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 deaths or serious injuries are reported, 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

9876–9900 of 13717

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; Emissio
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) 8
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) 8
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, i
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1073-2023·2023-02-15
Sterile Procedural Trays Recalled for Potential Blade Puncture
Medline sterile procedural trays for minor and breast biopsies are being recalled because sterile blades may puncture the outer foil packaging, compromising sterility. The recall affects 237 cases (1,242 units) distributed worldwide.
Product
Sterile Procedural Trays, labeled as the following: a. MINOR/BREAST BIOPSY-LF b. BREAST BIOPSY-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. CUH
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1076-2023·2023-02-15
Sterile Procedural Trays Recalled Due to Blade Puncture Risk
Medline Industries is recalling sterile procedural trays (ENDOSCOPY-LF and SEPTO/ENDO) because sterile blades may puncture the outer foil layer of the sterile packaging. The recall affects units distributed nationwide and internationally.
Product
Sterile Procedural Trays, labeled as the following: a. ENDOSCOPY-LF b. SEPTO/ENDO
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1064-2023·2023-02-15
Sterile Procedural Trays Recalled Over Potential Blade Puncture of Packaging
Medline Industries is recalling sterile procedural trays because sterile blades inside could puncture the outer foil packaging, compromising sterility. The recall affects units distributed worldwide.
Product
UNIVERSAL CORE DR RUNNELS PACK. Sterile Procedural Tray
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1099-2023·2023-02-15
Spinal Cement System Recalled for Incorrect Expiration Date
TEKNIMED SAS is recalling HIGH V+ Spinal Cement System (236 units) due to mislabeling showing expiration date of February 28, 2027 instead of the correct date February 28, 2025.
Product
HIGH V+ Spinal Cement System REF T040321K
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-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-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-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-1102-2023·2023-02-15
Smart Correction External Fixation Struts: Collar Release Pin May Back Out
The collar release pin on affected Smart Correction Dual Joint Express Struts may back out, preventing proper length adjustment and potentially delaying surgical correction.
Product
WishBone Medical Smart Correction Dual Joint Express Struts, external skeleton fixation device Type Part Number XXS 10-702-080095-0 XS 10-702-095115-0 Short 10-702-115150-0 Medium 10-702-140200 Long 10-702-190300-0
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1094-2023·2023-02-15
Sterile Procedural Trays Recalled Due to Blade Puncture Risk
MEDLINE INDUSTRIES is recalling sterile surgical trays used in robotic and laparoscopic procedures because blades within the kits can puncture the outer foil packaging. The recall affects 1,212 cases (2,101 units) distributed worldwide.
Product
Sterile Procedural Trays, labeled as the following: a. CELEBRATION ROBOTIC CDS b. DAVINCI CDS UCC-LF c. ROBOTICS PACK-LF d. ROBOTICS PACK-LF e. ROBOTIC PACK f. PELVISCOPY PACK-LF g. CUSTOM LITHOTOMY ROBOT PACK h. PERI GYN PACK i. ROBOTICS PACK j. LAP HYSTO PACK k.
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 l
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-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-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-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-1062-2023·2023-02-15
Medline sterile procedural trays recalled for blade packaging puncture
Medline is recalling sterile procedural trays (Lot 22IBG550) because sterile blades can puncture the foil packaging, compromising sterility. Units were distributed worldwide.
Product
LOCAL PACK. Sterile Procedural Tray.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1089-2023·2023-02-15
Sterile surgical trays recalled due to packaging puncture risk
MEDLINE INDUSTRIES is recalling six models of sterile surgical trays due to a potential for blades within the kits to puncture the sterile packaging. Affected trays were distributed worldwide.
Product
Sterile Procedural Trays, labeled as the following: a. GYN LAPAROTOMY HARPER PACK-LF b. OB GYN LAP PACK-LF c. VAGINAL HYSTERECTOMY PACK d. DELTA PACK e. MAJOR VAGINAL-LF f. GYN LAPAROSCOPY II
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1092-2023·2023-02-15
Sterile Procedural Trays With Blades That May Puncture Packaging
Medline recalls sterile surgical trays because internal blades can puncture the outer protective foil packaging, potentially compromising sterility.
Product
Sterile Procedural Trays, labeled as the following: a. C-SECTION OR 30 CDS b. C-SECTION CDS c. C-SECTION CDS d. C-SECTION CDS e. MAJOR ORTHO CDS-LF f. C-SECTION CDS g. C-SECTION CDS h. C-SECTION PROCEDURE i. C-SECTION CDS-LF j. C-SECTION CDS k. C-SECTION CDS l. C-
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1069-2023·2023-02-15
Medline Sterile Procedural Trays Risk Package Puncture and Sterility Compromise
Medline Industries is recalling sterile procedural trays because sterile blades may puncture the outer foil packaging, potentially compromising sterility. The recall affects 858 units distributed worldwide.
Product
Sterile Procedural Trays, labeled as the following: a. BREAST BIOPSY PACK-LF b. BREAST BIOPSY PACK c. LAPAROTOMY PACK d. BREAST PACK e. SOFT TISSUE PACK f. HEMORRHOID PACK g. RECTAL h. BREAST i. BREAST
Category
Medical Device
Distribution
Distributed nationwide

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9876–9900 of 13717