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 the agency’s own highest classification or reported deaths or serious injuries, 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

27451–27475 of 27722

HighFDA (Devices)·Z-2212-2012·2012-08-22
Zimmer Recalls Trabecular Metal Reverse Shoulder Liner Impactors
Zimmer, Inc. is recalling Trabecular Metal Reverse Shoulder Liner Impactors due to reports of alignment peg fractures in units made of 455 stainless steel.
Product
Trabecular Metal Reverse Shoulder Liner 40mm, part 00-4309-028-00 - Per surgical technique 97-4309-003-00 Revision 4: "Complete Poly Liner insertion by snapping the appropriate 60¿ (Standard) or 65¿ (Retentive) Poly Liner Impactor to the Poly Liner Impactor Handle. Then…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2214-2012·2012-08-22
Zimmer Recalls Trabecular Metal Reverse Shoulder Liner Impactors
Zimmer, Inc. is recalling specific Trabecular Metal Reverse Shoulder Liner Impactors due to reports of alignment peg fractures.
Product
00-4309-029-00- Trabecular Metal Reverse Shoulder Liner 36mm, Nonsterile Per surgical technique 97-4309-003-00 Revision 4: "Complete Poly Liner insertion by snapping the appropriate 60¿ (Standard) or 65¿ (Retentive) Poly Liner Impactor to the Poly Liner Impactor Handle. Then…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2213-2012·2012-08-22
Zimmer Trabecular Metal Reverse Shoulder Liner Impactors Recalled for Fractures
Zimmer, Inc. is recalling Trabecular Metal Reverse Shoulder Liner Impactors due to reports of alignment peg fractures in instruments made of 455 stainless steel.
Product
00-4309-028-01 - Trabecular Metal Reverse Shoulder Liner 40mm 65¿ Neck Angle Per surgical technique 97-4309-003-00 Revision 4: "Complete Poly Liner insertion by snapping the appropriate 60¿ (Standard) or 65¿ (Retentive) Poly Liner Impactor to the Poly Liner Impactor Handle.…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2196-2012·2012-08-22
Edwards Lifesciences Recalls Swan-Ganz Catheters Due to Guidewire Passage Issues
Edwards Lifesciences is recalling Swan-Ganz Thermodilution VIP Catheters because a J-tip guidewire may pass through the distal lumen hub.
Product
Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 151F7. For use in patients who require hemodynamic monitoring.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2193-2012·2012-08-22
Edwards Lifesciences Recalls Swan-Ganz Catheters Due to Guidewire Passage Issues
Edwards Lifesciences is recalling Swan-Ganz Thermodilution VIP Catheters because a J-tip guidewire may pass through the distal lumen hub.
Product
Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 141F7. For use in patients who require hemodynamic monitoring.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2189-2012·2012-08-22
Edwards Lifesciences Recalls Swan-Ganz Catheters Due to Guidewire Passage Issues
Edwards Lifesciences is recalling Swan-Ganz Thermodilution VIP Catheters because a J-tip guidewire may pass through the distal lumen hub.
Product
Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131F7P. For use in patients who require hemodynamic monitoring.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2197-2012·2012-08-22
Edwards Lifesciences Recalls Swan-Ganz Catheters Due to Guidewire Passage Issues
Edwards Lifesciences is recalling 32,145 Swan-Ganz Thermodilution VIP Catheters because a J-tip guidewire may pass through the distal lumen hub.
Product
Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 151HF7. For use in patients who require hemodynamic monitoring.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2202-2012·2012-08-22
Carestream DRX-1 System Battery Recall for Overheating Risk
Carestream Health is recalling DRX-1 system batteries manufactured before June 2012 due to two reported instances of lithium-ion battery overheating that may cause burns.
Product
Carestream DRX-1 System Battery --- Made in U.S.A. for Carestream Health, Inc., Carestream Health, Inc., 150 Verona St, Rochester, NY 14608. --- The battery may be sold with the DRX-1 imaging device or as a stand-alone accessory.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2191-2012·2012-08-22
Edwards Lifesciences Recalls Swan-Ganz Catheters Due to Guidewire Passage Issues
Edwards Lifesciences is recalling Swan-Ganz Thermodilution VIP Catheters because a J-tip guidewire may pass through the distal lumen hub.
Product
Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131HF7P. For use in patients who require hemodynamic monitoring.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2215-2012·2012-08-22
Zimmer Recalls Trabecular Metal Reverse Shoulder Liner Impactors Due to Fractures
Zimmer, Inc. is recalling specific Trabecular Metal Reverse Shoulder Liner Impactors due to reports of alignment peg fractures. The recall affects units manufactured from 455 stainless steel.
Product
00-4309-029-01 - Trabecular Metal Reverse Shoulder Liner 36 mm 65¿¿ Neck Angle Per surgical technique 97-4309-003-00 Revision 4: "Complete Poly Liner insertion by snapping the appropriate 60¿ (Standard) or 65¿ (Retentive) Poly Liner Impactor to the Poly Liner Impactor Handle.…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2210-2012·2012-08-22
Maquet Pediatric Arterial Cannula Recall for Limited Flexibility
Maquet Inc. is recalling certain pediatric arterial cannulas because the hardened tip may be too long, limiting flexibility during extracorporeal circulation procedures.
Product
Maquet Getinge Group Pediatric Arterial Cannula Maquet Cardiopulmonary AG Kehler Strabe 31 76437 Rastatt Germany Phone +49 7222 932-0 Fax: +49 7222 932-1888 [email protected] www.maquet.com Used to introduce blood and sterile solution to the circulation system during…
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-2188-2012·2012-08-22
Edwards Lifesciences Recalls Swan-Ganz Catheters Due to Guidewire Passage Issues
Edwards Lifesciences is recalling 32,145 units of Swan-Ganz Thermodilution VIP Catheters because a J-tip guidewire may pass through the distal lumen hub.
Product
Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131F7J. For use in patients who require hemodynamic monitoring.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2195-2012·2012-08-22
Edwards Lifesciences Recalls Swan-Ganz Catheters Due to Guidewire Passage Issues
Edwards Lifesciences is recalling 32,145 units of Swan-Ganz Thermodilution VIP Catheters because a J-tip guidewire may pass through the distal lumen hub.
Product
Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 141HF7P. For use in patients who require hemodynamic monitoring.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2198-2012·2012-08-22
Edwards Lifesciences Recalls Swan-Ganz Catheters Due to Guidewire Passage Issues
Edwards Lifesciences is recalling 32,145 Swan-Ganz Thermodilution VIP Catheters because a J-tip guidewire may pass through the distal lumen hub.
Product
Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model TS057HF7. For use in patients who require hemodynamic monitoring.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2136-2012·2012-08-15
GE OEC Medical Systems Recalls FluoroTrak Spinal Navigation Application
GE OEC Medical Systems is recalling 17 FluoroTrak Spinal Navigation Applications because they may display incorrect instrument positions relative to reference images.
Product
Radiological Image Processing System The system is an aid to locate anatomical structures during open or percutaneous surgical procedures. It is indicated for use in medical conditions that may benefit from the use of stereotactic surgical technique. The system provides a…
Category
Medical Device
Distribution
9 states
SevereFDA (Devices)·Z-2182-2012·2012-08-15
Siemens Dimension Reagent Management System Power Cord Recall
Siemens Healthcare Diagnostics is recalling 2,554 Dimension Reagent Management System power cords due to a fire hazard caused by partial cord insertion.
Product
Dimension(R) Reagent Management System (RMS) - Power Cord. The Siemens Healthcare Diagnostics Dimension(R) clinical chemistry analyzers are floor model, fully automated, microprocessor-controlled, integrated instrument systems that use prepackaged Flex(R) reagent test…
Category
Medical Device
Distribution
51 states
SevereFDA (Devices)·Z-2155-2012·2012-08-15
Stryker Luxor Retractor Base Recalled Due to Blade Disassembly
Stryker Spine is recalling 30 Luxor Retractor Base devices because blades may disassemble from the base, causing the retractor to collapse during use.
Product
LUXOR RETRACTOR BASE; Catalog Number: 48250030; Manufactured by: STRYKER Spine SAS; Z.I MARTICOT-33610-CESTAS-FRANCE; Distributed in the USA by: Stryker Spine. 2 Pearl Ct. Allendale, NJ 07401. Provides access to the thoracic and lumbar spine from a posterior approach via a…
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2165-2012·2012-08-15
Smith & Nephew TWINFIX Ultra Ti Suture Anchor Recall for Breakage Risk
Smith & Nephew is recalling 913 units of TWINFIX Ultra Ti Suture Anchors because the distal part may break during insertion into bone.
Product
Smith & Nephew 5.5 mm TWINFIX Ultra Ti Suture Anchor with two #2 ULTRABRAID sutures (blue, blue-COBRAID) with Needles Product Usage: intended for use for the reattachment of soft tissue to bone Part Number: 72202618
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2141-2012·2012-08-15
Baxter Recalls Automix 3+3 Compounder Systems Due to Electrical Failures
Baxter Healthcare is recalling 3,106 Automix 3+3 Compounder Systems because fluid ingress can cause incorrect responses, unexpected pump operations, or silent stops.
Product
AUTOMIX 3+3 Compounder System, product 2M8286 (115V) and 2M8286K (230V), automated nutrition compounders; Product Usage: The Automix Compounder Systems are electromechanical positive displacement fluid compounding devices used in the admixture of large volume parenteral…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2140-2012·2012-08-15
Baxter Recalls Automix Plus High Speed Compounder Systems
Baxter Healthcare is recalling 840 Automix Plus High Speed Compounder Systems due to electrical failures that may cause incorrect responses or undetected stops.
Product
AUTOMIX Plus High Speed Compounder System, product 2M8075; automated nutrition compounders; Product Usage: The Automix Compounder Systems are electromechanical positive displacement fluid compounding devices used in the admixture of large volume parenteral nutrition…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2142-2012·2012-08-15
Baxter Recalls Automix 3+3 Compounders Due to Electrical Failures
Baxter Healthcare is recalling 950 Automix 3+3 Compounders because fluid ingress can cause incorrect responses, unexpected pump operations, or silent stops.
Product
AUTOMIX 3+3 Compounder with Accusource Monitoring System, product 2M8287; automated nutrition compounders; Product Usage: The Automix Compounder Systems are electromechanical positive displacement fluid compounding devices used in the admixture of large volume parenteral…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2139-2012·2012-08-15
Baxter Recalls Automix High Speed Compounder Systems Due to Electrical Failures
Baxter Healthcare is recalling 270 Automix High Speed Compounder Systems worldwide due to potential electrical failures and incorrect device responses.
Product
AUTOMIX High Speed Compounder System, product 2M8077; automated nutrition compounders; Product Usage: The Automix Compounder Systems are electromechanical positive displacement fluid compounding devices used in the admixture of large volume parenteral nutrition formulations…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2168-2012·2012-08-15
Smith & Nephew TWINFIX Ultra Ti Anchor Recall for Breakage Risk
Smith & Nephew is recalling 4,411 units of TWINFIX Ultra Ti Anchors because the distal part may break during insertion into bone.
Product
Smith & Nephew 5.5 mm TWINFIX Ultra Ti Anchor with three #2 sutures (white, COBRAID- blue), sterile Part Number: 72202897 Product Usage: intended for use for the reattachment of soft tissue to bone
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2179-2012·2012-08-15
Medical Specialties Distributors Recalls Leaking Medstream Infusion Sets
Medical Specialties Distributors is recalling Medstream 81-inch infusion sets that may leak at the Y-site. The recall covers 472 cases distributed nationwide.
Product
Medstream 81" (206 cm) 20 Drop Standard bore Universal Administration Set with Y-Site, Sterile Manufactured for MSD (Medical Specialties Distributors LLC, Stoughton, MA. Product of China Product Number: MS721 Disposable Infusion set
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2167-2012·2012-08-15
Smith & Nephew TWINFIX Ultra Ti Anchor Recall for Potential Breakage
Smith & Nephew is recalling 2,204 units of TWINFIX Ultra Ti Anchors because the distal part may break during insertion into bone.
Product
Smith & Nephew 5.5 mm TWINFIX Ultra Ti Anchor with two #2 sutures (COBRAID-blue, COBRAIDblack), sterile Part Number: 72202896 Product Usage: intended for use for the reattachment of soft tissue to bone
Category
Medical Device
Distribution
Distributed nationwide

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27451–27475 of 27722