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

30776–30800 of 40325

ModerateFDA (Devices)·Z-1041-2016·2016-03-09
Volcano R-100 Sterile Equipment Covers Recalled for Incorrect Expiry Date Labeling
Volcano Corporation is recalling R-100 Sterile Equipment Covers because the outer shipping boxes may display incorrect expiry dates, although the inner product is correctly labeled.
Product
Volcano R100 Sterile Equipment Cover; Sterile; General Hospital: These Sterile Equipment covers are provided to cover equipment that is mean to be used in the sterile surgical field but cannot be sterilized. The sterile drapes are put over this equipment in case any sterile…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1023-2016·2016-03-09
Medtronic Perfusion Tubing Packs Recalled Due to Cuvette Safety Alert
Medtronic is recalling specific lots of Perfusion Tubing Packs because they contain Terumo CVS cuvettes subject to an Urgent Safety Alert.
Product
Medtronic Custom Perfusion Tubing Pack, Rx, Sterile EO. Terumo Cardiovascular Systems (Terumo CVS) has distributed an Urgent Safety Alert regarding the CD I¿ H/S Cuvette. The cuvette is packaged into Medtronic Perfusion Tubing Packs and only sold as part of the pack. This…
Category
Medical Device
Distribution
24 states
ModerateFDA (Devices)·Z-1037-2016·2016-03-09
Stryker AccuPlace Needle Guide Recalled for Sterility Breach Risk
Stryker is recalling AccuPlace Straight Level Needle Guides because packaging defects may compromise sterility. The recall affects 5,800 units distributed nationwide.
Product
(Stryker) AccuPlace Straight Level Needle Guide; Assists the user with inserting a needle at a predetermined angle for computer tomography.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1036-2016·2016-03-09
Medical Action Industries Recalls PICC/CVC Dressing Kits Due to Misbranding
Medical Action Industries is recalling 180 PICC/CVC Secure Dressing Change kits because the presence of CHG is not identified on the exterior labeling.
Product
PICC/CVC Secure Dressing Change kit, Ref: 73775, Lot 213403, Sterile Single Use, Medical Action Industries, Inc., Arden, NC. This kit is used by clinicians to change dressings
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1040-2016·2016-03-09
Stryker AccuPlace Drace Stereotaxic Needle Guide Recalled for Sterility Risk
Stryker is recalling 5,800 AccuPlace Drace Stereotaxic Needle Guides due to a potential breach in sterility caused by packaging damage.
Product
50001 (Inrad) AccuPlace Drace Stereotaxic Needle Guide; Assists the user with inserting a needle at a predetermined angle for computer tomography.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1042-2016·2016-03-09
Volcano Sterile Equipment Covers Recalled for Incorrect Expiry Date Labeling
Volcano Corporation is recalling certain lots of R-100 Sterile Equipment Covers because the outer shipping boxes may display incorrect expiry dates, although the inner product is correctly labeled.
Product
Volcano SpinVision Sterile Equip cover II; Sterile; General Hospital: These Sterile Equipment covers are provided to cover equipment that is mean to be used in the sterile surgical field but cannot be sterilized. The sterile drapes are put over this equipment in case any…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1033-2016·2016-03-09
FDA Recalls Mispackaged Pediatric Feeding Tubes Due to Labeling Error
The FDA is recalling 1,010 units of pediatric feeding tubes because 8FR PVC tubes were incorrectly packaged in 6.5FR polyurethane packs.
Product
Covidien Kangaroo Polyurethane Feeding Tube Radiopaque Line, Safe Enteral Connections 6.5 Fr/Ch (2.2 mm) x 36" (91 cm), Sterile; Catalog Number: 461438. Intended for pediatric feeding.
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-1019-2016·2016-03-09
Virage OCT Spinal Fixation System Recall for Updated Surgical Guidance
Zimmer Spine is issuing a Class II correction for the Virage OCT Spinal Fixation System to provide additional guidance in the surgical technique manual.
Product
Virage OCT Spinal Fixation System. Intended to promote fusion of the Occipital-Cervical-Thoracic spine (Occiput-T3).
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0799-2016·2016-03-02
Cook Inc. Recalls Single Lumen Central Venous Catheter Sets
Cook Inc. is recalling 1,341 single-lumen central venous catheter sets and trays due to a manufacturing defect that may cause catheter tip fracture or separation.
Product
Single Lumen Central Venous Catheter Sets and Trays The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated catheter. Product catalog numbers with heparin coating are designated by the suffix BH.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0921-2016·2016-03-02
Xeridiem EndoVive 3s Balloon Kits Recalled for Valve Leakage
Xeridiem is recalling 326 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00548350 (XMD P/N 70-0050-214) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0798-2016·2016-03-02
Cook Inc. Recalls Shuttle Select Slip-Cath Catheters Due to Tip Splits
Cook Inc. is recalling 9,519 Shuttle Select Slip-Cath Catheters worldwide due to reports of catheter tip splits and separation, which can cause loss of function or complications.
Product
Shuttle Select Slip-Cath Catheter. Angiographic catheter. For use in angiographic procedures as a conduit for the delivery of contrast media and can help physicians diagnose occlusion or stenosis. The catheters are designed for percutaneous introduction into the vascular…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0827-2016·2016-03-02
Draeger Medical Recalls Evita and Babylog Ventilators Due to Battery Defect
Draeger Medical is recalling Evita Infinity V500 and Babylog Infinity VN500 ventilators because the optional PS500 power supply unit batteries may discharge prematurely despite showing adequate charge.
Product
Evita Infinity V500 Ventilator; Babylog Infinity VN500 Ventilator. Ventilation.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0935-2016·2016-03-02
Xeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage
Xeridiem is recalling 189 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00548530 (XMD P/N 70-0050-416) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0800-2016·2016-03-02
Cook Inc. Recalls Single Lumen Pressure Monitoring Sets Due to Tip Fracture
Cook Inc. is recalling 2,280 single-lumen pressure monitoring sets and trays because a manufacturing defect may cause catheter tips to fracture or separate.
Product
Single Lumen Pressure Monitoring Sets and Trays The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated catheter. Product catalog numbers with heparin coating are designated by the suffix BH.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0802-2016·2016-03-02
Cook Inc. Recalls Radial Artery Pressure Monitoring Catheter Sets
Cook Inc. is recalling radial artery pressure monitoring catheter sets because a manufacturing defect may cause the catheter tip to fracture or separate.
Product
Radial Artery Pressure Monitoring Catheter Sets and Trays The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated catheter. Product catalog numbers with heparin coating are designated by the suffix BH.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0975-2016·2016-03-02
Xeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage
Xeridiem Mediem Medical Devices Inc is recalling 36 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.
Product
EndoVive 3s Low Profile Balloon Kits Part Number M00548430 (XMD P/N 70-0050-A14) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0992-2016·2016-03-02
Xeridiem EndoVive 3s Balloon Kits Recalled for Valve Leakage
Xeridiem is recalling 126 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00549420 (XMD P/N 70-0050-C22) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0981-2016·2016-03-02
Xeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage
Xeridiem Mediem Medical Devices Inc is recalling 39 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00548320 (XMD P/N 70-0050-B12) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0801-2016·2016-03-02
Cook Inc. Recalls Femoral Artery Pressure Monitoring Catheters Due to Tip Fracture Risk
Cook Inc. is recalling specific femoral artery pressure monitoring catheter sets and trays because a manufacturing defect may cause the catheter tip to fracture or separate.
Product
Femoral Artery Pressure Monitoring Catheter Sets and Trays The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated catheter. Product catalog numbers with heparin coating are designated by the suffix BH.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0930-2016·2016-03-02
Xeridiem EndoVive 3s Balloon Kits Recalled for Feeding Valve Leakage
Xeridiem is recalling 34 EndoVive 3s Low Profile Balloon Kits because the feeding valve may leak gastric contents when disconnected.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00548840 (XMD P/N 70-0050-320) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0804-2016·2016-03-02
Maquet Flow-i Anesthesia System Recalled for Electrical Control Issues
Maquet is recalling seven Flow-i Anesthesia Systems in the US due to electrical issues in control and monitoring sub-systems that can cause restarts or system disabling.
Product
Flow-i Anesthesia System Product Usage: The indication for the Flow-i Anesthesia System is administering inhalation anesthesia while controlling the entire ventilation of patients with no ability to breath, as well as in supporting patients with a limited ability to breath.…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0866-2016·2016-03-02
GSI Group Recalls PRN 50-M+ Paper Chart Recorders for Fire Risk
GSI Group Inc. is recalling 2,257 PRN 50-M+ Paper Chart Recorders due to a risk of fire or electrical shock.
Product
PRN 50-M+, GE part number 2062759-001, manufacturer part number 600-23310-01 Product Usage: The PRN 50M+ Paper Chart Recorder thermally records patient data on a paper strip. This device is intended for use under direct supervision of a licensed health care practitioner.…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0947-2016·2016-03-02
Xeridiem EndoVive 3s Balloon Kits Recalled for Feeding Valve Leakage
Xeridiem is recalling 40 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00548270 (XMD P/N 70-0050-612) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0994-2016·2016-03-02
Xeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage
Xeridiem is recalling 36 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00548460 (XMD P/N 70-0050-D14) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0936-2016·2016-03-02
Xeridiem EndoVive 3s Balloon Kits Recalled for Valve Leakage
Xeridiem Mediem Medical Devices is recalling 77 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00548690 (XMD P/N 70-0050-418) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The…
Category
Medical Device
Distribution
Distributed nationwide

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