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

25926–25950 of 27686

SevereFDA (Devices)·Z-2300-2013·2013-10-09
MedStream Programmable Pump Recalled for Excessive Drug Flow Rates
Codman & Shurtleff, Inc. is recalling 735 MedStream Programmable Pumps because they may deliver drug flow rates exceeding programmed levels.
Product
MedStream Programmable Pump; 20ml Pump EMEA 91-4200 Product Usage: The Medstream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market. Refill Kits- are intended for…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2296-2013·2013-10-09
MedStream Refill Kit Recalled for Excessive Drug Flow Rates
Codman & Shurtleff is recalling MedStream Refill Kits because they may allow drug flow rates to exceed programmed levels.
Product
MedStream Refill Kit (1 unit), EMEA: 91-4289 Product Usage: The Medstream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market. Refill Kits- are intended for use in…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0006-2014·2013-10-09
H&H Emergency Cricothyrotomy Kit Recall for Weakened Tubing
H & H Associates is recalling 6,619 Emergency Cricothyrotomy Kits because the medical device tubing may become weakened and ineffective.
Product
H&H Emergency Cricothyrotomy Kit (Part No. HHECT01/ HHECTK01, NSN 6515-01-573-0692), vacuum sealed and packaged in a 5 mil poly bags, labeled in part ***H & H Associates, Inc. CAGE 1NNH6 www.gohandh.com Ordinary, VA 23131 (800) 326-5708***. The product is used to maintain…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2273-2013·2013-10-09
CareFusion Recalls AVEA Ventilators for Barometric Pressure Error
CareFusion is voluntarily correcting AVEA ventilators to fix a barometric pressure compensation error identified during a proactive review.
Product
Product Name: AVEA¿ Ventilator. All Models. The affected devices are cleared under K073069 pm 1/25/2008 and K103211 on 05/06/2011. This device is a Class II medical Device. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0005-2014·2013-10-09
PhotoMedex Recalls SLT Fiber Delivery Systems Due to Sterility Concerns
PhotoMedex is recalling 549 units of SLT Fiber Delivery Systems because some may not have been sealed appropriately, compromising the sterile barrier.
Product
The product is labeled in part "***Surgical Laser Technologies, Inc. Montgomeryville, PA***SLT Fiber Delivery System***Sterile***Non-Pyrogenic***. The product is packaged in a flexible pouch and includes the following laser surgery accessories - SLT-SSRH 8, Catalog/Product…
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-2318-2013·2013-10-09
McKesson Horizon Medical Imaging System Recalled for Potential Image Loss
McKesson Information Solutions LLC is recalling Horizon Medical Imaging software versions 4.6.1 to 11.6. because a server configuration malfunction may cause the loss of digital medical images.
Product
McKesson Horizon Medical Imaging (HMI) Radiological Image Processing System, product versions 4.6.1 to 11.6., is a medical image and information management application intended to receive, transmit, store, retrieve, display, print and process digital medical images, digital…
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-0001-2014·2013-10-09
Maquet Recalls Ultima OPCAB Systems Due to Incorrect Blade Labeling
Maquet Cardiovascular is recalling specific lots of Ultima OPCAB Systems because standard and deep blades were incorrectly labeled, posing a risk during cardiac surgery.
Product
Ultima OPCAB System, Sterile, Rx Only, Product Usage: Intended for use during performance of minimally invasive cardiac surgery through a sternotomy incision approach. The ULTIMA Access RailPlatform in combination with the Activator II Drive Mechanism is used to spread the…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2292-2013·2013-10-09
Ebi Solitaire-35 Spinal Fusion Device Recalled for Screw Complaints
Ebi, LLC is recalling 1,730 units of the Solitaire-35 PEAK Solitaire Anterior Spinal System due to complaints regarding one of the three screws driving through the cage.
Product
Solitaire-35 Peek Solitaire Anterior Spinal System. The Solitaire-35 is an intervertebral body fusion device.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2301-2013·2013-10-09
Hologic Selenia Mammography System Software Recall for Image Deletion
Hologic is recalling 62 Selenia Full Field Digital Mammography Systems because software versions 5.0.x and 5.1.x may delete recent images when the hard drive reaches a 4,000-image threshold.
Product
Selenia Full Field Digital Mammography System with software versions 5.0.x and 5.1.x The Selenia Full Field Digital Mammography system generates digital mammography images that can be used for screening and diagnosis of breast cancer. The Selenia Full Field Digital…
Category
Medical Device
Distribution
19 states
SevereFDA (Devices)·Z-2270-2013·2013-10-02
Invacare Power Wheelchair Recall for Unintended Slowing or Acceleration
Invacare is recalling power wheelchairs with specific joysticks due to unintended slowing or acceleration. Users should stop using the device and contact Invacare.
Product
Invacare Power Wheelchair, one per box To provide mobility to a person restricted to a sitting position.
Category
Medical Device
Distribution
53 states
HighFDA (Devices)·Z-2285-2013·2013-10-02
CareFusion Recalls SmartSite Infusion Sets Due to Tubing Separation Risk
CareFusion is recalling SmartSite Low Sorbing Infusion Sets because the tubing sleeve may separate below the drip chamber.
Product
SmartSite Low Sorbing Infusion Set, Model# 10015048. Intravascular administration set.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2262-2013·2013-10-02
Maquet Cardiovascular Recalls QUADROX Oxygenators Due to Bond Strength Defects
Maquet Cardiovascular is recalling specific lots of QUADROX oxygenators used in cardiac surgery because they may not meet specifications for bond strength on connectors.
Product
QUADROX iD HMOD 2030 Diffusion Membrane Oxygenator; QUADROX-i ADULT HMO 70000 / HMO 71000; QUADROX-iD Pediatric HMOD 30000. The QUADROX oxygenators are intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2271-2013·2013-10-02
Stryker Vision Mounting Arm Recalled Due to Display Detachment Risk
Stryker Endoscopy is recalling 14,271 Vision Mounting Arms because excessive force can cause the display to detach and fall on users or patients.
Product
Stryker Vision Mounting Arm, for use with other Stryker Endoscopy medical device products for human patients. Model number 0240-095-200, manufactured by Stryker Endoscopy San Jose The intended use of the Stryker Vision Mount is to hold and position an LCD monitor. The…
Category
Medical Device
Distribution
51 states
HighFDA (Devices)·Z-2264-2013·2013-10-02
Endoplus 5mm Laparoscopic Grasper Recalled for Broken Jaw
Endoplus is recalling 81 units of 5mm Atraumatic Graspers because the moveable jaw broke during surgery. The devices were distributed in Florida, Texas, and Virginia.
Product
ENDOPLUS; Precision Laparoscopic Instruments; REF 346VA; Description 5mm Atraumatic Grasper S/A, Standard; Non-sterile; Manufactured by Endoplus; 750 Tower Rd., Suite A, Mundelein, IL 60060 USA. Intended for grasping, dissecting, retraction, clamping in conjunction with the…
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-2275-2013·2013-10-02
Maquet Recalls TEGRIS System Due to Missing Emergency Stop Button
Maquet is recalling 21 TEGRIS systems because a secondary touch screen display lacks an emergency stop button.
Product
TEGRIS system Four labels of the Tegris System include: Emergency button (1703.72) MAQUET GmbH & Co. KG Kehler-Strabe 31 Baden-Wuerttemberg 76437 Rastatt, Germany Touch screen (elo) Elo TouchSystems 301 Constitution Drive Menlo Park, CA 94025…
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-2261-2013·2013-10-02
Terumo Pall AL6X Arterial Blood Line Filter Recall for Defective Device
Terumo is recalling 15,817 arterial blood line filters used in cardiovascular procedures because the devices are defective.
Product
Terumo Pall AL6X Arterial Blood Line Filter, labeled in part Terumo Cardiovascular Systems Corporation, packaged as part of a Terumo Cardiovascular Procedure Kit or as a single, sterile filter unit Single/Sterile Terumo Pall AL6X Arterial Filter: The Terumo Pall AL6X Arterial…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2274-2013·2013-10-02
BD Recalls Epilor Syringes Due to Plunger Sticking Hazard
Becton Dickinson is recalling BD Epilor syringes because the plunger may stick, preventing users from detecting loss of resistance during epidural procedures.
Product
BD Epilor Syringe BD Franklin Lakes, NJ 07417 BD EDC Laagstraat 57, B-9140 Temse-Belgium The Epilor syringe is used in conjunction with an epidural needle with the purpose of finding the epidural space.
Category
Medical Device
Distribution
22 states
HighFDA (Devices)·Z-2282-2013·2013-10-02
Synthes Oracle Spacer System Slap Hammer Recalled for Breakage During Use
Synthes USA HQ, Inc. is recalling 27 units of the Oracle Spacer System Slap Hammer because the proximal end broke during use.
Product
Synthes Oracle Spacer System Slap Hammer, Part Number 03.809.690, Lot Number 3723847 The Oracle Spacer is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 whose condition requires the use of interbody fusion…
Category
Medical Device
Distribution
5 states
HighFDA (Devices)·Z-2263-2013·2013-10-02
Steris Reliance Endoscope Processing System Recalled for Air Pipe Defect
Steris is recalling 266 Reliance Endoscope Processing Systems because an air pipe defect prevents forced flow during the disinfection cycle.
Product
Reliance Endoscope Processing System (REPS), STERIS Corporation, 5960 Heisley Road, Mentor, OH 44060-1834 USA www.steris.com. The intended use of the REPS is washing and high level disinfection of up to two manually pre-cleaned, immersible, reusable, heat-resistant…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2277-2013·2013-10-02
Elekta Recalls Monaco RTP System Radiation Therapy Treatment Planning System
Elekta, Inc. is recalling 72 units of the Monaco RTP System Radiation Therapy Treatment Planning System because patients must be positioned as indicated by the treatment plan.
Product
Monaco RTP System Radiation Therapy Treatment Planning System. Radiation treatment planning.
Category
Medical Device
Distribution
28 states
HighFDA (Devices)·Z-2265-2013·2013-10-02
Endoplus 5 mm Traumatic Grasper Recalled for Broken Jaw
Endoplus is recalling 9 units of 5 mm Traumatic Graspers because the moveable jaw broke during laparoscopic procedures.
Product
ENDOPLUS; Precision Laparoscopic Instruments; REF 345VA; Description 5 mm Traumatic Grasper S/A, Standard; Non-sterile; Manufactured by Endoplus; 750 Tower Rd., Suite A, Mundelein, IL 60060 USA. Intended for grasping, dissecting, retraction, clamping in conjunction with the…
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-2284-2013·2013-10-02
Medtronic Xomed Recalls Universal Titanium Ear Prosthesis Due to Assembly Error
Medtronic Xomed is recalling 60 units of Universal Titanium Prosthesis because one lot was assembled with the wrong component.
Product
Universal Titanium Prosthesis, Round Head, with Flex H/A titanium shoe. The ear prosthesis is implantable and indicated for hearing loss.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2188-2013·2013-09-25
B. Braun Outlook ES Infusion Pumps Recalled for Display Error
B. Braun Medical Inc. is recalling Outlook ES pumps because the display may show infusion is active when the pump has actually stopped.
Product
Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets. Used to regulate the flow of primary and secondary fluids when positive pressure is required. The infusion system is capable of delivering fluid from a negative head height (when the IV fluid…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2227-2013·2013-09-25
Smith & Nephew Recalls OSTEORAPTOR Suture Anchors Due to Sterile Barrier Breach
Smith & Nephew is recalling OSTEORAPTOR suture anchors because pinholes in primary pouches may breach the sterile barrier, posing a risk of infection.
Product
OSTEORAPTOR CURVED 2.3 mm Suture Anchor ULTRABRAID COBRAID Suture, Black; Part Number: 72203291 Biodegradable suture anchor
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2223-2013·2013-09-25
Smith & Nephew Recalls OSTEORAPTOR Suture Anchors Due to Sterile Barrier Breach
Smith & Nephew is recalling OSTEORAPTOR 2.3 mm Suture Anchors because pinholes in primary pouches may breach the sterile barrier.
Product
OSTEORAPTOR 2.3 mm Suture Anchor with 1 ULTRABRAID COBRAID Suture, Black; Part Number: 72201992 Biodegradable suture anchor
Category
Medical Device
Distribution
Distributed nationwide

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25926–25950 of 27686