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

35876–35900 of 40449

SevereFDA (Devices)·Z-1543-2014·2014-05-14
Med-Mizer RetractaBed Recall Due to Insufficient Welding on Foot Cross Tube
Med-Mizer is recalling 2,980 RetractaBed Clinical Contour adjustable beds due to insufficient welding on the foot cross tube, which may cause bed collapse.
Product
RetractaBed , Clinical Contour, Med - Mizer Inc..... Model SS 801, 802, 803, 803A: 80 " bed with 1, 2, or 3, motors and autocontour 120 V, ...Max Safe Working Load 450 LBS. Acute/Longterm Care AC Powered Adjustable Bed for geriatric care.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1565-2014·2014-05-14
SpineFrontier S-Lift Lock Shaft Inserter Recalled for Potential Breakage
SpineFrontier is recalling S-Lift Lock Shaft Inserters because the impact cap or pin may break during spinal surgery, potentially releasing fragments into the sterile field.
Product
SpineFrontier S-Lift Lock Shaft Inserter, an instrument used with S-LIFT Intervertebral Body Fusion Device in spinal fusion surgery. Product Usage: The S-Lift Lock Shaft SI50001 mates with SI50002, Implant Inserter, to aid in securing the implant to the whole implant inserter…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1559-2014·2014-05-14
Teleflex Medical Recalls Bard Fixt Sutures Due to Needle Detachment Risk
Teleflex Medical is recalling Bard Fixt Sutures because the needle may detach from the suture during use, failing to meet minimum strength requirements.
Product
Bard Fixt Suture Braided Polyester, Rx Only, Teleflex Medical, Research Triangle Park, NC USA Assembled in Mexico. Indicated for use in soft tissue approximation.
Category
Medical Device
Distribution
28 states
HighFDA (Devices)·Z-1553-2014·2014-05-14
Siemens ADVIA Centaur XP Immunoassay System Recalled for Gas Spring Failure
Siemens Healthcare Diagnostics is recalling ADVIA Centaur XP Immunoassay systems because gas springs may fail, causing the instrument cover to fall.
Product
ADVIA Centaur XP Immunoassay system, an automated in vitro diagnostic analyzer. Catalog # 078-A011-03 - ADVIA Centaur XP, Catalog # 078-A011R03 - ADVIA Centaur XP refurb.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1564-2014·2014-05-14
Siemens ADVIA Centaur Folate Assay Recalled for Potential Out-of-Range Results
Siemens Healthcare Diagnostics is recalling specific lots of the ADVIA Centaur Folate assay because serum controls may go out of range low and whole blood patient results may shift.
Product
Siemens ADVIA Centaur Folate Cat No. 06891541 SMN 10325366 (500 tests) Cat No. 06367974 SMN 10310308 (100 tests) Cat No. 00203473 SMN 10331250 (Ref) (500 tests) Cat No. 09132781 SMN 10340209 (Ref) (2500 tests) For in vitro diagnostic use in the quantitative determination…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1557-2014·2014-05-14
Teleflex Medical Recalls Surgical Sutures Due to Needle Detachment Risk
Teleflex Medical is recalling specific lots of surgical sutures because the needles may detach from the suture during use, failing to meet minimum strength requirements.
Product
Teleflex Medical, Research Triangle Park, NC, Polypropylene, Rx Only, Sterile, Distributed by Boston Scientific, Natick, MA; CAPIO Green Braided Coated Polyglycolic Acid Suture, Synthetic Absorbable Surgical Suture SUP, RX Only, Teleflex; Deklene II Polypropylene Blue Monofil…
Category
Medical Device
Distribution
28 states
HighFDA (Devices)·Z-1562-2014·2014-05-14
AlloSource Recalls AlloFuse DBM Putty Due to Donor Hemodilution
AlloSource, Inc. is recalling 29 units of AlloFuse DBM Putty 5cc because the donor was hemodiluted. The product is used as a bone graft extender in orthopedic applications.
Product
AlloFuse DBM Putty 5cc, Catalog No. 90038005 AlloFuse is indicated for orthopedic applications as filler for gaps or voids that are not intrinsic to the stability of the bony structure. AlloFuse is indicated to be packed gently into bony gaps in the skeletal system as a bone…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1550-2014·2014-05-14
GE Healthcare Recalls Panda Wall-Mount Infant Warmers Due to Software Defect
GE Healthcare is recalling 15 Panda Wall-Mount Infant Warmers because a software defect may cause false alarm notifications for oxygen saturation and pulse rate.
Product
Panda¿ Wall-Mount Infant Warmers, integrated with Nellcor SpO2. Controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology with integrated monitoring feature used for continuous noninvasive monitoring of functional oxygen saturation…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1558-2014·2014-05-14
Teleflex Medical Recalls Fixt Sutures Due to Needle Detachment Risk
Teleflex Medical is recalling specific lots of Fixt Suture Bonded Plus Violet Braided Polyglycolic Acid Coated Sutures because the needles may detach during use.
Product
Fixt Suture Bonded Plus Violet Braided Polyglycolic Acid Coated Suture, Synthetic Absorbable Surgical Suture, Sterile, Rx Only, Teleflex Medical. Indicated for use in soft tissue approximation.
Category
Medical Device
Distribution
28 states
HighFDA (Devices)·Z-1555-2014·2014-05-14
Teleflex Recalls Deknatel Sutures Due to Needle Detachment Risk
Teleflex Medical is recalling specific lots of Deknatel nonabsorbable sutures because the needle may detach from the suture during use.
Product
Nonabsorbable Surgical Suture, U.S.P., Sterile - Do Not Resterilize, Deknatel. Indicated for use in soft tissue approximation.
Category
Medical Device
Distribution
28 states
HighFDA (Devices)·Z-1549-2014·2014-05-14
GE Healthcare Recalls Panda Freestanding Infant Warmers Due to Software Defect
GE Healthcare is recalling 21 Panda Freestanding Infant Warmers worldwide because a software defect may cause false alarm notifications for oxygen saturation and pulse rate.
Product
Panda¿ Freestanding Infant Warmers, integrated with Nellcor SpO2. Controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology with integrated monitoring feature used for continuous noninvasive monitoring of functional oxygen saturation…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1548-2014·2014-05-14
GE Healthcare Recalls Panda iRes Infant Warmers Due to Alarm Defect
GE Healthcare is recalling 723 Panda iRes Infant Warmers because defective software may cause false oxygen saturation and pulse rate alarms.
Product
Panda¿ iRes Infant Warmers integrated with Nellcor SpO2. Controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology with integrated monitoring feature used for continuous noninvasive monitoring of functional oxygen saturation of…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1556-2014·2014-05-14
Teleflex Medical Recalls Surgical Sutures Due to Needle Detachment Risk
Teleflex Medical is recalling specific lots of nonabsorbable surgical sutures because the needles may detach from the suture during use.
Product
Teleflex Medical, Research Triangle Park, NC, Braided Polyester Rx Only, Sterile, Distributed by Boston Scientific, Natick, MA; Tevdek II, Green Braided PTFE Impregnated Polyester Fiber, Nonabsorbable Surgical Suture, USP Sterile, Deknatel; Tevdek II, White Braided PTFE…
Category
Medical Device
Distribution
28 states
HighFDA (Devices)·Z-1538-2014·2014-05-14
Biorep Atrial Lift System Recalled for Support Arm Detachment
Biorep Technologies is recalling the Joseph Lamelas Atrial Lift System because the support arm may detach from the blade body during use.
Product
Joseph Lamelas Atrial Lift System, Model Number MI-ALS-001. A single surgical instrument or tool for retraction of the atrial wall tissue in cardiac surgery.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1551-2014·2014-05-14
GE Healthcare Recalls Nellcor SpO2 Upgrade Kits Due to Software Defect
GE Healthcare is recalling 301 Nellcor SpO2 Upgrade kits because a software defect may cause false positive or false negative oxygen saturation and pulse rate alarms.
Product
Nellcor SpO2 Upgrade kit, consists of a Nellcor SpO2 circuit board, an OEM part manufactured by a third party supplier; and an integral component of the Nellcor SpO2 device. Controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1560-2014·2014-05-14
Teleflex Medical Recalls Stainless Steel Sutures Due to Needle Detachment Risk
Teleflex Medical is recalling specific lots of Deknatel stainless steel sutures because the needle may detach from the suture during use.
Product
Deknatel Teleflex Medical Stainless Steel 2 (metric 5) Monofilament Stainless Steel Suture, Nonabsorbable Surgical Suture, U.S.P. Used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the…
Category
Medical Device
Distribution
28 states
HighFDA (Devices)·Z-1528-2014·2014-05-14
INOmax DSIR Nitric Oxide Delivery System Recalled for Monitoring Anomaly
INO Therapeutics is recalling 22 INOmax DSIR Nitric Oxide Delivery Systems due to a software anomaly that may trigger unintended alarms.
Product
INOmax DSIR, model 10007, Nitric Oxide Delivery System, with Software version 3.0.0. The INOmax DS delivery system delivers INOMAX (nitric oxide for inhalation) therapy gas and provides continuous monitoring of inspired O2, NO2, and NO, and a comprehensive alarm system. The…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1568-2014·2014-05-14
Medtronic Refill Kits Recalled Due to Occluded Extension Tubing Sets
Medtronic is recalling specific Refill Kits for implantable infusion pumps because some contain occluded extension tubing that prevents filling. No patient injuries beyond additional needle sticks have been reported.
Product
Refill Kit 8551/856X (includes Models 8561, 8562 and 8564) for use with Medtronic Implantable Programmable Infusion Pumps. Product Usage: The Refill Kits are intended for use in refilling Medtronic programmable, implantable infusion pumps with the exception of Medtronic…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1547-2014·2014-05-14
GE Healthcare Recalls Giraffe Infant Warmers Due to Alarm Defect
GE Healthcare is recalling 50 Giraffe Infant Warmers because a software defect may cause false oxygen saturation and pulse rate alarms.
Product
Giraffe¿ Infant Warmers integrated with Nellcor SpO2. Controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology with integrated monitoring feature used for continuous noninvasive monitoring of functional oxygen saturation of arterial…
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1563-2014·2014-05-14
Mar Cor Purification Recalls Central Water Platform Reverse Osmosis Systems
Mar Cor Purification is recalling 197 Central Water Platform (CWP) reverse osmosis systems because a specific lot of water inlet solenoid valves may fail, stopping water production.
Product
Mar Cor Purification, Central Water Platform (CWP), 102, 104 and 106. Product Usage: The CWP is a Central reverse osmosis system with the intended use of producing water for dialysis of multiple patients.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1554-2014·2014-05-14
Bausch & Lomb Recalls Biotrue Multi-Purpose Contact Lens Solution
Bausch & Lomb is recalling Biotrue Multi-Purpose Contact Lens Solution due to out-of-specification results for a disinfectant.
Product
Bausch & Lomb, Biotrue, Multi-purpose contact lens solution, 10 fl.oz., Sterile.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1569-2014·2014-05-14
Shimadzu Digital Radiography X-Ray System Recalled for Image Loss
Shimadzu Medical Systems is recalling its Digital Radiography X-Ray System because a report was received regarding lost images under certain circumstances.
Product
Shimadzu Digital Radiography X-Ray System, Catalog No. DAR-8000f. This device is intended to be used for radiography in the hospital with X-ray devices.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1537-2014·2014-05-14
Bio-Rad Variant II beta-thalassemia Short Program kits recalled for buffer issues
Bio-Rad is recalling Variant II beta-thalassemia Short Program kits because buffer issues may cause calibration and quality control failures.
Product
Variant II beta-thalassemia Short Program Model Numbers 270-2103 (250 tests) and 270-2154 (500 tests), Bio-Rad Laboratories, Inc. in vitro diagnostic. The Variant II Hemoglobin testing system uses the principals of high performance liquid chromatography (HPLC) for the…
Category
Medical Device
Distribution
11 states
ModerateFDA (Devices)·Z-1544-2014·2014-05-14
Stryker 12-Instrument Sterilization Tray Recalled for Validation Testing Gaps
Stryker Endoscopy is recalling 2,591 12-Instrument Sterilization Trays because gravity sterilization parameters in the reprocessing guide did not fully consider all worst-case scenarios during validation testing.
Product
12-Instrument Sterilization Tray; Product Usage: The 12-Instrument Tray is used to hold and protect surgical instruments during the sterilization process. Specifically, this tray is used for the Conquest Manual Instrument line. The tray consists of an interlocking tray and…
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1552-2014·2014-05-14
Tenex TX1 Tissue Removal System Recalled for Packaging Defect
Tenex Health Inc is recalling TX1 Tissue Removal Systems because cracks in the packaging may compromise the sterile barrier during transport in extreme cold.
Product
TX1 Tissue Removal System. TX1 Procedure Pack P/N 554-1003-001 (outer box), TX1 MicroTip P/N 554-1002-001 (inner tray). For use with the TX System Console as an ultrasonic surgical aspirator of soft tissue.
Category
Medical Device
Distribution
Distributed nationwide

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35876–35900 of 40449