| Ms. Stephanie Wasielewski 800-323-6305 |
| 100 Chaddick Dr |
| 41815 |
| Wheeling |
| Part #10450, Catalog # SA-500/US, lot number 16963 |
| Nationwide and internationally to Japan, Chile and Switzerland |
| 2005-09-13 |
| 2005-10-04 |
| Z-0001-2007 | Consignees were notified by letter on 05/31/2006 | 801-328-9300 | 384 Wright Brothers Dr | 46524 | Salt Lake City | ALL LOT NUMBERS -GE Part number 1006385 or 1006385-NAV | Nationwide, including one VA facility in PA. No military distribution. Foreign distribution to Canada, China, Italy, Japan, Spain. | 2006-05-31 | 2006-10-03 |
| Z-0001-2008 | Bio-logic sent a Safety Alert letters dated 7/26/07 to the affected customers, warning them that using the pole to transport the cart may cause the weld at the base of the pole to weaken, causing it t... | Customer Support 800-332-3114 | 1 Bio Logic Plaza | 53825 | Mundelein | Pole assembly 580-VIDPOL and 585-CYBPSM, used with Models 580-IPCART and 580-PNCART - the cart component of the Ceegraph/Sleepscan Netlink with Video. There are no serial numbers on the pole assembly... | Worldwide Distribution -- USA and China, Egypt, Hong Kong, Israel, Malaysia and Saudi Arabia | 2007-07-26 | 2007-11-03 |
| Z-0001-2009 | A letter was issued to customers prior to the release of the field correction during June 2008. The system software will be updated to correct the non-compliances. For information or support concern... | 425-487-7602 | 22100 Bothell Everett Hwy | 74807 | Bothell | Serial numbers: 400562, 400563, 400626, NDH009EI, NDH011EI, NDH012EI, NDH013EI, NDH016EI, NDH017EI, NDH025EI, NDH026EI, NDH027EI, NDH028EI, NDH030EI, NDH031EI, NDH034EI, NDHR080001, NDHR080002 and ND... | Nationwide Distribution --- USA including states of CO, FL, GA, IL, KY, NC, TN and TX. | 2008-04-10 | 2009-01-26 |
| Z-0001-2010 | The firm issued an Urgent Voluntary Field Removal Notice letter on 09/22/2009 to its consignees, asking them to inspect their stocks; remove affected product and place in quarantine for return to Penu... | 510-748-3200 | 1351 Harbor Bay Pkwy | 85486 | Alameda | Lot numbers F13733, F13751, F13773, F13799, F13817, F13826, F13856, F13865, F13880, F13899, F13934, F13960, F13970, F13971, F13980, F13997, F14007, F14028, F14045, F14046, F14047, F14048, F14102, F141... | Worldwide Distribution -- USA, Canada, Hong Kong, Chile, the UK, Denmark, Norway, Sweden, Finland, Netherlands, Germany, Switzerland, Austria, and Spain. | 2009-09-22 | 2009-10-05 |
| Z-0001-2011 | Baxter Healthcare Corporation sent "Urgent Product Recall" letters dated August 4, 2010 to all Colleague Infusion Pump customers in the U.S., to the attention of the Hospital Administrator, Chief Exec... | Center for One Baxter 800-422-9837 | 120 & Wilson Rd | 93646 | Round Lake | All product numbers and all serial numbers sold in the U.S. | Nationwide, including Puerto Rico | 2010-08-04 | 2010-10-12 |
| Z-0001-2012 | Medtronic sent an "Urgent Product Safety Notice" to all affected customers dated Jan 20, 2011. The letter included affected product and updated instructions for use. On-site training was given for th... | 720-890-3409 | 826 Coal Creek Circle | 97591 | Louisville | Part #962009S. Lot Number 090106. | Worldwide Distribution: Nationwide distribution including the states of CO and WI; and the country of South Korea | 2011-01-20 | 2011-10-03 |
| Z-0001-2013 | SYNTHES sent an Urgent Medical Device Labeling Correction letter dated June 18, 2012. The letter identified the product, the problem, and the action to be taken by the customer. Customers were ins... | Linda Hendrixson 610-719-5377 | 1302 Wrights Ln E | 111690 | West Chester | Minimally Invasive Redution Screw System (MIRS) - Labeling number J11031-A | Nationwide Distribution including CA, FL, ID, IN, MD, MI, MT, LA, NY, OH, PA, TX, VA and WA. | 2012-06-18 | 2012-10-01 |
| Z-0001-2014 | MAQUET sent an "Urgent Medical Device Recall" letter and "Field Recall Response Forms" dated September 20, 2013 to customers via Federal Express. The notification identifies the affected product; inf... | Mr. Mark Dinger 973-709-7691 | 45 Barbour Pond Dr | 122158 | Wayne | ULTIMA OPCAB System Part Nos. OM-2003S (LOT #25052176) and OM-2001D (LOT #25052200). | USA Nationwide Distribution in the states of: Florida, Maryland, New Jersey, New York and Texas. | 2013-09-20 | 2013-10-01 |
| Z-0001-2015 | The firm, Philips Healthcare, sent an "URGENT- Medical Device Recall" letter dated June 17, 2014, to its customers informing them of the product, problem and actions taken. The firm informed the custo... | Debra Levasseur 407-275-3220 Ext. 171 | 12151 Research Pkwy | 129828 | Orlando | Model 866120 with the following lots #'s: US33600006, US33600007, US33600011, US33600012 and US33600013 | Worldwide Distribution: US distribution in state of: CA and countries of: Poland, Singapore, and Sweden. | 2014-09-08 | 2014-10-01 |
| Z-0001-2016 | The firm, US Endoscopy, sent an "URGENT: HISTOLOCK" RESECTION DEVICE RECALL" letter and response form to their customers on July 14, 2015. The letter described the product, problem and action to be ta... | Mrs. Kia (NMI) Pennington 800-769-8226 | 5976 Heisley Rd | 139535 | Mentor | M/N: 00711117; Lot #: 1505956 | US Distribution to states of: AL, AR, CA, IL, IN, MS, OH, OK & TN. | 2015-07-14 | 2015-10-01 |
| Z-0001-2017 | Terumo (Planned Action) plans to execute the following steps as part of the correction activity: Notify all customers of the potential that a cuvette may disengage from the circuit (probe) leading to... | 410-392-7277 | 125 Blue Ball Rd | 149395 | Elkton | 6912 , 6913Â 6914, 6932, 6933Â 6934, 6922, 6923Â 6924, CV-6912, CV-6913, CV-6914Â Cardiovascular Procedure Kits- Various | Worldwide Distribution - USA (nationwide) Distribution. | 2015-12-11 |
| Z-0001-2018 | Zeiss sent a Field Safety Corrective Action letter dated August 30. 2017, to all affected customers via FedEx. Recall letters were issued by the U.S. Agent on behalf of the /recalling firm on 8/30/20... | 158631 | Intrabeam ser. #6402501246, Ion chamber ser. #SN001254; Intrabeam ser. #6402501241, Ion chamber ser. #SN001745; Intrabeam ser. #6402100932, Ion chamber ser. #SN001994; Intrabeam ser. #6402100958, Ion ... | Nationwide Distribution including AZ, CA, CT, DC, FL, GA, OH, and PA. | 2017-08-30 |
| Z-0001-2019 | The Field Safety Notice (FSN) sent to risk managers on 06/13/2018 asks customers to inspect inventory, locate and quarantine affected, unused Journey BCS Knee CoCr Femoral Components and JOURNEY BCS O... | 901-396-2121 | 1450 E Brooks Rd | 165169 | Memphis | All lots | Worldwide distribution, including US nationwide and Puerto Rico, Austria, United Arab Emirates, Australia, Belgium, Canada, China, Switzerland, Germany, Denmark, Finland, France, Great Britain, India... | 2018-06-13 | 2018-10-01 |
| Z-0001-2020 | The Metrix Company notified the direct account (distributors) by telephone on 09/21/2019. The firm asked if the consignees received any complaints of leaking during the divider rod removal and return... | Dave Wagner 800-752-3148 | 4400 Chavenelle Rd | 175552 | Dubuque | Lot Numbers:Â 66615-A3539, 66615-A5098 | US Nationwide distribution including the states of PA, MA, IL CA. | 2018-09-21 |
| Z-0001-2021 | Urgent Medical Device Recall notification letters dated 8/12/20 were sent to customers. Required Actions: 1.Please immediately quarantine and discontinue use of affected item codes with associated lo... | LP 60 Middletown Ave | 183095 | North Haven | Lot Numbers: Â T0A108XÂ T7H003XÂ T8D008XÂ T8K108XÂ T9G060XÂ T0E051XÂ T7L023XÂ T8H047X Â T8M079XÂ T7G003XÂ T8D007XÂ T8K047XÂ T9F132X | Worldwide distribution - US Nationwide and Global Distribution. | 2020-08-12 |
| Z-0001-2022 | Potomac River Group (PRG) sent communications to the purchasers of the affected units that were locked in the eye safe mode and distributed without the keys. PRG expects to offer all affected purchas... | Frank Frysiek 703-771-3003 | 19775 Belmont Executive Plz | 189418 | Ashburn | RAPTAR G02 (Wilcox Part #57200G02) | US Nationwide | 2021-04-21 |
| Z-0001-2023 | On 08/30/2022, Jiangsu Well Biotech Co. Ltd, notified its U.S. Distributor, DIVOC Diagnostics LLC via email with an "IMPORTANT!!! Recall Notice" and followed up with an "URGENT: MEDICAL DEVICE RECALL"... | 9 Changyang Rd | 195700 | West Changzhou | Catalog Number: CO-02 UDI-DI Code: No UDI Codes provided Lot Numbers: 202107192, 202108231, 202109231, 202111082, 202110111, 202201102, | U.S.: CA (pending firm supplying additional distribution locations/consignee list). O.U.S.: N/A | 2022-08-09 | 2022-10-08 |
| Z-0001-2024 | Teleflex/Arrow International issue an URGENT MEDICAL DEVICE RECALL notice on 08/10/2023 by FedEx 2nd day mail. The letter explained the problem, risk to patient, and requested the following actions: ... | 3015 Carrington Mill Blvd | 203280 | Morrisville | Batch/Lot number 33F23B0781 | US | 2023-08-10 | 2023-10-05 |
| Z-0001-2025 | On 7/31/24, Safety Alert notices were sent to customers, healthcare professionals, distributors who were told the following: 1) Always pay attention to alerts and alarms displayed on your pump. - Low... | Medtronic 24-Hr Technical Support 800-646-4633 | 18000 Devonshire St | 209491 | Northridge | REF/UDI-DI(GTIN): MMT-1714/00643169782396, 00763000253059; MMT-1715/00643169873841, 00763000190446, 00643169752726, 643169873834, 00763000317591, 00763000316655, 763000367053, 763000316655, 7630003... | US: CT, MI, PA, WA, IA, NY, ND, AZ, TX, OH, NC, AL, MN, IN, NJ, KY, UT, CA, FL, VA, MS, NM, NV, TN, GA, MA, NH, OK, VT, IL, ME, SC, LA, WY, RI, SD, KS, WI, MD, CO, DE, AR, AK, ID, MO, NE, WV, MT, OR, ... | 2024-07-31 | 2024-10-03 |
| Z-0001-2026 | On September 3, 2025, URGENT MEDICAL DEVICE CORRECTION letters were sent to customers. Actions to be taken: 1. Circulate this Urgent Medical Device Correction letter to all users of the system so that... | 215805 | Model Number: 722003; UDI-DI: N/A; Serial Numbers: 19, 21; | Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria... | 2025-09-03 | 2025-10-01 |
| Z-0002-04 | The firm notified territory managers by telephone on August 20, 2003 to hold all consigned devices for return. | Mary Edwards 480-303-2640 | 1625 W 3rd St | 29801 | Tempe | Models:Â Â XT75410, XT100410, XT120410 | OH, AL, MS, LA, VA | 2003-08-20 | 2003-10-15 |
| Z-0002-05 | Software problem, device may give overestimated platelet results. | T.M. Phillips 800-874-6218 Ext. 233 | 34 Bunsen | 34618 | Irvine | Part Numbers:Â Pentra 80 P8000000NUA10 | Nationwide | 2004-08-13 | 2004-10-05 |
Recall Number | Action | Additional Info Contact | Address Line 1 | CFRES ID | City | Code Info | Distribution Pattern | Event Date Initiated | Event Date Posted | Event Date Terminated | K Numbers | Postal Code | Product Code | Product Description | Product Quantity | Reason for Recall | Recall Status | Recalling Firm | RES Event Number | Root Cause Description | State |
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