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

4951–4975 of 5038

SevereFDA (Devices)·Z-2477-2012·2012-10-10
Zimmer Recalls VerSys Provisional Femoral Heads Due to Fit Issues
Zimmer, Inc. is recalling VerSys provisional femoral heads because they may fit too loosely or too tightly with mating components, posing a risk of intraoperative dislodging.
Product
00789503601 VerSys Femoral Head Provisional 36mm -3.5 00789503602 VerSys Femoral Head Provisional 36mm +0 00789503603 VerSys Femoral Head Provisional 36mm +3.5 00789503604 VerSys Femoral Head Provisional 36mm +7 00789503605 VerSys Femoral Head Provisional 36mm +10.5 12/14 Ne
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2474-2012·2012-10-10
Zimmer Recalls VerSys Provisional Femoral Heads Due to Fit Issues
Zimmer, Inc. is recalling VerSys provisional femoral heads because they may fit too loosely or too tightly with mating components, posing a risk of intraoperative dislodging.
Product
00789502601 VerSys Femoral Head Provisional 26mm -3.5 00789502602 VerSys Femoral Head Provisional 26mm +0 00789502603 VerSys Femoral Head Provisional 26mm +3.5 00789502604 VerSys Femoral Head Provisional 26mm +7 00789502605 VerSys Femoral Head Provisional 26mm +10.5 12/14 Ne
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2475-2012·2012-10-10
Zimmer VerSys Provisional Femoral Heads Recalled for Fit Issues
Zimmer, Inc. is recalling VerSys provisional femoral heads due to reports of sub-optimal fit with mating components, which can cause intraoperative dislodging.
Product
00789502801 VerSys Femoral Head Provisional 28mm -3.5 00789502802 VerSys Femoral Head Provisional 28mm +0 00789502803 VerSys Femoral Head Provisional 28mm +3.5 00789502804 VerSys Femoral Head Provisional 28mm +7 00789502805 VerSys Femoral Head Provisional 28mm +10.5 12/14 Ne
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2473-2012·2012-10-10
Zimmer Recalls VerSys Provisional Femoral Heads Due to Fit Issues
Zimmer, Inc. is recalling VerSys provisional femoral heads because they may fit too loosely or too tightly with mating components, posing a risk of intraoperative dislodging.
Product
00789502202 VerSys Femoral Head Provisional 22mm +0 00789502203 VerSys Femoral Head Provisional 22mm +3.5 00789502220 VerSys Femoral Head Provisional 22mm -2 00789502230 VerSys Femoral Head Provisional 22mm +3 12/14 Neck Taper The provisional heads replicate final femoral
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2484-2012·2012-10-10
Zimmer Recalls Provisional Femoral Heads Due to Fit Issues
Zimmer, Inc. is recalling provisional femoral heads used in hip surgery due to reports of sub-optimal fit with mating components.
Product
00780304001 MIS 12/14 Slotted Femoral Head Provisional -3.5X36 00780304002 MIS 12/14 Slotted Femoral Head Provisional +0X36 00780304003 MIS 12/14 Slotted Femoral Head Provisional +3.5X36 00780304004 MIS 12/14 Slotted Femoral Head Provisional +7X36 00780304005 MIS 12/14 Slotte
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2482-2012·2012-10-10
Zimmer Recalls Provisional Femoral Heads Due to Fit Issues
Zimmer, Inc. is recalling provisional femoral heads used in hip surgery due to reports of sub-optimal fit with mating components.
Product
00780303201 MIS 12/14 Slotted Femoral Head Provisional -3.5X32 00780303202 MIS 12/14 Slotted Femoral Head Provisional +0X32 00780303203 MIS 12/14 Slotted Femoral Head Provisional +3.5X32 00780303204 MIS 12/14 Slotted Femoral Head Provisional +7X32 00780303205 MIS 12/14 Slotte
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2479-2012·2012-10-10
Zimmer Recalls Provisional Femoral Heads Due to Fit Issues
Zimmer, Inc. is recalling specific provisional femoral heads used in hip surgery due to reports of improper fit with mating components.
Product
00780302201 MIS 12/14 Slotted Femoral Head Provisional -2X22 00780302202 MIS 12/14 Slotted Femoral Head Provisional +0X22 00780302203 MIS 12/14 Slotted Femoral Head Provisional +3.5X22 The provisional heads replicate final femoral implant geometry and are used to trial range
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2493-2012·2012-10-10
Zimmer Recalls Cemented Tibial Drills Due to Bone Perforation Reports
Zimmer, Inc. is recalling 60 Cemented Tibial Drills for the Persona Personalized Knee System after three reports of tibial cortex perforation during use.
Product
Cemented Tibial Drill Product Usage: The cemented tibial drill is used to prepare the tibial bone prior to the impaction of the applicable stemmed tibial broach. The cemented tibial drill has engraved lines that are size specific to guide the user as to the depth to insert th
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2433-2012·2012-10-03
FDA Recalls Covidien Duet TRS Surgical Staplers Due to Injury Risk
The FDA is recalling 94,301 units of the Covidien Duet TRS 45 3.5 mm Universal Articulating Single Use Loading Unit because the device may injure adjacent anatomical structures.
Product
Covidien Duet TRS 45 3.5 mm Universal Articulating Single Use Loading Unit. Product Code: DUET4535A. Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with Duet TRS reloads have applications in abdominal, gynecologic and pediatric su
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2462-2012·2012-10-03
Varian Eclipse Treatment Planning System Recalled for Dose Calculation Error
Varian is recalling Eclipse Treatment Planning Systems because a clock synchronization issue can cause incorrect dose calculations, potentially leading to under- or over-dosing of patients.
Product
Varian brand Eclipse Treatment Planning System, Model Number: H48; Eclipse 8.9 and 10.0 Reference/FSCA Identifier: CP-08922; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA The Eclipse Treatment Planning System (Eclipse TPS) is used to p
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2432-2012·2012-10-03
FDA Recalls Covidien Duet TRS Staplers Due to Injury Risk
The FDA is recalling 433,528 units of the Covidien Duet TRS 45 3.5 mm Universal Straight Single Use Loading Unit because the device may injure adjacent anatomical structures.
Product
Covidien Duet TRS 45 3.5 mm Universal Straight Single Use Loading Unit. Product Code: DUET4535. Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with Duet TRS reloads have applications in abdominal, gynecologic and pediatric surger
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2438-2012·2012-10-03
FDA Recalls Covidien Duet TRS Stapler Units Due to Injury Risk
The FDA is recalling 15,936 units of the Covidien Duet TRS 60 4.8 mm Universal Straight Single Use Loading Unit because the device may injure adjacent anatomical structures.
Product
Covidien Duet TRS 60 4.8 mm Universal Straight Single Use Loading Unit. Product Code: DUET6048. Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with Duet TRS reloads have applications in abdominal, gynecologic and pediatric surgery
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2436-2012·2012-10-03
FDA Recalls Covidien Duet TRS Staplers Due to Injury Risk
The FDA is recalling 22,218 units of the Covidien Duet TRS 60 3.5 mm Universal Straight Single Use Loading Unit because the device may injure adjacent anatomical structures.
Product
Covidien Duet TRS 60 3.5 mm Universal Straight Single Use Loading Unit Product Code: DUET6035. Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with Duet TRS reloads have applications in abdominal, gynecologic and pediatric surgery
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2459-2012·2012-10-03
Boston Scientific Z Flex 270 Steerable Sheath Recalled for Embolic Risk
Greatbatch Medical is recalling 787 units of Boston Scientific Z Flex 270 Steerable Sheaths because damaged internal liners could pose an embolic risk to patients.
Product
Boston Scientific, Z Flex 270, Steerable Sheath, Sterile EO, Rx only, Distributed by Boston Scientific Corporation, One Boston Scientific Place, Natick, MA 01760-1537, Manufactured by Greathbatch Medical, 2300 Berkshire Lane North, Minneapolis, MN 55441. To facilitate transv
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-2437-2012·2012-10-03
FDA Recalls Covidien Duet TRS Stapler Units Due to Injury Risk
The FDA is recalling 268,022 units of the Covidien Duet TRS 60 3.5 mm Universal Articulating Single Use Loading Unit because the device may injure adjacent anatomical structures.
Product
Covidien Duet TRS 60 3.5 mm Universal Articulating Single Use Loading Unit. Product Code: DUET6035A. Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with Duet TRS reloads have applications in abdominal, gynecologic and pediatric su
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2439-2012·2012-10-03
FDA Recalls Covidien Duet TRS Stapler Units Due to Injury Risk
The FDA is recalling 135,712 units of the Covidien Duet TRS 60 4.8 mm Universal Articulating Single Use Loading Unit because the device may injure adjacent anatomical structures.
Product
Covidien Duet TRS 60 4.8 mm Universal Articulating Single Use Loading Unit. Product Code: DUET6048A. Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with Duet TRS reloads have applications in abdominal, gynecologic and pediatric su
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2435-2012·2012-10-03
FDA Recalls Covidien Duet TRS Stapler Units Due to Injury Risk
The FDA is recalling 104,355 units of the Covidien Duet TRS 45 4.8 mm Universal Articulating Single Use Loading Unit because the device may injure adjacent anatomical structures.
Product
Covidien Duet TRS 45 4.8 mm Universal Articulating Single Use Loading Unit. Product Code: DUET4548A. Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with Duet TRS reloads have applications in abdominal, gynecologic and pediatric su
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2434-2012·2012-10-03
FDA Recalls Covidien Duet TRS Stapler Units Due to Injury Risk
The FDA is recalling 4,867 units of the Covidien Duet TRS 45 4.8 mm Universal Straight Single Use Loading Unit because the device may injure adjacent anatomical structures.
Product
Covidien Duet TRS 45 4.8 mm Universal Straight Single Use Loading Unit. Product Code: DUET4548. Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with Duet TRS reloads have applications in abdominal, gynecologic and pediatric surgery
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2353-2012·2012-09-26
Custom Medical Specialties Recalls Amnio Trays with PVP Prep Solution
Custom Medical Specialties is recalling CMS-2586 Custom Amnio Trays containing PVP Prep Solution because the product lacked microbial testing and did not meet finished goods specifications.
Product
CMS-2586 Custom Amnio Tray containing 2 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2352-2012·2012-09-26
Custom Vein Tray Recalled for Povidone Iodine Prep Solution Quality Issues
Custom Medical Specialties is recalling CMS-8450-R1 Custom Vein Trays because the included Povidone Iodine Prep Solution lacked microbial testing and failed finished goods specifications.
Product
CMS-8450-R1 Custom Vein Tray containing 4 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2360-2012·2012-09-26
Custom Medical Specialties Recalls Hysteroscopy Kits Due to Microbial Testing Failures
Custom Medical Specialties is recalling BR980-9600 Hysteroscopy Sterile Procedure Kits because the included Povidone Iodine Prep Solution lacked required microbial testing and failed finished goods specifications.
Product
BR980-9600 Hysteroscopy Sterile Procedure Kit containing 2 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2390-2012·2012-09-26
Instrumentation Laboratory ACL TOP 700 LAS Analyzer Recalled for Fibrinogen Errors
Instrumentation Laboratory is recalling ACL TOP 700 LAS analyzers because they may incorrectly report abnormal fibrinogen levels as normal or low.
Product
Instrumentation Laboratory ACL TOP 700 LAS PN 0000280030 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2354-2012·2012-09-26
Custom Medical Specialties Recalls PVP Prep Solution Due to Microbial Testing Failures
Custom Medical Specialties is recalling 75 cases of CMS-8162-R1 Fox Chase Specials Packs containing PVP Prep Solution because the product did not meet finished goods specifications and lacked microbial testing.
Product
CMS-8162-R1 Fox Chase Specials Pack containing 2 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2395-2012·2012-09-26
Hospira Recalls Empty Evacuated Containers Due to Embedded Iron Oxide Glass Defect
Hospira Inc. is recalling 191,094 units of Empty Evacuated Containers (250 mL and 1000 mL) because an embedded iron oxide glass defect may break off into the solution.
Product
Empty Evacuated Container 250 mL and 1000 mL. Empty Evacuated containers are used for mixing compatible medications or blood collections.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2355-2012·2012-09-26
Custom Medical Specialties Recalls Radiology Drainage Packs with PVP Prep Solution
Custom Medical Specialties is recalling Abington Radiology Drainage Packs containing PVP Prep Solution because the solution lacked microbial testing and did not meet finished goods specifications.
Product
CMS-8325-R2 Abington Radiology Drainage Pack and CMS-8325-R3 Abington Radiology Drainage Pack containing 4 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep
Category
Medical Device
Distribution
Distributed nationwide

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4951–4975 of 5038