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

8251–8275 of 40056

HighFDA (Devices)·Z-0827-2024·2024-02-07
Custom Surgical Procedure Kits Recalled for Sterilization Assessment Failures
American Contract Systems has recalled 2,717 custom surgical procedure kits used in neurosurgery nationwide. Components were added without proper assessment of their suitability for the sterilization process.
Product
Custom procedural convenience kits and trays, general hospital use, labeled as: a) IR NEURO PACK, kit number AGNE20J; b) ADULT CRANIOTOMY PACK, kit number LLCR99; c) LAMINECTOMY PACK, kit number LLLC26; d) KIT, CRANIOTOMY, kit number MMCR11J; e) KIT, NEURO SPINE, kit n
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0869-2024·2024-02-07
Knee replacement patella component recalled due to material oxidation risk
Howmedica Osteonics Corp. is recalling SCORPIO RECESSED PATELLA knee replacement components manufactured from UHMWPE raw material over 5 years of age, which may develop elevated oxidation affecting material properties.
Product
SCORPIO RECESSED PATELLA- Intended for Knee Replacement Part Number: 3044-0026
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0955-2024·2024-02-07
Philips MRI Coil Seal Adhesive May Fail and Create Sharp Patient Contact Surfaces
Philips has recalled certain SmartPath to dStream MRI coil components because the seal adhesive may fail, creating sharp edges that could contact patients during scanning and cause skin and tissue injuries.
Product
SmartPath to dStream for 1.5T. Model (REF) Numbers 781260, 782112.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0885-2024·2024-02-07
Knee Replacement Insert Recalled Due to Potential Material Oxidation
Howmedica Osteonics is recalling Scorpio-Flex knee prosthesis inserts due to potential oxidation in UHMWPE raw material over 5 years old, which could impact material properties.
Product
Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- -Intended for knee replacement Part Number: 72-16-0910
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0833-2024·2024-02-07
Orthopedic surgical kits recalled for unassessed external component sterilization
American Contract Systems recalls 5,524 orthopedic surgical kits due to unassessed sterilization of external components that may lose functionality, drug efficacy, or have excess sterilization chemical residue.
Product
Custom procedural convenience kits and trays, Othopedic use, labeled as: a) HIP FRACTURE, kit number AHHF15C; b) HIP FRACTURE, kit number AHHF15D; c) Hand Pack, kit number BBHP10E; d) Lower Extremity, kit number BBLE40B; e) Custom Podiatry, kit number BOCP70J; f) ROB
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0890-2024·2024-02-07
Knee replacement implant recalled due to material oxidation risk
Howmedica Osteonics is recalling a knee replacement patellar component that may have been manufactured with oxidized raw material. Products using UHMWPE over 5 years old can develop elevated oxidation and degraded material properties.
Product
SCORPIO TOTAL KNEE CONCENTRIC DOME PATELLA-SZ #11 -Intended for knee replacement Part Number: 73-2110
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0935-2024·2024-02-07
Olympus EZDilate Fixed Wire Balloon Device Recalled for Inflation and Deflation Failures
Olympus recalls 1,008 EZDilate Fixed Wire Balloon devices nationwide due to malfunction during use. Reported failures include inflation and deflation problems, bursting, leaking, and foreign body events in patients.
Product
EZDilate Fixed Wire Balloon 11-12-13. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Model: BD-400P-1380
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0826-2024·2024-02-07
Custom Procedural Convenience Kits Recalled for Sterilization Validation Failure
American Contract Systems is recalling 244 custom procedural kits (Baby PICC, Pediatric PICC, and PORT PACK) distributed nationwide. Components subjected to sterilization without proper validation documentation may have reduced functionality or elevated sterilization residuals.
Product
Custom procedural convenience kits and trays, general hospital use, labeled as: a) Baby PICC Kit, kit number UIBP90J; b) Baby PICC Kit, kit number UIBP90K; c) PORT PACK (PS 058330), kit number UIPO82AB; d) Pediatric PICC Kit, kit number UIPP76K;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0821-2024·2024-02-07
Gastroenterological and Urological Procedure Kits Recalled for Sterilization Process Failures
American Contract Systems is recalling AHN BIOPSY STERILE procedure kits nationwide because several components were improperly sterilized, potentially compromising device functionality and drug efficacy.
Product
Custom procedural convenience kits and trays, gastroenterological & urological, labeled as: AHN BIOPSY STERILE, kit number AHBP12A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0970-2024·2024-02-07
Vortex Surgical ACTU8 Forceps Recalled Due to Residue on Forceps Tips
Vortex Surgical has voluntarily recalled 800 ACTU8 FORCEPS units due to residue identified on forceps tips. The recall affects surgical instruments distributed in the US (OH, WA, MN, MI, IA) and Korea.
Product
Vortex Surgical ACTU8 FORCEPS, 25 GA, ADAPTIVE, REF VS0740.25
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0889-2024·2024-02-07
Total Knee Replacement Component Recalled Due to Oxidation Risk
Howmedica Osteonics Corp. is recalling SCORPIO Total Knee replacement components from specific manufacturing batches due to potential oxidation in raw materials over 5 years old. Oxidation can impact the material's properties.
Product
SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #9 -Intended for knee replacement Part Number: 73-0910
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0822-2024·2024-02-07
Custom Surgical Procedure Kits Recalled for Improper Sterilization Assessment
American Contract Systems is recalling 3,196 custom surgical procedure kits because sterilized components lacked documented suitability assessment. The components may have lost functionality or accumulated excessive sterilization residuals.
Product
Custom procedural convenience kits and trays, gastroenterological & urological, labeled as: a) LAP KIDNEY MODULE, kit number AGKD50L; b) ROBOTIC PROSTATE PACK - 264852, kit number ANPR34S; c) LAP CHOLE - 213388, kit number BFLC02AD; d) GENERAL LAPAROSCOPY PACK, kit numbe
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0832-2024·2024-02-07
Ophthalmic procedural kits recalled due to inadequate sterilization validation
American Contract Systems is recalling 940 ophthalmic surgical kits nationwide due to undocumented components that may lack functionality, drug efficacy, or contain elevated sterilization residuals.
Product
Custom procedural convenience kits and trays, Ophthalmic use, labeled as: a) EYE PACK, kit number LVEY27; b) Laminectomy, kit number UIOL34AG
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0971-2024·2024-02-07
Atlan Anesthesia Machine Backup Battery May Fail Unexpectedly During Operation
Draegerwerk has recalled Atlan A350 and A350 XL anesthesia machines because the internal backup battery may fail unexpectedly, potentially causing device shutdown during operation. No injuries or device failures have been reported.
Product
Atlan, Gas Machine for Anesthesia or Analgesia, Catalog numbers 8621500 (Atlan A350) and 8621600 (Atlan A350 XL)
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0867-2024·2024-02-07
Aesculap Needle Holders Distributed With Incorrect Product Labels and Packaging
Aesculap Inc. is recalling needle holder models that were distributed with incorrect product labels. The MB215R was labeled as MB362R and vice versa, which may cause procedural delays.
Product
MB215R - MILLS DUROGRIP TC Micro Needle Holder, straight, 8:, (203 mm), "TC MILLS NDLE HOLDRRND HNDLSTR203MM"
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0887-2024·2024-02-07
Knee Replacement Implant Recalled Due to Potential Material Degradation
Knee replacement components recalled due to potential oxidation in UHMWPE material that could affect durability. Approximately 76 units distributed in the US with additional international distribution.
Product
SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #5 -Intended for knee replacement Part Number: 73-0510
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0831-2024·2024-02-07
Custom OB/GYN Procedural Kits Recalled for Sterilization Process Failure
American Contract Systems recalled 144 custom OB/GYN procedural kits after discovering components were sterilized without proper documentation, potentially losing functionality or efficacy. Affected units were distributed nationwide.
Product
Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as: a) LavH, kit number BBLV21C; b) LAP HYST 247540, kit number BFHY75U
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0882-2024·2024-02-07
SCORPIO TS TIB INSERT Knee Replacement Components Recalled for Potential Material Degradation
Howmedica Osteonics is recalling SCORPIO TS TIB INSERT knee replacement inserts manufactured with aging raw material. The material may develop elevated oxidation that could affect performance.
Product
SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-7524
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0829-2024·2024-02-07
Obstetrical Labor and Delivery Kits Recalled for Potential Functionality Loss
American Contract Systems has recalled Labor and Delivery Packs because certain components may have lost functionality or efficacy due to unvalidated sterilization exposure.
Product
Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as: a) LABOR & DELIVERY PACK, kit number HILD52F; b) LABOR & DELIVERY PACK, kit number HILD52G
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0817-2024·2024-02-07
Custom Cardiac Procedural Kits Recalled for Inadequate Sterilization Assessment
American Contract Systems is recalling 4394 custom cardiac procedural kits due to components added without proper assessment for sterilization exposure, which may result in loss of functionality or drug efficacy.
Product
Custom procedural convenience kits and trays, cardiac, labeled as: a) HEART CATHETERIZATION TRAY, kit number JRHC45G; b) TAVR PACK, kit number LLTV10; c) CATH PED LF SJH, kit number SJCA21F; d) CATH HEART ADL LF SJH, kit number SJCH22F; e) INT RAD PORTS-LF - 206060, ki
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0896-2024·2024-02-07
SCORPIO U-DOME PATELLA Knee Implants Affected by Material Oxidation Risk
Certain SCORPIO U-DOME PATELLA knee replacement devices may experience material degradation due to aged raw material. The manufacturer is recalling affected units because material oxidation could compromise device durability and performance.
Product
SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3708
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0816-2024·2024-02-07
Custom Anesthesia Kits Recalled Over Sterilization Validation Failure
American Contract Systems recalls 182 anesthesia procedure kits due to improper sterilization assessment of added components. The kits may have compromised functionality, reduced drug efficacy, or elevated sterilant residue.
Product
Custom procedural convenience kits and trays, anesthesia, labeled as: a) HEART ANESTHESIA BUNDLE NS, Kit Number LMHA01V; b) OR/Anesthesia Central Line Insertion Kit, Kit Number UIAN43L
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0877-2024·2024-02-07
Knee Replacement Implant Insert Recalled Due to Material Degradation Risk
Howmedica Osteonics is recalling SCORPIO TS TIB INSERT knee replacement components due to potential oxidation of raw material. Material degradation could affect implant durability.
Product
SCORPIO TS TIB INSERT-Intended for knee replacement Part Number:72-4-7512
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0820-2024·2024-02-07
Custom Ear, Nose and Throat Surgical Kits Recalled Due to Sterilization Validation Failure
American Contract Systems is recalling 804 custom ear, nose and throat surgical kits nationwide because components were sterilized without validation that they could tolerate the process, potentially affecting functionality or drug efficacy.
Product
Custom procedural convenience kits and trays, ear, nose & throat, labeled as: a) T AND A PACK AGH ASC, kit number AGTA48J; b) OPSC EAR PACK, kit number LLEO66; c) T AND A PACK, kit number MMTA41F
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0883-2024·2024-02-07
Knee replacement implant insert recalled due to material oxidation risk
Howmedica Osteonics is recalling Scorpio-Flex knee implant inserts manufactured with over-5-year-old UHMWPE material, which may develop elevated oxidation levels that could affect material properties.
Product
Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- Intended for knee replacement Part Number: 72-15-0324
Category
Medical Device
Distribution
Distributed nationwide

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8251–8275 of 40056