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

5001–5025 of 5115

SevereFDA (Devices)·Z-0151-2013·2012-10-31
DePuy Mitek Recalls SpiraLok 6.5 Anchors Due to Post-Operative Fracture
DePuy Mitek is recalling SpiraLok 6.5 anchors because they may fracture after surgery, requiring patients to undergo revision procedures.
Product
SpiraLok 6.5 w/out Needles with Orthocord Product Number: 222971 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the foot/ankle, knee and elbow
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0144-2013·2012-10-31
DePuy Mitek Recalls SpiraLok 5.0mm Anchors Due to Fracture Risk
DePuy Mitek is recalling 400 units of SpiraLok 5.0mm anchors because they may fracture after surgery, requiring revision.
Product
SpiraLok 5.0mm with Ethibond without needles Product Number: 222964 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the foot/ankle, knee and elbow
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0142-2013·2012-10-31
DePuy Mitek Recalls SpiraLok Anchors Due to Post-Operative Fracture
DePuy Mitek is recalling 314 units of SpiraLok 6.5mm anchors because they may fracture after surgery, requiring patients to undergo revision surgery.
Product
SpiraLok 6.5mm with Ethibond and needles Product Number: 222962 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the foot/ankle, knee and elbow
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0146-2013·2012-10-31
DePuy Mitek Recalls 94 SpiraLok Anchors Due to Post-Operative Fracture
DePuy Mitek is recalling 94 SpiraLok 6.5mm anchors because they fractured after surgery, requiring patients to undergo revision procedures.
Product
SpiraLok 6.5mm with Ethibond without needles Product Number: 222966 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the foot/ankle, knee and elbow
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0140-2013·2012-10-31
DePuy Mitek Recalls SpiraLok Anchors Due to Post-Operative Fracture
DePuy Mitek is recalling 1,315 units of SpiraLok 5.0mm anchors because they may fracture after surgery, requiring patients to undergo revision procedures.
Product
SpiraLok 5.0mm with Ethibond and needles Product Number: 222960 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the foot/ankle, knee and elbow
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0154-2013·2012-10-31
DePuy Mitek Recalls SpiraLok 6.5 Anchors Due to Post-Operative Fracture
DePuy Mitek is recalling 4,151 units of SpiraLok 6.5 anchors because they may fracture after surgery, requiring revision. The recall covers worldwide distribution.
Product
SpiraLok 6.5 w/Needles with violet and blue Orthocord Product Number: 222987 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the foot/ankle, knee and elbow
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0150-2013·2012-10-31
DePuy Mitek Recalls Seven SpiraLok 6.5 Anchors Due to Fracture Risk
DePuy Mitek is recalling seven SpiraLok 6.5 anchors because they fractured after surgery, requiring patients to undergo revision procedures.
Product
SpiraLok 6.5 w/Needles with Orthocord Product Number: 222970 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the foot/ankle, knee and elbow
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0019-2013·2012-10-17
Accutron Recalls Flowmeter Packages for Incorrect Gas Function
Accutron is recalling 220 Flowmeter packages used in analgesia gas machines because they may function incorrectly when nitrous gas flows without oxygen.
Product
CM Flowmeter Pkg H, Model #36700, Serial # 13749 Product Usage: Conscious Sedation Unit Analgesia Gas Machine.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0027-2013·2012-10-17
OrthoHelix 3.8mm Cannulated Hex Drivers Recalled for Tip Breakage
Orthohelix Surgical Designs Inc is recalling 120 non-sterile 3.8mm cannulated hex drivers because the tips break while driving screws into patients.
Product
OrthoHelix Part #HCS-056-32 3.8MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the h
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0026-2013·2012-10-17
OrthoHelix 3.2mm Cannulated Hex Driver Recall Due to Tip Breakage
Orthohelix Surgical Designs Inc is recalling 47 non-sterile 3.2mm cannulated hex drivers because their tips are breaking while driving screws into patients.
Product
OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the h
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0017-2013·2012-10-17
Accutron Recalls Flowmeter Assemblies for Incorrect Nitrous Gas Function
Accutron is recalling specific Flowmeter assemblies used in analgesia gas machines because they function incorrectly when nitrous gas flows without oxygen.
Product
Flow Meter, CM Assembly, Model #27025, Serial # 13686, 13690, 13712, 13793. Flowmeter, CM Assembly, Model#31970, Serial#13692. Product Usage: Conscious Sedation Unit Analgesia Gas Machine.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0053-2013·2012-10-17
Terumo Sarns Centrifugal System Control Module Recalled for Power Loss
Terumo CVS is recalling Sarns Centrifugal System Control modules due to a report of power loss during cardiopulmonary bypass.
Product
Sarns Centrifugal System Control module System 9000 The Sarns Centrifugal System is indicated for use in cardiopulmonary bypass procedures only.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0049-2013·2012-10-17
Terumo Sarns Centrifugal System Battery Backup Recall for Malfunctions
Terumo CVS is recalling Sarns Centrifugal System batteries due to reports of charging and operational failures that could cause loss of arterial flow.
Product
Battery, 100/115V (Includes charger and connecting cable) The Sarns" Centrifugal System is indicated for use in cardiopulmonary bypass procedures only.
Category
Medical Device
Distribution
43 states
SevereFDA (Devices)·Z-0050-2013·2012-10-17
Terumo Sarns Centrifugal System Battery Backup Recall
Terumo CVS is recalling 289 Sarns Centrifugal System battery backups due to reported malfunctions that could cause unexpected loss of arterial flow.
Product
Battery, 220V (Includes charger and connecting cable) The Sarns" Centrifugal System is indicated for use in cardiopulmonary bypass procedures only.
Category
Medical Device
Distribution
43 states
SevereFDA (Devices)·Z-0051-2013·2012-10-17
Terumo Sarns Centrifugal System Control Module Recalled for Power Loss
Terumo CVS is recalling Sarns Centrifugal System Control modules due to a report of power loss during cardiopulmonary bypass.
Product
Sarns Centrifugal System Control module, 100/115V The Sarns Centrifugal System is indicated for use in cardiopulmonary bypass procedures only.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0028-2013·2012-10-17
Remington Medical Recalls Sterile Prostate Biopsy Needles Due to Sterility Concerns
Remington Medical Inc. is recalling 800 sterile automatic cutting needles for prostate biopsies because the product's sterility may be compromised.
Product
Automatic Cutting Needles, Soft Tissue Biopsy Needle, NAC-1820M, Sterile, Remington Medical, Inc., 5830 Meadowridge Court, Alpharetta, GA 30005. Prostate Biopsy Needles shall be single use only and are to be used by a Urologist in a healthcare setting to obtain needle biopsies
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2481-2012·2012-10-10
Zimmer Recalls Provisional Femoral Heads Due to Fit Issues
Zimmer, Inc. is recalling MIS and VerSys provisional femoral heads due to reports of sub-optimal fit with mating components, which can lead to intraoperative dislodging.
Product
00780302801 MIS 12/14 Slotted Femoral Head Provisional -3.5X28 00780302802 MIS 12/14 Slotted Femoral Head Provisional +0X28 00780302803 MIS 12/14 Slotted Femoral Head Provisional +3.5X28 00780302804 MIS 12/14 Slotted Femoral Head Provisional +7X28 00780302805 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-2476-2012·2012-10-10
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
12/14 Neck Taper 00789503201 VerSys Femoral Head Provisional 32mm -3.5 00789503202 VerSys Femoral Head Provisional 32mm +0 00789503203 VerSys Femoral Head Provisional 32mm +3.5 00789503204 VerSys Femoral Head Provisional 32mm +7 00789503205 VerSys Femoral Head Provisional 32
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2478-2012·2012-10-10
Zimmer Recalls VerSys Provisional Femoral Heads Due to Fit Issues
Zimmer, Inc. is recalling VerSys provisional femoral heads because complaints report sub-optimal fit with mating components, leading to intraoperative dislodging.
Product
12/14 Neck Taper 00789504001 VerSys Femoral Head Provisional 40mm -3.5 00789504002 VerSys Femoral Head Provisional 40mm +0 00789504003 VerSys Femoral Head Provisional 40mm +3.5 00789504004 VerSys Femoral Head Provisional 40mm +7 00789504005 VerSys Femoral Head Provisional 40
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-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-0011-2013·2012-10-10
Philips HeartStart XL Defibrillators Recalled for Battery Failure Risk
Philips is recalling HeartStart XL Defibrillators used with specific M3516A batteries that may fail without warning, potentially causing the device to shut down unexpectedly during use.
Product
Philips HeartStart XL M4735A Defibrillator/Monitors, used with the M3516A batteries The Heart Start XL Defibrillator/Monitor is a fully featured, defibrillator intended for use by qualified medical personnel, trained in either Advanced Cardiac Life Support or in the operation
Category
Medical Device
Distribution
Distributed nationwide

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