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

24926–24950 of 27722

HighFDA (Devices)·Z-2059-2014·2014-07-23
Mindray V-Series Patient Monitoring System Recalled for ECG Interpretation Errors
Mindray is recalling 113 V-Series Patient Monitoring Systems due to software issues causing false ECG measurements and incorrect interpretive statements.
Product
V-Series Patient Monitoring System, Manufactured for Mindray DS USA, Inc. Used for monitoring of human physiological parameters. The V-Series Monitor also has the capability of performing IV Drug and Hemodynamic Calculations and interfacing with network devices.
Category
Medical Device
Distribution
5 states
HighFDA (Devices)·Z-2049-2014·2014-07-23
Smith & Nephew Recalls SUTUREFIX Ultra S Sutures Due to Sterility Breach
Smith & Nephew is recalling 763 units of SUTUREFIX Ultra S Double Loaded Sutures because the sterile barrier was breached, compromising the device's sterility.
Product
SUTUREFIX Ultra S Double Loaded Suture Product Code: 72203854 Fastener, fixation, nondegradable, soft tissue
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2065-2014·2014-07-23
Instrumentation Laboratory Recalls ACL TOP 700 CTS Coagulation Instruments
Instrumentation Laboratory is recalling 266 ACL TOP 700 CTS automated coagulation laboratory instruments due to a potential for sample misidentification.
Product
ACL TOP 700 CTS, automated coagulation laboratory instrument.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1994-2014·2014-07-16
Intuitive Surgical Recalls Patient Side Cart Battery Boxes for Overheating Risk
Intuitive Surgical is recalling 2,606 Patient Side Cart Battery Boxes used with the da Vinci A surgical system because they may overheat and bulge during charging.
Product
Patient Side Cart Battery Box used in conjunction with the da Vinci A surgical system. Intuitive Surgical Inc. Sunnyvale, CA 94086
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2023-2014·2014-07-16
Invacare Aquatec Fixed Backrest Recalled for Structural Failure Risk
Invacare is recalling 465 Aquatec Fixed Backrests because they may detach from the frame under uneven load, posing a risk of injury.
Product
Aquatec Fixed Backrest - accessory for Mobile Shower and Toilet commode Aquatec Ocean, Ocean VIP and Ocean E-VIP family.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2034-2014·2014-07-16
Zimmer Hip Joint Prosthesis Recalled for Black Residue in Sterile Pouches
Zimmer, Inc. is recalling 852 units of M/L Taper Reduced Neck hip joint prostheses because black residue was observed in the sterile pouches.
Product
Zimmer M/L Taper Reduced Neck Standard & Extended Offset, HIP JOINT PROSTHESIS, Sizes:4, 5, 6, 7.5, 9, 10, 11 & 12.5. The femoral stem component of a modular system that consists of an acetabular component, femoral head, femoral stem, and the instrumentation necessary…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2022-2014·2014-07-16
B. Braun Stopcock Extension Sets Recalled for Reverse Assembly Defect
B. Braun Medical is recalling 10,835 Stopcock Extension Sets because some stopcocks are assembled in reverse, causing them to close when set to open.
Product
STOPCOCK EXT. SET W/ 3-WAY STOPCOCK WITH INJ. SITE AND SPINLOCK CONNECTOR, 22 inches and 37 inches
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2038-2014·2014-07-16
Pall Medical Breathing Circuit Filter Recall for Possible Air Leak
Pall Corporation is recalling specific lots of Medical Breathing Circuit Filters due to a possible leak at the filter end cap junction.
Product
PALL Medical Breathing Circuit Filter, REF BB50T and BB50T-BULK , Rx ONLY Single use, bi-directional bacterial/viral removal filter. The filters are individually packaged in a clear, plastic pouch with black writing - 50 per case, or in bulk packaged 100 filters/bag and two…
Category
Medical Device
Distribution
15 states
HighFDA (Devices)·Z-1996-2014·2014-07-16
RGI Medical Recalls 300psi I.V. Catheter Extension Sets
RGI Medical is recalling 19,200 units of Henora 300psi I.V. Catheter Extension Sets due to a defect that may cause the tubing to separate from the luer connection during use.
Product
Henora REF: 70-4026-09V1 300psi I.V. Catheter Extension Set Product Usage: Catheter extension set for high pressure procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2001-2014·2014-07-16
Vascular Technology Recalls VTI Bayonet Doppler Probes Due to Sterility Concerns
Vascular Technology, Inc. is recalling 25 VTI Bayonet Doppler probes because the sterile barrier may have been penetrated, potentially rendering the devices unsterile.
Product
VTI BAYONET DOPPLER, 20MHz DOPPLER PROBE, SLIM, BX 4, REF 108660 The Doppler probe is intended for the intraoperative and transcutaneous evaluation of blood flow.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1999-2014·2014-07-16
Mizuho Doppler Probe Recalled Due to Sterile Barrier Penetration
Vascular Technology, Inc. is recalling 147 Mizuho Doppler Probes because the sterile barrier was penetrated, potentially rendering the devices unsterile.
Product
07-150-10 MIZUHO, DOPPLER PROBE, SLIM, BX 4, REF 138660 The Doppler probe is intended for the intraoperative and transcutaneous evaluation of blood flow.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2000-2014·2014-07-16
Vascular Technology Recalls Sterile Doppler Probes Due to Barrier Penetration
Vascular Technology, Inc. is recalling 34 sterile Doppler probes because the sterile barrier may have been penetrated, potentially rendering the devices unsterile.
Product
07-150-12 MIZUHO, MINI, SLIM, STERILE, BOX OF 4, REF 138665 The Doppler probe is intended for the intraoperative and transcutaneous evaluation of blood flow.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2002-2014·2014-07-16
3M Attest Auto-reader Recalled for Missing Dry Natural Rubber Labeling
3M is recalling Attest Auto-readers because labels failed to disclose dry natural rubber content, posing an allergy risk.
Product
3M Attest Auto-reader. Model numbers 390, 390G,and 490. These devices incubate the biological indicators (BIs) to determine a positive or negative result for the sterilization cycle.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2027-2014·2014-07-16
Hospira MedNet Software Recall for Dosing Unit Transmission Defect
Hospira is recalling 13 units of MedNet MMS software due to a defect that may fail to send specific dosing units to infusion pumps.
Product
The Hospira MedNet Medication Management Suite (MMS). Product Usage: The Hospira MedNet Medication Management Suite (MMS) is intended to facilitate networked communication between MMS compatible computer systems and Hospira infusion pumps. The MMS provides trained healthcare…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2026-2014·2014-07-16
Steris 4085 General Surgical Table Recalled for Pressure Switch Defect
Steris Corporation is recalling 3,689 STERIS 4085 General Surgical Tables because a defective pressure switch may cause the hand control to incorrectly indicate that floor lock feet are locked.
Product
The STERIS 4085 General Surgical Table Product Usage: is an electro-hydraulically operated surgical table designed to support all general surgical procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2025-2014·2014-07-16
CareFusion Recalls SmartSite Infusion Sets Due to Unlabeled Filter
CareFusion is recalling SmartSite Low Sorbing Infusion Sets because the drip chamber contains a 15-micron filter not listed in the instructions, posing a risk of occlusion if used with blood.
Product
SmartSite Low Sorbing Infusion Set, Model Codes: 10014855A, 10015861A, 10061661A 14035457 14035485 14046894 14035458
Category
Medical Device
Distribution
5 states
HighFDA (Devices)·Z-1998-2014·2014-07-16
Mizuho Disposable Doppler Probe Recalled for Sterile Barrier Penetration
Vascular Technology, Inc. is recalling 164 Mizuho disposable Doppler probes because the sterile barrier was penetrated, potentially rendering the product unsterile.
Product
07-150-07 MIZUHO, MAL DISP DOPPLER PROBE BX 4, REF 138200 The Doppler probe is intended for the intraoperative and transcutaneous evaluation of blood flow.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2035-2014·2014-07-16
Zimmer M/L Taper Hip Prosthesis Recalled Due to Black Residue
Zimmer, Inc. is recalling M/L Taper Hip Prostheses with Kinectiv Technology because black residue was observed in the sterile pouches.
Product
Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology, HIP JOINT PROSTHESIS¿, Sizes:4, 5, 6, 7.5, 9, 10, 11 & 12.5. The femoral stem component of a modular system that consists of an acetabular component, femoral head, femoral stem, and the instrumentation necessary…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2039-2014·2014-07-16
Karl Storz Recalls Essential NEO Audio/Visual Units Due to Overheating Cable
Karl Storz Endoscopy is recalling 968 Essential NEO audio/visual integration units because the connected power cable could overheat, generate smoke, and cause the peripheral to stop working.
Product
Essential NEO, Audio/Visual Integration Unit An audio/visual integration unit.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1995-2014·2014-07-16
Cenorin HLD System Model 610 Recalled for Temperature Sensor Defect
Cenorin is recalling 25 HLD System Model 610 units because a temperature sensor defect may prevent water from heating during pasteurization.
Product
HLD System, Model 610, Medical Device Cleaning and High Level Disinfection Washer/Pasteurizer.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1997-2014·2014-07-16
FDA Recalls Devon Surgical Positioning Kits Due to Strap Separation Risk
The FDA is recalling 264 Devon Supine, Lithotomy and Trendelenburg Positioning Kits because straps may separate from the foam pad.
Product
Devon Supine, Lithotomy and Trendelenburg Positioning Kit; Product Code: 31151090 Product Usage: The device is intended to provide padding under the patient, and help maintain the position of an anesthetized patient during surgery.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2020-2014·2014-07-16
Intuitive Surgical Recalls Large Clip Applier Instruments Due to Jamming Risk
Intuitive Surgical is recalling Large Clip Applier instruments used with da Vinci S and SI systems because a manufacturing defect may cause the instrument to jam during insertion.
Product
Intuitive Surgical Inc. Large Clip Applier instruments used in conjunction with da Vinci S and da Vinci SI Surgical Systems Intuitive Surgical Inc., 'Sunnyvale, CA 94086
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2033-2014·2014-07-16
Zimmer M/L Taper Hip Stem Recall Due to Black Residue
Zimmer, Inc. is recalling M/L Taper Hip Stems because black residue was observed in the sterile pouches. The recall covers 1,487 units distributed worldwide.
Product
Zimmer M/L Taper Hip Stem Standard & Extended Offset, HIP JOINT PROSTHESIS, Sizes: 5.0, 7.5, 9.0, 10.0, 11.0, 12.5, 13.5, 15.0, 11.25, 17.25, 20.0 & 22.5. The femoral stem component of a modular system that consists of an acetabular component, femoral head, femoral stem…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1923-2014·2014-07-09
Medtronic Duet External Drainage System Tubing Disconnection Recall
Medtronic Neurosurgery is recalling Duet External Drainage and Monitoring Systems because the patient line tubing may become disconnected from the stopcock.
Product
Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites, Ventricular Catheter, Catalog No. 46916. Intended to allow drainage and measurement of cerebrospinal fluid (CSF) and other fluids of similar physical character from the ventricles or the lumbar…
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-1920-2014·2014-07-09
Medtronic Duet External Drainage System Tubing Disconnection Recall
Medtronic Neurosurgery is recalling Duet External Drainage and Monitoring Systems because the patient line tubing may disconnect from the stopcock.
Product
Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Catalog No. 46913. Intended to allow drainage and measurement of cerebrospinal fluid (CSF) and other fluids of similar physical character from the ventricles or the lumbar subarachnoid…
Category
Medical Device
Distribution
1 state

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24926–24950 of 27722