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

10076–10100 of 13717

HighFDA (Devices)·Z-0950-2023·2023-01-18
IMMULITE 2000 Thyroglobulin Diagnostic Kit Accuracy Issues
Siemens is recalling 7,543 kits of IMMULITE 2000 Thyroglobulin diagnostic tests due to potential accuracy and precision issues affecting diagnostic reliability.
Product
IMMULITE 2000 Thyroglobulin (OUS). For in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers for the quantitative measurement of thyroglobulin in serum or heparinized plasma, as an aid in monitoring patients who have undergone thyroidectomy. Catalog # Catalog # L2KT
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0951-2023·2023-01-18
FDA Recalls BIOSTOP G Cement Restrictor Due to Elevated Endotoxin Levels
DePuy Ireland is recalling all lots of BIOSTOP G Bioresorbable Cement Restrictor because endotoxin levels exceeded FDA regulatory guidance. Endotoxins can cause inflammatory responses, from mild fever to potential organ damage.
Product
BIOSTOP G BIORESORBABLE CEMENT RESTRICTOR Catalog Numbers: 546308000 (Size 8); 546310000 (Size 10); 546312000 (Size 12); 546314000 (Size 14); 546316000 (Size 16); 546318000 (Size 18); 546320000 (Size 20)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0938-2023·2023-01-18
Syringe Kit Recall: Potential Sterility Breach from Outer Bag Leaks
Stradis Healthcare is recalling HCT 12 CC Syringe Kits due to potential pinhole leaks in the outer bag that could compromise sterility. The recall affects 112,675 units distributed nationwide.
Product
HCT 12 CC SYRINGE KIT, 20/TRAY,5 TRAYS/BAG, 5 BAGS /CASE HCT. Distributed by Health Care Technology.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0917-2023·2023-01-18
Craniotome Attachment Ball Bearings May Separate During Surgery
The FDA is recalling a surgical craniotome attachment after ball bearings can separate from the device. Failure to follow inspection protocols may result in serious patient injury during neurosurgery.
Product
6.5 cm Adult Craniotome, Thin Foot Plate Attachment. Use with XMax¿, microMax, and eMax¿ Systems Ref: CRANI-A-01 intended for cutting and shaping bone including the spine and cranium by trained medical/surgical personnel
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0927-2023·2023-01-18
DeRoyal surgical procedure pack recalled for sterile barrier defect
DeRoyal is recalling certain surgical procedure packs containing Medtronic non-absorbable sutures due to a manufacturing error that may breach the sterile barrier protecting the surgical field.
Product
DeRoyal ORGAN RECOVERY PACK PGYBK, a) REF 89-9004.09 and b) 89-9004.10
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0909-2023·2023-01-18
Codman Surgical Patties Recalled for Out-of-Specification Endotoxin Levels
Integra LifeSciences is recalling one lot of Codman Surgical Patties due to out-of-specification endotoxin levels. The potential risk is a minor, transient fever.
Product
Codman Surgical Patties, Part number 801400; SURG PATXRAY 1/2X1/2-200; Lot 6396457
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0955-2023·2023-01-18
COVIDIEN Emprint Ablation Catheter recalled for incorrect expiration date
COVIDIEN Emprint Ablation Catheters (Lot 520200) are recalled because they are labeled with an incorrect expiration date. The 21 affected units were distributed to Hong Kong.
Product
COVIDIEN Emprint Ablation Catheter with Thermosphere Technology, Bronchoscopic Ablation, REF CA108L1
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0817-2023·2023-01-11
ETEST Amikacin Test Strips Recalled for Storage Condition Excursion
Biomerieux is recalling ETEST CLINICAL AMIKACIN AK 256 US S30 test strips (batch 1009209480) because temperature and time storage conditions were exceeded, and product performance cannot be guaranteed.
Product
ETEST CLINICAL AMIKACIN AK 256 US S30, CATALOG 412218
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0848-2023·2023-01-11
VITEK 2 Diagnostic Test Kit Recalled for Storage Parameter Exceedance
Biomerieux is recalling 39 units of a diagnostic test kit because storage temperature and time parameters were exceeded, which may affect test performance and reliability.
Product
VITEK 2 REAGENT AST-ST02 TEST KIT 20 CARDS, CATALOG 420915
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0793-2023·2023-01-11
Medical Diagnostic Reagent Recalled Due to Storage Temperature Damage
Biomerieux Inc is recalling PREVI COLOR GRAM diagnostic reagent (Catalog 29586) distributed nationwide because improper storage conditions may have degraded product performance.
Product
PREVI COLOR GRAM REAGENT IODINE-B (NA), CATALOG 29586
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0879-2023·2023-01-11
Detect COVID-19 Test may produce false negative results in affected lots
Detect Headquarters is recalling specific lots of Detect COVID-19 Test (Model 21205) due to risk of false negative results. Affected tests may fail to detect COVID-19 infection, potentially delaying treatment and increasing community spread.
Product
Detect Covid-19 Test Product/Model Number: 21205
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0784-2023·2023-01-11
Biomerieux API 20 E 25 Strips Recalled for Storage Condition Failure
Biomerieux Inc is recalling API 20 E 25 Strips (Batch 1009226560) because temperature and time excursions during storage exceeded specified parameters. Product performance cannot be guaranteed.
Product
API 20 E 25 STRIPS, CATALOG 20100
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0813-2023·2023-01-11
Culture Medium Recall Due to Temperature Excursion Affecting Product Performance
Biomerieux Inc recalls PPM INDUSTRY COMBOURG LPT BROTH culture medium batches 2117760 and 2120100 due to temperature excursion that may compromise product performance and reliability.
Product
PPM INDUSTRY COMBOURG LPT BROTH (4X3L), CATALOG 410849
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0812-2023·2023-01-11
FDA Recalls ASTUTE Electronic Quality Control Device for Storage Condition Excursion
Biomerieux Inc. is recalling ASTUTE electronic quality control devices due to temperature and time storage excursion that may compromise product performance in laboratory settings.
Product
ASTUTE REAGENT ASTUTE ELECTRONIC QUALITY CTRL DEVICE US, CATALOG 400016
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0794-2023·2023-01-11
FDA Recalls Reagent Nozzle Cleaning Solution Due to Storage Temperature Exceedance
Biomerieux Inc is recalling a reagent nozzle cleaning solution (Catalog 29588) because storage temperature and time conditions were exceeded, preventing product performance guarantee.
Product
PREVI COLOR GRAM REAGENT NOZZLE CLEANING SOLUTION (NA), CATALOG 29588
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0811-2023·2023-01-11
TEMPO Control Kit Reagents Recalled Due to Storage Temperature Excursion
Biomerieux is recalling TEMPO REAGENTS TEMPO CONTROL KIT (catalog 80000) due to storage conditions exceeding temperature and time limits, compromising product performance. Batch 1009477900 was distributed nationwide.
Product
TEMPO REAGENTS TEMPO CONTROL KIT , CATALOG 80000
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0797-2023·2023-01-11
Biomerieux VIDAS RUB IGG Tests Recalled Due to Storage Conditions
Biomerieux is recalling VIDAS RUB IGG diagnostic tests nationwide after storage temperature and duration exceeded specifications, affecting product performance guarantees.
Product
VIDAS CLINICAL VIDAS RUB IGG 60 TESTS, CATALOG 30226
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0857-2023·2023-01-11
VITEK 2 AST-XN09 test kit recalled for improper storage temperature and time conditions
Biomerieux is recalling VITEK 2 AST-XN09 test kits where performance cannot be guaranteed due to storage outside proper temperature and time parameters. Affected kits nationwide should not be used.
Product
VITEK 2 REAGENT AST-XN09 TEST KIT 20 CARDS, CATALOG 423425
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0865-2023·2023-01-11
Biomerieux Recalls VIDAS LH 60 Clinical Tests for Temperature-Induced Performance Issues
Biomerieux is recalling VIDAS LH 60 diagnostic test kits nationwide due to temperature and time excursion. The affected batch's product performance cannot be guaranteed due to storage conditions exceeding acceptable parameters.
Product
VIDAS CLINICAL VIDAS LH 60 TESTS, CATALOG 30406-01
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0783-2023·2023-01-11
Listeria Detection Test Strips Recalled for Unreliable Performance
Biomerieux is recalling API Listeria detection test strips that were exposed to temperature and time exceedance during storage. Product performance cannot be guaranteed as a result.
Product
API LISTERIA 10 STRIPS+10 MEDIA, CATALOG 10300
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0862-2023·2023-01-11
Nephrocheck Liquid Control Reagent Recall Due to Storage Condition Violation
Biomerieux is recalling one batch of Nephrocheck Liquid Control Reagent because the product was stored outside proper temperature and time parameters, making performance unreliable.
Product
ASTUTE REAGENT NEPHROCHECK LIQUID CONTROLS KIT US, CATALOG 500013
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0904-2023·2023-01-11
Laboratory quality control material with degraded potency affecting diagnostic verification
Randox Liquid Assayed Specific Protein Control Level 2 has lost potency in rheumatoid factor, causing laboratory quality control tests to fail and delaying patient test results.
Product
Liquid Assayed Specific Protein Control Level 2- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems Catalog Number: PS2683
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0827-2023·2023-01-11
ETEST Clinical Meropenem Susceptibility Test Recalled for Storage Condition Failure
Biomerieux is recalling 3 units of ETEST Clinical Meropenem MP 32 susceptibility test (catalog 412401) nationwide due to storage temperature and time exceedances that cannot guarantee product performance.
Product
ETEST CLINICAL MEROPENEM MP 32 US S30, CATALOG 412401
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0776-2023·2023-01-11
Guardian Glucose Monitoring App May Automatically Log Out and Block Data Upload
The Guardian continuous glucose-monitoring app may automatically log out, preventing data uploads and SMS alerts to care partners. This could result in missed detection of dangerous blood sugar levels.
Product
Guardian iOS app (MMT-8200) and Guardian Android app (MMT-8201), part of the Guardian 4 system
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0815-2023·2023-01-11
Clinical reagent recalled due to temperature and time excursion
Biomerieux Inc is recalling VITEK MS CLINICAL REAGENT VITEK MS-CHCA due to temperature and time excursions that may prevent product performance guarantees. No illnesses reported.
Product
VITEK MS CLINICAL REAGENT VITEK MS-CHCA, CATALOG 411071
Category
Medical Device
Distribution
Distributed nationwide

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10076–10100 of 13717