State

Alabama product recalls

73,722 recalls have nationwide distribution and so reach Alabama. 6,377 additional recalls listed Alabama specifically in their distribution scope.

What the numbers show

Total: 6,377
Critical: 1,129
Severe: 1,604
Most recent: 2026-10-28

Of the 6,377 recalls naming Alabama we have scored against our rubric, 1,129 (18%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1,604 (25%) are Severe.

Which agencies issued them

These figures cover only the 6,377 recalls whose distribution notice names Alabama specifically. The 73,722 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

29451–29475 of 80099

HighFDA (Devices)·Z-0197-2021·2020-10-28
ICU Medical Recalls Smallbore Pressure Infusion Extension Sets Due to Seal Defect
ICU Medical is recalling specific lots of smallbore pressure infusion extension sets because a manufacturing defect may prevent the NanoClave from sealing properly.
Product
7" (18 cm) Appx 0.31 ml, Smallbore Pressure Infusion (400psig) Ext Set w/Remv MicroClave Clear, Clamp, NanoClave T-Connector (Purple Ring), Rotating Luer; unit per pouch, 50 multivac pouches per case.…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0207-2021·2020-10-28
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 from sealing properly.
Product
13 IN(33cm) APPX 1.0 ml, SMALLBORE SET, 4 MicroClave Clear, NanoClave T-Conn, Filter; 1 unit per pouch, 50 pouches per case. UDI:(01)10887709085210(17)250101(30)50(10)4572801; (01)10887709085227(17)250101(30)50(10)4589920; (01)10887709085227(17)250101(30)50(10)4572950. The…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0170-2021·2020-10-28
Smith & Nephew Recalls HEALICOIL Absorbable Suture Anchors for Seal Issues
Smith & Nephew is recalling HEALICOIL absorbable suture anchors because improper or incomplete packaging seals may breach the sterile barrier.
Product
HEALICOIL RG SA 5.5MM W/2 UB-BL CBR BL-- Absorbable Suture anchor Product Number: 72203706
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0277-2021·2020-10-28
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.
Product
7 IN(18 cm)APPX 1.2ml. EXT SET, NanoClave T-CONNECTOR, CLAMP, ROTATING LUER. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709075501(17)250101(30)50(10)4558474. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0279-2021·2020-10-28
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
10 IN (25cm) APPX 1.1ml, SMALLBORE EXT w/3-Port NanoClave Manifold, Check Valve. 1 unit per pouch, 50 pouches per case. UDI: (01)10887709083346(17)250201(30)50(10)4718652. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0210-2021·2020-10-28
ICU Medical Recalls NanoClave Sets Due to Potential Seal Defect
ICU Medical is recalling specific lots of NanoClave intravascular administration sets due to a potential manufacturing defect that may inhibit a proper seal.
Product
13 IN (33cm) APPX 0.96 ml, PENTAFUSE SMALLBORE SET, NanoClave, 3 MicroClave Clear. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709090245(17)250101(30)50(10)4557533; (01)10887709090245(17)250101(30)50(10)4572968. The Intravascular Administration Set is a single use…
Category
Medical Device
Distribution
Distributed nationwide
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