State

Montana product recalls

73,596 recalls have nationwide distribution and so reach Montana. 3,572 additional recalls listed Montana specifically in their distribution scope.

What the numbers show

Total: 3,572
Critical: 688
Severe: 953
Most recent: 2026-10-14

Of the 3,572 recalls naming Montana we have scored against our rubric, 688 (19%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 953 (27%) are Severe.

Which agencies issued them

These figures cover only the 3,572 recalls whose distribution notice names Montana specifically. The 73,596 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

28251–28275 of 77168

HighFDA (Devices)·Z-0236-2021·2020-10-28
ICU Medical Recalls NanoClave Intravascular Administration Sets Due to Seal Defect
ICU Medical is recalling specific lots of NanoClave intravascular administration sets because a manufacturing defect may prevent a proper seal with the spike.
Product
7 IN (18cm) APPX 1.2ml Ext Set w/6-Port NanoClave Manifold, Check Valve. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709067582(17)241201(30)50(10)4548270; (01)10887709067582(17)250101(30)50(10)4558614; (01)10887709067582(17)250201(30)50(10)4733732…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0144-2021·2020-10-28
Smith & Nephew Recalls Ultra Fast-Fix Absorbable Suture Anchors
Smith & Nephew is recalling Ultra Fast-Fix AB Assembly curved absorbable suture anchors due to improper or incomplete packaging seals that may breach the sterile barrier.
Product
ULTRA FAST-FIX AB ASSEMBLY - CURVED-Absorbable Suture anchors Product Number: 72201494
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0164-2021·2020-10-28
Smith & Nephew Recalls TWINFIX ULTRA HA Absorbable Suture Anchors
Smith & Nephew is recalling TWINFIX ULTRA HA absorbable suture anchors due to improper or incomplete packaging seals that may breach the sterile barrier.
Product
TWINFIX ULTRA HA 6.5 W/2 UB (BLUE & BLK)- Absorbable Suture anchor Product Number: 72202631
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0162-2021·2020-10-28
Smith & Nephew Recalls TWINFIX ULTRA HA Absorbable Suture Anchors
Smith & Nephew is recalling TWINFIX ULTRA HA absorbable suture anchors due to improper or incomplete packaging seals that may breach the sterile barrier.
Product
TWINFIX ULTRA HA 4.5 W/2 UB BLUE & BLK- Absorbable Suture anchor Product Number: 72202624
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0240-2021·2020-10-28
ICU Medical Recalls NanoClave Intravascular Administration Sets Due to Seal Defect
ICU Medical is recalling specific lots of NanoClave intravascular administration sets because a manufacturing defect may prevent a proper seal with the spike.
Product
11 IN(28cm)APPX 0.97ml,SMALLBORE SET,NanoClave,6-PORT NanoClave MANIFOLD,BCV.1 unit per pouch, 50 pouches per case. UDI:(01)10887709088354(17)250101(30)50(10)4557643. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0218-2021·2020-10-28
ICU Medical Recalls Intravascular Administration Sets Due to Seal Defect
ICU Medical is recalling specific lots of intravascular administration sets because a manufacturing defect may prevent the NanoClave spike from sealing properly.
Product
126" (320 cm) 16.4 ml, 15 Drop Primary Set w/2 MicroClave Clear, Remv 2 Gang 4-Way NanoClave Stopcock, Rotating Luer, 1 Ext; 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709070902(17)250201(30)50(10)4724881. The Intravascular Administration Set is a single…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0206-2021·2020-10-28
ICU Medical Recalls Smallbore Trifuse Extension Sets Due to Seal Defect
ICU Medical is recalling specific lots of Smallbore Trifuse Extension Sets because a manufacturing defect may prevent the NanoClave from sealing properly.
Product
60" (152 cm) Appx 1.0 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear, NanoClave, 0.2 Micron Filter, 1.2 Micron Filter, 4 Clamps (2 Blue, Yellow, White), Rotating Luer; 1 unit per pouch, 50 multivac pouches per case UDI:(01)10887709083889(17)241201(30)50(10)4514845…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0191-2021·2020-10-28
ICU Medical Recalls Smallbore Bifuse Extension Sets Due to Seal Defect
ICU Medical is recalling specific lots of smallbore bifuse extension sets because a manufacturing defect may prevent a proper seal, potentially affecting fluid administration.
Product
5" (13 cm) Appx 0.39 ml, Smallbore Bifuse Ext Set w/NanoClave T-Connector, 2 Clamps, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709053028(17)250101(30)50(10)4603262. The Intravascular Administration Set is a single use, sterile, non-pyrogenic…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0265-2021·2020-10-28
ICU Medical Recalls Smallbore Extension Sets Due to Seal Defect
ICU Medical is recalling specific lots of smallbore extension sets because a manufacturing defect may prevent the NanoClave from sealing properly.
Product
7" (18 cm) Appx 0.29 ml, Smallbore Ext Set w/MicroClave Clear, NanoClave, Clamp, Rotating Luer. 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10840619066014(17)250201(30)50(10)4718521;(01)10840619066014(17)250201(30)50(10)4735100. Administration sets and their…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0242-2021·2020-10-28
ICU Medical Recalls NanoClave Intravascular Administration Sets Due to Seal Defect
ICU Medical is recalling specific lots of NanoClave intravascular administration sets because a manufacturing defect may prevent a proper seal with the spike.
Product
11 IN (28cm) APPX 1.5ml EXT SET NanoClave, 6-Port NanoClave Manifold . 1 unit per pouch, 50 pouches per case. UDI:¿(01)10887709098937(17)241201(30)50(10)4493669;(01)10887709098937(17)250101(30)50(10)4558624. The Intravascular Administration Set is a single use, sterile…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0138-2021·2020-10-28
Smith & Nephew Recalls TWINFIX Suture Anchors Due to Seal Defects
Smith & Nephew is recalling TWINFIX 5.0MM AB Suture Anchors because improper or incomplete packaging seals may breach the sterile barrier.
Product
TWINFIX 5.0MM AB SUTURE ANCHOR-Absorbable Suture anchors Product Number: 7210711
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0140-2021·2020-10-28
Smith & Nephew Recalls TWINFIX Suture Anchors Due to Packaging Seal Issues
Smith & Nephew is recalling TWINFIX 6.5mm suture anchors because improper packaging seals may breach the sterile barrier.
Product
TWINFIX 6.5MM AB PRELOADED SUTURE ANCHOR- Absorbable Suture anchors Product Number: 7210713
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0171-2021·2020-10-28
Smith & Nephew Recalls HEALICOIL Absorbable Suture Anchors Due to Seal Issues
Smith & Nephew is recalling HEALICOIL absorbable suture anchors because improper or incomplete pouch seals may breach the sterile barrier.
Product
HEALICOIL RG SA 5.5MM W/3 UB-BL CB BL BK- Absorbable Suture anchor Product Number: 72203707
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0235-2021·2020-10-28
ICU Medical Recalls NanoClave Intravascular Administration Sets Due to Seal Defect
ICU Medical is recalling specific lots of NanoClave intravascular administration sets because a manufacturing defect may prevent a proper seal with the spike.
Product
10 IN (25cm) APPX 1.5ml EXT w/6-Port NanoClave Manifold, Check Valve. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709067322(17)250101(30)50(10)4565730; (01)10887709067322(17)250201(30)50(10)4713953; (01)10887709067322(17)250201(30)50(10)4730099…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0209-2021·2020-10-28
ICU Medical Recalls Smallbore Bifuse Extension Sets Due to Seal Defect
ICU Medical is recalling specific lots of Smallbore Bifuse Extension Sets because a manufacturing defect may prevent the NanoClave spike from sealing properly.
Product
9.5" (24 cm) 0.53 ml, Smallbore Bifuse Ext Set w/NanoClave, 3 Clamps, Rotating Luer;1 unit per pouch, 50 multivac pouches per case. UDI: ¿(01)10887709090238(17)250101(30)50(10)4572966; (01)10887709090238(17)250101(30)50(10)4557530. The Intravascular Administration Set is a…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0115-2021·2020-10-28
Siemens Recalls HER-2/neu Assay Kits Due to Inaccurate Results
Siemens Healthcare Diagnostics is recalling specific HER-2/neu assay kits and calibrators because the Upper Limit of Normal was not achieved, potentially causing false positive or negative results.
Product
Atellica IM HER-2/neu (H2n) assay, 50 Test Kit, Catalog No. SMN 10995591, UDI Codes: (01)00630414599151(10)98034139(17)20210130 and (01)00630414599151(10)32478139(17)20210130 Atellica IM HER-2/neu (H2n) calibrator, 2 Pack, Catalog No. SMN 10995592, UDI Code…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0270-2021·2020-10-28
ICU Medical Recalls NanoClave Administration Sets Due to Manufacturing Defect
ICU Medical is recalling specific lots of NanoClave administration sets due to a potential manufacturing defect on the internal surface that may inhibit a proper seal.
Product
165cm (65 IN)APPX 2.2ml, PUR EXT SET, 3-PORT NanoClave MANIFOLD, BCV, NanoClave. 1 unit per pouch, 50 pouches per case. UDI:(01)10840619062761(17)241201(30)50(10)4553703. Administration sets and their accessories are single use, pre-sterilized devices that provide access for…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0199-2021·2020-10-28
ICU Medical Recalls NanoClave Intravascular Administration Sets Due to Seal Defect
ICU Medical is recalling specific lots of NanoClave intravascular administration sets due to a manufacturing defect that may prevent a proper seal.
Product
9.5 IN (24cm)APPX 1.1ml SMALLBORE TRIFUSE SET,3 MicroClave CLEAR, NanoClave, 3 CHECK VALVES; 1 unit per pouch, 50 pouches per case. UDI:(01)10887709069340(17)250101(30)50(10)4558471. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0167-2021·2020-10-28
Smith & Nephew Recalls HEALICOIL Absorbable Suture Anchors Due to Seal Defects
Smith & Nephew is recalling HEALICOIL absorbable suture anchors because improper or incomplete packaging seals may breach the sterile barrier.
Product
HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BL- Absorbable Suture anchor Product Number: 72203697
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0136-2021·2020-10-28
Smith & Nephew Recalls TWINFIX Suture Anchors Due to Seal Issues
Smith & Nephew is recalling TWINFIX 5.0mm suture anchors because improper packaging seals may breach the sterile barrier.
Product
TWINFIX 5.0MM AB SUTURE ANCHOR WITH TWO Absorbable Suture anchors Product Number: 7210309
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0142-2021·2020-10-28
Smith & Nephew Recalls TWINFIX AB 5.0 Suture Anchors Due to Seal Issues
Smith & Nephew is recalling TWINFIX AB 5.0 Suture Anchors because improper or incomplete packaging seals may breach the sterile barrier.
Product
TWINFIX AB 5.0 SUTR ANCHR W/2 38 DURAB-Absorbable Suture anchors Product Number: 72200785
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0145-2021·2020-10-28
Smith & Nephew Recalls Ultra Fast-Fix Absorbable Suture Anchors
Smith & Nephew is recalling Ultra Fast-Fix AB Assembly absorbable suture anchors due to improper or incomplete packaging seals that may breach the sterile barrier.
Product
ULTRA FAST-FIX AB ASSEMBLY-REVERSE CURVE-Absorbable Suture anchor Product Number: 72201495
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0175-2021·2020-10-28
Smith & Nephew Recalls Microraptor RegenSorb Suture Anchors for Seal Issues
Smith & Nephew is recalling Microraptor RegenSorb Suture Anchors because improper or incomplete pouch seals may breach the sterile barrier.
Product
MICRORAPTOR REGENESORB SUTURE ANCHOR- Absorbable Suture anchor Product Number: 72204984
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0125-2021·2020-10-28
BD Nexiva Closed IV Catheter System Recalled for Dull Needles
Becton Dickinson is recalling 12,020 units of BD Nexiva Closed IV Catheter Systems due to dull needles that may delay medical treatment.
Product
BD Nexiva Closed IV Catheter System Dual Port (20 GA 1.75 IN) Catalog (Ref) No. 383538 BD Nexiva closed IV catheter systems are intended to be inserted into a patient s vascular system for short term use to sample blood, monitor blood pressure, or administer fluids.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0161-2021·2020-10-28
Smith & Nephew Recalls TWINFIX ULTRA Suture Anchors Due to Seal Issues
Smith & Nephew is recalling TWINFIX ULTRA PLLA HA 6.5MM suture anchors because improper or incomplete packaging seals may breach the sterile barrier.
Product
TWINFIX ULTRA PLLA HA 6.5MM W/ NEEDLES- Absorbable Suture anchor Product Number: 72202620
Category
Medical Device
Distribution
Distributed nationwide