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Fresenius Medical Care Holdings, Inc.

140 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
5008X Blood Tubing Set, 24 units per case. Includes the below model numbers and descriptio recall (Z-2702-2026)Fresenius Medical Care Holdings, Inc.2026-07-08
Bicarby Dialysate; Model number: RFP-400-G; recall (Z-2401-2026)Fresenius Medical Care Holdings, Inc.2026-06-11
Bicarby" Dialysate; Model Numbers: RFP-400-G, RFP-401-G, RFP-402-G, RFP-404-G, RFP-407-G, recall (Z-2321-2026)Fresenius Medical Care Holdings, Inc.2026-06-05
5008X CAREsystem +CLiC +CDX; recall (Z-0936-2026)Fresenius Medical Care Holdings, Inc.2025-12-17
Optiflux High Flux E-beam Dialyzer Model Numbers: (1) 0500316E OPTIFLUX F160NRe 12/CS 1.5S recall (Z-0041-2026)Fresenius Medical Care Holdings, Inc.2025-10-03
5008X HDF Hemodialysis Blood Tubing Set, 24 units per case, with the following models: a. recall (Z-1992-2025)Fresenius Medical Care Holdings, Inc.2025-06-18
Dialyzer Optiflux 160NRe recall (Z-0801-2025)Fresenius Medical Care Holdings, Inc.2025-01-03
Blood Pressure Module BPM3 TM-2917B (Spare Part Numbers 191378 or 191389) with firmware ve recall (Z-3124-2024)Fresenius Medical Care Holdings, Inc.2024-09-11
190904 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare part, Model Number recall (Z-2340-2024)Fresenius Medical Care Holdings, Inc.2024-07-11
190828: 2008K@HOME HEMODIALYSIS SYSTEM - Blood Pump Rotor spare part, Model Number: F40015 recall (Z-2341-2024)Fresenius Medical Care Holdings, Inc.2024-07-11
191014: 2008K@HOME HD SYSTEM W/BIBAG (CANADA) - Blood Pump Rotor spare part, Model Number: recall (Z-2342-2024)Fresenius Medical Care Holdings, Inc.2024-07-11
190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model Numbe recall (Z-2343-2024)Fresenius Medical Care Holdings, Inc.2024-07-11
RTL190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model Nu recall (Z-2344-2024)Fresenius Medical Care Holdings, Inc.2024-07-11
RTL190828: 2008K@HOME HEMODIALYSIS SYSTEM - Blood Pump Rotor spare part, Model Number: F40 recall (Z-2345-2024)Fresenius Medical Care Holdings, Inc.2024-07-11
RTL190904: 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare part, Model Nu recall (Z-2346-2024)Fresenius Medical Care Holdings, Inc.2024-07-11
RTLR190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model N recall (Z-2347-2024)Fresenius Medical Care Holdings, Inc.2024-07-11
US AquaA 900H-Typ USA-3 x 208v-Intended for the purification of water to be used for hemod recall (Z-2141-2024)Fresenius Medical Care Holdings, Inc.2024-06-13
Blood Pump Rotor, Model Number: F40015481 Rev A recall (Z-1866-2024)Fresenius Medical Care Holdings, Inc.2024-05-17
2008T BlueStar Hemodialysis Machine, Model 191124 with Component: Blood Pump Rotor, Model recall (Z-1867-2024)Fresenius Medical Care Holdings, Inc.2024-05-17
2008T BlueStar Hemodialysis Machine, Model 191126 with Component: Blood Pump Rotor, Model recall (Z-1868-2024)Fresenius Medical Care Holdings, Inc.2024-05-17
2008T BlueStar Hemodialysis Machine, Model 191128 with Component: Blood Pump Rotor, Model recall (Z-1869-2024)Fresenius Medical Care Holdings, Inc.2024-05-17
2008T BlueStar Hemodialysis Machine, Model 191130 with Component: Blood Pump Rotor, Model recall (Z-1870-2024)Fresenius Medical Care Holdings, Inc.2024-05-17
Novalung sensor box is a component of the Novalung Console (F30000162)-Indicated for long- recall (Z-1822-2024)Fresenius Medical Care Holdings, Inc.2024-05-15
stay-safe /Safe Lock Catheter Ext. 12 in recall (Z-1323-2024)Fresenius Medical Care Holdings, Inc.2024-03-26
stay-safe /Luer Lock Adapter 4 in recall (Z-1324-2024)Fresenius Medical Care Holdings, Inc.2024-03-26
stay-safe /Luer Lock Catheter Ext. 12 in recall (Z-1325-2024)Fresenius Medical Care Holdings, Inc.2024-03-26
stay-safe /Luer Lock Catheter Ext. 18 in recall (Z-1326-2024)Fresenius Medical Care Holdings, Inc.2024-03-26
stay-safe /Luer Catheter Ext. 6 in recall (Z-1327-2024)Fresenius Medical Care Holdings, Inc.2024-03-26
Liberty Select Cycler, Model numbers RTLR180343 and RTLR180111 recall (Z-0619-2024)Fresenius Medical Care Holdings, Inc.2023-12-26
Stay Safe Cap recall (Z-0507-2024)Fresenius Medical Care Holdings, Inc.2023-12-07
10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a cas recall (Z-0005-2024)Fresenius Medical Care Holdings, Inc.2023-10-06
10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case recall (Z-0006-2024)Fresenius Medical Care Holdings, Inc.2023-10-06
3ML Syringe Luer Lock with needle 20GX1, Part Number 15-03ML-0, 100 per box, 24 boxes per recall (Z-0007-2024)Fresenius Medical Care Holdings, Inc.2023-10-06
2008T Hemodialysis SYS, with CDX recall (Z-0028-2024)Fresenius Medical Care Holdings, Inc.2023-10-06
2008T Hemodialysis System without CDX recall (Z-0029-2024)Fresenius Medical Care Holdings, Inc.2023-10-06
2008T Hemodialysis System w/Bibag recall (Z-0030-2024)Fresenius Medical Care Holdings, Inc.2023-10-06
2008T GEN 2 Bibag without CDX recall (Z-0031-2024)Fresenius Medical Care Holdings, Inc.2023-10-06
2008T HD SYS. CDX BLUESTAR recall (Z-0032-2024)Fresenius Medical Care Holdings, Inc.2023-10-06
2008T HD SYS. CDX W/BIBAG BLUESTAR recall (Z-0033-2024)Fresenius Medical Care Holdings, Inc.2023-10-06
2008T HD SYS. W/O CDX BLUESTAR recall (Z-0034-2024)Fresenius Medical Care Holdings, Inc.2023-10-06
2008T HD SYS. W/O CDX W/BIBAG BLUESTAR recall (Z-0035-2024)Fresenius Medical Care Holdings, Inc.2023-10-06
2008T and 2008TBluestar Hemodialysis Machines with CDX-Indicated for acute and chronic dia recall (Z-0734-2023)Fresenius Medical Care Holdings, Inc.2022-12-20
NaturaLyte Liquid Acid concentrate, Part Number 08-0231-4, four (4) one-gallon bottles per recall (Z-0181-2023)Fresenius Medical Care Holdings, Inc.2022-11-04
AquaC UNO H [120V, 60Hz, 1000VA, US-Version - a reverse osmosis unit intended for use with recall (Z-1769-2022)Fresenius Medical Care Holdings, Inc.2022-09-19
AquaC UNO H [120V, 60Hz, 1700VA, US-Version- a reverse osmosis unit intended for use with recall (Z-1770-2022)Fresenius Medical Care Holdings, Inc.2022-09-19
AquaC UNO H [120V, 60Hz, 1700VA, Fresenius US-Version: 24-0970-1 Vivonic Part Number: G020 recall (Z-1463-2022)Fresenius Medical Care Holdings, Inc.2022-07-25
AquaC UNO H [120V, 60Hz, 1000VA, Fresenius US-Version: 24-10VA-1 Vivonic Part Number: G020 recall (Z-1464-2022)Fresenius Medical Care Holdings, Inc.2022-07-25
NaturaLyte Liquid Acid concentrate bottles, Model Number 08-1251-1 - Product Usage: used i recall (Z-0811-2021)Fresenius Medical Care Holdings, Inc.2021-01-11
NaturaLyte Liquid Acid concentrate bottles, Model Number 08-1301-4 - Product Usage: used i recall (Z-0812-2021)Fresenius Medical Care Holdings, Inc.2021-01-11
NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2201-5 - Product Usage: used i recall (Z-0813-2021)Fresenius Medical Care Holdings, Inc.2021-01-11
NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2231-2 - Product Usage: used i recall (Z-0814-2021)Fresenius Medical Care Holdings, Inc.2021-01-11
NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2251-0 - Product Usage: used i recall (Z-0815-2021)Fresenius Medical Care Holdings, Inc.2021-01-11
NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2301-3 - Product Usage: used i recall (Z-0816-2021)Fresenius Medical Care Holdings, Inc.2021-01-11
NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2351-8 - Product Usage: used i recall (Z-0817-2021)Fresenius Medical Care Holdings, Inc.2021-01-11
NaturaLyte Liquid Acid concentrate bottles, Model Number 08-3201-4 - Product Usage: used i recall (Z-0818-2021)Fresenius Medical Care Holdings, Inc.2021-01-11
NaturaLyte Liquid Acid concentrate bottles, Model Number 08-3231-1 - Product Usage: used i recall (Z-0819-2021)Fresenius Medical Care Holdings, Inc.2021-01-11
NaturaLyte Liquid Acid concentrate bottles, Model Number 08-3251-9 - Product Usage: used i recall (Z-0820-2021)Fresenius Medical Care Holdings, Inc.2021-01-11
NaturaLyte Liquid Acid concentrate bottles, Model Number 08-3301-2 - Product Usage: used i recall (Z-0821-2021)Fresenius Medical Care Holdings, Inc.2021-01-11
NaturaLyte Liquid Acid concentrate bottles, Model Number 08-4231-0 - Product Usage: used i recall (Z-0822-2021)Fresenius Medical Care Holdings, Inc.2021-01-11
NaturaLyte Liquid Acid concentrate drums, Model Number 13-1251-1 - Product Usage: used in recall (Z-0823-2021)Fresenius Medical Care Holdings, Inc.2021-01-11
NaturaLyte Liquid Acid concentrate drums, Model Number 13-2201-5 - Product Usage: used in recall (Z-0824-2021)Fresenius Medical Care Holdings, Inc.2021-01-11
NaturaLyte Liquid Acid concentrate drums, Model Number 13-2251-0 - Product Usage: used in recall (Z-0825-2021)Fresenius Medical Care Holdings, Inc.2021-01-11
NaturaLyte Liquid Acid concentrate drums, Model Number 13-3251-9 - Product Usage: used in recall (Z-0826-2021)Fresenius Medical Care Holdings, Inc.2021-01-11
Citrasate Liquid Acid concentrate bottles, Model Number 08-3251-CA - Product Usage: used i recall (Z-0827-2021)Fresenius Medical Care Holdings, Inc.2021-01-11
Citrasate Liquid Acid concentrate drums, Model Number 13-2251-CA - Product Usage: used in recall (Z-0828-2021)Fresenius Medical Care Holdings, Inc.2021-01-11
Citrasate Liquid Acid concentrate drums, Model Number 13-3251-CA - Product Usage: used in recall (Z-0829-2021)Fresenius Medical Care Holdings, Inc.2021-01-11
Naturalyte Liquid Acid concentrate bottles, Product Code 08-1251-1 - Product Usage: used i recall (Z-0831-2021)Fresenius Medical Care Holdings, Inc.2021-01-11
Naturalyte Liquid Acid concentrate bottles, Product Code 08-2201-5 - Product Usage: used i recall (Z-0832-2021)Fresenius Medical Care Holdings, Inc.2021-01-11
Naturalyte Liquid Acid concentrate bottles, Product Code 08-2251-0 - Product Usage: used i recall (Z-0833-2021)Fresenius Medical Care Holdings, Inc.2021-01-11
Citrasate Liquid Acid concentrate bottles, Product Code 08-2251-CA - Product Usage: used i recall (Z-0834-2021)Fresenius Medical Care Holdings, Inc.2021-01-11
Naturalyte Liquid Acid concentrate bottles, Product Code 08-2301-3 - Product Usage: used i recall (Z-0835-2021)Fresenius Medical Care Holdings, Inc.2021-01-11
Naturalyte Liquid Acid concentrate bottles, Product Code 08-2351-8 - Product Usage: used i recall (Z-0836-2021)Fresenius Medical Care Holdings, Inc.2021-01-11
Naturalyte Liquid Acid concentrate bottles, Product Code 08-3251-9 - Product Usage: used i recall (Z-0837-2021)Fresenius Medical Care Holdings, Inc.2021-01-11
Naturalyte Liquid Acid concentrate bottles, Product Code 08-4231-0 - Product Usage: used i recall (Z-0838-2021)Fresenius Medical Care Holdings, Inc.2021-01-11
Naturalyte Liquid Acid concentrate drums, Product Code 13-2251-0 - Product Usage: used in recall (Z-0839-2021)Fresenius Medical Care Holdings, Inc.2021-01-11
Naturalyte Liquid Acid concentrate drums, Product Code 13-3251-9 - Product Usage: used in recall (Z-0840-2021)Fresenius Medical Care Holdings, Inc.2021-01-11
Citrasate Liquid Acid concentrate drums, Product Code 13-2251 -CA - Product Usage: used in recall (Z-0841-2021)Fresenius Medical Care Holdings, Inc.2021-01-11
Naturalyte Liquid Bicarbonate Concentrate 6.4 liter bottle A Dialysate Concentrate for Hem recall (Z-2373-2015)Fresenius Medical Care Holdings, Inc.2015-08-12
NaturaLyte Liquid Bicarbonate Concentrate (Dialysate Concentrate for Hemodialysis (liquid) recall (Z-1827-2015)Fresenius Medical Care Holdings, Inc.2015-06-22
CRIT-LINE Blood Chamber- an accessory to the Crit line III- Monitors in real time blood pa recall (Z-1716-2015)Fresenius Medical Care Holdings, Inc.2015-06-05
2008 Series Hemodialysis Machines: 2008Kathome - 190895 2008T GEN 2 BIBAG WITHOUT CDX; 190 recall (Z-1549-2015)Fresenius Medical Care Holdings, Inc.2015-04-29
2008 Series Hemodialysis Machines: 2008T with the following product code and description: recall (Z-1550-2015)Fresenius Medical Care Holdings, Inc.2015-04-29
2008 Series Hemodialysis Machines: 2008K with the following product code and description: recall (Z-1551-2015)Fresenius Medical Care Holdings, Inc.2015-04-29
2008 Series Hemodialysis Machines: 2008K2 with the following product code and description: recall (Z-1552-2015)Fresenius Medical Care Holdings, Inc.2015-04-29
Fresenius Crit Line in a Clip (CLiC) with SW version 2.51 Model Number: CL10041001. A cont recall (Z-1047-2015)Fresenius Medical Care Holdings, Inc.2015-02-03
ASSY, POWER SUPPLY 130V 50HZ. This component is used with the following machines: 2008T He recall (Z-1015-2015)Fresenius Medical Care Holdings, Inc.2015-01-27
Fresenius Naturalyte Liquid Bicarbonate Concentrate Product Number: 08-4000-LB The concent recall (Z-2686-2014)Fresenius Medical Care Holdings, Inc.2014-09-23
BD Vacutainer Serum Tubes (RED TOP PLAIN TUBE 6.0 ML)Part Number: BD 367815 FMC Part Numbe recall (Z-2629-2014)Fresenius Medical Care Holdings, Inc.2014-09-12
BD Vacutainer EDTA Tubes (LAVENDER TOP TUBE 2.0ML) Part Number: BD 367841 Part Number: FMC recall (Z-2630-2014)Fresenius Medical Care Holdings, Inc.2014-09-12
BD Vacutainer SST Tubes (RED/GREY TOP SST TUBE 3.5ML) Part Number: BD 367981 Part Number: recall (Z-2631-2014)Fresenius Medical Care Holdings, Inc.2014-09-12
BD Vacutainer Trace Element Tubes (ROYAL BLUE TOP TUBE 6.0ML) Part Number: 363083 Part Num recall (Z-2632-2014)Fresenius Medical Care Holdings, Inc.2014-09-12
BD Vacutainer Citrate Tubes (LIGHT BLUE TOP TUBE 2.7ML)Part number: BD 363083 Part Number: recall (Z-2633-2014)Fresenius Medical Care Holdings, Inc.2014-09-12
BD Vacutainer PST Tubes (GOLD TOP PST TUBE 3ml) Part Number: BD 367960 FMC part Number: 87 recall (Z-2634-2014)Fresenius Medical Care Holdings, Inc.2014-09-12
NaturaLyte Liquid Bicarbonate Concentrate, 6.4 liter bottle to be used with a hemodialysis recall (Z-1739-2014)Fresenius Medical Care Holdings, Inc.2014-06-09
Naturalyte Liquid Bicarbonate Concentrate, 6.4 Liter Bottle Part Number: 08-4000-LB The co recall (Z-1639-2014)Fresenius Medical Care Holdings, Inc.2014-05-22
Fresenius 2008T Hemodialysis Machine with Revision K Actuator Test Boards and also sold as recall (Z-1618-2014)Fresenius Medical Care Holdings, Inc.2014-05-13
Revision K Actuator Test Boards sold as replacement parts for use with Fresenius 2008-Seri recall (Z-1619-2014)Fresenius Medical Care Holdings, Inc.2014-05-13
Optiflux F160NRe High Flux Dialyzers; Product Number: 0500316E. Single Use acute or chroni recall (Z-1098-2014)Fresenius Medical Care Holdings, Inc.2014-02-26
Optiflux F160NR High Flux Dialyzers; Product Number: 0500316N. Single Use acute or chronic recall (Z-1099-2014)Fresenius Medical Care Holdings, Inc.2014-02-26
Optiflux F180NRe High Flux Dialyzers; Product Number: 0500318E. Single Use acute or chroni recall (Z-1100-2014)Fresenius Medical Care Holdings, Inc.2014-02-26
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Every clearance here is in the API, with alerts when new ones post.