The Recall Desk

State

Massachusetts product recalls

72,940 recalls have nationwide distribution and so reach Massachusetts. 8,209 additional recalls listed Massachusetts specifically in their distribution scope.

What the numbers show

Total
8,209
Critical
1,171
Severe
2,013
Most recent
2026-09-09

Of the 8,209 recalls naming Massachusetts we have scored against our rubric, 1,171 (14%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2,013 (25%) are Severe.

These figures cover only the 8,209 recalls whose distribution notice names Massachusetts specifically. The 72,940 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

4726–4750 of 81149

  • HighFDA (Devices)·Z-0363-2026·2025-11-05

    ChemosafeLock bag spikes recalled over port weld separation risk

    ICU Medical is recalling 134,700 ChemosafeLock Bag Spikes because the port weld of the drug transfer device may separate or break during use and leak.

    Product
    ICU Medical ChemosafeLock Bag Spike REF: KL-BS001U3
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0348-2026·2025-11-05

    Closed vial spikes with skirt recalled over port weld separation risk

    ICU Medical is recalling 8,475 ChemoLock Closed Vial Spikes with Skirt because the port weld of the drug transfer device may separate or break during use and leak.

    Product
    ICU Medical ChemoLock Closed Vial Spike w/Skirt, 5 Units REF: CL-80S-5
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0340-2026·2025-11-05

    73 inch smallbore extension sets recalled over port weld separation risk

    ICU Medical is recalling 200 73-inch smallbore extension sets with ChemoLock port because the port weld of the drug transfer device may separate or break during use and leak.

    Product
    ICU Medical 73" (185 cm) Appx 2.5 ml, Ext Set, Smallbore w/ChemoLock Port, Clamp, ChemoLock w/Red Cap REF: CL4176
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0130-2026·2025-11-05

    Testosterone and triamcinolone 12.5 mg pellets recalled over metal particulate

    FarmaKeio Outsourcing is recalling 18,124 sterile Testosterone / Triamcinolone Acetonide 12.5MG/2.5MCG pellets over the potential presence of metal particulate matter.

    Product
    Testosterone / Triamcinolone Acetonide, 12.5MG/2.5MCG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0363-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0346-2026·2025-11-05

    ChemoLock closed vial spikes recalled over port weld separation risk

    ICU Medical is recalling 6,150 ChemoLock Closed Vial Spikes because the port weld of the drug transfer device may separate or break during use and leak.

    Product
    ICU Medical ChemoLock Closed Vial Spike REF: CL-80
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0136-2026·2025-11-05

    Testosterone and triamcinolone 100 mg pellets recalled over metal particulate matter

    FarmaKeio Outsourcing is recalling 103,444 sterile Testosterone / Triamcinolone Acetonide 100MG/20MCG pellets over the potential presence of metal particulate matter.

    Product
    Testosterone / Triamcinolone Acetonide Pellet (100MG/20MCG), 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0367-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0347-2026·2025-11-05

    ChemoLock vial spikes recalled because port weld may separate and leak

    ICU Medical is recalling 53,050 ChemoLock 20mm Vial Spikes because the port weld of the drug transfer device may separate or break during use and leak.

    Product
    ICU Medical ChemoLock Vial Spike, 20mm REF: CL-80S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0101-2026·2025-11-05

    Unit dose prazosin 1 mg cartons recalled over nitrosamine impurity

    Amerisource Health Services is recalling 1,970 unit dose cartons of Prazosin Hydrochloride Capsules 1 mg over N-nitroso Prazosin impurity C above the acceptable intake limit.

    Product
    PRAZOSIN HYDROCHLORIDE — PRAZOSIN HYDROCHLORIDE (PRAZOSIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0366-2026·2025-11-05

    Parathyroid hormone assay recalled over falsely depressed results at low range

    Siemens Healthcare Diagnostics is recalling 3,318 units of the IMMULITE 2000 Intact PTH assay over the potential for falsely depressed patient results at the low end of the assay range.

    Product
    Assay: IMMULITE 2000 Intact PTH; Test Code: iPT; Siemens Material Number (SMN): (1) 10381441, (2) 10381442; Catalog Number: (1) L2KPP2, (2) L2KPP6;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0409-2026·2025-11-05

    Dialysis connectivity software recalled because prescription changes may not reach cyclers

    Vantive is recalling the Sharesource Connectivity Platform for Homechoice Claria because a software defect may stop updated prescription settings from saving on the patient's cycler.

    Product
    Sharesource Connectivity Platform for Use with Homechoice Claria Product Code 5CGM01 software versions 7.13.3 (China), 8.13.2 (APAC and Korea), and 8.13.4 (US, EMEA, and LATAM)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0343-2026·2025-11-05

    Universal vented vial spikes recalled over port weld separation risk

    ICU Medical is recalling 16,850 ChemoLock Universal Vented Vial Spikes because the port weld of the drug transfer device may separate or break during use and leak.

    Product
    ICU Medical ChemoLock Universal Vented Vial Spike REF: CL-70
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0360-2026·2025-11-05

    Graduated adapter extension sets recalled over port weld separation risk

    ICU Medical is recalling 5,700 7.5-inch extension sets with a ChemoLock port and graduated adapter because the port weld may separate or break during use and leak.

    Product
    ICU Medical 7.5" (19 cm) Appx 1.5 ml, Ext Set w/ChemoLock" Port, Clamp, Graduated Adapter REF: CL3967
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0137-2026·2025-11-05

    Testosterone and triamcinolone 200 mg pellets recalled over metal particulate matter

    FarmaKeio Outsourcing is recalling 264,664 sterile Testosterone / Triamcinolone Acetonide 200MG/40MCG pellets over the potential presence of metal particulate matter.

    Product
    Testosterone / Triamcinolone Acetonide Pellet (200MG/40MCG), 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0364-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0322-2026·2025-11-05

    SyncAR navigation platform recalled over image layer misalignment in 2D fusion

    Surgical Theater is recalling 14 units of its SyncAR SNAP platform because a software anomaly may misalign secondary image layers against the primary layer.

    Product
    SyncAR Surgical Navigation Advanced Platform Patient Engagement (SyncAR SNAP), software version SNP.1.12.0, imaging processing radiological system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0361-2026·2025-11-05

    Six inch extension sets recalled because port weld may separate and leak

    ICU Medical is recalling 1,600 6-inch extension sets with MicroClave Clear and ChemoLock port because the port weld of the drug transfer device may separate or break during use and leak.

    Product
    ICU Medical 6" (15 cm) Ext Set w/MicroClave" Clear, ChemoLock" Port, Y-Connector, Rotating Luer REF: CL4118
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0384-2026·2025-11-05

    Coated and nude regular tampons recalled because product lacks 510k clearance

    Daye is recalling 3,074 packs of 9 Coated Regular and 9 Nude Regular Tampons because the product lacks 510(k) clearance.

    Product
    9 Coated Regular and 9 Nude Regular Tampons; Model Number: FG-TMP-REF09000900;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0147-2026·2025-11-05

    Lisdexamfetamine capsules recalled after failing dissolution at twelve month stability

    Sun Pharmaceutical Industries is recalling two lots of Lisdexamfetamine Dimesylate Capsules 40 mg after an out-of-specification dissolution result at the 12-month stability station.

    Product
    LISDEXAMFETAMINE DIMESYLATE — LISDEXAMFETAMINE DIMESYLATE (LISDEXAMFETAMINE DIMESYLATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0405-2026·2025-11-05

    Three month all in one bundles recalled for lacking 510k clearance

    Daye is recalling 3,074 packs of its Initiation 3 Month All in One Bundle because the product lacks 510(k) clearance.

    Product
    Initiation 3 Month All in One Bundle; Model Number: FG-BNDL-PC-MM-IBAIO;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0398-2026·2025-11-05

    Refill three month heavy flow bundles recalled for lacking 510k clearance

    Daye is recalling 3,074 packs of its Refill 3 Month Heavy Flow Bundle because the product lacks 510(k) clearance.

    Product
    Refill 3 Month Heavy Flow Bundle; Model Number: FG-BNDL-PC-MM-REFHF;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0392-2026·2025-11-05

    Refill regular and super tampon packs recalled for lacking 510k clearance

    Daye is recalling 3,074 packs of Refill 18 Coated Regular and 18 Coated Super Tampons because the product lacks 510(k) clearance.

    Product
    Refill 18 Coated Regular and 18 Coated Super Tampons; Model Number: FG-TMP-MM-REF18180000;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0394-2026·2025-11-05

    Refill coated and nude super tampons recalled for lacking 510k clearance

    Daye is recalling 3,074 packs of Refill 18 Coated Super and 18 Nude Super Tampons because the product lacks 510(k) clearance.

    Product
    Refill 18 Coated Super and 18 Nude Super Tampons; Model Number: FG-TMP-MM-REF00180018;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0379-2026·2025-11-05

    Coated and nude super tampon packs recalled for lacking 510k clearance

    Daye is recalling 3,074 packs of 9 Coated Super Tampons and 9 Nude Super Tampons because the product lacks 510(k) clearance.

    Product
    9 Coated Super Tampons and 9 Nude Super Tampons; Model Number: FG-TMP-RET00090009;
    Category
    Medical Device
    Distribution
    Distributed nationwide