Medical device recalls

A no-JavaScript view of recent medical device recalls in the latest Recall Radar snapshot. For the compact cross-category view, use the snapshot summary. To compare product, firm, code, and reason clues, use the private match checker, product clue index, code clue index, reason clue index, or search starter links. For all loaded records, use the latest recall digest, the newly reported recalls page, the report-date index, the source status page, the nationwide recalls page, the location clue index, the highest concern page, the ongoing recalls page, the recall action checklist, the recall field guide, or interactive Recall Radar Devices filter.

GeneratedSep 23, 2026, 8:30 PM EDT
Loaded12
Class I0
Ongoing12
Class II Ongoing Reported Sep 16, 2026

Getinge PVC Thoracic Catheter, Soft PVC Straight, 10 per Case; Size(Model Number): 1. 16FR(8016), 2. 24FR(8024), 3. 28FR(8028), 4. 32FR(8032), 5. 36FR(8036);

An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters.

US Nationwide distribution.

Firm
Atrium Medical Corporation
Recall began
Aug 7, 2026
Quantity
3618
Codes
1. Model Number(Size): 8016(16FR); UDI-DI: 00650862130164; Lot Number: ME244878; 2. Model Number(Size): 8024(24FR); UDI-DI: 00650862130249; Lot Number: ME244835; 3. Model Number(Si...
FDA IDs
Z-3111-2026 / event 99680
Source
openFDA source record
Class II Ongoing Reported Sep 16, 2026

Getinge PVC Thoracic Catheter, Firm PVC Straight, 10 per Case; Size(Model Number): 1. 28FR(15028), 2. 36FR(15036);

An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters.

US Nationwide distribution.

Firm
Atrium Medical Corporation
Recall began
Aug 7, 2026
Quantity
256
Codes
1. Model Number(Size): 15028(28FR); UDI-DI: 00650862150285; Lot Number: ME244891; 3. Model Number(Size): 15036(36FR); UDI-DI: 00650862150360; Lot Number: ME244850;
FDA IDs
Z-3113-2026 / event 99680
Source
openFDA source record
Class II Ongoing Reported Sep 16, 2026

Product Name: DermaV Laser System Model/Catalog Number: DermaV Medical laser device that delivers pulsed laser energy at wavelengths of 532 nm and 1064 nm through a fiber-optic han...

Utilizing higher fluences at 1064nm wavelength with current cryogen parameters may result in a spark/loud noise during treatment, potentially resulting in patient burn.

Worldwide distribution - US Nationwide and the countries of Canada and European Union.

Firm
Lutronic Corporation
Recall began
Aug 6, 2026
Quantity
1065
Codes
Lot Code: Model: DermaV Software Version: 1.06 UDI #: 08800291820200 Serial Numbers: DV025A010, DV025A011, DV025A012, DV025A013, DV025A014, DV025A015 DV025A016, DV025A018, DV025A01...
FDA IDs
Z-3110-2026 / event 99601
Source
openFDA source record
Class II Ongoing Reported Sep 16, 2026

MedicaLyte Liquid Bicarbonate Concentrate REF: BC-100 and BC+201

Hemodialysis concentrates contain high endotoxin levels

Worldwide - US Nationwide distribution in the states of FL, GA, IL, MD, MI, NC, NJ, NV, OH, PA, and the countries of Guatemala and Panama.

Firm
Nipro Renal Soultions USA, Corporation
Recall began
Aug 5, 2026
Quantity
3,286 cases
Codes
BC-100 - Lot:N4L022 (exp.11/13/2026), N4L037(exp.11/18/2026) BC+201- Lot: N4L010(exp.11/06/2026)
FDA IDs
Z-3133-2026 / event 99573
Source
openFDA source record
Class II Ongoing Reported Sep 16, 2026

MedicaLyte Bicarbonate Powder REF: DB+201-2.1(45X) and DB+201-25 (35X, 36.83X, 45X))

Hemodialysis concentrates contain high endotoxin levels

Worldwide - US Nationwide distribution in the states of FL, GA, IL, MD, MI, NC, NJ, NV, OH, PA, and the countries of Guatemala and Panama.

Firm
Nipro Renal Soultions USA, Corporation
Recall began
Aug 5, 2026
Quantity
2,327 cases
Codes
DB+201-2.1: Lot -NDB5E004(exp.4/30/2027) DB+201-25: Lots - NDB5M011(Exp.12/05/2027, NDB4J003(exp.9/25/2026)
FDA IDs
Z-3134-2026 / event 99573
Source
openFDA source record
Class II Ongoing Reported Sep 16, 2026

Citric Complete Liquid Citric Acid Concentrate REF: LC+200-D,LC+201, LC+225(45X)

Hemodialysis concentrates contain high endotoxin levels

Worldwide - US Nationwide distribution in the states of FL, GA, IL, MD, MI, NC, NJ, NV, OH, PA, and the countries of Guatemala and Panama.

Firm
Nipro Renal Soultions USA, Corporation
Recall began
Aug 5, 2026
Quantity
100 drums/1072 cases
Codes
LC+200-D: Lot-N4J030 (Exp.9/20/2026), N5D043(Exp.4/16/2027); LC+225: Lot-N6A025(Exp.1/8/2028)
FDA IDs
Z-3136-2026 / event 99573
Source
openFDA source record
Class II Ongoing Reported Sep 16, 2026

AMS Convenience Kit: DSAEK Pack - RX, Part Number AMS12394B

The convenience kits contain .0.9% Sodium Chloride Injection, USP products in Single Dose freeflex bags, which may contain blue Break-off-Parts (BOPs) that have detached from the infusion port during manipulation.

US Nationwide distribution in the states of CA, GA, WA.

Firm
Windstone Medical Packaging, Inc.
Recall began
Jul 29, 2026
Quantity
3,260 kits
Codes
UDI-DI:B098AMS12394B0; Lot Numbers: 241907, 241223, 241034, 240904, 240705, 240633, 240269, 238361, 238197, 238146, 238085, 238084, 238041, 237957, 237901, 237843, 237663, 237444,...
FDA IDs
Z-3138-2026 / event 99658
Source
openFDA source record
Class II Ongoing Reported Sep 16, 2026

HeartSine SAM 350P 350P US Device, US English - 2 Min CPR UDI-DI codes: 0506016712067 350P US Device, US English (American Airlines) - 2 Min CPR UDI-DI code: 0506016712207 350P US...

Due to a damaged (over stretched) membrane tail that causes an intermittent fault.

Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AZ, CA, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, MA, MD, ME MI, MN, NC, NJ, NM, NV, NY, OH, OK, OR, PA, SD,TN, TX, UT, VA, WA, WI, WV and WY. The countries of Argentina, Australia,...

Firm
HeartSine Technologies Ltd
Recall began
Jul 27, 2026
Quantity
11,912
Codes
350P US Device, US English - 2 Min CPR Item code: 350-STR-US-10 UDI-DI codes: 0506016712067 Serial Numbers: 22D91164357L22 22D91164989L22 22D91180808K23 23D98000415K23 23D98000597K...
FDA IDs
Z-3120-2026 / event 99568
Source
openFDA source record
Class II Ongoing Reported Sep 16, 2026

Products that contain the Pericare Wipes: Bardex Lubricath Foley Catheter Tray REF: 899914 899916 899918 UDI codes: 00801741024801¿ 10801741024808 00801741024818¿ 10801741024815 00...

Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.

Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI and W...

Firm
C.R. Bard Inc
Recall began
Jun 25, 2026
Quantity
12,463 trays/kits
Codes
Catalog Numbers / UDI codes: 899914 / 00801741024801¿ 10801741024808 Lot Number: NGKU4611 899916 / 00801741024818¿ 10801741024815 Lot Numbers: NGKU2448 NGKU4610 899918 / 0080174102...
FDA IDs
Z-3114-2026 / event 98840
Source
openFDA source record
Class II Ongoing Reported Sep 16, 2026

Products that contain the Pericare Wipes: Bard¿ Foley Tray With Lubri-Sil¿ All-Silicone Foley Catheter REF: 947314 947316 947318 UDI codes: 00801741024924¿ 10801741024921 008017410...

Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.

Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI and W...

Firm
C.R. Bard Inc
Recall began
Jun 25, 2026
Quantity
283883 trays/kits
Codes
Bard¿ Foley Tray With Lubri-Sil¿ All-Silicone Foley Catheter Catalog Numbers / UDI codes: 947314 / 00801741024924¿ 10801741024921 Lot Numbers: NGKT2599 NGKU0115 947316 / 0080174102...
FDA IDs
Z-3115-2026 / event 98840
Source
openFDA source record
Class II Ongoing Reported Sep 16, 2026

Products that contain the Pericare Wipes: SureStep" Foley Tray System Add-A-Foley Catheter REF: A153200 UDI code: 00801741121067¿ 10801741121064 SureStep" Foley Tray System Complet...

Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.

Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI and W...

Firm
C.R. Bard Inc
Recall began
Jun 25, 2026
Quantity
33850 units/kits
Codes
SureStep" Foley Tray System Add-A-Foley Catheter A153200 / 00801741121067¿ 10801741121064 Lot Number: NGKS2397 SureStep" Foley Tray System Complete Care¿ Add-A-Foley Catheter A3044...
FDA IDs
Z-3118-2026 / event 98840
Source
openFDA source record
Class II Ongoing Reported Sep 16, 2026

Products that contain the Pericare Wipes: (Canada Only) SureStep" Foley Tray System Bardex¿ IC Complete Care¿ REF: A300314AC UDI-DI code: 00801741143243 SureStep" Foley Tray System...

Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.

Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI and W...

Firm
C.R. Bard Inc
Recall began
Jun 25, 2026
Quantity
364
Codes
(Canada Only) SureStep" Foley Tray System Bardex¿ IC Complete Care¿ REF: A300314AC UDI-DI code: 00801741143243 Lot Number: NGKT2492 SureStep" Foley Tray System Bardex¿ IC Complete...
FDA IDs
Z-3119-2026 / event 98840
Source
openFDA source record