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

40301–40325 of 40480

ModerateFDA (Devices)·Z-1997-2012·2012-07-18
PSC Industries Recalls Surgical Forceps Due to Labeling Errors
PSC Industries is recalling Bayonet Forceps due to typos in the inner packaging labels. The errors did not affect the part or lot numbers.
Product
Bayonet Forceps 8.25 (209.6 mm) 0.5mm Tips, Sterile Single Use Surgical/Bipolar Forceps, Model #20-13420, 510 (k) #K884175. The surgical device is package one (1) per Tyvek peel pouch with ten (10) Tyvek peel pouches per box. Bipolar Forceps and Cords - Olsen Medical Bipolar…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1995-2012·2012-07-18
PSC Industries Recalls Misbranded Electrosurgical Bayonet Forceps
PSC Industries is recalling 5 units of Model #41604 Bayonet Forceps because the label incorrectly states the tip size is 0.5mm when it is actually 1.0mm.
Product
Bayonet Forceps 8.5" (215.9mm) Serrated 1.0 mm Tips Electrosurgical/Monopolar Forceps/Reusable, Model #41604, 510 (k) #K885199. The surgical device is package in non-sterile small plastic tubes. Monopolar Reusable Forceps - are intended for use in cutting and coagulating…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1999-2012·2012-07-18
PSC Industries Recalls Irrigating Bayonet Forceps Due to Labeling Errors
PSC Industries is recalling 125 units of Irrigating Bayonet Forceps because of typographical errors on the inner packaging labels.
Product
Irrigating Bayonet Forceps 8.25" (209.6 mm) 1.5 mm Tips, Electrosurgical Irrigating Bipolar Forceps, Model #20-0431, 510 (k) #K072937. Each unit of this sterile surgical device is packaged in a Tyvek peel pouch in boxes which contain five (5)Tyvek peel pouches per box.…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1975-2012·2012-07-18
Abbott i-Stat Analyzers Recalled for Excessive Heat in Battery Area
Abbott Point of Care is recalling i-Stat Analyzers because they can become uncomfortably hot to touch in the battery area.
Product
Fuso Analyzer 300F; Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2, and the i-Stat 200 analyzer as port of the i-Stat System, are intended for use in the in vitro quantitization of…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1978-2012·2012-07-18
Abbott i-Stat Portable Clinical Analyzer Recall for Overheating Battery Area
Abbott Point of Care is recalling i-Stat Portable Clinical Analyzers because the battery area can become uncomfortably hot to touch.
Product
Military Kit Portable Clinical Analyzer ; Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2, and the i-Stat 200 analyzer as port of the i-Stat System, are intended for use in the in…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1961-2012·2012-07-18
Stryker Arthroscope and Hardware Set Tray Recall for Sterilization Labeling
Stryker Endoscopy is recalling 6,388 Arthroscope and Hardware Set Trays because the Instructions for Use incorrectly listed sterilization methods that were not validated at worst-case conditions.
Product
Stryker brand Arthroscope and Hardware Set Tray (sterilization tray); Model/Part Number: 233-032-116; Product is manufactured and distributed by Stryker Endoscopy, San Jose, CA The Arthroscope and Hardware Set Tray is used to hold and protect surgical devices during the…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1955-2012·2012-07-18
CIVCO General Purpose Sensor Recalled for Calibration Errors
Civco Medical Instruments Inc is recalling 9 CIVCO General Purpose Sensor kits due to incorrect calibration that may affect needle path projection accuracy.
Product
CIVCO General Purpose Sensor, Non-sterile reusable general purpose electromagnetic sensor, for use with 3D Guidance medSAFE trackers, Ref. 610-1067. The firm name on the label is CIVCO, Kalona, IA. The kit contains sensor component part number 410-240. The general purpose…
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-1987-2012·2012-07-18
Philips Medical Systems Recalls IntelliSpace Portal and Extended Brillance Workspace Software
Philips Medical Systems is recalling 38 units of IntelliSpace Portal and Extended Brillance Workspace software due to inconsistent diagnostic results when using specific time-based methods.
Product
IntelliSpace Portal software and Extended Brillance Workspace software Intellispace Portal is a multimodality thin-client applications server that delivers full diagnostic viewing and clinical applications to the enterprise. The Philips Extended Brillance Workspace is…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1969-2012·2012-07-18
Terumo Perfusion System 1 Recalled for Roller Pump Occlusion Malfunctions
Terumo CVS is recalling 648 Advanced Perfusion System 1 units due to roller pump occlusion malfunctions that could prevent pump use during surgery.
Product
System 1 Base 220/240V The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1963-2012·2012-07-18
Terumo Advanced Perfusion System 1 Gas System Recall
Terumo is recalling 648 Advanced Perfusion System 1 units because users reported difficulty adjusting the gas system flow control knob.
Product
Terumo Advanced Perfusion System 1 System 1 Base, 100/120V. The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1979-2012·2012-07-18
Smiths Medical Recalls HOTLINE 3 Blood and Fluid Warmer Units
Smiths Medical is recalling 2,247 HOTLINE 3 Blood and Fluid Warmers because a microswitch may become damaged and unusable if not correctly installed.
Product
Smiths Medical HOTLINE 3 Blood and Fluid Warmer, Reorder Numbers: HL-390 Product Usage: The Micro-switch is used on the HOTLINE¿ 3 Blood and Fluid Warmer. This product, for use in conjunction with HOTLINE¿ 3 L-370 Fluid Warming Set are intended for the delivery of warmed…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1984-2012·2012-07-18
Integra Pudenz Flushing Valve Recalled for Incorrect Labeling
Integra LifeSciences is recalling 39 Pudenz Flushing Valves because the pouch labels list the wrong model and closing pressure.
Product
Pudenz Flushing Valve with Integral Connectors, catalog number NL850-1330. Integra Neurosciences, Plainsboro, NJ. Device is used for the treatment of hydrocephalic patients when shunting cerebrospinal fluid from the ventricles of the brain.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1964-2012·2012-07-18
Terumo Advanced Perfusion System 1 Gas Control Recall
Terumo is recalling 992 Advanced Perfusion System 1 units due to reported difficulty adjusting the gas flow control knob.
Product
Terumo Advanced Perfusion System 1 System 1 Base, 220/240 V. The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1974-2012·2012-07-18
Abbott i-Stat Portable Clinical Analyzer Recall for Overheating Battery
Abbott Point of Care is recalling i-Stat Portable Clinical Analyzers because the battery area can become uncomfortably hot to touch. This is a recall extension.
Product
i-Stat Portable Clinical Analyzer; Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2, and the i-Stat 200 analyzer as port of the i-Stat System, are intended for use in the in vitro…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1998-2012·2012-07-18
PSC Industries Recalls Surgical Forceps Due to Labeling Errors
PSC Industries is recalling 40 units of Model #20-1360K surgical forceps because of typos in the inner packaging labels. The errors did not affect the part or lot numbers.
Product
Bayonet Forceps 7.-1/8 (181.0mm) 0.75mm Non-Insulated Tips, Sterile Single Use Surgical/Bipolar Forceps, Model #20-1360K 510 (k) #K884656. The surgical device is package one (s) per plastic Tyvek peel pouch, 10 plastic Tyvek peel pouches per box. Bipolar Forceps and Cords…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1994-2012·2012-07-18
PSC Industries Recalls Bipolar Bayonet Forceps Due to Packaging Labeling Error
PSC Industries is recalling 7 units of Bipolar Bayonet Forceps because the manufacturer symbol was incorrectly replaced by the expiry symbol on the packaging.
Product
Bayonet Forceps 7.75" (196.9 mm) 0.5 mm Tips Non-Stick Electrosurgical/Bipolar Forceps/Reusable, Model #90-7004 (k) #K982705. The surgical device is package non-sterile into small plastic tubes. Olsen Medical Biopolar Reusable Bayonet Forceps and cords are intended for use…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1990-2012·2012-07-18
PSC Industries Recalls Button Switch Pen Electrodes Due to Labeling Errors
PSC Industries is recalling 50 units of Button Switch Pen Electrodes due to a labeling error where the manufacturer symbol replaced the expiration date symbol.
Product
Button Switchpens, w/Extendable Needle Electrode 2 mm Exposure Single Use Electrosurgical./Extendable Pencils, 510(k) #K936304, Model Number: 75820. The device is packaged in a sterile Tyvek peel pouch within a cardboard box which contains 24 pouches per box. Pens/Pencils…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1996-2012·2012-07-18
PSC Industries Recalls Bayonet Forceps Due to Incorrect Expiration Date
PSC Industries is recalling 80 units of Bayonet Forceps because the outer carton lists an incorrect sterile expiration date, though the individual pouch labels are correct.
Product
Bayonet Forceps 7.-1/8 (181.0mm) 0.75mm Insulated Tips, Sterile Single Use Surgical/Bipolar Forceps, Model #20-1360I, 510 (k) #K884656. The surgical device is package one (s) per plastic Tyvek peel pouch, 10 plastic Tyvek peel pouches per box. Bipolar Forceps and Cords…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1991-2012·2012-07-18
PSC Industries Recalls Button Switchpens Due to Labeling Errors
PSC Industries is recalling Button Switchpens because the packaging labels incorrectly state the devices include a holster. The recall covers 725 units distributed nationwide.
Product
Button Switchpens, w/Extendable Needle Electrode 10 mm Exposure, Single Use device, Electrosurgical./Extendable Pencils, 510(k)#K936304, Model Number: 75800. The device is packaged in a sterile Tyvek peel pouch within a cardboard box. The cartons contain 25 pouches per box.…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1900-2012·2012-07-11
CareFusion AirLife Infant Breathing Circuits Recalled for Cracking Adapter
CareFusion is recalling AirLife infant breathing circuits because a Y adapter may crack, causing a leak that reduces air delivery to ventilated patients.
Product
AirLife Isothermal Breathing Circuit, Infant Respiratory Circuit, Non-Heated; an Rx device for single patient use; CareFusion, 22745 Savi Ranch Parkway, Yorba Linda, CA 92887 USA, Made in Mexico Respiratory breathing circuits are used with a ventilator when mechanical…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1937-2012·2012-07-11
DePuy Spine Side Fire Needles Recalled for Breakage Reports
DePuy Mitek is recalling 683 units of Confidence Spinal Cement System Side Fire Needles due to reports of breakage during use.
Product
Depuy Spine Side Fire Needles 13G X 6IN, part of the Confidence Spinal Cement System Product Code 283904613. The Confidence Side Fire Needle is used to place bone cement in an intra-vertebral fashion at a desired location. the cement extrudes fro the needle through a port…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1940-2012·2012-07-11
DePuy Spine Side Fire Needles Recalled for Breakage Reports
DePuy Mitek is recalling 6,979 Confidence Spinal Cement System Side Fire Needles due to reports of breakage. The needles are used to place bone cement in the spine.
Product
Depuy Spine Side Fire Needles 13G X 4IN Side-Fire Needle, part of the Confidence Spinal Cement System Product Code 283904413. The Confidence Side Fire Needle is used to place bone cement in an intra-vertebral fashion at a desired location. the cement extrudes fro the needle…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1938-2012·2012-07-11
DePuy Spine Side Fire Needles Recalled for Breakage Reports
DePuy Mitek is recalling 704 units of Confidence Spinal Cement System Side Fire Needles due to reports of breakage.
Product
Depuy Spine Side Fire Needles 11G X 4IN, part of the Confidence Spinal Cement System Product Code: 283904411. The Confidence Side Fire Needle is used to place bone cement in an intra-vertebral fashion at a desired location. the cement extrudes fro the needle through a port…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1915-2012·2012-07-11
DePuy Recalls Luster and Ultima Hip Stems Implanted with Metal-on-Metal
DePuy Orthopaedics is issuing a Field Safety Notice for Luster and Ultima hip stems implanted with metal-on-metal articulations.
Product
LUSTER HIP SZ 1 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors. Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1899-2012·2012-07-11
CareFusion AirLife Infant Respiratory Circuits Recalled for Cracking Adapter
CareFusion is recalling AirLife Isothermal Breathing Circuits because the Y adapter may crack, causing a leak that reduces the air volume delivered to ventilated patients.
Product
AirLife Isothermal Breathing Circuit, Infant Respiratory Circuit, Heated; an Rx device for single patient use; CareFusion, 22745 Savi Ranch Parkway, Yorba Linda, CA 92887 USA, Made in Mexico Respiratory breathing circuits are used with a ventilator when mechanical ventilation…
Category
Medical Device
Distribution
Distributed nationwide

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