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

4576–4600 of 39824

HighFDA (Devices)·Z-1095-2025·2025-02-12
Hologic Rapid fFN Specimen Collection Tubes May Contain Incorrect Extraction Buffer Volumes
Hologic Rapid fFN Specimen Collection Tubes from three lots may contain incorrect amounts of extraction buffer, potentially causing invalid test results or diagnostic errors in preterm delivery assessment.
Product
The Rapid fFN Specimen Collection Tube (PN: 71550-001) is a component of the Rapid fFN Specimen Collection kit (PN: 71738-001). The Collection Tube (PN: 71550-001) is manufactured by a third-party supplier, MML Diagnostics Packaging, and includes the transport tube, cap, and extr
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1093-2025·2025-02-12
Philips Azurion patient tables recalled for finger entrapment risk
Philips is recalling Azurion 7 M12 and Allura patient tables used in medical imaging systems due to a finger entrapment hazard during manual repositioning. Operators and service personnel may suffer finger injury if fingers are caught between the tabletop and guiding rails.
Product
Azurion 7 M12 System Code: (1) 722078 (2) 722223 (3) 722233
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1087-2025·2025-02-12
Philips Azurion and Allura Patient Tables: Finger Entrapment Hazard
Philips patient tables on Azurion and Allura imaging systems can trap fingers between the tabletop and rails during manual repositioning. Operators and service personnel are at risk of finger injury.
Product
Azurion 3 M12 System Code: (1) 722063 (2) 722221
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1091-2025·2025-02-12
Philips Azurion and Allura System Patient Tables: Finger Entrapment Risk
Philips Azurion and Allura system patient tables may trap fingers between the guiding rails and tabletop during manual repositioning, risking finger injury to operators and service personnel.
Product
Azurion 7 B12 System Code: (1) 722067 (2) 722225 (3) 722235
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1105-2025·2025-02-12
NeiMed NasoGel nasal spray recalled due to stability failure
Neilmed Pharmaceuticals is recalling NasoGel for Dry Noses due to stability failure that may allow microbial growth. The product was distributed across 30 U.S. states and to five countries.
Product
NeiMed NasoGel for DRY NOSES UDI-DI/UPC code: 00705928045309 SKU GSP30-2R-48-ENU-USL GSP30-0R-96-ENU-USL GSP30-ARA-INTL GSP30-SWE-INTL GSP30-ENG-INT GSP30-MAL-INTL GSP30-SPA-INT NasoGel Spray is a saline-based gel formula that can be sprayed to moisturize and lubricate dry and i
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1092-2025·2025-02-12
Philips Azurion patient tables recalled for finger entrapment hazard
Philips is recalling Azurion 7 B20 patient tables due to a finger entrapment hazard between the tabletop and guiding rails during manual repositioning. Operators and service personnel could suffer finger injury.
Product
Azurion 7 B20 System Code: (1) 722068 (2) 722226 (3) 722236
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1099-2025·2025-02-12
Belmont Medical 3-Spike Disposable Set May Leak During Use
The Belmont Medical 3-Spike Disposable Set may leak during priming due to a crack in its female quick connector, potentially delaying warmed infusions in hospital settings.
Product
Belmont Medical 3-Spike Disposable Set used with the Belmont Rapid Infuser RI-2. Designed to be used in general operation in hospital or alternate care environments to provide warmed blood and fluids to any patients e10 kg requiring warmed infusion. Part Number:903-00006
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1081-2025·2025-02-12
Philips AlluraXper FD20 Biplane Patient Table Finger Entrapment Risk
Philips AlluraXper FD20 Biplane patient tables may cause finger entrapment between the tabletop and guiding rails during manual repositioning, affecting operators and service personnel.
Product
AlluraXper FD20 Biplane System Code: (1) 722008 (2) 722013
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1111-2025·2025-02-12
Temporary Titanium Abutments May Fracture in Dental Implants
DDS Lab temporary titanium abutments may have been installed in some dental implant restoration cases instead of definitive abutments. The components may fracture, risking restoration loosening, oral tissue injury, and aspiration.
Product
Temporary Titanium Abutments
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1044-2025·2025-02-12
Medical X-Ray System Permits Bypass of Radiation Exposure Control
GE Medical Systems' Discovery XR656HD X-Ray imaging systems can allow radiation exposures to exceed the Automatic Exposure Control limit without blocking further exposure. Approximately 3,149 units are affected worldwide, including 1,697 in the United States.
Product
Discovery XR656HD. X-Ray imaging system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1094-2025·2025-02-12
Philips Azurion and Allura Patient Table Finger Entrapment Risk
Philips Azurion 7 M20 and Allura patient tables pose a finger entrapment risk during manual repositioning. Fingers can get caught between the tabletop and guiding rails, potentially causing finger injury to operators and service personnel.
Product
Azurion 7 M20 System code: (1) 722224 (2) 722079 (3) 722234 (4) 722282 System Code: (1) 722078 (2) 722223 (3) 722233
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1090-2025·2025-02-12
Philips Azurion 5 M20 Patient Tables Recalled for Finger Entrapment Hazard
Philips Azurion 5 M20 x-ray system patient tables can trap fingers between the tabletop and guiding rails during repositioning. The hazard may cause finger injury to operators and service personnel.
Product
Azurion 5 M20 System Code: (1) 722228 (2) 722232 (3) 722281
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1077-2025·2025-02-12
Philips AD7 and AD7X patient tables recalled due to finger entrapment risk
Philips has recalled the AD7 and AD7X patient tables used in medical imaging systems because fingers can become entrapped between the tabletop and guiding rails during manual repositioning, potentially causing injury.
Product
Allura Xper FD10 Catalog (1) 722003 (2) 722010 (3)722026
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1045-2025·2025-02-12
GE Discovery XR656 HD X-ray system AEC control malfunctions during imaging
GE Medical Systems is recalling the Discovery XR656 HD X-ray imaging system due to a malfunction in the Automatic Exposure Control (AEC) feature. The defect allows continued X-ray exposure beyond intended limits without requiring operator acknowledgment.
Product
Discovery XR656 HD. X-Ray imaging system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1097-2025·2025-02-12
PERMA-HAND Silk Sutures Recalled for Packaging Sterility Breach
Ethicon is recalling PERMA-HAND Silk Sutures that may have open seals on packaging due to manufacturing defects, risking sterility compromise and patient infection. Approximately 78,792 units were distributed nationwide and internationally.
Product
PERMA-HAND Silk Suture, REF: K872H, W723H, 623H, K833H; Perma-hand Silk Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurosurgical procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1114-2025·2025-02-12
Endodontic Files Recalled for Excess Irradiation Causing Package Integrity Issues
US Endodontics is recalling endodontic files due to irradiation above specification, which may compromise package integrity. The recall affects 789,729 devices distributed in the US and internationally.
Product
Brasseler ESR Rotary/Reciprocating Endodontic File Device SKU AP120213PK AP120253PK AP120313PK AP125213PK AP125253PK AP125313PK AP135213PK AP135253PK AP135313PK AP145213PK AP145253PK AP145313PK AP1GP213PK AP1GP253PK AP1GP313PK O.U.S. Products: EdgeFile X7 REF
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1101-2025·2025-02-12
Dental implants recalled for manufacturing defect affecting sterile packaging
Nobel Biocare recalled N1 TiUltra TCC dental implants due to a manufacturing defect that may puncture the sterile blister packaging. The defect is a sharp pin created during injection molding that could compromise product sterility.
Product
. Nobel Biocare N1 TiUltra TCC RP 4.0x9mm . Nobel Biocare N1 TiUltra TCC RP 4.0x11mm . Nobel Biocare N1 TiUltra TCC RP 4.0x13mm Nobel Biocare N1 TiUltra TCC implants are intended for use as an endosseous dental implant in the maxilla or mandible for anchoring or supporting
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1112-2025·2025-02-12
Beckman Coulter Access PCT Reagent Pack Recalled for Calibration Failures
Beckman Coulter Inc. is recalling specific lots of Access PCT Reagent Pack due to high rates of calibration failures that delay test result reporting on immunoassay systems used in healthcare and laboratory settings.
Product
Access PCT Reagent Pack, Catalog Number C53987, when used on Access 2 and UniCel Dxl Immunoassay Systems
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1104-2025·2025-02-12
Integra Miltex Cryosolutions Cartridges Recalled for Premature Valve Opening
The Integra Miltex Cryosolutions Cartridges (Model C-CA-23) are being recalled because the valve may open prematurely during assembly, causing the cartridge to empty before use. Approximately 3,352 units were distributed nationwide in the US and Canada.
Product
Integra Miltex Cryosolutions Cartridges 4 Pack (23.5g N2O each), Model: C-CA-23, Item: 33517;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1103-2025·2025-02-12
Nitrous Oxide Cartridges Recalled Due to Premature Valve Opening
Integra Miltex CryoSolutions N2O cartridges are recalled because the valve may open prematurely, causing partial or complete cartridge emptying before use. Affected units were distributed nationwide and to Canada.
Product
Integra Miltex CryoSolutions Cartridges 10 Pack (23.5g N2O each), Model: C-CA-23, Item: 33516;
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0992-2025·2025-02-05
Medline General Surgery Arterial Line Tray kits recalled for manufacturing defect
Medline arterial line tray kits (models ART600 and ART690) are being recalled because the catheter hub contains excess material from manufacturing. The recall affects 58 kits distributed nationwide.
Product
Medline General Surgery Tray kits: 1) ARTERIAL LINE TRAY, Item Number ART600; 2) A LINE TRAY, Item Number ART690
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0991-2025·2025-02-05
Medline Arterial Line Insertion Kits Recalled for Catheter Hub Defect
Medline Industries is recalling 942 arterial line insertion kits due to excess material on the catheter hub of the catheter subassembly. The manufacturing defect prompted a FDA Class I recall of products distributed nationwide.
Product
Medline General Surgery Tray Kits: 1) ARTERIAL LINE INSERTION KIT, Item Number ART1185B; 2) ARTERIAL LINE BUNDLE, Item Number ART255; 3) ARTERIAL LINE TRAY, Item Number ART350; 4) ARTERIAL LINE BUNDLE, Item Number ART355; 5) ARTERIAL LINE BUNDLE, Item Number ART355 ; 6)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1033-2025·2025-02-05
HOT AXIOS Stent Delivery System Outer Sheath May Detach, Preventing Stent Expansion
Boston Scientific's HOT AXIOS stent delivery system has a defect where the outer sheath can detach and prevent proper stent expansion, requiring device replacement.
Product
HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 8mmx8mm UPN: M00553530
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1038-2025·2025-02-05
Knee implant articular surface recalled for incorrect metal post assembly
Zimmer, Inc. is recalling NexGen LCCK knee implant articular surface components due to incorrect assembly of the metal support post. The defect was identified internally in a small number of units.
Product
NexGen LCCK Legacy Articular Surface with Locking Screw - Striped Purple/C,D - Height 14 mm, Item Number 00-5994-022-14
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1057-2025·2025-02-05
Karl Storz Uretero-Renoscope with Unapproved Reprocessing Instructions Recalled
Karl Storz Endoscopy is recalling 59 units of its uretero-renoscope due to instructions for use containing reprocessing procedures that the FDA has not reviewed or approved for safety and efficacy.
Product
KARL STORZ - ENDOSKOPE, REF: 27001L, Uretero-Renoscope, 8 Fr., 6¿, 43 cm, NON STERILE, RxONLY, CE 0123
Category
Medical Device
Distribution
Distributed nationwide

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4576–4600 of 39824