Baxter Healthcare Corporation recall records

273 reported ongoing

306 records in this archive. Latest source date Aug 17, 2026.

FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

Records and reported status

FDA device enforcement

GEM NEUROTUBE, Absorbable Woven Polyglycolic Acid Mesh Tube, Product Codes: a) 5311-01240-010, b) 5311-01240-012; for peripheral nerve repair

The product is brittle and potentially crumbling upon handling or when being removed from its package.

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide and the countries of China, Germany, Sweden, Norway, Netherlands, Greece, Switzerland, France

Official source for GEM NEUROTUBE, Absorbable Woven Polyglycolic Acid Mesh Tube, Product Codes: a) 5311-01240-010, b)...
FDA device enforcement

Baxter MiniCap Disconnect Cap with Povidone-Iodine Solution, 5C4466P; Accessory to disposable administration set for peritoneal dialysis

MiniCap Disconnect Cap with Povidone-Iodine are packaged in foil pouches, which may have been incorrectly sealed, i.e., the pouches may have open or weak seals. This could lead to exposure to air, resulting in insufficient iodine/dry sponge inside the MiniC...

Class IIReported ongoing

Distribution: US Nationwide distribution and Canada.

Official source for Baxter MiniCap Disconnect Cap with Povidone-Iodine Solution, 5C4466P; Accessory to disposable adm...
FDA device enforcement

Revaclear 400 Dialyzer. Product Code: 114746L. Used to treat chronic and acute renal failure by hemodialysis.

Potential for Internal Blood Leaks due to a twisted gasket in the dialyzer

Class IIReported ongoing

Distribution: Worldwide distribution. US Nationwide including Guam and St. Thomas USVI; Canada, China, Australia, New Zealand, Austria, Egypt, France, Germany, Ireland, Italy, Morocco, Qatar,...

Official source for Revaclear 400 Dialyzer. Product Code: 114746L. Used to treat chronic and acute renal failure by h...
FDA device enforcement

Revaclear 400 Dialyzer. Product Code: 114749M. Not distributed in the USA. Used to treat chronic and acute renal failure by hemodialysis.

Potential for Internal Blood Leaks due to a twisted gasket in the dialyzer

Class IIReported ongoing

Distribution: Worldwide distribution. US Nationwide including Guam and St. Thomas USVI; Canada, China, Australia, New Zealand, Austria, Egypt, France, Germany, Ireland, Italy, Morocco, Qatar,...

Official source for Revaclear 400 Dialyzer. Product Code: 114749M. Not distributed in the USA. Used to treat chronic ...
FDA device enforcement

Revaclear 300 dialyzers. Indicated for treatment of chronic and acute renal failure by hemodialysis.

Reports of Polyurethane Displacement in the dialyzer, and might be identified as a blood leak

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide and the countries of Canada, China, Australia, New Zealand, Austria, Egypt, France, Germany, Ireland, Italy, Morocco, Qatar, Saudi Arabia,...

Official source for Revaclear 300 dialyzers. Indicated for treatment of chronic and acute renal failure by hemodialysis.
FDA device enforcement

Revaclear 400 dialyzers. Indicated for treatment of chronic and acute renal failure by hemodialysis.

Reports of Polyurethane Displacement in the dialyzer, and might be identified as a blood leak

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide and the countries of Canada, China, Australia, New Zealand, Austria, Egypt, France, Germany, Ireland, Italy, Morocco, Qatar, Saudi Arabia,...

Official source for Revaclear 400 dialyzers. Indicated for treatment of chronic and acute renal failure by hemodialysis.
FDA device enforcement

Revaclear 400 dialyzers. Indicated for treatment of chronic and acute renal failure by hemodialysis.

Reports of Polyurethane Displacement in the dialyzer, and might be identified as a blood leak

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide and the countries of Canada, China, Australia, New Zealand, Austria, Egypt, France, Germany, Ireland, Italy, Morocco, Qatar, Saudi Arabia,...

Official source for Revaclear 400 dialyzers. Indicated for treatment of chronic and acute renal failure by hemodialysis.
FDA device enforcement

Hill-Rom Progressa Bed System

The compression links on impacted Progressa beds, listed in Appendix A, may bend when raising the head section. The labeling for these beds list a maximum patient weight of 500 lbs., however the bending may still occur with a patient weight of less than 500...

Class IIReported ongoing

Distribution: Worldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, HI, IN, LA, MA, MO, NC, NM, NV, NY, OK, OR, PA, SC. TN, TX, WA, and WI. (UPDATED: States of PA and SC and...

Official source for Hill-Rom Progressa Bed System
FDA device enforcement

Hillrom Centrella Hospital Bed with WatchCare Incontinence Management System, Product code/Part numbers: P7900B100193, P7900B100195, P7900B100230, P7900B100236, P7900B100239, P7...

Radio frequency emission from a functioning WatchCare device may potentially impact other devices (including, but not limited to telemetry devices, bladder scanner, fetal monitor/doppler, infusion pumps, and insulin pumps).

Class IReported ongoing

Distribution: US

Official source for Hillrom Centrella Hospital Bed with WatchCare Incontinence Management System, Product code/Part n...
FDA device enforcement

Hillrom Hospital Bed Accessory, Watch Care Incontinence Management System for Centrella Bed, Product Code/Part Number P00697905

Radio frequency emission from a functioning WatchCare device may potentially impact other devices (including, but not limited to telemetry devices, bladder scanner, fetal monitor/doppler, infusion pumps, and insulin pumps).

Class IReported ongoing

Distribution: US

Official source for Hillrom Hospital Bed Accessory, Watch Care Incontinence Management System for Centrella Bed, Prod...
FDA device enforcement

Hillrom Hospital Bed Accessory, Watch Care Incontinence Management System for Progressa Bed, Product Code/Part Number P00697903.

Radio frequency emission from a functioning WatchCare device may potentially impact other devices (including, but not limited to telemetry devices, bladder scanner, fetal monitor/doppler, infusion pumps, and insulin pumps).

Class IReported ongoing

Distribution: US

Official source for Hillrom Hospital Bed Accessory, Watch Care Incontinence Management System for Progressa Bed, Prod...

Reasons in these listed records

  • The product is brittle and potentially crumbling upon handling or when being removed from its package.
  • ExataMed 20 mL oral dispenser component of the Clear Pharmacy Pack may have particulate matter.
  • Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
  • The electrical safety testing was not properly performed on the impacted devices and additional testing is required

These examples come from this result page and are not a ranking of every recall reason.

Checking Baxter Healthcare Corporation

Is there a recall on baxter healthcare corporation right now?

This archive contains 306 records, including 273 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.

How do I check my package or product?

Compare the product, firm and lot, date, model or serial identifiers with the notice. Use the label-check guide if you need help locating an identifier.

Does a matching name mean every item is included?

A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.

What if the search finds no matching record?

This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. Check source coverage and the agency's current notices.

Where can I find older records?

Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.

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