DC recalls
3295 federal recalls on file affecting DC - 218 DC-specific plus 3077 nationwide. Sourced from CPSC, FDA, USDA, and NHTSA.
- 2025-11-05FDA-DeviceDayeClass IINationwideHeavy Flow Bundle; Model Number: FG-BNDL-PC-REFHF;
Product lacks 510(k) clearance.
- 2025-11-05FDA-DeviceDayeClass IINationwideRegular Flow Bundle; Model Number: FG-BNDL-PC-REFRF;
Product lacks 510(k) clearance.
- 2025-11-05FDA-DeviceDayeClass IINationwideAll in One Bundle; Model Number: FG-BNDL-PC-REFAIO;
Product lacks 510(k) clearance.
- 2025-11-05FDA-DeviceDayeClass IINationwideTrial Tampon Box; Model Number: FG-TMP-REF04050504;
Product lacks 510(k) clearance.
- 2025-11-05FDA-DeviceDayeClass IINationwide9 Coated Super and 9 Nude Super Tampons; Model Number: FG-TMP-REF00090009;
Product lacks 510(k) clearance.
- 2025-11-05FDA-DeviceDayeClass IINationwide9 Coated Regular and 9 Nude Regular Tampons; Model Number: FG-TMP-REF09000900;
Product lacks 510(k) clearance.
- 2025-11-05FDA-DeviceDayeClass IINationwide9 Coated Regular and 9 Coated Super Tampons; Model Number: FG-TMP-REF09090000;
Product lacks 510(k) clearance.
- 2025-11-05FDA-DeviceDayeClass IINationwide18 Coated Super Tampons; Model Number: FG-TMP-REF00180000;
Product lacks 510(k) clearance.
- 2025-11-05FDA-DeviceDayeClass IINationwide18 Coated Regular Tampons; Model Number: FG-TMP-REF18000000;
Product lacks 510(k) clearance.
- 2025-11-05FDA-DeviceDayeClass IINationwide9 Coated Regular Tampons and 9 Nude Regular Tampons; Model Number: FG-TMP-RET09000900;
Product lacks 510(k) clearance.
- 2025-11-05FDA-DeviceDayeClass IINationwide9 Coated Super Tampons and 9 Nude Super Tampons; Model Number: FG-TMP-RET00090009;
Product lacks 510(k) clearance.
- 2025-11-05FDA-DeviceFresenius KabiClass IINationwideIvenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
Potential issue that can cause the device to register "phantom" touches in the lower-left corner of the touchscreen during operation.
- 2025-11-05FDA-DeviceAnatomy Supply PartnersClass IINationwideSAFE-T-FILL Micro Capillary Blood Collection, 125 ¿L Prepared with Dipotassium EDTA Purple, Model: 07 6011; SAFE-T-FILL Micro Capillary Blood Collection, 125 ¿L Prepared with Dipotassium EDTA Self-sealing Cap, Purple, Model: 07 6013; SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L Prepared with Dipotassium EDTA Purple, Model: 07 7051; SAFE-T-FILL Micro Capillary Blood Collection, 150 ¿L Prepared with Dipotassium EDTA Purple, Model: 07 7052; SAFE-T-FILL Micro Capillary Blood Collection,
All RAM SAFE-T-FILL Micro Capillary Blood Collection tubes manufactured between July 31, 2023 to February 28, 2025 cause false positive results when used with Magellan Diagnostics LeadCare Testing Systems. False positive lead results may cause delayed results and additional unnecessary testing.
- 2025-11-05FDA-DeviceCareFusionClass IINationwideAll Serial Numbers/BD Pyxis CII Safe ES Tower Main, REF: 1116-00
Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.
- 2025-11-05FDA-DeviceCareFusionClass IINationwideBD Pyxis Pro MedStation Main, REF: 1155-00
Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.
- 2025-11-05FDA-DeviceCareFusionClass IINationwideVarious models of BD Pyxis Pro 7-Drawer Auxiliary, Reference numbers: 1149-00 and 1152-00
Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.
- 2025-11-05FDA-DeviceCareFusionClass IINationwideVarious models of BD Pyxis MedFlex, Reference numbers: 1119-00 1139-00 139038-01 139039-01 139040-01 139041-01 139043-01 139044-01 139045-01 139046-01 139049-01 139051-01 139052-01 139053-01 139054-01 139055-01 139056-01 139058-01 139059-01 139060-01 139061-01 139064-01 139065-01 139066-01 139067-01 139068-01 139069-01 139070-01 139071-01 139072-01 139164-01 139165-01 300
Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.
- 2025-11-05FDA-DeviceCareFusionClass IINationwideVarious models of BD Pyxis Medbank: Reference numbers: 1137-00 1145-00 1146-00 1147-00 1148-00 138902-01 138903-01 138905-01 138906-01 138907-01 138908-01 138909-01 138910-01 138911-01 138912-01 138913-01 138914-01 138915-01 138916-01 138917-01 138918-01 138919-01 138920-01 138921-01 138922-01 138923-01 138924-01 138926-01 138927-01 138928-01 138929-01 138930-01 138931-01 138932-01 138933-01 138934-01 138936-01 138937-01 138938-01 138939-01 138940-01 13
Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.
- 2025-11-05FDA-DeviceSiemensClass IINationwideAssay: IMMULITE 2000 Intact PTH; Test Code: iPT; Siemens Material Number (SMN): (1) 10381441, (2) 10381442; Catalog Number: (1) L2KPP2, (2) L2KPP6;
The potential for falsely depressed Intact PTH patient results at the low end of the assay range, less than or equal to 50 pg/mL (less than or equal to 5.3 pmol/L), when using specific lots identified by the firm on the IMMULITE 2000/IMMULITE 2000 XPi systems. The bias is observed in both serum and plasma samples.
- 2025-11-05FDA-DeviceICU MedicalClass IINationwideICU Medical ChemosafeLock Vial Adapter REFs: KL-VA001U3 KL-VA002U3 KL-VA131U3 KL-VA201U3 KL-VA202U3 KL-VA321U3
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
- 2025-11-05FDA-DeviceICU MedicalClass IINationwideICU Medical ChemosafeLock Connecter REF: KL-FNU3
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
- 2025-11-05FDA-DeviceICU MedicalClass IINationwideICU Medical ChemosafeLock Bag Spike REF: KL-BS001U3
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
- 2025-11-05FDA-DeviceICU MedicalClass IINationwideICU Medical Oncology Kit w/2 ChemoLock", 13mm Closed Vial Spike w/ChemoLock" Port, ChemoLock" Bag Spike, Ext Set w/ChemoLock" Port, Clamp, Graduated Adapter REF: CL4188
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
- 2025-11-05FDA-DeviceICU MedicalClass IINationwideICU Medical 6" (15 cm) Ext Set w/MicroClave" Clear, ChemoLock" Port, Y-Connector, Rotating Luer REF: CL4118
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
- 2025-11-05FDA-DeviceICU MedicalClass IINationwideICU Medical 7.5" (19 cm) Appx 1.5 ml, Ext Set w/ChemoLock" Port, Clamp, Graduated Adapter REF: CL3967
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
- 2025-11-05FDA-DeviceICU MedicalClass IINationwideICU Medical 31" (79 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros", Purple Cap, Hanger REF: CL3951
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
- 2025-11-05FDA-DeviceICU MedicalClass IINationwideICU Medical 8" (20 cm) Ext Set w/MicroClave Clear, ChemoLock Port, Y-Connector, Rotating Luer, REF: CL-3950
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
- 2025-11-05FDA-DeviceICU MedicalClass IINationwideICU Medical ChemoLock Port w/Spiros, Red Cap REF: CL-35
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
- 2025-11-05FDA-DeviceICU MedicalClass IINationwideICU Medical Syringe Transfer Set w/MicroClave, ChemoLock Port REF: CL-34
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
- 2025-11-05FDA-DeviceICU MedicalClass IINationwideICU Medical ChemoLock w/Mini Bag Spike ¿ REF: C-17
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
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