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

10601–10625 of 39932

CriticalFDA (Devices)·Z-1056-2023·2023-02-15
GE Nuclear Medicine Imaging Systems detector fall hazard
GE Nuclear Medicine 600/800 series imaging systems may have faulty detectors that could fall, causing serious injury. Mitigation measures may not be properly implemented on 34 units distributed worldwide.
Product
GE Nuclear Medicine 600/800 series systems, specifically: a) OPTIMA O640 X 3/8 inch NR, b) DISCOVERY O640 X 3/8 inch, c) NM OPTIMA O640 X 3/8 inch, d) O640 NM Gantry 3/8 inch, e) O640 NM GANTRY FINAL ASSY, f) OPTIMA O640 X 3/8 inch; Emission Computed Tomography System
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1057-2023·2023-02-15
GE Nuclear Medicine Systems Recall Due to Potential Detector Fall Hazard
GE is recalling 86 Nuclear Medicine 600/800 series systems worldwide due to a potential failure in a safety mitigation. If not correctly implemented, the detector can fall and cause life-threatening injury.
Product
GE Nuclear Medicine 600/800 series systems, specifically: a) 870 CZT O540+ Gantry 7.25mm, b) D670 CZT Gantry 7.25mm, c) DISCOV NM/CT 870 CZT, d) Discovery NMCT 670 CZT O540+, e) NM/CT 870 CZT CYBER DEFENCE, f) NM/CT 870 CZT O540, g) NM/CT 870 CZT WSO, h) NM/CT 870 CZT…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1058-2023·2023-02-15
GE Nuclear Medicine 600/800 Systems Recalled for Detector Fall Risk
GE Medical Systems is recalling 380 GE Nuclear Medicine 600/800 series diagnostic imaging systems worldwide due to potential failure in detector mitigation that could allow the detector to fall, risking life-threatening injury.
Product
GE Nuclear Medicine 600/800 series systems, specifically: a) 850, b) 850 / Dismount, c) 850 3/8 inch NM Gantry, d) 860 / Dismount, e) 860 3/8 inch NM Gantry, f) 860 5/8 inch NM Gantry, g) 860 BJ, h) NM 830 3/8 inch BJ, i) NM/CT 850 3/8 inch BJ, j) NM/CT 850 3/8 inch…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1053-2023·2023-02-15
GE Nuclear Medicine 600/800 Series Systems Detector Fall Risk
GE Nuclear Medicine 600/800 series systems have a safety mitigation that may not be correctly implemented, allowing the detector to fall and cause life-threatening injury. 557 units are affected worldwide.
Product
GE Nuclear Medicine 600/800 series systems, specifically: a) 870, b) 870 DR 3/8 inch NM GANTRY WITH NEW ROTOR - MEA, c) 870 DR / Dismount, d) 870 DR / Dismount / 60HZ, e) 870 DR 3/8 inch WSO, f) 870 DR 3/8 inch NM Gantry, g) 870 DR 3/8 inch, h) 870 DR 3/8 inch CH, i)…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1054-2023·2023-02-15
GE Nuclear Medicine Systems: Detector Fall Risk Due to Faulty Mitigation
GE Nuclear Medicine 600/800 series systems (748 units distributed worldwide) may have improperly implemented detector fall mitigations. If the mitigation fails, the detector can fall and cause life-threatening bodily injury.
Product
GE Nuclear Medicine 600/800 series systems, specifically: a) 830, b) 830 / Dismount, c) 830 /, d) 830 / 5842894-20, e) 830 / Dismount / 50HZ, f) 830 / Dismount / 60HZ, g) 830 3/8 inch Detector, h) 830 BJ, i) 830 BJ / 5144407, j) 830 BJ / Dismount, k) 830 ES DEM, l)…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1055-2023·2023-02-15
GE Nuclear Medicine BRIVO B615 Imaging System Detector Fall Risk
GE Nuclear Medicine BRIVO B615 imaging systems may have an ineffective safety mitigation, allowing the detector to fall and cause life-threatening injury. The FDA issued a Class I recall for seven units distributed worldwide.
Product
GE Nuclear Medicine 600/800 series systems, specifically: a) BRIVO B615 3/8 inch DHP BJG NR, b) BRIVO 615 3/8 inch, c) BRIVO B615 3/8 inch DHP BJG NR, d) B615 with new rotor, e) BRIVO B615 3/8 inch BJG, f) BRIVO B615 3/8 inch DHP BJG NR, g) B615 with new rotor…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1101-2023·2023-02-15
RipCord Syndesmosis Button suture may break during orthopedic surgery
The RipCord Syndesmosis Button's pull suture can break when excessive tension is applied during orthopedic surgery. TriMed Inc. is recalling 76 units due to this structural failure risk.
Product
RipCord Syndesmosis Button, REF: STA001K
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1078-2023·2023-02-15
Medline Sterile Surgical Trays Recalled for Potential Blade Puncture of Packaging
Medline Industries is recalling sterile procedural trays because blades in the kits may puncture the outer packaging, potentially compromising sterility.
Product
Sterile Procedural Trays, labeled as the following: a. ST. ANNE'S MAJOR BASIN SET UP b. SINGLE BASIN SET c. DOUBLE BASIN SET d. LAPAROTOMY BASIN e. ORTHOPEDIC CUSTOM BASIN SET f. OISC BASIN TRAY g. BASIN PACK h. BASIN SET i. SURGI START PACK j. PK, GEN-SET UP…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1097-2023·2023-02-15
Sterile arthroscopy trays recalled for potential blade puncture risk
Medline Industries recalls multiple sterile arthroscopy surgical trays because blades in the kits may puncture the outer foil packaging, potentially compromising sterility. Affected products were distributed worldwide.
Product
Sterile Procedural Trays, labeled as the following: a. KNEE ARTHROSCOPY CDS-LF b. ARTHROSCOPY CDS c. ARTHROSCOPY LV - EDOC PACK-LF d. ARTHROSCOPY PACK-LF e. ARTHROSCOPY PACK f. ARTHRO PACK-LF g. ARTHROSCOPY PACK-LF h. ARTHROSCOPY PACK-LF i. ARTHROSCOPY KNEE TRAY-LF…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1091-2023·2023-02-15
Sterile Surgical Trays Recalled for Potential Sterile Packaging Puncture
Medline Industries recalls sterile surgical procedural trays because blades within the kits could puncture the sterile outer packaging, potentially compromising sterility during surgical use.
Product
Sterile Procedural Trays, labeled as the following: a. GYN-URO LAPSCP CDS-LF b. ROBOTIC CDS c. GYN LAPAROSCOPY CDS-LF d. GYN LAPAROSCOPY e. GYN LAPAROSCOPY CDS f. UNIVERSAL ROBOTIC ORLANDO g. GYN ROBOTIC CDS h. GYN LAPAROSCOPY CDS-1 i. CUH GYN LAPAROSCOPY CDS j.…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1079-2023·2023-02-15
Sterile Procedural Trays Recalled for Potential Blade Puncture of Packaging
Medline Industries is recalling multiple sterile procedural trays because blades within the kits can potentially puncture the outer foil packaging, compromising sterility. The recall affects approximately 215,456 units distributed worldwide.
Product
Sterile Procedural Trays, labeled as the following: a. BASIN SET-UP PACK b. LAP CHOLE CDS c. MAJOR CDS d. UROLOGY MINOR CDS e. UROLOGY MAJOR CDS f. SINGLE BASIC CDS g. ORGAN RECOVERY CDS h. GENERAL ABD CDS i. BURN CDS j. MINOR k. MAJOR VASCULAR l. BASIC CORE CDS m. ROBOTIC…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1074-2023·2023-02-15
Sterile Procedural Trays Recalled Due to Blade Packaging Puncture Hazard
Medline Industries is recalling multiple sterile procedural trays because blades within the kits can puncture the outer foil packaging. The products were distributed worldwide.
Product
Sterile Procedural Trays, labeled as the following: a. LAPAROTOMY CDS-LF b. LAPAROSCOPY CDS-LF c. BASIC LAPAROSCOPY CDS d. LAPAROSCOPY CDS-LF e. GENERAL LAPAROSCOPY PROCEDURE f. LAP CHOLE CDS g. COLO-RECTAL CDS-LF h. MAJOR PROCEDURE-LF i. HYPOSPADIUS CDS j. LAPAROSCOPY-GENERAL…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1071-2023·2023-02-15
Medline Sterile Procedural Trays Recalled Due to Blade Puncture Risk
Medline Industries is recalling sterile procedural trays (Rhinoplasty Pack, OSC Otology Pack-LF, and Rhyzotomy) distributed worldwide because sterile blades within the kits may puncture the outer foil layer of sterile packaging, potentially compromising sterility.
Product
Sterile Procedural Trays, labeled as the following: a. RHINOPLASTY PACK b. OSC OTOLOGY PACK-LF c. RHYZOTOMY
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1082-2023·2023-02-15
Sterile Procedural Trays recalled due to potential sterile packaging puncture
Medline Industries is recalling Sterile Procedural Trays (IM NAIL) because sterile blades may puncture the outer foil layer of sterile packaging, potentially compromising sterility. No illnesses or injuries have been reported.
Product
Sterile Procedural Trays, labeled as the following: IM NAIL
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1087-2023·2023-02-15
Medline Procedural Trays Recalled for Blade Packaging Risk
Medline Industries is recalling Ambulatory Mini Pack sterile procedural trays because blades within the kits may puncture the outer sterile packaging, potentially compromising sterility.
Product
Sterile Procedural Trays, labeled as the following: AMBULATORY MINI PACK
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1086-2023·2023-02-15
Sterile Procedural Trays Recalled Due to Potential Blade Packaging Puncture
Medline Industries is recalling sterile procedural trays because blades within the kits may puncture the outer foil packaging, potentially compromising sterility.
Product
Sterile Procedural Trays, labeled as the following: DR MOTT DRAPE PACK
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1085-2023·2023-02-15
Sterile Procedural Trays Recalled Due to Blade Puncture Risk
Medline Industries is recalling Sterile Procedural Trays (LS MS PACK) because the sterile blade inside can potentially puncture the outer packaging layer, compromising sterility.
Product
Sterile Procedural Trays, labeled as the following: LS MS PACK
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1080-2023·2023-02-15
Medline Sterile Procedural Trays Recalled Due to Blade Puncture Risk
Medline recalls sterile surgical trays (Universal Plastic and Knee Arthroscopy Pack) because sterile blades can puncture the outer foil packaging, potentially compromising sterility.
Product
Sterile Procedural Trays, labeled as the following: a. UNIVERSAL PLASTIC b. KNEE ARTHROSCOPY PACK
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1060-2023·2023-02-15
Medline Sterile Procedural Trays Recalled for Packaging Puncture Risk
Medline Industries is recalling ANCILLARY PACK-LF sterile procedural trays because sterile blades in the kits may puncture the outer foil layer of sterile packaging, potentially compromising the sterility of the contents.
Product
ANCILLARY PACK-LF. Sterile Procedural Tray.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1068-2023·2023-02-15
Sterile Procedural Trays Recalled Due to Blade Package Puncture Risk
Medline sterile procedural trays are recalled because sterile blades within the kits can puncture the outer foil packaging, potentially compromising sterility. 622 cases (1,619 units) have been distributed worldwide.
Product
Sterile Procedural Trays, labeled as the following: a. PORT/TRACH INSERTION CDS-3 b. RESIDENT DERM SURG PACK c. THROMBECTOMY PACK-LF d. AV FISTULA PACK e. AV SHUNT PACK-LF f. RR-VP SHUNT PACK-LF g. VEIN HARVESTING PACK-LF h. AV FISTULA PACK-LF i. PK, GEN-BARIATRIC j.…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1095-2023·2023-02-15
Sterile Ophthalmic Procedure Trays Recalled for Packaging Integrity Risk
Medline Industries is recalling sterile ophthalmic procedure trays because blades in the kits can puncture the outer foil packaging, potentially compromising sterility. The recall affects 1,200 units distributed worldwide.
Product
Sterile Procedural Trays, labeled as the following: a. BASIC EYE PACK-LF b. VITRECTOMY PACK-LF c. EYE PACK-EAST-LF d. OSC OCULAR PLASTIC PACK-LF e. EYE PACK f. OCULOPLASTIC PACK g. EYE PLASTIC PACK h. PLASTIC EYE PACK i. DR H BLEPH PACK j. BLEPH PACK k.…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1108-2023·2023-02-15
Vascular Covered Stent Recalled Due to Deployment Failure Risk
Bard Peripheral Vascular Inc is recalling approximately 10,815 Covera Vascular Covered Stent devices due to poor slide block bonding that may prevent proper deployment during vascular procedures.
Product
The Covera Vascular Covered Stent is a flexible, self-expanding endoprothesis comprised of ePTFE encapsulating a nitinol stent framework. The inner lumen of the covered stent is carbon impregnated.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1107-2023·2023-02-15
Surgical instrument tracker recalled for structural failure during use
Trackx Technology is recalling 464 units of its Insight Base Modular Instrument Tracker because the device breaks and falls off from surgical instruments during procedures. No injuries have been reported.
Product
TrackX Insight Base Modular Instrument Tracker, 5L, REF #604-3TX, Sterile; and TrackX Insight Base Modular Instrument Tracker, 6.5L, Model #605-3TX, Sterile.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1061-2023·2023-02-15
Sterile Trach Pack procedure kits recalled due to blade puncture risk
Medline Industries is recalling TRACH PACK sterile procedure kits because sterile blades within the kits can puncture the outer foil packaging, potentially compromising product sterility.
Product
TRACH PACK. Sterile Procedural Tray.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1072-2023·2023-02-15
Medline Sterile Procedural Trays Recalled for Potential Packaging Puncture Risk
Medline Industries is recalling approximately 27,563 units of sterile procedural trays used in surgery because sterile blades may puncture the outer foil packaging layer, potentially compromising sterility.
Product
Sterile Procedural Trays, labeled as the following: a. EAR CDS-LF b. SINUS CDS-1 c. ZALE FESS CDS d. ZALE OTOLOGY CDS e. ZALE HEAD & NECK CDS f. CUH PARA/THYROIDECTOMY CDS g. CAM ENDOSCOPIC SINUS/SEPTO CDS h. HEAD AND NECK CDS i. HEAD AND NECK CDS-LF j. NASAL k. ENT SET UP CDS…
Category
Medical Device
Distribution
Distributed nationwide

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10601–10625 of 39932