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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 98603

3 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
April 08, 2026
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Becton, Dickinson and Company

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

3 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 3

Swan-Ganz Catheter, Models: 131F7/131F7P, 131F7J, 141F7, 151F7, 834F75, 096F6/096F6P, C144F7, 782F75M, 132F5, C146F7, 831F75/831F75P, TS105F5, 774F75, 777F8, AIQSGF8;

Z-2202-2026
Recall number
Z-2202-2026
Initiated
April 08, 2026
Classification
Class II
Status
Ongoing
Quantity
589,223

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection, medication loss, and/or blood loss.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection, medication loss, and/or blood loss.

Code information

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834F75/00690103151756/ 66149781(11/20/2026), 66169452(11/21/2026), 66169453(11/22/2026), 66169454(11/22/2026), 66225269(1/17/2027), 66292951(2/6/2027), 66295865(2/25/2027), 66325010(2/21/2027), 66358925(2/25/2027), 66360368(2/24/2027), 66384531(3/21/2027), 66384532(3/21/2027), 66384533(3/31/2027), 66419531(3/15/2027), 66597740(4/25/2027), 66704730(6/6/2027), 66710835(10/16/2027), 66739754(7/2/2027), 66748559(6/11/2027), 66748561(6/10/2027), 66829581(7/5/2027), 66832094(8/1/2027), 66894451(7/31/2027), 66894452(8/1/2027), 66987645(8/30/2027), 67025475(10/13/2027), 67045003(9/17/2027), 67047807(10/14/2027), 67075111(9/27/2027), 67197192(11/11/2027), 67205219(11/18/2027); 096F6, 096F6P/00690103000245, 00690103218602/66687312(6/9/2027), 66687922(6/10/2027), 66687924(6/13/2027), 66780053(6/26/2027), 66822159(9/22/2027); C144F7/00690103005134/66822158(7/15/2027); 782F75M/00690103197303/66725374(6/19/2027); 132F5/00690103000467/66687936(6/9/2027), 66467271(6/9/2027); C146F7/00690103153132; 831F75P/831F75-00690103003031, 00690103218282/66175089(11/26/2026), 66175090(12/2/2026), 66175091(12/2/2026), 66175092(12/3/2026), 66175093(11/26/2026), 66175094(11/27/2026), 66175095(11/28/2026), 66175096(11/29/2026), 66175097(11/29/2026), 66175103(12/4/2026), 66175104(12/5/2026), 66175105(12/5/2026), 66175120(12/9/2026), 66175121(12/10/2026), 66175122(12/11/2026), 66208306(12/12/2026), 66208323(12/13/2026), 66211381(12/16/2026), 66211385(1/8/2027), 66211386(1/9/2027), 66225264(1/13/2027), 66225265(1/14/2027), 66225266(1/15/2027), 66225267(1/16/2027), 66225268(1/22/2027), 66268847(1/23/2027), 66278675(2/5/2027), 66283844(2/14/2027), 66283845(2/26/2027), 66283846(2/20/2027), 66296223(3/3/2027), 66298719(3/1/2027), 66301299(2/17/2027), 66301300(2/19/2027), 66439365(4/3/2027), 66439366(4/5/2027), 66439367(4/11/2027), 66488586(3/28/2027), 66529347(5/31/2027), 66554378(4/12/2027), 66591113(5/2/2027), 66660610(5/20/2027), 66664653(5/21/2027), 66667556(5/17/2027), 66667557(5/19/2027), 66704725(6/5/2027), 66704758(6/27/2027), 66739799(7/15/2027), 66758829(7/11/2027), 66759128(6/12/2027), 66767284(6/25/2027), 66782068(7/28/2027), 66804400(6/30/2027), 66804401(7/2/2027), 66804402(7/3/2027), 66826032(7/26/2027), 66873891(8/8/2027), 66934651(8/23/2027), 66934677(8/29/2027), 66964714(8/25/2027), 66972587(9/18/2027), 66972588(9/22/2027), 67003703(9/30/2027), 67003704(10/1/2027), 67005151(9/9/2027), 67005156(9/3/2027), 67005540(10/7/2027), 67005541(10/9/2027), 67005542(9/10/2027), 67005543(9/11/2027), 67005544(9/23/2027), 67005545(10/10/2027), 67184885(11/1/2027); TS105F5/00690103018295; 774F75/00690103146998/66521746(5/7/2027), 66844440(7/8/2027), 66844441(7/9/2027), 66844442(7/10/2027), 66844443(7/11/2027), 66844444(7/11/2027), 66844445(7/12/2027), 66844446(7/14/2027), 66844447(7/15/2027), 66844448(7/15/2027), 66844449(7/16/2027), 66844450(7/16/2027), 66844451(7/17/2027), 66844452(7/18/2027), 66844453(8/4/2027), 66919298(8/6/2027), 66919299(8/20/2027), 66920022(8/5/2027); 777F8/00690103146554/66417428(4/21/2027), 66417429(4/22/2027), 66417430(4/22/2027), 66419577(4/11/2027), 66419578(4/12/2027), 66419579(4/14/2027), 66419580(4/14/2027), 66419581(4/15/2027), 66419582(4/15/2027), 66419583(4/16/2027), 66419584(4/16/2027), 66419585(4/21/2027), 66438181(4/23/2027), 66465249(4/25/2027), 66523321(4/23/2027), 66523328(4/24/2027), 66523330(4/28/2027), 66523331(4/25/2027), 66544242(4/30/2027), 66568201(5/7/2027), 66590392(5/12/2027), 66600645(4/28/2027), 66600646(4/29/2027), 66600647(4/29/2027), 66600648(4/30/2027), 66600649(4/30/2027), 66615750(5/1/2027), 66615751(5/3/2027), 66615752(5/19/2027), 66615753(5/20/2027), 66619148(5/2/2027), 66643587(5/22/2027), 66643588(5/23/2027), 66643589(5/26/2027), 66643590(5/27/2027), 66643591(5/27/2027), 66643592(5/28/2027), 66643593(5/29/2027), 66643594(5/30/2027), 66643595(6/2/2027), 66643596(6/3/2027), 66646363(5/12/2027), 66646364(5/13/2027), 66646365(5/14/2027), 66646366(5/15/2027), 66646367(5/16/2027), 66646368(5/16/2027), 66660611(6/3/2027), 66660612(6/4/2027), 66660613(6/4/2027), 66660614(6/5/2027), 66660615(6/5/2027), 66660616(6/7/2027), 66687707(6/7/2027), 66687708(6/9/2027), 66687805(6/9/2027), 66694839(7/5/2027), 66704726(6/10/2027), 66704727(6/11/2027), 66704728(6/11/2027), 66704729(6/12/2027), 66764452(6/12/2027), 66764453(6/13/2027), 66764454(6/16/2027), 66764455(6/16/2027), 66764456(6/17/2027), 66764457(6/17/2027), 66769776(6/18/2027), 66769777(6/23/2027), 66782069(7/7/2027), 66800668(6/23/2027), 66804171(6/28/2027), 66928758(8/7/2027), 67142955(10/30/2027), 67142972(11/14/2027), 67143094(11/27/2027); AIQSGF8/00690103217094/66414809(3/16/2027), 66487805(5/11/2027), 66417072(3/22/2027), 66493141(5/18/2027), 66493138(5/12/2027), 66417073(3/23/2027), 66437580(3/28/2027);

Distribution pattern

Worldwide - US Nationwide distribution including in the states of TX, SC, CT, GA, VA, MO, NM, UT, NJ, CA, FL, PA, IN, TN, WA, KY, MD, WV, MI, MA, NC, MN, NY, AZ, AL, LA, CO, OK, HI, MS, IL, OH, NE, DC, KS, NV, WI, SD, IA, AR, ID, OR, WY, MT, RI, VT, DE, AK, NH, ND, ME, PR and the countries of Japan, Brazil, Colombia, Australia, New Zealand, Poland, Czech Republic, South Africa, Mauritius, Germany, Israel, Iran, Slovakia, Switzerland, Slovenia, Bulgaria, Cyprus, Saudi Arabia, United Arab Emirates (UAE), Kuwait, Malta, Bahrain, Qatar, Hungary, Morocco, Romania, Lebanon, Tunisia, Oman, Turkey, Austria, Belgium, Luxembourg, France, Netherlands, Italy, Spain, Canary Islands, Portugal, United Kingdom, Northern Ireland, Ireland, Denmark, Sweden, Iceland, Norway, Estonia, Finland, Greece, Chile, Puerto Rico, Canada.

device · product 2 of 3

Swan-Ganz Jr Catheter, Models: SGPT54, SGPT64P, SGPT755P

Z-2203-2026
Recall number
Z-2203-2026
Initiated
April 08, 2026
Classification
Class II
Status
Ongoing
Quantity
183

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection, medication loss, and/or blood loss.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection, medication loss, and/or blood loss.

Code information

Model-UDI-DI(Expiration): SGPT755P/00690103219388/65869018(6/24/2026), 66010501(9/23/2026), 67122784(10/28/2027); SGPT54/00690103219289/65956343(8/19/2026); SGPT64P/00690103219371

Distribution pattern

Worldwide - US Nationwide distribution including in the states of TX, SC, CT, GA, VA, MO, NM, UT, NJ, CA, FL, PA, IN, TN, WA, KY, MD, WV, MI, MA, NC, MN, NY, AZ, AL, LA, CO, OK, HI, MS, IL, OH, NE, DC, KS, NV, WI, SD, IA, AR, ID, OR, WY, MT, RI, VT, DE, AK, NH, ND, ME, PR and the countries of Japan, Brazil, Colombia, Australia, New Zealand, Poland, Czech Republic, South Africa, Mauritius, Germany, Israel, Iran, Slovakia, Switzerland, Slovenia, Bulgaria, Cyprus, Saudi Arabia, United Arab Emirates (UAE), Kuwait, Malta, Bahrain, Qatar, Hungary, Morocco, Romania, Lebanon, Tunisia, Oman, Turkey, Austria, Belgium, Luxembourg, France, Netherlands, Italy, Spain, Canary Islands, Portugal, United Kingdom, Northern Ireland, Ireland, Denmark, Sweden, Iceland, Norway, Estonia, Finland, Greece, Chile, Puerto Rico, Canada.

device · product 3 of 3

Swan-Ganz Pacing Catheter, Models: D200F7;

Z-2204-2026
Recall number
Z-2204-2026
Initiated
April 08, 2026
Classification
Class II
Status
Ongoing
Quantity
53

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection, medication loss, and/or blood loss.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection, medication loss, and/or blood loss.

Code information

Model-UDI-DI/Lot(Expiration): D200F7-00690103147315/66725358(7/2/2027)

Distribution pattern

Worldwide - US Nationwide distribution including in the states of TX, SC, CT, GA, VA, MO, NM, UT, NJ, CA, FL, PA, IN, TN, WA, KY, MD, WV, MI, MA, NC, MN, NY, AZ, AL, LA, CO, OK, HI, MS, IL, OH, NE, DC, KS, NV, WI, SD, IA, AR, ID, OR, WY, MT, RI, VT, DE, AK, NH, ND, ME, PR and the countries of Japan, Brazil, Colombia, Australia, New Zealand, Poland, Czech Republic, South Africa, Mauritius, Germany, Israel, Iran, Slovakia, Switzerland, Slovenia, Bulgaria, Cyprus, Saudi Arabia, United Arab Emirates (UAE), Kuwait, Malta, Bahrain, Qatar, Hungary, Morocco, Romania, Lebanon, Tunisia, Oman, Turkey, Austria, Belgium, Luxembourg, France, Netherlands, Italy, Spain, Canary Islands, Portugal, United Kingdom, Northern Ireland, Ireland, Denmark, Sweden, Iceland, Norway, Estonia, Finland, Greece, Chile, Puerto Rico, Canada.

Field note

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