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

2751–2775 of 39987

CriticalFDA (Devices)·Z-0154-2026·2025-10-29
IV burette sets recalled over missing internal shutoff valve component
ICU Medical is recalling 23,203 IV administration sets because the burette component is missing an internal shutoff valve intended to stop fluid flow.
Product
IV Administration sets. 23" (58 cm) 150 mL Burette Set (Clave, Shut Off) w/Clave, Luer Lock, REF: B33359; 23" (58 cm) 150 ml Burette Set (w/Shut Off), MicroClave, Clamp, REF: B9213; 70" (178 cm) 150 ml Burette Set (Clave, Shut-Off) w/3-Way Stopcock, Clave, Graduated Adapter,
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0136-2026·2025-10-29
Impella controllers recalled over purge pressure issues from retainer failures
Abiomed is recalling Automated Impella Controllers over the potential for purge pressure issues caused by purge retainer failures, covering 9,177 distributed units.
Product
Automated Impella Controller (AIC) labeled as the following with corresponding Product Codes: 1. AIC w/Impella Connect for ECP, Product Code: 1000432. 2. Dbl optical, AIC Impella Connect, Phg US, Product Code: 1000201. 3. Impella Controller, Packaged, AU, Product Code: 0042-00
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0296-2026·2025-10-29
Maxicam gamma cameras recalled over risk of detector falling from mount
GE HealthCare is recalling 37 Maxicam gamma cameras because systems past guaranteed service may have been moved without adequate detector support, risking a detector fall.
Product
Maxicam; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0238-2026·2025-10-29
BD MAX instruments recalled after service credentials accessed by unauthorized actor
Becton Dickinson is recalling 62 BD MAX System instruments after product service credentials used by some technical support teams were accessed by an unauthorized actor.
Product
BD MAX System, for in vitro diagnostic (IVD) use, labeled as the following: 1. BD MAX System, BD MAX Instrument, Catalog Numbers: 44191609, 441927.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0237-2026·2025-10-29
Blood culture systems recalled after service credentials were accessed by unauthorized actor
Becton Dickinson is recalling 1,086 BD BACTEC Blood Culture Systems after product service credentials used by some technical support teams were accessed by an unauthorized actor.
Product
BD BACTEC Blood Culture System, labeled as the following: 1. BACTEC 9120 System, Catalog Numbers: 445570, 445702. 2. INSTRUMENT BACTEC 9120 UNREPAIRED, Catalog Number: 44557008.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0301-2026·2025-10-29
Optima NX gamma camera recalled over risk of detector falling
GE HealthCare is recalling one Optima NX gamma camera because systems past guaranteed service may have been moved without adequate detector support, risking a detector fall.
Product
Optima NX; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0236-2026·2025-10-29
BACTEC FX instruments recalled after service credentials accessed by unauthorized actor
Becton Dickinson is recalling 177 BD BACTEC Blood Culture System instruments after product service credentials used by some technical support teams were accessed by an unauthorized actor.
Product
BD BACTEC Blood Culture System, labeled as the following: 1. BD BACTEC FX, Instrument Top, Packaged, Catalog Number: 44138509. 2. Instrument Top Remanufactured Bactec Fx, Catalog Number: 441676. 3. BACTEC 9240 System, Catalog Number: 445569. 4. BD BACTEC FX40 Instrum
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0216-2026·2025-10-29
Immunoassay analyzers recalled over dilution factor anomaly affecting patient results
Beckman Coulter is recalling 571 DxI 9000 Access Immunoassay Analyzers over a software anomaly that may not apply user-specified manual dilution factors, risking false low or high results.
Product
DxI 9000 Access Immunoassay Analyzer, Part Number C11137
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0239-2026·2025-10-29
Automated microbiology systems recalled after service credentials were accessed by unauthorized actor
Becton Dickinson is recalling 4,283 BD Phoenix M50 Automated Microbiology Systems after product service credentials used by some technical support teams were accessed by an unauthorized actor.
Product
BD Phoenix M50 Instrument, labeled as the following: 1. BD Phoenix M50 Automated Microbiology System, Catalog Numbers: 443624, 44362409.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0210-2026·2025-10-29
Dual lumen stomach tubes recalled after anti-reflux valve breakage complaints
Cardinal Health is recalling all lots of Salem Sump dual lumen stomach tubes with anti-reflux valve after complaints of valve breakage due to excessive force during use.
Product
Salem Sump PVC Tubes: Product Code/Product Name: 266122 Salem Sump" Stomach Tube, Dual Lumen with Anti-Reflux Valve, 14 Fr/Ch (4.7 mm) 266130 Salem Sump" Stomach Tube, Dual Lumen with Anti-Reflux Valve, 16 Fr/Ch (5.3 mm) 266148 Salem Sump" Stomach Tube, Dual Lumen with Anti
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0240-2026·2025-10-29
Veritor Connect software recalled after service credentials accessed by unauthorized actor
Becton Dickinson is recalling 38 BD Veritor Connect Software units after product service credentials used by some technical support teams were accessed by an unauthorized actor.
Product
BD Veritor Connect Software, labeled as the following: 1. Veritor (NUC), Catalog Number: 444881. Transfers in vitro diagnostic results data on the BD Veritor Plus Analyzer to BD Synapsys.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0290-2026·2025-10-29
Elscint Cardial gamma cameras recalled over risk of detector falling
GE HealthCare is recalling 11 Elscint Cardial gamma cameras because systems past guaranteed service may have been moved without adequate detector support, risking a detector fall.
Product
Elscint Cardial; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0207-2026·2025-10-29
PVC stomach tubes recalled after anti-reflux valve breakage complaints
Cardinal Health is recalling all lots of Salem Sump dual lumen stomach tubes after complaints of anti-reflux valve breakage due to excessive force during use.
Product
Salem Sump PVC Tubes: Product Code/Product Name: 264929 Salem Sump" Stomach Tube, Dual Lumen, 12 Fr/Ch (4.0 mm) 264945 Salem Sump" Stomach Tube, Dual Lumen, 14 Fr/Ch (4.7 mm) 264960 Salem Sump" Stomach Tube, Dual Lumen, 16 Fr/Ch (5.3 mm) 264986 Salem Sump" Stomach Tube, Du
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0211-2026·2025-10-29
Gastroduodenal sump tubes recalled after anti-reflux valve breakage complaints
Cardinal Health is recalling all lots of Salem Sump PVC gastroduodenal tubes after complaints of anti-reflux valve breakage due to excessive force during use.
Product
Salem Sump PVC Tubes: Product Code/Product Name: 1180264408 Salem Sump" PVC Gastroduodenal Tube, 10 Fr/Ch (3.3 mm) x 90 cm 1180264416 Salem Sump" PVC Gastroduodenal Tube, 12 Fr/Ch (4.0 mm) x 114 cm 1180264424 Salem Sump" PVC Gastroduodenal Tube, 14 Fr/Ch (4.7 mm) x 114 cm
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0215-2026·2025-10-29
Clinical analyzer modules recalled over dilution factor software anomaly affecting results
Beckman Coulter is recalling 160 DxC 500i Clinical Analyzer modules over a software anomaly that may not apply user-specified manual dilution factors, risking false low or high results.
Product
DxC 500i Clinical Analyzer Modules, DxC 500 AU Module w/ISE, DxC 500i (Part Number C63522), DxC 500 AU Module, DxC 500i (Part Number C63521), and Access 2 Module, DxC 500i (Part Number C13252)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0294-2026·2025-10-29
Elscint Varicam gamma cameras recalled over risk of detector falling
GE HealthCare is recalling 15 Elscint Varicam gamma cameras because systems past guaranteed service may have been moved without adequate detector support, risking a detector fall.
Product
Elscint Varicam; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0231-2026·2025-10-29
ECG trunk cables recalled because improper module placement can cause overheating
GE is recalling 29,225 MAC VU360 acquisition trunk cables and module holders because incorrect placement of the module can wear the cable until it overheats in use.
Product
MAC VU360 Acquisition Trunk Cable and Module Holder, high performance, multichannel resting electrocardiograph, Model Number 2030360-001, Product Codes VU2 and VU4
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0292-2026·2025-10-29
Elscint SPX4 gamma cameras recalled over risk of detector falling
GE HealthCare is recalling 45 Elscint SPX4 gamma cameras because systems past guaranteed service may have been moved without adequate detector support, risking a detector fall.
Product
Elscint SPX4; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0212-2026·2025-10-29
AC joint fixation implants recalled over potentially missing slotted button assembly
Biomet is recalling 98 ZipTight Acute AC Joint Implants from one lot because of the potential for a missing slotted button assembly.
Product
BIOMET ZipTight, Acute AC Joint Implant, Single Ziploop , Model/Catalog Number: 904834; Fixation System for AC Joint Repair
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0297-2026·2025-10-29
Millenium gamma cameras recalled over risk of detector falling from mount
GE HealthCare is recalling 1,386 Millenium MG/MC gamma cameras because systems past guaranteed service may have been moved without adequate detector support, risking a detector fall.
Product
Millenium MG/MC; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0234-2026·2025-10-29
Prefilled saline flush syringes recalled over sodium chloride concentration shortfall
Medline is recalling 8,267,150 Excelsior Medical 0.9% Sodium Chloride prefilled flush syringes because a limited quantity may not meet the required concentration of sodium chloride.
Product
Excelsior Medical, 0.9% Sodium Chloride Injection, USP - 10 mL Fill, Item Number EMZ111240. Prefilled saline flush syringes
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0208-2026·2025-10-29
Silicone stomach tubes recalled after anti-reflux valve breakage complaints
Cardinal Health is recalling all lots of Salem Sump silicone dual lumen stomach tubes after complaints of anti-reflux valve breakage due to excessive force during use.
Product
Salem Sump PVC Tubes: Product Code/Product Name: 8888265108 Salem Sump Silicone Dual Lumen Stomach Tube, Radiopaque Line, 10 Fr/Ch (3.3 mm), 36 (91 cm) 8888265116 Salem Sump Silicone Dual Lumen Stomach Tube, Radiopaque Line, 12 Fr/Ch (4.0 mm), 48 (122 cm) 8888265124 Salem
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0288-2026·2025-10-29
Defibrillator pad packs recalled over damaged pins disrupting electrical contact
HeartSine Technologies is recalling 1,291,165 Pad-Pak units because defibrillator pads may contain damaged pins that disrupt the mechanical fit and electrical contact.
Product
HeartSine Pad-Pak, REF: PAD-PAK-01, PAD-PAK-02, PAD-PAK-03, PAD-PAK-04, PAD-PAK-07, PAD-PAK-03J, PAD-PAK-04J
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0291-2026·2025-10-29
Elscint 4XX gamma cameras recalled over risk of detector falling
GE HealthCare is recalling 64 Elscint Model 4XX gamma cameras because systems past guaranteed service may have been moved without adequate detector support, risking a detector fall.
Product
Elscint Model 4XX; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0299-2026·2025-10-29
Millenium MPR gamma cameras recalled over risk of detector falling
GE HealthCare is recalling 292 Millenium MPR gamma cameras because systems past guaranteed service may have been moved without adequate detector support, risking a detector fall.
Product
Millenium MPR; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
Category
Medical Device
Distribution
0 states

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2751–2775 of 39987