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-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-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 ROW,
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-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
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-1081-2023·2023-02-15
Sterile Procedural Trays Recalled Due to Potential Blade Puncture of Packaging
Medline Industries recalls sterile procedural trays (Wound Closure Tray and Wound Pack) distributed worldwide because sterile blades may puncture the outer foil packaging.
Product
Sterile Procedural Trays, labeled as the following: a. WOUND CLOSURE TRAY b. WOUND PACK
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1103-2023·2023-02-15
Thoracic Navigation System Recalled for Incorrect Cable Causing Grainy Imaging
Olympus is recalling the SPiN Thoracic Navigation System (model SYS-4000) due to an incorrect DVI cable that produces grainy images during bronchoscopy procedures, requiring extended troubleshooting time.
Product
SPiN Thoracic Navigation System Model: SYS-4000 (SYS-4000D)
Category
Medical Device
Distribution
11 states
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
HighFDA (Devices)·Z-1083-2023·2023-02-15
Medline Sterile Procedural Trays Recalled for Potential Blade Puncture in Packaging
Medline Industries is recalling sterile procedural trays because blades in the kits may puncture the outer foil sterile packaging, compromising sterility. No injuries have been reported.
Product
Sterile Procedural Trays, labeled as the following: a. MAJOR CDS-LF b. BURN PACK-LF c. BURN PACK d. SMALL BURN
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1084-2023·2023-02-15
Sterile Procedural Trays Recalled Due to Potential Packaging Puncture
Medline Industries is recalling sterile procedural trays because sterile blades may puncture the outer packaging foil, potentially compromising sterility. No injuries have been reported.
Product
Sterile Procedural Trays, labeled as the following: MINOR BASIC PACK-LF
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1105-2023·2023-02-15
Roche cobas Influenza Test Recall Due to False Negative Results
Roche Molecular Systems is recalling its cobas Influenza A/B & SARS-CoV-2 test because it has reported false negative results for Influenza A, which may delay diagnosis and treatment.
Product
cobas SARS-CoV-2 & Influenza A/B Qualitative nucleic acid test for use on the cobas 5800/6800/8800 Systems; Material Number 09446125190
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-1067-2023·2023-02-15
Sterile Procedural Trays Recalled Due to Blade Puncture Risk
Medline Industries is recalling sterile procedural trays because sterile blades within the kits may puncture the protective foil packaging. Approximately 12,964 cases (23,379 units) distributed worldwide are affected.
Product
Sterile Procedural Trays, labeled as the following: a. EP LAB PACEMAKER PACK b. OPEN HEART CDS c. OPEN HEART CDS d. AAA CDS e. OPEN HEART CDS f. PACEMAKER CDS g. HEART CDS h. VALVE PACK i. OPEN HEART CDS-3 j. OPEN HEART PACK k. OPEN HEART PACK l. OPEN HEART ADULT m. OPEN HEART C
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1088-2023·2023-02-15
Medline Sterile Surgical Trays Recalled Due to Blade Puncture Risk
Medline Industries recalls sterile surgical procedural trays because sterile blades within the kits may puncture the outer foil packaging, potentially compromising sterility. No injuries or illnesses have been reported.
Product
Sterile Procedural Trays, labeled as the following: a. AV SHUNT CDS b. ZALE V-P SHUNT CDS c. NEURO CDS-LF d. MAJOR NEURO e. NEURO PACK-LF f. CUSTOM NEURO PACK-LF g. NEURO PACK-LF h. NEURO PACK-LF i. NEURO PACK-LF j. NEURO PACK-LF k. NEURO/LAMINECTOMY BASIN PK-LF l
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-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-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-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-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-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-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 - MIDWE
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-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-1090-2023·2023-02-15
Sterile Procedural Trays Recalled Due to Potential Packaging Compromise
Medline Industries recalls sterile pelviscopy trays because blades inside may puncture the protective foil packaging, potentially compromising sterility. 316 units distributed worldwide are affected.
Product
Sterile Procedural Trays, labeled as the following: a. PELVISCOPY PACK b. D-PELVISCOPY
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1096-2023·2023-02-15
Medline Sterile Procedural Trays Recalled Due to Packaging Puncture Risk
Medline recalls sterile procedural trays because blades may puncture the foil packaging, potentially compromising sterility. The recall affects over 227,000 units distributed worldwide.
Product
Sterile Procedural Trays, labeled as the following: a. SPINAL b. SPINE CDS c. TOTAL ORTHO CDS d. TOTAL KNEE CDS e. CDS HIP-LF f. KNEE TOTAL PACK-LF g. EXTREMITY CDS h. SHOULDER ARTHRO CDS i. GLENNON EXTREMITY CDS j. KNEE ARTHROSCOPY k. TOTAL KNEE l. TOTAL HIP REPLACEMENT m. TO
Category
Medical Device
Distribution
Distributed nationwide

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9876–9900 of 13717