uncleared Marketing Status
Siemens Healthcare Diagnostics Inc is recalling CLINITEK Status+ Analyzers with Sample Interference Notes enabled because they were not cleared for US marketing.
Product
CLINITEK Status+ Analyzer (portable urine chemistry analyzer). Catalog number 10490946.
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-1513-2014·2014-05-07
Brainlab ExacTrac 6.0 Radiation Positioning System Recalled for Targeting Error
Brainlab AG is recalling ExacTrac 6.0 systems because they may position patients to unintended radiation targets, potentially delivering dose to the wrong location.
Product
ExacTrac 6.0 is a patient positioning and monitoring system. Model/catalogue numbers: 20833B EXACTRAC 6.0 IR POSITIONING SOFTWARE 49936 ET SOFTWARE UPDATE 6.0.X TO 6.0.3 49926B ET UPGRADE SOFTWARE 3.X TO 6.0 (IR+XR) 49934A EXACTRAC UPGRADE 5.5 TO 6.0 BASIC 49927B ET…
Category
Medical Device
Distribution
7 states
SevereFDA (Devices)·Z-1482-2014·2014-05-07
Hospira Recalls Acclaim Infusion Pumps Due to Broken Door Assemblies
Hospira is recalling 13,218 Abbott Acclaim Infusion Pumps because broken door assemblies may prevent the door from closing, potentially causing unrestricted flow or therapy delays.
Product
Abbott Acclaim Infusion Pump Designed to deliver parenteral infusions including whole blood or red blood cell components and enteral fluids using a wide variety of standard administration sets and fluid containers.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1483-2014·2014-05-07
Hospira Acclaim Encore Infusion Pump Recall for Broken Door Assemblies
Hospira is recalling 13,218 Acclaim Encore infusion pumps because broken door assemblies may prevent proper closure, causing unrestricted flow or therapy delays.
Product
Hospira Acclaim Encore Infusion Pump Designed to deliver parenteral infusions including whole blood or red blood cell components and enteral fluids using a wide variety of standard administration sets and fluid containers.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1512-2014·2014-05-07
Hospira Recalls GemStar Docking Stations Due to Power and Voltage Issues
Hospira is recalling GemStar Docking Stations because they may cause infusion pumps to fail to power up or stop infusions due to voltage errors.
Product
GemStar Docking Station, used with GemStar infusion pump, in combination with other GemStar accessories such as the GemStar Lock Box and patient bolus cord. The docking station is also used for hosting the GemStar pump for general infusions. List Numbers: 13075-XX-XX.
Category
Medical Device
Distribution
53 states
HighFDA (Devices)·Z-1515-2014·2014-05-07
Acumed Osteo-Clage System Recalled for Non-Specification Stainless Steel
Acumed LLC is recalling the Osteo-Clage System because the stainless steel used in manufacturing was not within specifications.
Product
The Osteo-Clage System consists of stainless steel cable/sleeves and compression plates. . 2.0 mm x 850mm SS Cable/Sleeve; Part Number 01-0020-S 2.0 mm SS Sleeve Only; Part Number 01-0022-S 8, 7 hole, SS compression plate; Part Number 02-2007-S 10, 9 hole, SS compression…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1533-2014·2014-05-07
GE Healthcare Recalls MRI Scanners Due to Cradle Release Malfunction
GE Healthcare is recalling 1,548 MRI scanners because a malfunctioning cradle release mechanism could delay or impede patient egress from the system.
Product
GE Healthcare Discovery MR450, Discovery MR750, Optima MR450w, Optima MR450w equipped with the GEM option, Discovery MR750w, and Discovery MR750w equipped with the GEM option products. Affected devices are whole body magnetic resonance scanners indicated for use as a…
Category
Medical Device
Distribution
6 states
HighFDA (Devices)·Z-1510-2014·2014-05-07
Philips ADAC Nuclear Gamma Cameras Recalled for Potential Patient Contact
Philips Medical Systems is recalling 1,043 ADAC nuclear gamma cameras because a belt slippage issue could cause the detector head to drift and contact patients.
Product
Nuclear gamma cameras (ADAC Vertex Plus, ADAC Solus, ADAC Vertex V60 & ADAC Vertex Classic) Philips Medical System, Cleveland, OH 44143. Used to produce images depicting the anatomical distribution of single photon and positron emitting radioisotopes with the human body for…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1511-2014·2014-05-07
GE Healthcare Recalls CardiacVX Software Due to Inaccurate Flow Values
GE Healthcare is recalling CardiacVX and CardiacVX Flow software because it may report flow values higher than actual. The recall affects 101 units distributed worldwide.
Product
GE Healthcare, CardiacVX [CardiacVX (1.1.0 Ext. d) and CardiacVX Flow (1.1.0 Ext. d) analysis software running on Advantage Workstation]. Model #'s 5434389-2 and 5434384-2. The GE Cardiac VX for MRI is an analytical software tool, which provides reproducible tools for the…
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1521-2014·2014-05-07
Fisher Scientific Recalls Sterile Swabs Due to Organism Contamination
Fisher Scientific is recalling Fisherbrand Sterile Swabs after a customer reported the presence of an organism in a lot of wood applicator swabs.
Product
Fisherbrand Sterile Swabs, Calcium Alginate Fiber Tipped Aluminum Applicator Swab, .025 and .035 in Diameter, all lots, 100 per pack Fisherbrand Sterile Swabs, Calcium Alginate Fiber Tipped Plastic Applicator Swab, all lots, 100 per pack Fisherbrand Sterile Swabs, Calcium…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1516-2014·2014-05-07
Acumed Recalls Tension Band Pins Due to Steel Specification Defect
Acumed LLC is recalling specific lots of Tension Band Pins because they were manufactured with stainless steel that does not meet specifications.
Product
The Acumed Tension Band Pin is a fixation pin which is .0625" in diameter and is available in lengths between 35mm and 90mm. It is to be used in conjunction with commonly used orthopedic wire. 50.0 mm Tension Band Pin; Part Number 30-0097 70.0 mm Tension Band Pin; Part…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1530-2014·2014-05-07
Alfa Wassermann ACE AST Reagent Recalled for Low Absorbance Readings
Alfa Wassermann is recalling specific lots of ACE AST Reagent because they produce extremely low absorbance readings, which may affect clinical test results.
Product
Alfa Wassermann Diagnostic Technologies, LLC. ACE AST Reagent. Product Usage: For quantitative determination of AST in serum and lithium heparin plasma using ACE¿, ACE Alera¿ and ACE Axcel Clinical Chemistry Systems. This test is intended for use in clinical laboratories…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1519-2014·2014-05-07
Ortho-Clinical Diagnostics Recalls VITROS Specialty Diluent Due to Inaccurate CRP Results
Ortho-Clinical Diagnostics is recalling VITROS Specialty Diluent because it may cause C-Reactive Protein test results to be approximately 51% lower than expected.
Product
VITROS Chemistry Products Specialty Diluent, REF 855 9825, 6 x 3 mL, IVD --- Ortho-Clinical Diagnostics, Inc. Rochester, NY
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1517-2014·2014-05-07
Siemens IMMULITE Total IgE Assay Recalled for Positive Bias
Siemens Healthcare Diagnostics is recalling IMMULITE Total IgE assays due to a confirmed 23% positive bias against the WHO 2nd IRP 75/502.
Product
IMMULITE /IMMULITE 1000 Systems TIE Total IgE, REF LKIE1, SMN 10380867, IVD --- Siemens Healthcare Diagnostics Products Ltd. For in vitro diagnostic use with the IMMULITE, IMMULITE 1000, and IMMULITE 2000/ IMMULITE 2000 XPi Systems Analyzers - for the quantitative measurement of…
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1531-2014·2014-05-07
Siemens IMMULITE Androstenedione Assay Recalled for Over-Recovery
Siemens recalls IMMULITE Androstenedione assays because they over-recover samples above 5.5 ng/mL, contradicting the stated 10 ng/mL linearity limit.
Product
IMMULITE/IMMULITE 1000 Systems Androstenedione (Test Code AND), REF LKAO1, SMN 10381158, IVD, 100 test kit size --- Siemens Healthcare Diagnostics Products Ltd. Llanberis, Gwynedd, LL55 4EL, UK For in vitro diagnostic use with the IMMULITE/IMMULITE 1000 and 2000 Systems…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1529-2014·2014-05-07
Alfa Wassermann ACE ALT Reagent Recalled for Low Absorbance Readings
Alfa Wassermann is recalling 731 kits of ACE ALT Reagent due to extremely low absorbance readings that may affect test accuracy.
Product
Alfa Wassermann Diagnostic Technologies, LLC. ACE ALT Reagent. Product Usage: For quantitative determination of ALT in serum and lithium heparin plasma using ACE¿, ACE Alera¿ and ACE Axcel Clinical Chemistry Systems. This test is intended for use in clinical laboratories…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1532-2014·2014-05-07
Siemens Androstenedione Assay Recall Due to Over-Recovery
Siemens recalls Androstenedione assays because they over-recover samples above 5.5 ng/mL, contradicting the stated 10 ng/mL limit.
Product
IMMULITE 2000/2000 XPi Systems Androstenedione (Test Code AND), REF L2KAO2, SMN 10381188, IVD, 200 test kit size --- Siemens Healthcare Diagnostics Products Ltd. Llanberis, Gwynedd, LL55 4EL, UK For in vitro diagnostic use with the IMMULITE/IMMULITE 1000 and 2000 Systems…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1526-2014·2014-05-07
Medtronic External Neurostimulators Recalled for Cycling Feature Labeling Issue
Medtronic is recalling external neurostimulators because current labeling indicates the cycling feature improves device longevity and recharge interval.
Product
Medtronic, External neurostimulator, ENS (37021) & ENS (37022). Including the external neurostimulators which are associated with software application run on the NVision Clinician Programmer and used during trialing for spinal cord stimulation (SCS) patients.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1520-2014·2014-05-07
Ortho-Clinical Diagnostics Recalls VITROS Chemistry Diluent Packs Due to Inaccurate Results
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products FS Diluent Pack 3 because internal testing found it may cause C-Reactive Protein test results to be approximately 51% lower than expected when used for dilution.
Product
VITROS Chemistry Products FS Diluent Pack 3, REF 680 1754, 3 x 45 mL, (D1)/15 mL (D2), IVD --- Ortho-Clinical Diagnostics, Inc. Rochester, NY, 14626
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1535-2014·2014-05-07
Teleflex Recalls Dekna-lok Sutures for Failing Resorption Strength Requirements
Teleflex Medical is recalling 7,380 units of Dekna-lok sutures because they did not meet minimum resorption strength requirements. The affected products were distributed in the US, Ireland, and Singapore.
Product
Dekna-lok, 1 x 17.78 cm, Violet Braided Polyglycolic Acid Coated Suture, Synthetic Absorbable Surgical Suture USP, Rx Only, Sterile. Teleflex Product Code: 200101-01.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1536-2014·2014-05-07
BD Biosciences Recalls Mislabeled Anti EpCAM PE Reagent Lots
BD Biosciences is recalling two lots of Anti EpCAM PE reagent because the vials contain CD9 PE antibody instead of the labeled EpCAM antibody.
Product
Anti EpCam PE - Analyte Specific Reagent. Anti-EpCAM is directed against human epithelial adhesion molecule that has been identified as a 40 -kilodalton (kd) protein in Western Blotting.
Category
Medical Device
Distribution
7 states
ModerateFDA (Devices)·Z-1534-2014·2014-05-07
Teleflex Recalls CAPIO Absorbable Surgical Sutures for Strength Defects
Teleflex Medical is recalling CAPIO absorbable surgical sutures because they did not meet minimum resorption strength requirements. The recall affects 7,380 units distributed in the US, Ireland, and Singapore.
Product
CAPIO, Monodeck, Violet Monofilament Polydioxanone Suture, 1 x 48 inches (122cm) Absorbable Surgical Suture, Rx Only, Teleflex Medical. Product Code: 833-137.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1518-2014·2014-05-07
Siemens Recalls IMMULITE 2000 Total IgE Assays Due to Positive Bias
Siemens Healthcare Diagnostics is recalling specific lots of IMMULITE 2000 Total IgE assays because they show a 23% positive bias against the WHO standard.
Product
IMMULITE 2000 /IMMULITE 2000 XPi Systems TIE Total IgE, REF L2KIE2, SMN 10380873, and L2KIE6, SMN 10380872, IVD --- Siemens Healthcare Diagnostics Products Ltd. For in vitro diagnostic use with the IMMULITE, IMMULITE 1000, and IMMULITE 2000/ IMMULITE 2000 XPi Systems Analyzers…
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1527-2014·2014-05-07
Laurimed Recalls PolypVac Microdebriders Due to Premature Mechanism Shutdown
Laurimed LLC is recalling 58 PolypVac 3.5mm Microdebriders because the reciprocation mechanism may turn off prematurely due to a component failure in the handle.
Product
PolypVac 3.5mm Microdebrider; Catalog Number FG-000016; contents: 1 Microdebrider, 1 Stylet, 1 filter. Sterile. Used for the excision of polyps in the nasal passageways and in sinuses for which access has been previously established.
Category
Medical Device
Distribution
11 states

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35901–35925 of 40449