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Baxter Healthcare Corp. Rt.: Epidural Infusion Pumps sold under the following labels; ...

Potential overinfusion in the Auto-Ramp mode with software versions 3.00 or higher

FDAAug 17, 2005Nationwide• Baxter Healthcare Corp. Rt.

Stryker Howmedica Osteonics Corp.: Hoffman II compact Sterile Wrist Kit is used in the stabi...

Stryker Orthopaedics became aware that the pin of the Hoffmann II Compact External Fixation System may jam into the Soft Tissue protector.

FDAAug 17, 2005Nationwide• Stryker Howmedica Osteonics Corp.

Unknown Manufacturer: Amplatz Goose Neck Microsnare Kit, Model SK400 (175 cm l...

ev3 has determined that one test unit from each of two lots did not meet mininum tensile strength requirements and therefore the entire lots are being recalled.

FDAAug 16, 2005AL, AR, CA +11 more

Cordless Drill/Driver (JS Products) – Potential Malfunction (2005)

The recall involves certain MAC-brand 14.4 Volt and 18.0 Volt 3/8-inch drive cordless drill/drivers. The 14.4 Volt units have part number CDD14438 or CDD14438-Kit and the 18.0 Volt units have Part Number CDD18012 or CDD18012-KIT. The part number can be found on the side of the drill near the logo.

CPSCAug 16, 2005Nationwide• JS Products, of Las Vegas, Nev.

International Biophysics Corp: IBC Suction Handle (Sterile), a component of Blood Recove...

Tyvek pouches containing device labeled as sterile have defective seals.

FDAAug 16, 2005FL, IN• International Biophysics Corp

Gambro Renal Products: Prisma continuous renal replacement system.

Critically ill patients undergoing continuous renal replacement therapy may suffer excessive fluid loss.

FDAAug 16, 2005Nationwide• Gambro Renal Products

Caroline Flower Baby Sandals (Gymboree) – Size Safety Concern (2005)

This recall includes the Caroline Flower Baby Sandal with SKU number 140002069 sold in sizes 1 to 8. The SKU number is printed on the price tag above the bar code. The sandal has a white upper sole and a cork covered outer sole. A white decorative plastic flower is attached to the top of the front strap. The front and back strap have adjustable touch fasteners. The name "Gymboree" is printed in aqua on the sole of the sandal.

CPSCAug 12, 2005Nationwide• The Gymboree Corp., of San Francisco, Calif.

Siemens Medical Solutions USA, Inc: Magnetom Espree. Magnetic Resonance Imaging System. model...

there is a misalignment of the patient table that may occur between the patient table and the opening to the magnet bore

FDAAug 12, 2005Nationwide• Siemens Medical Solutions USA, Inc

Event Medical: INSPIRATION Ventilator Model Numbers: F7100000-XX, F7200...

Firm received reports of combustion within the blender system of the Inspiration Ventilator.

FDAAug 12, 2005Nationwide• Event Medical

Siemens Medical Solutions USA, Inc: Magnetom Avanto. Magnetic Resonance Imaging System. Model...

there is a misalignment of the patient table that may occur between the patient table and the opening to the magnet bore

FDAAug 12, 2005Nationwide• Siemens Medical Solutions USA, Inc

Stryker Howmedica Osteonics Corp.: T2 Recon Nail System.

The blister pack containing the Recon 6.5 Lag Screws may become damage during shipment resulting in loss of sterility.

FDAAug 12, 2005Nationwide• Stryker Howmedica Osteonics Corp.

Holmes® Tower Heater Fans (Holmes Group) – Electrical Safety (2005)

The recall involves Holmes® models HFH6498-U, HFH6500-U and HFH6500TG-U and Bionaire® model BFH3530-U. The recalled heaters also have date codes beginning with 2604 through 3804 for all units, except for Holmes® model 6500TG-U, which has date codes ranging from 2604 through 4704. The model and date code can be found on the silver label on the back of the unit. The heater fans are 26 inches tall; come in all gray, two-tone gray, or black and gray; and have either the word Holmes® or Bionaire® printed on the front of the base.

CPSCAug 11, 2005Nationwide• The Holmes Group Inc., of Milford, Mass.

Stryker Howmedica Osteonics Corp.: Scorpio Total Knee Cruciate Retaining Femoral Component, ...

The Left Scorpio Total Knee Cruciate Retaining Waffle Femoral Component #7 packaged and labeled as left may contain a Right and vice versa.

FDAAug 11, 2005Nationwide• Stryker Howmedica Osteonics Corp.

Ritchey Bicycle Wheels (Ritchey Design) – Rear Wheel Issue (2005)

The above wheels were sold by Ritchey as wheel sets and as rear wheel only and as original equipment on 2004 model year Fuji and Motobecane USA bicycles and the 2005 model year Prestige road bike from Raleigh. The recalled wheels have high flange hubs measuring 60 milimeters in diameter and the hub body is straight between the flanges.

CPSCAug 11, 2005Nationwide• Ritchey Design, of San Carlos, Calif. (manufactured under license from American Classic Inc., of Tampa, Fla.)

Boston Scientific Corporation One Boston: Renegade Hi-Flo Microcatheter Kits, Catalog/Order # 18-29...

Outer box of the product may have an incorrect expiration date listed as 2007-06, while the correct expiration date is 2007-04

FDAAug 10, 2005KY, TX• Boston Scientific Corporation One Boston

Kelty Speedster Jogging Strollers (Kelty) – Frame Safety Concern (2005)

The recalled strollers have an aluminum frame and a cloth seat with a sun canopy. The recalled single seat Speedster Deluxe stroller has model number 20050116 and serial numbers: S2000001D0504 through S2000500D0504 and S2000001D0505 through S2000100D0505. The recalled double seat Speedster Deuce Jogging strollers have model number: 20050216 and serial numbers: S3000001D0504 through S3000300D0504 and S3000001D0505 through S3000075D0505. Each stroller has a tag, located inside the child's seat compartment, which lists the model name and model number. A sticker on the rear frame lists the serial number.

CPSCAug 10, 2005Nationwide• Kelty Division of American Recreation Products Inc., of Boulder Colo.

Beckman Coulter Inc: Aqueduct Hematology Workflow Manager, software

Potentail for misidentification of historical patient results within the Aqueduct Hematology Workflow Manager software. In instances where the workflow manager software receives the same patient identifier for more than one patient the Aqueduct Workflow Manager software merges all results into one Patient File. The may cause test results to be associated with the wrong patient.

FDAAug 10, 2005AK, AZ, CA +15 more• Beckman Coulter Inc

Pascal Co Inc: product labeled in part: ''***banicide ADVANCED, A Reusa...

The product, Banicide Advanced, a resuable sterilizing and disinfecting solution, is likely to be ineffective for its intended use because testing found it failed testing for sporicidal use.

FDAAug 9, 2005Nationwide• Pascal Co Inc

Depuy Mitek, a Johnson & Johnson Co.: DePuy Mitek Straightshot Ligament Graft Passer/Protector,...

Mislabeled: The kit contained the incorrect Ligament Passer. The package contained a 9.5 mm instead of the labeled 11.5mm ligament passer

FDAAug 9, 2005CA, NC, VA• Depuy Mitek, a Johnson & Johnson Co.

Trek Diagnostic Systems: VersaTREK Myco AS.

Invitro diagnostic test kit used for testing to confirm the presence of tuberculosis contains interfering bioburden which can cause false positive results.

FDAAug 8, 2005AL, IL, IN +6 more• Trek Diagnostic Systems

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