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

10401–10425 of 13748

HighFDA (Devices)·Z-0718-2023·2022-12-21
Siemens allergy test kits recalled for false mold allergen reactivity results
Siemens Healthcare Diagnostics is recalling 560 allergy diagnostic kits (Lot 565) due to potential for falsely elevated mold allergen reactivity, which may result in incorrect test results.
Product
IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests Japan Siemens Material Number (SMN): 10711939 For the quantitative measurement of allergen-specific IgE in human serum, as an aid in the clinical diagnosis of IgE mediated allergic disorders.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0569-2023·2022-12-21
DeRoyal PICC line trays recalled due to sterile drape defects
DeRoyal Industries is recalling 918 PICC line procedure packs containing 3M sterile drapes that were separately recalled. The affected kits were distributed across 23 U.S. states to healthcare facilities.
Product
DeRoyal PICC LINE TRAY PGYBK, REF 89-6150.13
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0507-2023·2022-12-21
Surgical Procedure Trays Recalled for Potential Sterility Breach
Stradis Medical recalls Henry Schein Basin Pack surgical trays due to potentially incomplete outer packaging seals that may compromise sterility of the medical kits.
Product
HENRY SCHEIN, Basin Pack, Item No.570-1692
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0504-2023·2022-12-21
Surgical Trays Recalled Due to Incomplete Bag Sealing
Stradis Healthcare is recalling surgical trays due to incomplete outer bag sealing that may compromise sterility of the surgical kit.
Product
HENRY SCHEIN, Novasure Pack, Item No.570-1462, general surgery tray
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0516-2023·2022-12-21
Stradis Healthcare Major Extremity Surgical Kits Recalled for Potential Sterility Breach
Stradis Healthcare is recalling Henry Schein Major Extremity surgical kits due to incomplete outer bag sealing that could compromise kit sterility. Affected kits were distributed nationwide in the US and Canada.
Product
HENRY SCHEIN, MAJOR EXTREMITY PACK, Item No.570-2783,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0686-2023·2022-12-21
Medical Device Recall: DeRoyal HAND PACK Kit Lot 57685848
DeRoyal Industries Inc is voluntarily recalling DeRoyal HAND PACK kits (Lot 57685848) distributed across 23 US states. The reason for recall has not been publicly disclosed.
Product
DeRoyal HAND PACK, REF 89-10314.03
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0477-2023·2022-12-21
Surgical Microscope Power Supply May Overheat and Cause Unexpected Shutdown
Leica surgical microscopes (M530 OHX) may experience power supply overheating due to component overstressing, which can cause unexpected device shutdown. 148 units nationwide are affected.
Product
Leica MICROSYSTEMS M530 OHX, Part Number 10448737, surgical microscope system
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0720-2023·2022-12-21
Cordis Angiographic Catheter Extensions Recalled for Male Connector Separation Risk
Cordis angiographic catheter extensions may experience separation at the male connector during use. Approximately 2,915 US units were distributed; users should verify affected lot numbers.
Product
Cordis Angiographic Catheter Extensions. Used to transport fluid from the power injector to the catheter for injection into the patient.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0677-2023·2022-12-21
FDA recalls DeRoyal CRANI PACK medical device over defect
The FDA has recalled DeRoyal CRANI PACK devices (Lot 57389117, expiring 9/1/2026) due to a device defect. The recall affects 16 kits distributed across 23 US states.
Product
DeRoyal CRANI PACK, REF 89-10202.05
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0427-2023·2022-12-21
Arrow AutoCAT2 Intra-Aortic Balloon Pump: Short Battery Run-Time Issue
Arrow International is recalling 6 refurbished Arrow AutoCAT2 intra-aortic balloon pumps worldwide due to a potential issue with battery run-times. The affected devices may not operate for sufficient duration during medical use.
Product
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 IAPB, REFURBISHED, REF IAP-0400X (IPN000311), cardiac pump
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0475-2023·2022-12-21
Surgical microscope power supply may overheat and cause unexpected shutdown
Leica Microsystems is recalling 43 Proveo 8 surgical microscopes nationwide due to a potential power supply defect that may cause device overheating and unexpected shutdown during use.
Product
Leica MICROSYSTEMS Proveo 8, Part Number 10449058, surgical microscope system
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0537-2023·2022-12-21
Stradis Healthcare Phlebectomy Pack Recall Due to Sterility Breach Risk
Stradis Healthcare recalls its Phlebectomy Pack (Item No. 682-001) due to incomplete sealing of outer bags, which may compromise sterility of surgical kits distributed nationwide.
Product
STRADIS HEALTHCARE, Phlebectomy Pack, Item No.682-001,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0506-2023·2022-12-21
General Surgery Procedure Kit Recalled for Sterility Concerns
Stradis Medical is recalling surgical procedure kits with potentially incomplete outer bag seals that may compromise sterility. The recall affects 35 units distributed nationwide in the US and Canada.
Product
HENRY SCHEIN, PROCEDURE KIT, Item No.570-1508, general surgery tray
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0560-2023·2022-12-21
DeRoyal Minor Oral and ENT Procedure Packs Recalled for Defective Steri Drapes
DeRoyal procedure packs distributed across multiple U.S. states are being recalled because they contain previously recalled 3M Steri Drapes. Affected healthcare facilities should stop using the packs and contact the manufacturer.
Product
DeRoyal MINOR ORAL / ENT PACK, REF 89-2576.15
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0512-2023·2022-12-21
Medical and Surgical Procedure Trays Recalled for Incomplete Seal
Stradis Medical recalled Henry Schein Basic Pack medical and surgical procedure trays due to manufacturing defects causing incomplete outer bag seals that may compromise sterility. The affected kits were distributed nationwide in the US and Canada.
Product
HENRY SCHEIN, BASIC PACK, Item No.570-2719, UDI/DI (case) H65857027191, UDI/DI (kit)M75257027190, Serial/Lot Numbers: 22242489505
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0695-2023·2022-12-21
Hip replacement surgical kits recalled by DeRoyal Industries
DeRoyal Industries Inc has recalled 19 anterior approach total hip replacement surgical kits distributed across 23 U.S. states. This Class II recall was initiated voluntarily by the manufacturer.
Product
DeRoyal ANTERIOR APPROACH TOTAL HIP A&B PGYBK, REF 89-10612.01
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0670-2023·2022-12-21
Surgical Spinal Fusion Device Recalled Across 23 US States
DeRoyal is recalling its Posterior Lumbar Fusion Pack medical device across 23 states. The voluntary recall affects specific lot numbers; patients should consult their healthcare provider.
Product
DeRoyal POSTERIOR LUMBAR FUSION PACK, REF 89-10060.02
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0466-2023·2022-12-21
NexGen Stemmed Tibial Component Recalled Due to Higher Revision Rates
Zimmer is recalling NexGen Option Stemmed Tibial Components due to higher revision rates when used with certain femoral components in knee replacements.
Product
NexGen Option Stemmed Tibial Component Size 3, Item Number 00-5986-037-01
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0453-2023·2022-12-21
Intra-Aortic Balloon Pump Recalled for Potential Short Battery Runtime
The Arrow AutoCAT2WAVE intra-aortic balloon pump is recalled due to a potential issue with short battery run-times. The FDA Class I recall affects 4 units distributed worldwide.
Product
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500NL (IPN000326), cardiac pump
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0690-2023·2022-12-21
FDA Recalls DeRoyal CNRV Spinal Pack Medical Devices
DeRoyal has voluntarily recalled 69 kits of CNRV Spinal Pack medical devices distributed to 23 US states. The manufacturer initiated the recall on November 3, 2022.
Product
DeRoyal CNRV SPINAL PACK, REF 89-10532.03
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0476-2023·2022-12-21
Leica Provido surgical microscope models at risk of unexpected power shutdown
Leica Provido surgical microscope systems may experience unexpected shutdown due to power supply overheating. Affected units should be identified by serial number and serviced immediately.
Product
Leica MICROSYSTEMS Provido, Part Numbers 10448950 (Premium), 10448976 (Standard). Surgical microscope system
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0546-2023·2022-12-21
Stradis Healthcare Venous Access Pack Recalled for Potential Sterility Breach
Stradis Medical is recalling Venous Access Packs because the outer bag may be incompletely sealed, potentially compromising the sterility of the kit. Affected units were distributed in the US and Canada.
Product
STRADIS HEALTHCARE, VENOUS ACCESS PACK, Item No.682-1993R1,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0561-2023·2022-12-21
DeRoyal Oral Procedure Packs Recalled for Affected Steri Drapes
DeRoyal Industries is recalling MAJOR ORAL PACK RF kits containing recalled 3M Health Care Steri Drapes. The affected lots were distributed to healthcare facilities in 23 US states.
Product
DeRoyal MAJOR ORAL PACK RF, REF 89-3936.15
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0548-2023·2022-12-21
Stradis Healthcare Surgical Procedure Kits Recalled for Incomplete Sealing
Stradis Medical recalls Vein & Laser surgical procedure kits due to incomplete outer bag sealing that may compromise sterility. The recall affects 10 units distributed in the US and Canada.
Product
STRADIS HEALTHCARE, Vein & Laser, Item No.682-334R1,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0519-2023·2022-12-21
Henry Schein Pacemaker Surgical Kits Recalled for Sterility Concerns
Surgical procedure kits supplied by Henry Schein may have incompletely sealed outer bags, potentially compromising sterility. Affected units should not be used.
Product
HENRY SCHEIN, PACEMAKER PACK IItem No.570-2793
Category
Medical Device
Distribution
Distributed nationwide

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10401–10425 of 13748