Alcon Patient Care Kits Product Usage: A Patient Care Kit is an assemblage of single-use medical devices and accessories designed by medical professionals for specific procedures. The Patient Care kits are configured with customer-specific components

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    SPCK50319 SPCK50317 SPCK50304 SPCK50277 SPCK50263 SPCK50262 SPCK50244 SPCK50241 SPCK50233 SPCK50229 SPCK50227 SPCK50224 SPCK50223 SPCK50221 SPCK50218 SPCK50208 SPCK50207 SPCK50205 SPCK50203 SPCK50202 SPCK50198 SPCK50196 SPCK50193 SPCK50192 SPCK50187 SPCK50182 SPCK50180 SPCK50177 SPCK50176 SPCK50174 SPCK50172 SPCK50171 SPCK50168 SPCK50164 SPCK50162 SPCK50155 SPCK50149 SPCK50148 SPCK50142 SPCK50141 SPCK50135 SPCK50134 SPCK50129 SPCK50128 SPCK50126 SPCK50119 SPCK50115 SPCK50113 SPCK50112 SPCK50107 SPCK50103 SPCK50102 SPCK50100 SPCK50099 SPCK50097 SPCK50096 SPCK50094 SPCK50091 SPCK50083 SPCK50075 SPCK50073 SPCK50070 SPCK50065 SPCK50063 SPCK50059 SPCK50053 SPCK50048 SPCK50044 SPCK50031 SPCK50030 SPCK50022 SPCK50021 SPCK50013 SPCK50004 SPCK43027 SPCK42997 SPCK42948 SPCK42836 SPCK42779 SPCK42721 SPCK42701A SPCK42610 SPCK42604 SPCK42593 SPCK42548 SPCK42543 SPCK42504 SPCK42496 SPCK42491 SPCK42448A SPCK42425 SPCK42065A SPCK41975 SPCK41932A SPCK41916C SPCK41895A SPCK41877A SPCK41842 SPCK41816A SPCK41734 SPCK41712A SPCK41570A SPCK41313A SPCK41304 SPCK41102A SPCK41018 SPCK40978 SPCK40945 SPCK40846A SPCK40759A SPCK40647A SPCK40644A SPCK40585 SPCK40572B SPCK40449 SPCK40401A SPCK40288B SPCK40170B SPCK40161 SPCK40157B SPCK40105 SPCK40102B SPCK40096B SPCK02117
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Alcon Research, Ltd.
Reason for Recall:
Alcon is initiating a Voluntary Medical Device Removal because the product supplier has stated that there is potential for sterile packaging to be compromised.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

Alcon Patient Care Kits Product Usage: A Patient Care Kit is an assemblage of single-use medical devices and accessories designed by medical professionals for specific procedures. The Patient Care kits are configured with customer-specific components

Product Codes/Lot Numbers:

SPCK50319 SPCK50317 SPCK50304 SPCK50277 SPCK50263 SPCK50262 SPCK50244 SPCK50241 SPCK50233 SPCK50229 SPCK50227 SPCK50224 SPCK50223 SPCK50221 SPCK50218 SPCK50208 SPCK50207 SPCK50205 SPCK50203 SPCK50202 SPCK50198 SPCK50196 SPCK50193 SPCK50192 SPCK50187 SPCK50182 SPCK50180 SPCK50177 SPCK50176 SPCK50174 SPCK50172 SPCK50171 SPCK50168 SPCK50164 SPCK50162 SPCK50155 SPCK50149 SPCK50148 SPCK50142 SPCK50141 SPCK50135 SPCK50134 SPCK50129 SPCK50128 SPCK50126 SPCK50119 SPCK50115 SPCK50113 SPCK50112 SPCK50107 SPCK50103 SPCK50102 SPCK50100 SPCK50099 SPCK50097 SPCK50096 SPCK50094 SPCK50091 SPCK50083 SPCK50075 SPCK50073 SPCK50070 SPCK50065 SPCK50063 SPCK50059 SPCK50053 SPCK50048 SPCK50044 SPCK50031 SPCK50030 SPCK50022 SPCK50021 SPCK50013 SPCK50004 SPCK43027 SPCK42997 SPCK42948 SPCK42836 SPCK42779 SPCK42721 SPCK42701A SPCK42610 SPCK42604 SPCK42593 SPCK42548 SPCK42543 SPCK42504 SPCK42496 SPCK42491 SPCK42448A SPCK42425 SPCK42065A SPCK41975 SPCK41932A SPCK41916C SPCK41895A SPCK41877A SPCK41842 SPCK41816A SPCK41734 SPCK41712A SPCK41570A SPCK41313A SPCK41304 SPCK41102A SPCK41018 SPCK40978 SPCK40945 SPCK40846A SPCK40759A SPCK40647A SPCK40644A SPCK40585 SPCK40572B SPCK40449 SPCK40401A SPCK40288B SPCK40170B SPCK40161 SPCK40157B SPCK40105 SPCK40102B SPCK40096B SPCK02117

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1837-2017

Related Recalls

CONSTELLATION ULTRAVIT 10K and CONSTELLATION HYPERVIT 20K, Description/REF: 25+ TOTALPLUS CP PAK 20K CPM BWV .9 IU/ 8065000093; 25+ TOTALPLUS CP PAK 20K CPM BV .9 IU/ 8065000095; 27+ TOTALPLUS CP PAK 20K CPM BV .9 IU/ 8065000096; 23GA BEVEL ULTRAVIT 10,000 CPM/ 8065752413; 25+ BEVEL ULTRAVIT 10,000 CPM/ 8065752415; 27+ BEVEL ULTRAVIT 10,000 CPM/ 8065752417; TOTAL PLUS,23G,10K VALVE STD/ 8065752435; TOTAL PLUS,23GA,10K VALVE WD/ 8065752436; TOTAL PLUS,25+,10K VALVE STD/ 8065752437; TOTAL PLUS,25+,10K VALVE WD/ 8065752438; TOTAL PLUS,27+,10K VALVE STD/ 8065752439; 23G CMB PAK 10K CPM,V,STD 0.9/ 8065752448; 23G CMB PAK 10K CPM,V,WA 0.9/ 8065752449; 25+ CMB PAK 10K CPM,V,STD 0.9/ 8065752450; 25+ CMB PAK 10K CPM,V,WA 0.9/ 8065752451; 27+ CMB PAK 10K CPM,V,STD 0.9/ 8065752452; 25+TTLPL VPK 20000CPM BEV VAL/ 8065753106; 27+TTLPL VPK 20000CPM BEV VL/ 8065753109; HYPERVIT 25+BEV 20000 CPM/ 8065830026; HYPERVIT 27+BEV 20000 CPM/ 8065830027; 25+ TTL PLUS VPAK 20000CPM BWV/ 8065830077; 25G VIT 25G OPTICARE EYE HLTH CTR/ 10924-15; VITRECTOMY 25G NORTHSIDE HOSP/ 11220-25; VITRECTOMY 25G NORTHSIDE HOSP/ 11220-27; 23G CONSTELLATION NORTHERN MICH SPPLY AL/ 12568-09; AUS-25GA VIT RET BRISBANE WATERS/ 12641-13; AUS-25GA VIT RET BRISBANE WATERS/ 12641-14; AUS-23GA 10K COMBINED VR PAK NEW CHILDRE/ 12852-16; 23G VIT CONSTELLATION LOMA LINDA COMM HO/ 13501-08; 25+G 20K VIT CONSTELLATION LOMA LINDA CO/ 13502-10; 23G VIT CONSTELLATION VALVED BAYSTATE ME/ 13591-13; 25G CONSTELLATION VALVED BAYSTATE MEDICA/ 13592-15; VITRECTOMY 25G V A HOSPITAL/ 14129-10; J-COMB PAK - 25G 20K CVS NAKAGAMI HOSPIT/ 14283-12; CDN-CVS VIT 25G VE 10K TIMMINS DH/ 14501-09; CDN-CVS VIT 25G+ VE 10K CIUSSS MCQ/ 14512-09; CDN-CVS VIT 25G+ VE 10K CIUSSS MCQ/ 14512-10; CDN-CVS VIT 23G 10K WA SASKATOON HR/ 14532-06; CDN-CVS VIT 23G 10K WA SASKATOON HR/ 14532-07; CDN-CVS VIT 10K 25G+ HSC, ST JOHN'S/ 14540-08; CDN-CVS COMBO 23G VE 10K HD KINGSTON/ 14541-16; CDN-CVS VIT 25G+ 20K BV JEWISH GH/ 14597-07; CDN-CVS VIT 23G 10K ROCKYVIEW HOSPITAL/ 14603-15; CDN-CVS COMBO 25G VE 10K TIMMINS DH/ 14669-10; CDN-CVS COMBO 25G VE 10K TIMMINS DH/ 14669-11; CDN-CVS VIT 23G VE ROYAL ALEXANDRA HOSP/ 14671-09; CDN-CVS VIT 25G+ 10K ROCKYVIEW HOSPITAL/ 14672-11; CDN-CVS VIT 25G+ BWV 20K CUSM/MUHC/ 14873-06; CDN-CVS VIT 25G+ BWV 20K CUSM-MUHC/ 14873-07; CDN-VIT 23G VE 10K ST MICHAEL'S HOSP/ 14955-08; CDN-VIT 23G VE 10K ST MICHAELS HOSP/ 14955-09; CDN-CVS 25G+ VIT VE 10K ST MICHAEL'S/ 14956-07; CDN-CVS 25G+ VIT VE 10K ST MICHAELS/ 14956-08; CDN-CVS VIT 25G+ 10K WESTERN MH/ 15006-06; CDN-CVS VIT 25G+ 20K WA WESTERN MH/ 15006-07; CDN-CVS COMBO 23G 10K ROCKYVIEW HOSPITAL/ 15108-09; CDN-CVS CMB 25G+ V 10K OAKVILLE-TRAFALGA/ 15167-08; 25G PLUS VITRECTOMY PEACE HEALTH ST JOSE/ 15223-13; CDN-VIT 23G 10K GRM741746 CUO-HSS/ 15294-14; CDN-COMBO 23G 10K GRM741759 CUO-HSS/ 15295-12; CDN-CVS VIT 25G+ VE 10K MISERICORDIA HC/ 15318-05; CDN-CVS VIT 25G+ VE 10K MISERICORDIA HC/ 15318-06; CDN-CVS VIT 25G+ VE 10K MISERICORDIA HC/ 15318-07; CDN-CVS COMBO 23G V 10K ST MICHAEL'S HSP/ 15324-07; CDN-COMBO 25G 20K GRM743287 CUO-HSS/ 15421-13; CDN-COMBO 25G 20K GRM743287 CUO-HSS/ 15421-14; CDN-UHN 23G COMBO VE 10K TORONTO WESTERN/ 15455-08; CDN-UHN 23G COMBO VE 10K TORONTO WESTERN/ 15455-09; CDN-UHN 23G COMBO VE 10K TORONTO WESTERN/ 15455-10; CDN-UHN 23G VIT VE 10K TORONTO WESTERN/ 15456-04; CDN-UHN 23G VIT VE 10K TORONTO WESTERN/ 15456-05; CDN-UHN 23G VIT VE 10K TORONTO WESTERN/ 15456-06; CDN-CVS 23G COMBO VE 10K SUNNYBROOK GH/ 15464-05; CDN-CVS 23G VIT VE 10K SUNNYBROOK GH/ 15465-05; 23G VIT PACK CALLAHAN EYE FOUNDATION HOS/ 15491-05; 23G VIT PACK CALLAHAN EYE FOUNDATION HOS/ 15491-06; 27G VIT PACK CALLAHAN EYE FOUNDATION HOS/ 15492-02; 27G VIT PACK CALLAHAN EYE FOUNDATION HOS/ 15492-03; 25G+ VIT PACK CALLAHAN EYE FOUNDATION HO/ 15493-05; 25G+ VIT PACK CALLAHAN EYE FOUNDATION HO/ 15493-06; CDN-CVS VIT 25G+ 10K PASQUA HOSPITAL/ 15525-04; CDN-CVS COMBO 23G VE 10K KENSINGTON EI/ 15552-05; CDN-CVS 23G VIT VE 10K KENSINGTON EYE IN/ 1

Alcon Research

Class I - Dangerous

XXX

Sep 15, 2025 Other Medical Devices Nationwide View Details →

Due to incomplete seals in the pouch which provide the sterile barrier.

Aug 5, 2025 Implants & Prosthetics Nationwide View Details →