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

22076–22100 of 27663

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
HighFDA (Devices)·Z-0901-2016·2016-03-02
Olympus Video Colonoscopes Recalled Due to Internal Coil Detachment Risk
Integrated Medical Systems Inc is recalling 122 Olympus video colonoscopes because excessive pressure may cause the internal coil pipe assembly to detach, affecting angulation.
Product
Olympus, Model No. PCF-Q180AL, flexible scope, large diameter, video colonoscope
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0867-2016·2016-03-02
Stryker T2 K-Wire Recall Due to Potential Pouch Seal Integrity Issues
Stryker is recalling T2 K-Wires because a packaging review found the pouch seal integrity may be decreased, potentially affecting sterility.
Product
Stryker, T2 K-Wire 1.8 x 310 mm, Sterile Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0826-2016·2016-03-02
Siemens Syngo Dynamics Software Recalled for Potential Patient Data Mixing
Siemens is recalling Syngo Dynamics PACS software because it may mix data from multiple patients in echo trend graphs.
Product
software for Syngo Dynamics a Picture Archiving and Communication System (PACS) intended for acceptance, transfer, display, storage, archive and manipulation of digital medical images, including quantification and report generation. Syngo Dynamics is not intended to be used…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1002-2016·2016-03-02
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: M00548950 (XMD P/N 70-0050-E20) 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-0857-2016·2016-03-02
Philips PIIC Classic Upgrade Patient Monitor Recall for ECG Waveform Misrepresentation
Philips is recalling PIIC Classic Upgrade patient monitors because reconstructed ECG leads may misrepresent waveforms on the Information Center iX.
Product
Philips Healthcare PIIC Classic Upgrade, 866117 Physiological, Patient Monitor (With Arrhythmia Detection or Alarm)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0907-2016·2016-03-02
Olympus PCF-140L Video Colonoscope Recalled for Internal Coil Detachment
Integrated Medical Systems Inc is recalling three Olympus PCF-140L video colonoscopes because the internal coil pipe assembly may detach under excessive pressure.
Product
Olympus, Model No. PCF-140L, flexible scope, large diameter, video colonoscope
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1011-2016·2016-03-02
Xeridiem EndoVive 3s Balloon Kits Recalled for Valve Leakage
Xeridiem is recalling 37 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: M00548490 (XMD P/N 70-0050-G14) 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-0825-2016·2016-03-02
Siemens BCS XP Analyzer Recalled for False Clotting Results
Siemens Healthcare Diagnostics is recalling BCS XP Automated Blood Coagulation Analyzer Systems because they may produce falsely short clotting times and low INR values for specific patient samples.
Product
BCS XP Automated Blood Coagulation Analyzer System, Multipurpose system for in vitro coagulation studies, Catalog Numbers: 10459330 (BCS XP SYSTEM, COMPLETE), 10462449 (BCS XP ANALYZER SYSTEM), 10461894 (BCS XP), 10470625 (BCS XP REFURBISHED); IVD --- Device Listing D060801
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0963-2016·2016-03-02
Xeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage
Xeridiem is recalling 91 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: M00548570 (XMD P/N 70-0050-816) 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-0949-2016·2016-03-02
Xeridiem EndoVive 3s Balloon Kits Recalled for Valve Leakage
Xeridiem is recalling 154 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: M00548550 (XMD P/N 70-0050-616) 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-0938-2016·2016-03-02
Xeridiem EndoVive 3s Balloon Kits Recalled for 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: M00549340 (XMD P/N 70-0050-422) 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-0948-2016·2016-03-02
Xeridiem EndoVive 3s Balloon Kits Recalled for Feeding 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: M00548390 (XMD P/N 70-0050-614) 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-0978-2016·2016-03-02
Xeridiem EndoVive 3s Low Profile Balloon Kits Recalled for 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: M00548910 (XMD P/N 70-0050-A20) 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-0900-2016·2016-03-02
Olympus GIF-140 Video Gastroscope Recalled for Detached Coil Pipe Assembly
Integrated Medical Systems Inc is recalling 12 Olympus GIF-140 video gastroscopes because the internal coil pipe assembly may detach under pressure, causing angulation failure.
Product
Olympus, Model No. GIF-140, flexible scope, large diameter, video gastroscope
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1012-2016·2016-03-02
Xeridiem EndoVive 3s Balloon Kits Recalled for Feeding Valve Leakage
Xeridiem 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: M00548650 (XMD P/N 70-0050-G16) 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-0924-2016·2016-03-02
Xeridiem EndoVive 3s Low Profile Balloon Kits Recalled for 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: M00548830 (XMD P/N 70-0050-220) 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-0973-2016·2016-03-02
Xeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage
Xeridiem Mediem Medical Devices Inc. is recalling 34 EndoVive 3s Low Profile Balloon Kits due to a feeding valve leakage issue that may allow gastric contents to leak.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00549530 (XMD P/N 70-0050-924) 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-0919-2016·2016-03-02
Xeridiem EndoVive 3s Low Profile Balloon Kits Recalled for 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: M00549310 (XMD P/N 70-0050-122) 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-0860-2016·2016-03-02
Hill-Rom Bariatric Power Recliner Recalled for Missing Foot Rest Shields
Hill-Rom is recalling 216 Bariatric Power Recliners (Model P9096) because they were shipped without foot rest ottoman linkage side shields, which could result in consumer injury.
Product
Hill-Rom Bariatric Power Recliner, Product Model # P9096 Hill-Roms 660 lb Powered Bariatric Recliner was created to provide an aesthetically pleasing design that will enhance the overall experience for the bariatric patient. Using spring box construction and an exceptionally…
Category
Medical Device
Distribution
39 states
HighFDA (Devices)·Z-1000-2016·2016-03-02
Xeridiem EndoVive 3s Balloon Kits Recalled for 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: M00548630 (XMD P/N 70-0050-E16) 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-1015-2016·2016-03-02
Xeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage
Xeridiem Mediem Medical Devices Inc. is recalling 32 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: M00549460 (XMD P/N 70-0050-G22) 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-0906-2016·2016-03-02
Olympus Video Gastroscope Recall Due to Internal Coil Detachment Risk
Integrated Medical Systems Inc is recalling four Olympus GIF-XQ140 video gastroscopes because excessive pressure can cause the internal coil pipe assembly to detach, preventing proper angulation.
Product
Olympus, Model No. GIF-XQ140, flexible scope, large diameter, video gastroscope
Category
Medical Device
Distribution
Distributed nationwide

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22076–22100 of 27663