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 5111

SevereFDA (Devices)·Z-2256-2014·2014-08-27
Ortho Development Recalls Knee Implants Due to Improper Foil Pouch Sealing
Ortho Development is recalling various knee implant components because foil pouches failed to seal properly, allowing air to enter and potentially degrading the material properties of the implants.
Product
Tibila Insert UC, Balanced Knee System, REF163-3YYY Product Usage: UHMWPE component used in TKA procedures to serve as a tibial bearing surface for articulation with the femoral component
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2254-2014·2014-08-27
Ortho Development Recalls Knee Implant Components Due to Sealing Defects
Ortho Development is recalling specific knee implant components because defective foil pouches allowed air to enter, potentially degrading the material properties of the implants.
Product
Patella 38mm, REF164-0038 Product Usage: UHMWPE component used in a TKA procedure to resurface the patella and serve as a bearing surface for sliding contact with the femoral component
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2261-2014·2014-08-27
AngioDynamics Recalls Uni*Fuse Infusion Systems Due to Potential Guidewire Size Error
AngioDynamics is recalling Uni*Fuse Infusion Systems with Cooper Wire because they may contain a guidewire that is too long.
Product
Uni*Fuse INFUSION SYSTEM WITH COOPER WIRE, 5F x 90 cm x 30 cm Infusion Pattern, Catalog No./REF 12401808, Product No. H787124018085, STERILE -- AngioDynamics, 603 Queensbury Avenue, Queensbury, NY 12804
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2225-2014·2014-08-20
Zimmer Recalls Nonsterile Orthopedic Rasp Handles Due to Assembly Failure
Zimmer, Inc. is recalling 412 nonsterile VER2 D8L Offset Rasp Handles because the handle may fail to remain assembled to the rasp during use.
Product
VER2 D8L OFFSET RASP HANDLE, RT Nonsterile
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2206-2014·2014-08-20
Gambro Recalls PrisMARS Kits Due to Connector Breakage and Leakage
Gambro Renal Products is recalling PrisMARS Kits because connector breakages can cause liquid or blood to leak.
Product
PrisMARS Kit (component of MARS Treatment Kit Type 1115/1 PrisMARS US), 1 MARS Treatment Kit per carton box, Product Number 800480, Batch
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2204-2014·2014-08-20
Gambro Recalls Prismaflex HF 1000 Dialysis Sets Due to Connector Breakage
Gambro Renal Products is recalling Prismaflex HF 1000 dialysis sets because connector breakages can cause leakage of liquid or blood.
Product
Prismaflex HF 1000. Product number 107140. Each set is packaged in a plastic pouch, 4 pouches per carton box
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2231-2014·2014-08-20
Zimmer Recalls 23.5 Degree Rasp Handle Assemblies Due to Assembly Failure
Zimmer, Inc. is recalling 23.5 Degree Rasp Handle Assemblies because the handle may fail to remain attached to the rasp during use.
Product
23.5 Deg Rasp Handle Assy- RIGHT Nonsterile
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2177-2014·2014-08-20
Carestream Recalls Kodak DirectView DR 7500 X-Ray Systems Due to Loose Parts
Carestream Health is recalling 589 Kodak DirectView DR 7500 diagnostic x-ray systems because the x-ray tube assembly may detach from the overhead crane due to insufficiently tightened hardware.
Product
Kodak DirectView DR 7500 Diagnostic X-Ray System Product Usage: The DR 7500 system is a permanently installed diagnostic x-ray system composed of 4 main components: an operator console, over head tube crane, x-ray tube assembly including a collimator and stationary generator
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2209-2014·2014-08-20
Medical Positioning Rapid Response HUT Table Recalled for Malfunction Risk
Medical Positioning Inc is recalling two Model # 1019 HUT tables due to a component defect that may cause the table to drop into the Trendelenburg position more rapidly than normal.
Product
Medical Positioning Rapid Response HUT table, Powered Medical Examination table, Model # 1019. Product Usage: Used to conduct syncope examinations.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2230-2014·2014-08-20
Zimmer Recalls 23.5 Degree Rasp Handle Assemblies Due to Assembly Failure
Zimmer, Inc. is recalling 412 units of 23.5 Degree Rasp Handle Assemblies because the handle may fail to remain assembled to the rasp during use.
Product
23.5 Deg Rasp Handle Assy- LEFT Nonsterile
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2202-2014·2014-08-20
Gambro Recalls Prismaflex M100 Dialysis Sets Due to Connector Breakage
Gambro Renal Products is recalling Prismaflex M100 dialysis sets because connector breakages can cause leakage of liquid or blood.
Product
Prismaflex M100. Product number 106697. Each set is packaged in a plastic pouch, 4 pouches per carton box
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2203-2014·2014-08-20
Gambro Recalls Prismaflex M150 Dialysis Sets Due to Connector Breakage
Gambro Renal Products is recalling Prismaflex M150 dialysis sets because connector breakages can cause liquid or blood to leak.
Product
Prismaflex M150. Product number 109990. Each set is packaged in a plastic pouch, 4 pouches per carton box
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2199-2014·2014-08-20
Gambro Recalls Prisma M100 PRE Pump Infusion Sets Due to Connector Breakage
Gambro Renal Products is recalling Prisma M100 PRE pump infusion sets because connector breakages can cause liquid or blood to leak.
Product
Prisma M100 PRE pump infusion set. Product number 107791. Each set is packaged in a plastic pouch, 4 pouches per carton box
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2159-2014·2014-08-13
ICU Medical Recalls Arterial Monitoring Kits Due to Fluid Leak Risk
ICU Medical is recalling specific arterial monitoring kits because a component connection may crack, causing a fluid leak.
Product
Arterial Safeset Transpac IT w/3 ml Reservoir and Single CSP, With Velcro Arm Strap, Patient Mount, Item No. 011-46104-42 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and montoring of
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-2021-2014·2014-07-30
Blood Glucose Test Strips Recalled for Inappropriate Labeling and Marketing
Diabetic Supply of Suncoast, Inc. is recalling Advocate Redi-Code+ blood glucose test strips because they were inappropriately labeled and marketed.
Product
ADVOCATE Redi-Code+ BMB-BA006A Blood Glucose test strips Product Usage: The ADVOCATE¿ Redi-Code+ BMB-BA006A Blood Glucose test strips are used only with the ADVOCATE¿ Redi-Code+ BMB-EA004S meter to quantitatively measure glucose in fresh capillary whole blood samples drawn fr
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2068-2014·2014-07-30
GE Healthcare Recalls DateX-Ohmeda S/5 Airway Modules Due to CO2 Measurement Failure
GE Healthcare is recalling DateX-Ohmeda S/5 Single-Width Airway Modules and E-miniC accessories because a CO2 detector failure may cause incorrect low readings, potentially impairing clinical decision-making for ventilated patients.
Product
DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES. DATEX-OHMEDA S/5TM FM WITH L-FICU04 ANDL-FICUO4A SOFTWARE AND N-FCREC MODULE **(OUS only). E-miniC and accessories is indicated for monitoring C02 and respiration rate of all hospital patients.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1468-2014·2014-07-30
Trinity Care Solutions Recalls Normal Saline Syringes Due to Sterility Concerns
Trinity Care Solutions is recalling Normal Saline 10 mL syringes in Florida due to quality control concerns identified during an FDA inspection.
Product
Normal Saline 10 mL/10 mL Syringe, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, Rx # 28839, Discard After 05/5/15; Rx # 29163, Discard After 05/8/15
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-2080-2014·2014-07-30
Stryker Recalls Disposable StrykeFlow Tips Due to Sterility Concerns
Stryker Endoscopy is recalling 496 boxes of Disposable StrykeFlow Tips because a deformed blister pouch could compromise the product's sterility.
Product
Disposable StrykeFlow Tip, Stryker Disposable Suction/I irrigator Tip; Sterile, Rx only, Latex Free. Stryker Suction Irrigation system, used to provide a clean and clear operative site through the evacuation and aspiration of irrigant solution. for endoscopic use.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1442-2014·2014-07-23
CareFusion Recalls ChloraPrep Applicators Due to Sterility Concerns
CareFusion is recalling 23,000 ChloraPrep applicators because immediate product pouches may not be properly sealed, potentially compromising sterility.
Product
ChloraPrep With Tint, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), 26 mL APPLICATOR, Hi-Lite Orange. Rx Only. CareFusion, El Paso, TX 79912. NDC: 054365-400-13.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2046-2014·2014-07-23
Smith & Nephew Recalls SUTUREFIX Ultra Anchor XL Due to Sterility Breach
Smith & Nephew is recalling 136 units of SUTUREFIX Ultra Anchor XL devices because a breach in the sterile barrier compromised the device's sterility.
Product
SUTUREFIX Ultra Anchor XL with one (#2) Ultrabraid Cobraid Suture Product Code: 72203842 Fastener, fixation, nondegradable, soft tissue
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2058-2014·2014-07-23
Siemens Coat-A-Count Direct Androstenedione Assay Recalled for Inaccurate Results
Siemens Healthcare Diagnostics is recalling Coat-A-Count Direct Androstenedione assays because they show higher frequency of results greater than 10 ng/mL compared to other platforms.
Product
Coat-A-Count Direct Androstenedione, SMN 10381049, Catalog Number TKAN1. Siemens Healthcare Diagnostics
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2023-2014·2014-07-16
Invacare Aquatec Fixed Backrest Recalled for Structural Failure Risk
Invacare is recalling 465 Aquatec Fixed Backrests because they may detach from the frame under uneven load, posing a risk of injury.
Product
Aquatec Fixed Backrest - accessory for Mobile Shower and Toilet commode Aquatec Ocean, Ocean VIP and Ocean E-VIP family.
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-1994-2014·2014-07-16
Intuitive Surgical Recalls Patient Side Cart Battery Boxes for Overheating Risk
Intuitive Surgical is recalling 2,606 Patient Side Cart Battery Boxes used with the da Vinci A surgical system because they may overheat and bulge during charging.
Product
Patient Side Cart Battery Box used in conjunction with the da Vinci A surgical system. Intuitive Surgical Inc. Sunnyvale, CA 94086
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1959-2014·2014-07-09
Atrium Express Dry Seal Chest Drain Recall Due to Leaking Risk
Atrium Medical Corporation is recalling 1,170 units of the Express Dry Seal Chest Drain ATS Blood Recovery because the tubing may leak or disconnect.
Product
Atrium Express Dry Seal Chest Drain ATS Blood Recovery, Catalog Number: 4050-100N. Autotransfusion Apparatus.
Category
Medical Device
Distribution
9 states
SevereFDA (Devices)·Z-1991-2014·2014-07-09
Siemens Recalls ADVIA Centaur TnI-Ultra Assay Kits Due to Reagent Appearance
Siemens Healthcare Diagnostics is recalling ADVIA Centaur TnI-Ultra assay kits because a darker solid phase reagent in some lots may lead to incorrect test results.
Product
ADVIA Centaur¿ Systems TnI-Ultra assay; Catalog Number 02789602 (100 tests), SMN 10317708 and 02790309 (500 tests), SMN 10317790
Category
Medical Device
Distribution
Distributed nationwide

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4576–4600 of 5111